Memory Hole (8 November): Mostly about lawyers

Scientific Misconduct Blog Memory Hole: Events of November 8th

Definitions of the day

LAWFUL, adj. : Compatible with the will of a judge having jurisdiction.
LAWYER, n. : One skilled in circumvention of the law.
LITIGANT, n. : A person about to give up his skin for the hope of retaining his bones.
LITIGATION, n. : A machine which you go into as a pig and come out of as a sausage.
(The Devil's dictionary)

23 years ago today: Arthur Rudolph: US hides Nazi crimes

On 8 November 1984 it was reported that Arthur Rudolph imported from Nazi Germany to head the NASA Saturn Program (which led to the moon landing) was known to be an "Ardent Nazi" and a war criminal. He was operator of a slave camp. More importantly, the US knowingly provided cover for him. This is directly relevant to the more specific concerns on this blog - it concerns the role of government in a democracy.
"Papers Show Saturn Rocket Chief Was Called 'Ardent Nazi by U. S.": New York Times, 8 Nov 1984.

14 years ago today: Inventing scientific findings is not fraud say lawyers

On 8 November 1993 the muddle of Scientific Misconduct "rules" reached the outer limits of farce
(Hilts, Philip J. "Science and Law Clash Over Fraud-Case Appeals," New York Times, 8 November 1993).

Procedures of science are designed to ensure the integrity of the scientific record, just as court procedures are designed to make sure that the legal game is played. This is an article about attempts to alter the procedures for deciding whether a scientist is operating within the rules of science. This was the midst of the Baltimore and Gallo "investigations". New rules were put in place by Bernadine Healy when director of the NIH to make lawyers the judge of appropriate science, radically altering the game in retrospect, and leading to these two cases being "lost" (at least legally).

"In the first case before the hearing board under the new rules, Rameshwar Sharma, a scientist at the Cleveland Clinic Foundation, was charged with making false statements in an application to the National Institutes of Health. He wrote that he had done a series of experiments and described the results, when in fact he had not done the work."

By any definition that would constitute research misconduct and a major offense against science, the public, and patients. This is not a game, and it is exactly how patients die.

In his defense, he said that he no intent to deceive but that his statements were 'anticipator writing' because he expected to do the work later. The hearing said this was not misconduct because the Office of Research Integrity could not prove the deliberately false statements were intended to be false. The need to prove intent is part of the new definition. Falsifying results does not constitute intent.

This is lawyers and the "big boys" of science saying that saying that science and honesty don't matter. The muddle began here.

Source: Hilts, Philip J. "Science and Law Clash Over Fraud-Case Appeals" New York Times, 8 Nov 1993

10 years ago today: UK "initiatives" to tackle scientific misconduct

The Journal Science published a bit of reality-free gobbledegook about a November 8th 1997 meeting concerning UK initiatives to "tackle scientific misconduct and fraudulent publication in a more systematic way". There is a disconnect between what folk say and what they fear to do.

Williams, Nigel. "Editors Seek Ways to Cope With Fraud" Science 278 (14 November 1997), p. 1221 [Full report].

Some quotes from the article:

• A new committee, set up by the editors of nine prominent medical journals called last week for governments to tackle scientific misconduct and fraudulent publication in a more systematic way.
• Cases are still exposed mostly by chance, and we worry about the scale of the problem
• "Normal peer review can sometimes identify problems, but sorting through raw data to investigate them can be a miserable business".
• These incidents were described without revealing names because of worries about libel laws [describing scientific deviations is libel]
• The meeting backed calls by one of the legal experts on the committee, Ian Kennedy of University College London, for the development of a protocol for editors to help protect genuine whistle blowers.
• COPE's efforts are being matched by other initiatives in Europe.
• And at the most recent meeting of the European heads of research councils in Dublin last month, the problem of scientific misconduct was at the top of the agenda.
• The council heads are looking in particular at Danish efforts that have culminated in a new national committee on scientific dishonesty. Unlike the U.S. Office of Research Integrity, which can investigate misconduct claims only when they involve government funds, the Danish committee can work across the scientific spectrum.
• Editors can only go so far," says Kennedy. "Eventually you need an independent body to investigate claims fairly.

So what happened ten years later?:

See:
http://scientific-misconduct.blogspot.com/2007/10/memory-hole-15-october-uk-research.html
UK research misconduct Hit-Squad announced (UK-PRI)

Self quotation: You should treat any offer of support from UK-PRI in the same way you would treat the offer of fellatio from a crocodile.

8 years ago today: German Professor fakes 80 clinical studies - not a crime

On 8 November 1999 German investigators report that dozens of bogus scientific papers were published by a cancer research professor over 15 years.

The Professor was Friedhelm Herrmann, a leading cancer research specialist. The report states that "at least 80 of his published papers were faked", and "they developed an aversion to using genuine data."

The last sentence of the news report states: "Faking scientific research, however, is not a criminal offence under German law".

Source: German scientist 'faked cancer research', The Guardian, Nov 8, 1999

4 years ago today: Medical journal editors colluding with fraud

On 8 November 2003 there were some choice quotes from a BMJ article: Have editors got their priorities right? (BMJ 327:1113; 8 Nov 2003):

"Journal editors are much more frightened of being sued for libel by academics or drug companies than they are of publishing fraudulent research" Peter Wilmshurst claimed last week.

He said that every time that he submitted an article highlighting research fraud, every word was scrutinised by an army of libel lawyers and the article was frequently rejected.

"I have submitted many scientific articles for publication and many had implications for survival of patients, but no journal has ever asked me to prove that I got the results claimed. This might suggest that medical journal editors are more concerned with the reputations of academics and their institutions than the lives of patients.

"The simple truth is that editors are most concerned with money. Journals are never sued for publishing false results no matter how many patients died. In scientific research they can have the best of both worlds. They are absolved from blame if a study is wrong and gain an improved impact rating if the research is an important advance..."

"I would like to see whether the policies at journals changed if some were sued by patients harmed by implementation of treatments based on their publications."

"I believe that there should be random checks of raw data of work in progress and of submitted work. We know that the use of performance enhancing drugs is common in competitive sports because of enforced drug checks without warning at sporting events and between events. If we did not have these checks we might mistakenly conclude that doping was not common in sport."

"Failure to produce the raw data should be considered the equivalent of failing the inspection and should result in a ban on future research for a specified period and a review of previous research published.

"The code of silence that pervades the medical profession and the research establishment: There is still considerable reluctance to shop another doctor, no matter how dishonest".

2 years ago today: SSRI advertisements not exactly science-based

On 8 November 2005 PLoS medicine published as article titled: "Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature" (Lacasse JR, Leo J 2005 PLoS Med 2(12): e392).

Apparently direct to consumer advertisements for drugs are not exactly truthful. What a surprise. Next episode - the disconnect between the scientific literature and the underlying raw data. Hat tip HCR.

Earlier|Later|Main Page

Memory Hole (7 November): What else happened

Scientific Misconduct Blog Memory Hole: Events of November 7th

3 years ago today: More high-science from GSK

On 7 November 2004 secret plans to "double sales" of the anti-depressant Seroxat "by marketing it as a cure for a raft of less serious mental conditions" (like "shyness") were revealed with exposure of a 250-page document GlaxoSmithKline (The Guardian, 7 Nov 04). Richard Brook, chief executive of Mind who submitted the secret GSK document to MPs said it was "all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good".

GSK is a another company based on the selling of honest science, so they do actually need to engage in honest science. Actual scientists are not that impressed (See "advantages" of Seroxat). "Science" from the same pot as colonic irrigation.

Glaxo Smithkline Mission statement: "We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer."

2 years ago today: Pfizer - science is our product

On 7 November 2005 an interesting scientific statement in the Wall Street Journal from Pfizer Chief Executive Officer (CEO) Henry A. McKinnell PhD:

"It looks like a combination of raising HDL and lowering LDL cholesterol could have dramatic impact, maybe eliminating cardiovascular risk".

Remember this is a company whose product is science. McKinnell's PhD is in business, from Stanford.

Pfizer mission statement: We demand of ourselves and others the highest ethical standards, and our products and processes will be of the highest quality. We play an active role in making every country and community in which we operate a better place to live and work, knowing that the ongoing vitality of our host nations and local communities has a direct impact on the long-term health of our business.

2 years ago today: Self regulation

On 7 November 2005 Bloomberg news published an important investigative series on commercial IRB's.

It was noted that In 1991, 80% of trials were done in academia. In 2005 most (75%) drug trials are done by commercial firms.

The FDA has farmed out much of the responsibility for overseeing safety in these tests to private companies known as institutional review boards. These boards are financed by pharmaceutical companies. The trials themselves are conducted in private experimental clinics rather than in a clinical context. "The fundamental problem is a system in which investor-owned businesses have control over the evaluation of their own products".

So, the drug industry is paying the people who do the tests, the people who write up the results, the people who analyze and filter the results, the people who regulate the system, the journals who publish the science, and the academic authors who put their names to all of this. Perhaps we should not be surprised that this has not always resulted in high quality, ethical, honest or innovative science.

Earlier|Later|Main Page

Memory Hole (7 November): Boots payout for scientific misconduct

10 years ago today: Scientific misconduct payouts: Boots Nov 1997, Merck Nov 2007

On 7 November 1997 it was reported that Knoll Pharmaceutical Co. agreed to pay at least $98 million to settle dozens of lawsuits charging that the company cheated consumers by suppressing publication of a study on one of its drugs. The story related to research performed 7 years ago by Betty Dong's group at the University of California, San Francisco.

Exactly ten years later this week, Merck has reached a $4.85 Billion settlement in 27,000 suits covering about 47,000 plaintiffs, three years after withdrawing Vioxx from the market.

In 1990, Dong, a researcher at UCSF was funded by Boots to carry out research on a widely use thyroid treatment (Synthroid). She discovered the Boots drug was no more effective than three much cheaper competitors. When she tried to publish, Boots threatened to sue. The publication was withdrawn. She received no institutional support. Company executives attempted successfully to publish an inaccurate version of the findings while excluding Dong and threatening legal action. Nine years later the sordid details were exposed in the press and Dong’s paper was published. The company paid around $170 million to "settle" class action lawsuits.

Both these settlements were "good" for the companies concerned and "good" for lawyers. In the case of the Dong affair, it is estimated that the company made a profit of $3billion in inflated costs during the nine year delay. They paid out less than $200 million in compensation. No company executives were prosecuted. The regulators turned a blind eye. In the case of Vioxx, the company has escaped serious sanction for the systematic misleading of patients/doctors and disobeying the rules of science leading to tens of thousands of excess deaths.

Some References:

April 1996: How a Drug Firm Paid for University Study, Then Undermined It," WSJ, 25 April 1996
July 1996: ""A cautionary tale" Science: 273. pp. 411
Nov 1997: Rennie D, "Thyroid storm" JAMA, Apr 1997; 277: 1238 - 1243
Nov 1997: Kaiser, Jocelyn. "Firm Pays Dearly for Suppressed Study", Science 278 (7 Nov 1997)
Nov 2007: Pharmalot: Law Prof On Vioxx Deal: A Good Gamble For Merck
Merck research excoriated by the Lancet
Vioxx and a quacking duck

Earlier|Later|Main Page

Memory Hole (7 November): Psychiatrist Ewen Cameron and professional collaboration with evil

19 years ago today: C.I.A funding of unethical research and professional silence

On 7 November 1988 Lawyer for victims of C.I.A LSD experiments wrote in the NY times about the out of court settlement with 9 Canadians who sued the US over experiments done by Dr. Ewen Cameron. The article was titled "The C.I.A. and the Evil Doctor". Cameron was a psychiatrist with McGill University. Experiments were carried with secret funding from the C.I.A without participant consent. The work involved LSD administration, sleep deprivation and so called psychic driving. These 9 patients formed only a tiny part of Cameron's research.

"...(H)e induced severe regression in the patients using combinations of extremely intensive electric shock, barbiturate- induced sleep for up to 60 days at a stretch, sensory deprivation, and hallucinogenic drugs. These techniques left patients dazed, confused, incontinent and often in a state of utter panic."

Many colleagues knew about this research for years and said nothing at all. Some of the research was discussed openly and published in the psychiatric literature.

D. Ewen Cameron, "Psychic Driving," American Journal of Psychiatry 112 (January, 1956), pp. 502-509.

"The effect of this procedure (psychic driving) has been studied under various conditions, among them drug disinhibition, ordinary and prolonged sleep treatment, hypnosis under stimulant drugs and after prolonged psychological isolation."

D. Ewen Cameron, et al., "Repetition of Verbal Signals: Behavioral and Physiological Changes," American Journal of Psychiatry 115 (May, 1959), pp. 985-996.

This paper states: "This work was carried out with the assistance of a grant from the Society for the Investigation of Human Ecology."

Just as some depression "support" groups are a front for GlaxoSmithKline and other pharmaceutical companies, "The Society for the Investigation of Human Ecology" was a front for the C.I.A.

"Dr. Cameron had the support of many psychiatrists and psychiatric residents, whom he trained or worked with, and not one had the guts or integrity to speak out or criticize his brainwashing methods. The Canadian Psychiatric Association and American Psychiatric Association are also culpable for refusing to denounce Dr. Cameron or his experiments. It is not only Dr. Cameron, the C.I.A. and the Canadian Government that should be on trial in these experiments, but psychiatry itself." [Link]

Here is a selection of quotes about collaborators, bystanders and the shame of all those who say nothing. There are many in medicine who remain silent while professing virtue:

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

Sources - Cameron and the C.I.A:
-Rubenstein, Leonard S. "The C.I.A. and the Evil Doctor," New York Times, 7 November 1988, p. A19.
-New York Times, "U.S. to Pay $750,000 In Suit on LSD Testing" 12 Oct 1988

Earlier|Later|Main Page

Memory Hole (5 November): What else happened?

Scientific Misconduct Blog Memory Hole: Events of November 5th

7 years ago today: "Naturalness" as a property of matter

On 5 November 2000 a reminder that "naturalness" is not always perfect goodness.

The pesticide, rotenone, is extracted from the dried roots, seeds and leaves of various tropical plants that produce their own "natural" pesticides. It is widely used on home-grown fruits and vegetable produces Parkinson's disease in rats. Because it is "naturally" occurring it is advertised as being safer than synthetic pesticides. It is also used to kill unwanted fish. It is allowed to be used to grow "organic" produce.

Science has to apply to the natural and unnatural.

"Pesticide Found to Produce Parkinson's Symptoms in Rats," New York Times, 5 Nov 2000

4 years ago today: FDA chair advises FDA to ignore own decision

On 5 November 2003 Dr. Thomas Whalen, Chairman of FDA's advisory committee that had voted on Nov 3 to approve resumption of silicone breast implants, wrote to FDA Commissioner, Marc McLellan, urging him to ignore the vote of his own committee and not approve. Whalen said "I felt morally compelled" to do so. "Long-term safety, the concern that prompted removal from the market 11 years ago was clearly not demonstrated".

I have a better idea: Why not publish the honest and complete raw data and let science work as it should? Patients (and their doctors) and scientists have a right to draw conclusions or even decide to make dumb decisions based on proper unfiltered data. It's called science.

FDA advisor: Ignore breast implant vote. Associated Press 5 Nov 2003.

Earlier|Later|Main Page

Memory Hole (5 November): Merck research excoriated by the Lancet

Scientific Misconduct Blog Memory Hole: Events of November 5th

3 years ago today: The Lancet accuses Merck of irresponsible deception

On 5 November 2004 the Lancet published an important paper and an excoriating editorial about Vioxx, accusing Merck and the FDA of acting "out of ruthless short-sighted and irresponsible self-interest".

From the Lancet - Editorial 5 Nov 2004 (Volume 364, Number 9448)

"Today we publish results from a cumulative meta-analysis which show that the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as early as 2000-a full 4 years before the drug was finally withdrawn from the market by its manufacturer, Merck. This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the US Food and Drug Administration's regulatory oversight. In a recent Editorial, we commended Merck for acting promptly in the face of new findings about the safety of Vioxx. Our praise was premature. The evidence showing that Vioxx caused significant adverse events was apparent well before data from the APPROVe trial triggered Merck's overdue intervention."

"These findings also come in the wake of new disclosures that suggest Merck was indeed fully aware of Vioxx's potential risks by 2000. Investigations by the Wall Street Journal have revealed e-mails that confirm Merck executives' knowledge of their drug's adverse cardiovascular profile-the risk was "clearly there", according to one senior researcher. Merck's marketing literature included a document intended for its sales representatives which discussed how to respond to questions about Vioxx-it was labelled "Dodge Ball Vioxx". "Merck's own understanding of Vioxx's true risk profile and its attempt to gloss over these risks in their public statements at the time"

"The FDA's position is no less comfortable."

"But, too often, the FDA saw and continues to see the pharmaceutical industry as its customer." "Worse still, the FDA's Office of Drug Safety co-exists in the same centre - the Centre for Drug Evaluation and Research (CDER) - as the Office of New Drugs, the part of the agency that works most closely with the industry to license new medicines. Once a licensing approval has been made, it is naturally in CDER's own interest to stand by its original decision."" The inherent precedence that licensing of new drugs takes over safety evaluation is a serious flaw". ". . . the FDA tried to shore up its tarnished reputation by posting on its website an early version of a recently completed observational study into the safety of Vioxx."

"its [FDA's] decision to try to undermine the integrity of [Graham's] work shows, that the agency's senior management is more concerned with external appearance than rigorous science".

"… with Vioxx, Merck and the FDA acted out of ruthless short-sighted and irresponsible self-interest."

"Another important point to come out of this is how little confidence we can have in our medical specialists to act in any independent and critical manner. Virtually every expert rheumatologist, gastroenterologist and cardiologist who should have been ringing the alarm bells is a consultant for the same companies."

In the parallel study published in the November 5, 2004 of the Lancet researchers' pooled data from more than 25,000 patients who participated in 18 clinical trials and 11 observational studies all conducted before 2001. The results showed that patients taking Vioxx had 2.3 times the risk of heart attack as those prescribed placebos or other NSAIDs. This increased risk applied to short trem therapy as well.

In concluding, the researchers stated that "If Merck's statement in their recent press release that 'given the availability of alternative therapies, and the questions raised by the data, we conclude that a voluntary withdrawal is the responsible course to take.' was appropriate in September, 2004, then the same statement could and should have been made several years earlier, when the data summarized here first became available. Instead, Merck continued to market the safety of Rofecoxib. This clearly demonstrated that Merck had, by the end of 2000, sufficient statistically significant information that required the immediate withdrawal of Vioxx".
Earlier|Later|Main Page

Memory Hole (4 November): What happened this day

Scientific Misconduct Blog Memory Hole: Events of November 4th

19 years ago today: If you won't supply raw data we won't publish

This is about the status of raw data (Hat Tip - Al Higgins). On this day, 4 November 1988, the Editor of the journal Cell (Benjamin Lewin) stated that it is the policy of Cell that if authors are unwilling to share raw data, they should not publish (in Cell or presumably anywhere).

It is hard to know why anyone honest would disagree. Presumably we agree that a large part of the research published by the pharmaceutical industry should not be published either, and is not science in the conventional sense.

What made Lewin's statement odd was that Cell had published the infamous paper by Baltimore, et. al. in 1986. When asked by concerned scientists to supply the raw data, Baltimore et al., refused.

Bowledge, Tabitha M. "Getting Serious About Fraud and Misconduct," AAAS Observer, Science supplement (4 November 1988), pp. 1ff.

19 years ago today: The Phillip Berger case

On 4 November 1988 it was reported that a Stanford Inquiry had cast doubt on 11 papers. Very prominent scientist Phillip Berger was involved. He had resigned in May 1987.

Stanford had earlier been criticized for sham internal procedure, delay, secrecy and attempts to minimize the problem. More to follow.

"Stanford Inquiry Casts Doubt on 11 Papers," Science 242, 4 Nov 1988

9 years ago today: Chris Chapman died

On 4 November 1998 Dr Chris Chapman, a biochemist in Leeds (UK) died at age 56 after drawing attention to serious research fraud and financial misconduct at Leeds University. The persistent but failed internal attempts at whitewashing had taken their toll. He was also dismissed (one day before he could legally receive an employer's pension).
See: Earlier post

1 years ago today: Angry whistleblowing doctor fired

I have included this mainly for the quotation. On this day, 4 November 2006 a news report discussed the plight of "whistleblower" Dr Phillip O'Dowd who had dared to discuss financial fraud involving the CEO of a US hospital. He was fired. The CEO (Robert Urcuioli) was later convicted of fraud.

In the article O'Dowd relates that the cited reason for his firing was "anger-management problems". Asked whether he had anger issues, he said:

'I did have anger-management problems. I was very angry at the management.'

Earlier|Later|Main Page