Wednesday, October 31, 2007

Memory Hole (31 October): Culpable silence

Scientific Misconduct Blog Memory Hole: Events of October 31st

81 years ago today: Houdini died

On 31 October 1926 Harry Houdini died. See Memory Hole 24 October

Who us?

21 years ago today: Slutsky case raises the obligation of coauthors

On 31 October 1986 an article in Science discussed the tough approach of University of California-San Diego (UCSD) towards collaborator responsibility.

I won't discuss the Slutsky case in detail here. Robert Slutsky, a cardiologist resigned on April 30 1985. His downfall began when a colleague raised questions about apparent duplications in his published articles. He had published 137 articles in 7 years. UCSD investigated every article in which his name appeared and concluded that at least 48 of these were questionable and 12 fraudulent.

The University were extremely critical of his co-authors - why did co-authors on faked publications not bother to check the data? In fact, although Slutsky was exposed in 1985, his colleagues knew about his fraudulent work for many years before that (BMJ).

We have learned very little. Two decades later some assert that even first authors are not permitted to see raw data.

Source: Science "San Diego's Tough Stand on Research Fraud" 234 (31 Oct 1986) 534-535.

5 years ago today: Andrew Fastow indicted

On 31 October 2002 former Enron Corporation chief financial officer Andrew Fastow was indicted on 78 counts of wire fraud, money laundering, conspiracy and obstruction of justice.

For anyone interested in the regulatory and structural failures in the pharmaceutical industry the documentary movie Enron: The Smartest Guys in the Room (2005) is a stupendous must-see.

“Our lives begin to end the day we become silent about things that matter.”
Martin Luther King, Jr.
(one of the three quotes on Enron’s series of inspirational notepads)

2 years ago today: Donald Rumsfeld

On 31 October 2005 it was reported that US Secretary of Defense Donald Rumsfeld held a stake in Gilead Sciences valued at between $5 million and $25 million. Former Secretary of State George Shultz is on Gilead's board and sold $7 million worth of Gilead. Gilead is associated with Roche pharmaceuticals. Who do politicians represent?

2 years ago today: PhRMA and the Karasik conspiracy

On 31 October 2005 more on the Karasik Conspiracy was revealed. This ludicrous saga involved the integrity of the US Pharmaceutical industry lobby group the Pharmaceutical Research and Manufacturers of America (PhRMA).

"What argument do they have that physicians and patients should trust them?"

Briefly, the Pharmaceutical Research and Manufacturers of America (PhRMA) admitted that they paid a publisher to have a thriller written about Croatian terrorists using Canadian pharmacy websites to slaughter millions of Americans. Jayson Blair working for Phoenix Books, was tasked with editing this book, called "The Karasik Conspiracy." The goal was supposedly "to scare Americans into opposing any amendment to existing legislation" that formally bans the import of low-cost prescriptions from Canada.

See also 21 October Memory Hole

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Tuesday, October 30, 2007

Memory Hole (30 October): Junk science

Scientific Misconduct Blog Memory Hole: Events of October 30th

8 years ago today: Science versus quackery in SSRI drug trials

On 30 October 1999 an important, worrying and predictive article by Sarah Boseley appeared in the Guardian. This is about open, honest and properly represented science versus quackery. The problems are obvious.

An abbreviated version of the Guardian article is reproduced below:
Bad scienceThey said it was safe, The Guardian Oct 30 1999

Since the launch of Prozac there has been a spate of disturbing accounts of violence and suicide committed by people prescribed the drug. Victims and families of killers have sued Eli Lilly but no cases had reached a verdict because Lilly settled out of court.

However in 1999 for the first time, Lilly came up against a family in the US who would not settle. The Forsyths wanted a hearing. Internal documents belonging to Lilly were produced in court, and these "showed that Lilly knew as long as 20 years ago that Prozac can produce in some people a strange, agitated state of mind that can trigger in them an unstoppable urge to commit suicide or murder".

Lilly's own internal documents show it was identified as early as 1978. On August 2 of that year, when only three trials were under way, minutes of a meeting of the Fluoxetine (Prozac) Project Team run thus: "There have been a fairly large number of reports of adverse reactions... Another depressed patient developed psychosis... Akathisia and restlessness were reported in some patients." A similar meeting 10 days earlier had noted that "some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off [the] drug."

The minutes further state that "in future studies the use of benzodiazepines to control the agitation will be permitted". So, from that point on, Lilly's trial subjects would be put on tranquillisers to get them over the akathisia experienced by some in the early days on the drug. Yet once Prozac was on the market, there was no warning to doctors that such action might be necessary.

Those who developed akathisia or who had any suicidal tendencies were excluded from the trial data on the basis that they would otherwise obscure the results of the drug's success in treating depression. Yet the German licensing authority, the Bundes Gesundheit Amt (BGA), on scrutinising the results, expressed concerns about the drug's safety. On May 25, 1984, according to Lilly's internal documents, a letter from the BGA stated: "During the treatment with the preparation [Prozac], 16 suicide attempts were made, two of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation [Prozac]."

During the licensing process in the US, however, Lilly did not tell the Food and Drugs Administration (FDA) of the German concerns. Some of Lilly's own scientists had reservations about this.

One of them, John Heiligenstein, wrote in an internal memo on September 14, 1990: "We feel caution should be exercised in a statement that 'suicidality and hostile acts in patients taking Prozac reflect the patient's disorder and not a causal relationship to Prozac'.

A memo from Thompson ran: "I hope Patrick [probably a Lilly employee, but not identified fully in the memo] realises that Lilly can go down the tubes if we lose Prozac, and just one event in the UK can cost us that."

A memo from the German office to Lilly's US headquarters in that November indicates that Lilly was keen to root out the word "suicide" altogether from its database record of side-effects experienced by patients on the drug: Claude Bouchy and Hans Weber in Germany were alarmed by suggestions from their US superiors that, when GPs reported a suicide attempt on Prozac to them, they should record it as "overdose" (even though it is not possible to kill yourself by overdosing on Prozac), and that a GP's report of "suicidal ideation" should be recorded as "depression" - "Hans has medical problems with these directions and I have great concerns about it," runs a memo from Bouchy to Thompson. "I do not think I could explain to the BGA, to a judge, to a reporter or even to my family why we would do this, especially on the sensitive issue of suicide and suicide ideation."

Something had to be done. Lilly finally agreed to undertake the study suggested by the FDA, and look at the suicide rate among UK patients on Prozac, but it didn't. Instead, the company put together a "meta-analysis". Lilly's own scientists, led by Charles Beasley, did the work.

Beasley's study was published in the British Medical Journal in 1991. It had "the appearance of scientific rigour", says Dr Healy, but it is clear, he says, in the light of the documents that emerged in the Forsyth case, that the so-called meta-analysis had included only 3,065 patients out of around 27,000 involved in the trials and that it had also included data that the FDA had rejected during licensing. Among those excluded from Lilly's study were the 5% of patients who had shown akathisia-like symptoms during the clinical trials and had dropped out, and also the 13 or 15 suicides. Nor was there any mention of the fact that a considerable number of patients had been put on benzodiazepines to suppress the very problem that Lilly was claiming did not occur.
Is this science?? Has the Beasley paper been retracted or corrected? We cannot claim to prescribe under the banner of science if we fail to deal with this.

Sources: They said it was safe, The Guardian Oct 30 1999
Related patient blogs: Furious Seasons, Soulful Sepulcher

Medical Leadership

2 years ago today: UK Drug regulator undeclared links with Syngenta

On 30 October 2005 Britain’s drugs safety watchdog (the MHRA) was "forced to declare an interest in one of the world’s largest pesticide companies, following an investigation by the Sunday Herald". Sir Alasdair Breckenridge, the chairman of the MHRA "changed his mind only after responding to a series of allegations about potential conflicts of interest". He formally declared his involvement with Swiss agrochemical giant, Syngenta. The revelation has prompted fierce criticism.

"This was also not the first time that Breckenridge had been caught up in controversy about an alleged conflict of interest". There have been calls "for Breckenridge’s resignation over alleged failings in regulating anti-depressant drugs". "From 1992 to 1997, Breckenridge was a scientific adviser to SmithKline Beecham (now GlaxoSmith-Kline), which manufactured one of the drugs, Seroxat". Three other members of the MHRA’s committee on the safety of medicines – professors Chipman, Park and Griffiths – declared interests in Syngenta in 2004. Ian Kimber, head of research at Sygenta’s central toxicology laboratory in Cheshire, is a member of the MHRA’s committee on the safety of devices.

So much for that stated "independence".

Source: Drugs watchdog linked to pesticide company - Sunday Herald 30 Oct 2005

2 years ago today: The purpose of a University

On 30 October 2005 the Times newspaper and BBC revealed that a lecturer at Southampton Solent University in the UK secretly filmed meetings with senior academics at which she was put under pressure to pass students whom she believed should have failed. “As a new lecturer I was under huge pressure to pass the students. The college was financially driven. It was a pure bums-on-seats policy. It wasn’t about education at all.”

A colleague stated on film: “Essentially, in the end you have to fit with the system. It’s as simple as that.

Source: Lecturer reveals university pressure to pass poor students Times Online Oct 30 2005

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Monday, October 29, 2007

Memory Hole (29 October): Sweeping at INSERM - the Bihain case

Scientific Misconduct Blog Memory Hole: Events of October 29th


9 years ago today: Scientific Misconduct, INSERM and the case of Bernard Bihain

On 29 October 1998 it was announced in Nature that the French government had quietly dropped plans to investigate research misconduct at INSERM (Nature 395, 29 Oct 1998,829). This case has a strong smell of whitewash about it.
  1. The matter concerned the activities of the INSERM Laboratory of Nutrition Lipo-protein Metabolism and Atherosclerosis at the University of Rennes and its director Bernard Bihain. The science involved cloning of a "lipolysis stimulated receptor".
  2. Much money was involved. INSERM and the French biotechnology company Genset had jointly applied for a patent as part of plans costing US$10 million to build a new laboratory near Rennes. INSERM's director general, Claude Griscelli, called it an example of the "policy of industrial partnerships that INSERM wishes to reinforce".
  3. Twenty "whistleblowers" raised concerns about "an alteration of the truth in the translation of the results of experiments … to make them coincide with a hypothesis". An initial inquiry report and underlying evidence was never made available, but could apparently be summarized as "we have not excluded scientific fraud". The report apparently also stated that some of the laboratory's work poses "many problems" and an "an in-depth analysis carried out by international experts in the field is absolutely necessary." Nothing happened and the whistleblowers then complained.
  4. In May 1998 Daniel Nahon (director-general of the Ministry of National Education, Research and Technology) announced that four international experts would carry out an inquiry into the laboratory and its director Bernard Bihain.
  5. The laboratory itself was then closed by INSERM in August after Bihain asked to be discharged from his duties. Scientists expressed concerns that the closure might be used to allow a whitewash.
  6. That is exactly what happened: According to Nature in October 1998 the ministry abandoned the inquiry. "We stopped everything" said Vincent Courtillot, principal adviser to the science minister. "The affair is over, the guy is in America, the lab does not exist, so we are not going to make an inquiry committee work on something where there are no consequences."
  7. Further criticism followed, including from the SNTRS-CGT, a trade union representing INSERM scientists. INSERM was said to be creating an "office of scientific integrity". Claude Griscelli, the agency's director-general, says the unit's remit will be to investigate "promptly and effectively" all allegations (where have we heard that before?).
  8. Bihain, the accused scientist went on to become vice-president of genomics at Genset, and chief scientific officer of the US–French company Valigen.
  9. Then in 2002 Nature announced that "Bernard Bihain, the obesity researcher who left French research in 1998 amid allegations of scientific misconduct, is to take up a post with his former employers INSERM". Christian Brechot, director-general of INSERM stated “The opinion was that although some of his hypotheses have not been confirmed, his contribution was of value”.
  10. Further criticism followed, so something needed to be done. In 2003, after he had been reappointed the final clouding-over came. A new ruling "by the Tribunal de Grande Instance in Rennes, concludes a separate judicial investigation of some aspects of the affair." "In reaching its decision on the charges, the tribunal was only permitted by law to consider certain limited classes of documents. This is because the misdemeanour ‘faux et usage de faux’ (‘forgery and use of forgeries’) applies only to a “document or other medium of expression of which the object is, or effect may be, to provide evidence of a right or of a situation carrying legal consequences”.
Who is fooled? This is part of a pattern of behavior.

Most importantly we are not allowed to judge based on evidence, as is expected in science itself. Nothing is public. The reports and underlying evidence are hidden. Bihain might wish to declare himself "cleared" by his friends and peers - but if he so wishes, he should place all the evidence against himself and his rebuttal into the public domain. That is the way of proper open science, and the usual behavior of scientists who are truly innocent (as Bihain may well be).

The French minister is correct, "there are no consequences". None at all. Science and the public are the losers in all this.

  • Nature, "French ministry reopens inquiry into conduct of INSERM unit" 391, 519-520, 5 Feb 1998 (reference)
  • Nature, "French Inquiry Into Misconduct is Shelved", 395, 29 Oct 1998, p829 (reference stub)
  • Nature, Accused obesity researcher returns to the French fold, 418, 1 Aug 2002

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Memory Hole (29 October): Redefining scientific misconduct

Scientific Misconduct Blog Memory Hole: Events of October the 29th

Quote of the day

It is sayd there be a rage of mountaynes in the Easte, on one syde of the which certayn conducts are immorall, yet on the other syde they are holden in good esteeme; wherebye the mountayneer is much conveenyenced, for it is given to him to goe downe eyther way and act as it shall suite his moode, withouten offence.
Gooke's Meditations

15 years ago today: Lead studies and the Needleman case

On 29 October 1992 after a decade of debate two new studies of lead levels and IQ in children were reported. One by Baghurst showed impairment in neurological development as lead rose from 10 to 30ug/dL. Another by Bellinger showed significant IQ deficits over a similar range. Previous studies had been challenged repeatedly by industry.

Other studies had not properly controlled for confounding variables (such as maternal IQ) and had therefore been "rejected". Psychologists Claire Emhart and Sandra Scarr hired by the owners of a lead smelter had accused Herbert Needleman of research misconduct following his landmark - but flawed - 1979 study in NEJM. Needleman had in turn (wrongly in my view) refused skeptics access to his raw data. Industry have every right to query scientific findings (just as industry has an obligation to reveal raw data supporting scientific statements).

Source: "Study Documents Lead-Exposure Damage in Middle-Class Children," New York Times, 29 Oct 1992

Defining scientific misconduct

14 years ago today: A missed ball in scientific misconduct

On 29 October 1993 the journal Science discussed the attempts to frustrate the efforts of the US Office for Research Integrity (ORI) to bring fraudsters to book. The appeals process were insisting that the ORI must prove a) intent to deceive, b) that the false statements were important to the thrust of research claims.

Herein lies a large problem. There are many real-world examples of serious scientific misconduct that make this appear ludicrous. It also presupposes that scientific misconduct must involve the making of false statements. This attempt at narrow redefinition may have had much to do with attempts to protect Gallo and Baltimore at the time. None of this goes back to the purpose of defining misconduct in the first place.

Murder (intentional killing particularly with premeditation) is a crime. So is carrying a loaded gun on an airplane. There is no proof of intent to kill, but there is intent to breach an agreed contract. That is how society protects itself. Here we have lawyers saying that the contract of science is irrelevant to them.

It is sayd there be a raunge of mountaynes in the Easte, on one syde of the which certayn conducts are immorall, yet on the other syde they are holden in good esteeme; wherebye the mountayneer is much conveenyenced, for it is given to him to goe downe eyther way and act as it shall suite his moode, withouten offence.
Gooke's Meditations

Source: "Another Blow for ORI" Science 262 (29 October 1993), p343

13 years ago today: More on the scientific failures in NIH fialuridine case

On 29 October 1994 it was revealed that knowledge of previous hidden studies would have prevented the deaths of patients that occurred in a hepatitis drug trial carried out by Dr. Jay Hoofnagle at the NIH (see Memory hole 23 Oct).

In brief, a clinical trial ended in catastrophe - with the iatrogenic deaths of five participants. The drug was fialuridine, to treat hepatitis B. 5 of the 15 patients who took the drug died, and two more required liver transplantation.

There are comparisons with the regulatory and scientific disaster involving TGN1412 in the UK in that multiple patients were exposed to an "unknown".

Dr. Jay Hoofnagle, the principal scientist in the NIH study had stated that he thought some patients' symptoms were associated with the underlying illnesses, until the deaths began to occur.

Now it is revealed that dangerous side effects in at least two other studies, and four deaths in earlier experiments were not reported to the F.D.A. The FDA stated that "overview of the data, in which deaths and serious adverse experiences were analyzed cumulatively, was not produced and thus was not available" to scientists carrying out the study or to the Government.

Nothing learned in 13 years.

Patients don't matter much in all of this.

Source: "Speed of F.D.A. Action on Rules for Drug Tests is Questioned" New York Times, 29 Oct 1994

8 years ago today: The decline of Dr Koop

On 29 October 1999 a further scandal was revealed involving Dr. C. Everett Koop, the former US Surgeon General.

In spring 1997 Koop made a telephone call to Dr. Linda Rosenstock, director of the National Institute for Occupational Safety and Health. "The agency was about the warn health workers that latex gloves could cause serious, even life- threatening allergic reactions. Dr. Koop told her that the language was "way overstated" and could cause health workers to abandon gloves that could protect them against infection"

Then Koop testified in the House on March 25 before the oversight and investigations subcommittee of the Committee on Education and the Work Force. Dr. Koop told the panel that the hazards being linked to the gloves by scientists and other health authorities were exaggerated. "Borderline hysteria," he called them.

However now it is revealed that Koop had received substantial sums of money under a four-year, $1 million contract he signed in 1994 with a leading manufacturer of the latex gloves, a relationship he did not disclose to Dr. Rosenstock or the subcommittee.

"What this long admired and respective man has done in taking money from a glove manufacturer and than speaking out on its behalf is wrong," said Susan Wilburn, senior specialist in occupational safety and health for the American Nurses Association. "Niosh studies show that 10 percent of workers regularly exposed to the gloves and 17 percent with heavy exposure have developed allergies".

"Dr. Koop has long been one of the nation's most trusted health experts, a reputation he gained as Surgeon General in the 1980's".

"According to filings with the Securities and Exchange Commission, the glove company contract called for Dr. Koop to deliver four speeches a year on health and nutrition. He gave the company the right to use his "name, picture, speeches, and biographical information" and agreed to serve as a company adviser. He also agreed not to endorse products of competitors, and to submit his speeches for editing"

Dr. Koop's testimony in March was still being cited in state legislatures as reasons to delay action on the gloves, even though "it was based on a study that was never done."

Source: Koop Criticized for Role in Warning on Hospital Gloves NYT Oct29, 1999

6 years ago today: The EU Clinical Trial directive and scientific fraud

On 29 October 2001 the BBC discussed the threat to research caused by the new EU clinical trial directive.

"The future of clinical trials in the UK will be jeopardised by a new EU directive, according to research experts". "it will radically increase how much it costs to carry out academic work, or many drug trials". "it will require a huge dossier of information to be compiled by researchers about virtually every aspect of the trial".

"another aim of the directive - to make research fraud more difficult - will fail because determined cheats would still succeed." "There's no evidence that doing this would help the situation"

Not a word about who those "determined cheats" are. Not a word about the beneficiaries of the confusion. The losers are small innovative biotech companies and innovative academics. The control of clinical "findings" are driven away from clinicians and into the hands of those who have incentives to cheat and who have done so repeatedly. Scientific fraud is neatly hidden beneath a layer of impenetrable and expensive red tape.

There is no integrity in any of this. Nor was this ever the intent.

Source: BBC News, Red-tape 'disaster' for medical research 29 Oct 2001

5 years ago today: Neurontin documents exposed

On 29 October 2002 the contents of internal Warner-Lambert documents unsealed in a neurontin lawsuit were revealed.

Instead of conducting clinical trials to test the safety and efficacy of Neurontin (gabapentin) for the conditions it promoted, Warner-Lambert (now owned by Pfizer) spent money "educating" doctors, encouraging them to prescribe the drug for unproven uses in patients with diabetes and bi-polar disorder.

Marketing executives at Warner-Lambert urged their superiors to promote the epilepsy drug Neurontin outside of the domain of science. In a memo, dated May 5, 1997, the marketing executives propose that Neurontin be promoted to treat pain in diabetic patients by creating education classes for doctors, and sponsoring a symposium with the American Diabetes Association. Another memorandum details how Warner-Lambert tracked prescriptions written by doctors after they attended dinner meetings paid for by the drug company at which Neurontin was discussed. The memo, dated June 26, 1995, said that in the Northeast, doctors attending the dinners wrote 70 percent more prescriptions for Neurontin than doctors who did not attend. In the memo, Warner-Lambert executives recommended against doing studies needed to get Neurontin approved to treat diabetic patients.

For detailed discussion of the neurontin documents and the consequences of these actions see "The Promotion of Gabapentin: An Analysis of Internal Industry Documents", Ann Int Med, 5 August 2006 145 :284-293.

The leadership of medicine remains mute. Patients no doubt suffered as as a consequence of thinking that decisions were being made on the basis of scientific evidence. Was anyone punished in any way?

On the same day the press reported that Pfizer had "agreed to pay $49 million to settle charges that a subsidiary defrauded the Medicaid program" over the cholesterol-lowering drug Lipitor.


Odds and ends

  • 78 years ago on 29 October 1929 the NY Stock Exchange crashed.
  • 38 years ago on 29 October 1969 the first computer link was established on ARPANET, the precursor to the Internet.
  • 9 years ago on 29 October 1998 in South Africa, the post apartheid "Truth and Reconciliation Commission" presents its report, which condemns both sides for committing atrocities.
  • 3 years ago on 29 October 2004 the consumer group Public Citizen renewed its call a ban of the statin Crestor. It was felt that the rate of acute renal failure or renal insufficiency was far higher for Crestor than for all other statin drugs combined. The FDA disagreed with this assessment.

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Sunday, October 28, 2007

Memory Hole (28 October): Making punishment fit the crime

6 years ago today: Oxycontin - 282 deaths - purposeful misbranding

On 28 October 2001 "An extensive federal review of autopsy data has found that the powerful painkiller OxyContin is suspected of playing a role in the overdose deaths of 282 people in the last 19 months, more than twice the number in some previous estimates."

Although it was initially put out that the deaths were related to illicit abuse of the drug, in fact less than 10 of the deaths were due to intravenous abuse and only 1 to snorting. Most were conventional patients who took the tablets orally or after crushing. Purdue Pharma heavily promoted the drug as safer than other narcotics because its active ingredient was in a time-release mechanism.

In 2007 the Purdue Frederick Company pleaded guilty to felony charges that they purposely misbranded the OxyContin with intent to mislead and defraud. Purdue and the three executives paid $634,515,475. Those named are President Michael Friedman, Executive Vice President Howard Udell, and former Executive Vice President Paul D. Goldenheim.

Is this scientific fraud? Did anyone go to prison?

See also Pharmagossip Make the punishment fit the crime

Source: New York Times Overdoses of Painkiller Are Linked to 282 Deaths, Oct 28 2001

2 years ago today: MIT fires Van Parijs - fabricating and falsifying

On 28 October 2004 M.I.T fired a biology professor (Luk Van Parijs) for fabricating research data. A group of colleagues reported faking to MIT administrators. Van Parijs admitted to fabricating and falsifying data in a paper several manuscripts and grant applications. The journal "Current Opinion in Molecular Therapeutics" later published a correction of an 2004 article. Van Parijs earned a doctorate in immunology from Harvard. He worked with Cal Tech President David Baltimore.

Another nice easy case. The same names and institutions keep cropping up, but perhaps a coincidence or a confounding variable.

New York Times, M.I.T. Dismisses a Researcher, Saying He Fabricated Some Data, 28 Oct 2005

Odds and ends

  • 515 years ago on 28 October 1492 - Christopher Columbus lands in Cuba (predating Michael Moore by 514 years).
  • 139 years ago on 28 October 1868 - Thomas Edison applied for his first patent, an electrical vote recorder. [See also <G Bush]

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Saturday, October 27, 2007

Memory Hole (27 October): What else happened?

Scientific Misconduct Blog Memory Hole: Events of October 27th

Quote of the day

"Much of what passes for government policy today is nothing more than theater designed to create the illusion that the nation's problems are being addressed."

"We're looking for the illusion of due diligence, Mr. Pope. Two criminal acts successfully prosecuted -- it gives us that illusion."

From the Movie Syriana (worth watching)

P&G telephone records

16 years ago today: P&G in another spying case

On 27 October 1991 the New York Times reported on a further incident involving spying by Procter and Gamble.

Phone records were at the center of the scandal. P&G had tried to find who was talking to a journalist by enlisting the Cincinnati police who checked the records of all 800,000 business and home phones.

Legal scholars said First Amendment protections had been violated by accessing thousands of phone records of people who had nothing to do with the company. Procter & Gamble admitted it made "a mistake."

Another case is also discussed where a chemist at the Hanford nuclear store started speaking out about safety problems, and was intimidated and threatened.

See also Procter and Gamble goes dumpster diving

Source: "Sometimes, the Disloyal Are Watched" New York Times, 27 Oct 1991, pE10.

6 years ago today: UK Government says whistleblowing laws are "effective"

On 27 October 2001 "The UK government has acted to dispel fears that NHS staff who report safety concerns may not be protected from reprisals under whistleblowing laws". In the case of Steve Bolsin, "Professor Ian Kennedy said that the "good faith" requirement was problematic because it could easily be argued that the whistleblower acted from mixed motives". "He suggested, for example, that the act might be amended to protect disclosures to the General Medical Council (GMC)".

Hmmmmmm....yes and no .... why would anyone report anything to the GMC? Have the people who say these things spoken to a selection of people who have tried?

Sadly the lay press and public discussion remains the most important and only plausible route for raising concerns of public interest. That was 2001 and things are just much worse.

It's an interesting word that -- "effective".

Law is effective in protecting whistleblowers, report says -- Dyer 323 (7319): 954 -- BMJ

3 years ago today: Legal rules in UK prevent whistleblowing

On 27 October 2004 The UK government faced a row with MPs over new rules for employment tribunals which keep whistleblowing claims over corruption and fraud secret regardless of public safety. The rule change was slipped in on the quiet. The government creates rules ostensibly to protect whistleblowers, and then subverts them to prevent discussion. New Labour democracy in action.

Source: The Guardian, Row over keeping whistleblowing claims under wraps, Oct 27 2004

2 years ago today: 9/11 Intelligence officer bullied

On 27 October 2005 The Hill reported on the case of US Army Reserve Lt. Col. Anthony Shaffer who let it be known that the intelligence cell in which he worked identified the Sept. 11 terrorists a year before the attacks, and that related documents had been destroyed.

In exchange the pentagon disciplined him for a series of actions (from misuse of government property to flashing military identification while intoxicated) which had nothing to do with the information he provided. The path to obfuscation is interesting.

Source: The Hill, "Hunter asks for probe of Pentagon actions against whistle-blower" Oct 27 2005

2 years ago today: Lester Crawford FDA - the mystery revealed

On 27 October 2005 the stock dealings underlying the resignation of FDA commissioner Dr. Lester M. Crawford were revealed in the New York Times. He never went to prison.

Source: Ex-Head of F.D.A. or Wife Sold Stock in Regulated Area, NYT, Oct 27 2005, also see Memory Hole 16 Oct and FDA Conflicts of Interest Update.

1 years ago today: UK Government interferes with a research study

On 27 October 2006 the following appeared in Private Eye.
Private Eye # 1170 9 27 October 2006
WHY is no one surprised that Defra [UK - Department for Environment, Food and Rural Affairs] is threatening to pull the plug on a detailed investigation into whether farmers exposed to sheep dips suffer serious long-term health damage?

"For more than two years researchers at University College London have carried out extensive psychological testing on farmers who were exposed to organophosphates contained in the pesticides. But their study is now in jeopardy after the Veterinary Medicines Directorate (VMD) suddenly expressed concerns last month that the study contains no suitable control for comparison, i.e some other rural group who were not exposed to the nerve gas-related chemicals.

One might think it a bit late in the day to criticise the way the study was composed. After all, it was designed in collaboration with both Defra and the VMD over a four-year period and was approved by both in-house scientists and independent peer reviewers. Twelve different control groups were identified and work was about to start on retired rural police until the VMD lobbed its spanner in the works. In any event the "problem" could easily be remedied by finding a control group that was acceptable."
Good open science as usual. Seems pretty obvious what happened here. I have no idea whether farmers suffer side effects, but it would be nice to see science carried out without government meddling. Private Eye have done a good job exposing bad science, incompetence and cover-up (the Bristol Heart scandal, paternalistic we-know-best-what-you-need-to-know government behaviour over BSE). Whistleblowers take note.

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Memory Hole (27 October): Questionable Harvard research in China

Scientific Misconduct Blog Memory Hole: Events of October 27th

harvard research in china

4 years ago: Ethical violations by Harvard researchers in China

This week in October 2003 a reporter in the Chinese press (China Daily) raised troubling questions about a Harvard research study. 200,000 Chinese farmers had supplied DNA to a Harvard genetic database. Much of this was reportedly without informed (or un-informed) consent. Many violations were reported - compounded by institutional "self-investigation", shredding of evidence, possible fabrication of consent forms, and whitewashing.

The experiments were co-sponsored by Millenium Pharmaceuticals and were conducted in China's Anhui Province in the mid 1990s. Complaints were initially filed by Dr. Gwendolyn Zahner, an epidemiologist: The concerns were that investigators failed to obtain IRB approval for studies actually done, failed to disclose to subjects their rights to refuse, forged or post dated consent forms, and that participants had been coerced into taking part. Where IRB approval was obtained, the number of subjects recruited apparently bore no relation to the number studied. There was also concern that "the communist government's eugenics policies could put individuals with genetically linked diseases at risk of sterilization". The main investigator in several studies was Dr Xu Xiping of the Harvard School of Public Health.

Lawrence Summers, then President at Harvard stated :

"It's the responsibility of the dean of the School of Public Health and, ultimately, it's my responsibility as president of [Harvard] university to see to it that where wrong can be put right it is and, more importantly, to see to it that it never happens again." (Boston Globe, 2002)

In fact, nothing has ever been "put right". All we got was another sham internal self-investigation.

The US federal federal office for Human Research Protection (OHRP) received two boxes of documents from Harvard, which were then mysteriously shredded "to save space" [Link]. OHRP did however issue 3 letters of findings confirming gross violations of informed consent. See: [Link] [Link] [Link]

OHRP then asked Harvard to investigate itself having done the shredding. Harvard mumbled and blustered, and made no apparent attempt to interview the participants or to examine anything of substance. They did not interview a single farmer.

This led Chinese reporters to conduct their own fact-finding investigation. They interviewed the farmers and local doctors who had been ordered to produce a lists of potential participants and their families. It was revealed that many participants thought they were going for a "free check up". They were told the check-up would benefit them, and free medical treatment would be offered." The Washington Post (Dec. 2000) reported villagers of Anhui saying "We were told there would be free medical care". No treatment arrived. Xu’s hospital projects were also criticized for possible use of Communist Party officials to induce "volunteering".

Then in May 2003 the OHRP essentially dropped the China "investigation" letting Harvard researchers off the hook without ever interviewing any of the Chinese human subjects, their families or local medics who had first-hand knowledge. The two federal agencies that are authorized to investigate ethical violations in human research were both headed by administrators who were on leave from Harvard.

Below the references I have included a summary of an article by Margaret Sleeboom (University of Amsterdam) discussing the anthropology of the incident, and a powerful China Daily report discussing the dismal collusion of rarified academic "bioethicists".

Some other Sources (links not always available):
  9. The Boston Globe, Harvard-affiliated gene studies in China face federal inquiry, Aug. 1, 2000.
  10. Chinese Human Genome Project Millenium Pharmaceuticals Harvard School of Public Health The Washington Post, Dec. 20, 2000
  11. John Pomfret, Harvard Rebukes Head of China Gene Study. Washington Post, August 9, 2001

The Harvard case of Xu Xiping: exploitation of the people, scientific advance, or genetic theft?

Amsterdam School of Social Science Research, University of Amsterdam
May be obtainable at [Link] or [Link]. An abstracted summary of the paper is below

"Many consider the Xu Xiping case as a textbook example of ruthless Western exploitation of development countries".

The article goes on to present the perspectives of 10 different stakeholders in the saga "to examine "the self-justification of behaviour":

1. Xu Xiping: The lead researcher
"Despite the criticism of smuggling data, breaking promises of free health care, unethical data collection and accomplice to forcing co-operation form patients, Xu showed no sense of responsibility for any of these allegations. Instead, he blamed less enlightened people, such as local physicians". He asked the ministry of education to censure the reports of Xiong Lei (below). He asked China’s deputy education minister that details should not be given to ‘foreigners’. He is is reported as writing the vice-president of the Chinese Academy of Sciences, urging him to take action against Yang Huanming, a Chinese geneticist who had criticised his work.

2. Xiong Lei: The Chinese reporter
Spent a long time on the Xu Xiping case trying to stand up for ‘the people’ of China.

3. Local scientists:

4. Harvard University, the NIH and the OHRP:
"It seems that the main concern of Harvard, the NIH and Brigham’s Women’s Hospital is the reputation of their institutes and the clarification of procedures..... Mistakes are related to professional damage rather than to moral failure". Thus, it was only in 2001 that Xu was reprimanded when he sought to interfere with critics. "It was the smell of diplomatic trouble and accusations of interference with China’s internal politics for which Bloom reprimand Xu, not for unethical research."

5. Chu Jiayou: Chinese Academy of Medical Sciences.

6. Qiu Renzong: one of China’s leading medical ethicists.

7. Yang Huanming: director of sequencing for the Chinese Human Genome Project.
"I hope that Harvard and the School of Public Health will understand that the [recruiting] methods they used in China are unacceptable to the Chinese". "Many of the papers of Chinese IRB were forged".

8. China Production Daily, Beijing Youth:
"For the sake of our national security: carefully preserve our genetic code" (a claim that genetic engineering is used to make ethnic specific biological weapons).

9. Fang Zhouzi: A San Diego biochemist:
"nonsense to think that Americans are trying to destroy the Chinese by unravelling their genetic code"
This kind of talk "hampers proper criticism of Xu Xiping’s behaviour, takes the Chinese people for fools, and uses libel as a source of patriotic rubbish’ (Fang, 2000).

10. Chinese officials:
"American science is good for China"

CHINA DAILY Research subjects' right to know must be respected XIONG LEI Oct 2003 08:02:38 page 4

Who profits? Who benefits? Who loses? Such questions were the theme of a panel at a working conference on bioethics held in the German capital Berlin earlier this month.

A determined gathering of nearly 100 biologists, philosophers, international law experts, journalists and human-rights advocates from over 30 countries in Africa, America, Asia, Europe and Oceania exchanged views and experiences on issues concerning ethics in the life sciences. They agreed that close attention should be paid to bioethics in all research involving human subjects.

It is essential to know who profits, who benefits and who loses in all research involving human subjects, since our basic rights as human beings are involved. Unfortunately, however, it is often the case that researchers intentionally evade this kind of questions, while many of those taking part as research subjects are not aware enough to ask them.

One example of such evasion is the Harvard-affiliated projects involving Chinese farmers in East China's Anhui Province.

Harvard University in Massachusetts launched a series of genetic research projects in 1994 and has been publishing research papers since then. Starting in 1999, the US Government conducted a three-year investigation into the projects and found them to have been at fault. But, during the investigation period, the wrongdoers continued to publish research papers based on the genetic data illegally obtained. The US federal investigators effectively cleared Harvard in May this year by acknowledging all its "corrective actions."

The faulty human genetic studies involved some 200,000 Chinese farmers, but the US federal investigators did not dispatch any of their own staff to the sites in China, interview a single farmer or consult any Chinese who were critical of the projects or who had evidence revealing possible fraud by the principal Harvard researchers.

We have fascinating principles of bio-ethics in human genetic research. There is the first part of the 1947 Nuremberg Code: "The voluntary consent of the human subject is absolutely essential." The Helsinki Declaration, first adopted in 1964, contains the commitment: "The right of the research subject to safeguard his or her integrity must always be respected." The 1997 Universal Declaration on the Human Genome and Human Rights advocates international co-operation with developing countries in a way that prevents abuse and benefits all.

Yet those researchers who come for our genes never bother to throw pennies to pay for cultivating our awareness of them. They are far more enthusiastic about collecting our DNA samples than honouring our rights. The ordinary people - the silent majority - are kept ignorant of these principles and this ignorance is often abused by some researchers.

If Harvard did take any "corrective actions," they remain unknown to the Chinese public, not to mention the Anhui farmers whose right to know was ignored when their blood was taken away. Here can be felt the powerlessness of those fascinating bioethical principles - they only establish norms for what researchers should do but fail to discipline or punish anyone violating those norms.

When I learned that an international conference on bioethics was due to be held in Beijing in April this year, I proposed to the programme committee that they "add some Chinese farmers and grass-roots medical workers to the list of guests" to be invited to this very important meeting. I e-mailed my proposal to every committee member and told them the Chinese people who gave blood for those developed countries' human genetic projects "have had little opportunity to exchange views with the investigators and researchers on an equal footing. And many of those who were so eager to take their blood samples have shown little interest in what they think and aspire to and would have to say."

I held that the scheduled conference would "offer a good chance to correct this mistake."

My proposal was turned down. The programme committee included famous scholars from England's University of Oxford, Harvard and the Chinese Academy of Social Sciences and they decided that the conference "is an academic meeting which will focus on the ethical issues emerging in human research." They added: "We don't think it is appropriate to invite non-bioethical professionals to attend our conference."

In the end, the conference was not convened because of SARS (severe acute respiratory syndrome). Nevertheless, I was appalled by its organizers' outright denial of the right of so-called "non-bioethical professionals" to discuss with the academics on an equal basis an issue concerning their basic rights as human beings.

I think ethical principles should start with the involvement of all participants, not only the professionals. When it comes to ethics, we are no longer dealing with an exclusively academic issue.

If ethical issues concerning human research must be discussed exclusively by professionals who consider themselves rule makers and have no interest in what other people think, this will only lead researchers into arrogance and violations of human rights. Silent and unnoticed, Chinese farmers have been making contributions to the life sciences, and they deserve a chance to air their views on issues concerning their rights and dignity to life.

As a "non-bioethical professional," I took part in the Berlin conference, entitled "Within and Beyond the Limits of Human Nature." I left it with a stronger belief that those professionals must respect ordinary people's right to know and must discard the arrogant approach that holds that the silent majority's role is nothing more than to offer passively what the professionals want.

If we agree that bioethical principles must be honoured, we should take the issue of bioethics out of the grip of so-called "bioethical professionals." It is an issue that concerns everyone, and nobody is privileged in the face of bioethics.

We in China should put our own house in order through better legislation and enforcement, while companies and institutions collecting gene specimens in our country must be urged to put resources into bioethics education and into promoting bioethical principles among the public so they know how to safeguard their rights. An international tribunal should be established to punish those who violate bioethical principles. An international coalition composed of both professionals and non-professionals should then be formed to make biological research really benefit the majority of the people, starting from honouring our right to know.

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Friday, October 26, 2007

Memory Hole (26 October): Why there is no scientific fraud in Britain

We english could never commit fraud

5 years ago today: British ethics chief explains why fraud never happens in Britain

On 26 October 2002 Dr Michael Wilks, chairman of the British Medical Association's medical ethics committee explained why research fraud never happens in Britain.

His explanation followed a 26 October 2002 BBC broadcast about the the Duke University study in the USA (see 23 October memory hole). The study showed that clinical trials of many new drugs and treatments are flawed and unethical, and that researchers fail to follow international guidelines in studies funded by the pharmaceutical industry.

The BBC cited Dr Michael Wilks, chairman of the British Medical Association's medical ethics committee saying:

"It is different in the UK. Studies are approved by research ethic committees before they can go ahead and I don't think there would ever be a case where they would allow a study to proceed if there was a chance that the drug company could prevent publication of the findings."

Have you heard of GSK or Seroxat Dr Wilks? We can think of many other examples I am sure. I have wondered why the BMA ethics committee has said nothing at all about the most serious integrity lapses in medicine, and why fraud is so effectively hidden here. I think we may have the explanation.

We British are just fine.

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Memory Hole (26 October): Olivieri report released

Nancy Olivieri

6 years ago today: Report into the case of Nancy Olivieri

On 26 October 2001 the Committee of Inquiry into the dispute involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. issued their landmark report (compulsory reading for all those who pretend to be concerned about academic fraud).

"The Hospital and the University should have defended vigorously the right of clinical researchers to disclose risks to research subjects and patients. They had a responsibility to protect the public interest and academic freedom from inappropriate actions by Apotex, but they did not do so".

The committee's report contains 31 recommendations, including:
  • Contracts involving industrial sponsorship of clinical research should never prevent researchers from informing patients or the scientific community of any risks.
  • All universities and affiliated teaching hospitals should have in place policies and practices that are effective in protecting academic freedom, as well as principles of research and clinical ethics.
  • Health Canada should review the current regulation of health research and make appropriate changes to protect the public interest and the rights of patients who volunteer to be subjects of research.
  • The University and the Hospital should provide redress to Dr. Olivieri for the unfair treatment she has received.

The public interest is not served by allowing academic institutions to investigate and exonerate themselves with impunity.

A further article by Karen Birmingham (2000. Nature Medicine 6, 609-610) summarized the 9 page Report of a panel investigating Gideon Koren signed by the University of Toronto President, Robert Prichard.

"Being an accomplished medical researcher and teacher is sufficient to excuse behavior that includes destroying institutional equipment, harassing colleagues and lying to them and to superiors - at least at the University of Toronto and at the Hospital for Sick Children in Toronto."

  1. The Olivieri Report (2001)
  2. See The Olivieri Case: Context and Reflections (Ecclectica, Dec 2005)
  3. Defending Medicine: Clinical Faculty and Academic Freedom (2004)
  4. A Schafer, Biomedical conflicts of interest: a defence of the sequestration thesis—learning from the cases of Nancy Olivieri and David Healy, J Med Ethics 2004; 30: 8-24. doi:10.1136/jme.2003.005702
  5. Scullduggery : "L'affaire Olivieri" by Donald Forsdyke

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Memory Hole (26 October): What else happened?

Scientific Misconduct Blog: More Events of October the 26th

30 years ago today: Smallpox - lest we forget

On 26 October 1977 the last natural case of smallpox was discovered in Merca district, Somalia.

Smallpox killed an estimated 400 million people in the 20th century. As recently as 40 years ago, there were about 2 million deaths from smallpox each year. Native South Americans were deliberately infected by Spanish colonists, and native North Americans were deliberately given infected blankets by British colonists. The epidemics that followed killed more than half the population.

7 years ago today: Government misled the public over BSE

On 26 October 2000 the long awaited report by Lord Phillips into BSE or (mad cow disease) in the UK was released. The report severely criticized government scientists and government ministers for misleading the public and making dogmatic scientific statements going beyond the bounds of that which they could possibly have known. Furthermore, for six months the government hid scientific information.

Mr Gummer, agriculture minister was censured for his decision to publicly feed his four-year-old daughter a beef burger. Health Secretary Mr Dorrell was censured for providing public assurances in "terms more extreme than he could justify".

The report was welcomed by the families of the victims. BSE caused fewer deaths than some anticipated, but next time I would like to decide for myself thank you. Paternalistic politicians and regulators are clearly better at filtering facts and making decisions than scientists or the public. Is it only scientists who can be guilty of scientific fraud?

Patriot Act

6 years ago today: Unhappy Anniversary

On 26 October 2001 George W. Bush signed the Patriot Act.

Apart from the creeping fascism, the act allows the government to seize patients' medical records without a probable cause or a warrant. It prohibits doctors from telling anyone, including the patient, that their sensitive medical records have been seized. A provision was slipped into the Homeland "Security" bill to shield drug companies from litigation.

How fortunate for governments that the people they administer don't think.
(Adolf Hitler)

On March 23, 1933, Adolf Hitler forwarded the the "Enabling Act" which provided the newly elected Nazi government with additional powers to act against enemies of the state.

5 years ago today: Michael Bellesiles resigns over gun book

On 26 October 2002 Emory University professor Michael Bellesiles resigned after an academic panel released a report critical of his research.

The report concluded that Bellesiles had omitted data that contradicted his arguments.

Bellesiles had written that he had studied more than 11,000 probate records in 40 counties around the country and that he had found that from 1765 to 1790, only 14 percent of estate inventories listed guns. Those who tried to examine the research found that they could not, because Mr. Bellesiles said his records had been destroyed in a flood. The records they could check showed many errors, almost all supporting his thesis.

It is depressing the way scholars align for or against possible fraudsters based on their subject matter rather than integrity. The problem then becomes a matter of gun-rights instead of academic integrity.

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Thursday, October 25, 2007

Memory Hole (25 October): The system is fully protected

Scientific Misconduct Blog Memory Hole: Events of October the 25th

16 years ago today: Money and David Baltimore

On 25 October 1991 it was reported in Science that Rockefeller University had received a further $20 million from David Rockefeller, who said the gift reflected his "absolute confidence" in Dr. David Baltimore, the university president.

Oh what money can buy.

The Baltimore affair was a turning point in the muddling of rules of conduct of science, legal obfuscation of standards, and the acceptance of scientific bullying as part of the game. I am sure it will occupy much space on these pages.


16 years ago today: Robert Gallo - more hot water over the HIV virus

On 25 October 1991 Science reported on the ongoing tribulations of Robert Gallo. It would appear that Gallo's frozen samples yielded no trace of any relevant virus. Hard to know what actually happened when such money and power are involved. According to some a massive whitewash. According to others such as Bernadine Healy - who was in the hotseat at the NIH at the time - just an unfortunate collection of easy-to-airbrush minor mistakes.

Bernadine of the "minor mistake" school of thought is of course the previous NIH director who appears to dislike actual evidence. She wrote an attack on Evidence Based Medicine accusing it of being "an attack on physicians" and there to support a "microfascist" ideological agenda. For that she was roundly criticized (see here). Her views are telling.

Ditto the Baltimore affair above - Bernadine was involved with that too.

"Gallo Investigation Raises New Questions," Science 254, 25 Oct 1991

4 years ago today: Lancet blasts AstraZeneca over Crestor

On 25 October 2003 a blistering editorial in the Lancet took AstraZeneca to task for an "unprincipled campaign" surrounding the marketing of its newly approved statin, rosuvastatin (Crestor).
  • "AstraZeneca's tactics" ... "raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines".
  • "With no hard clinical end point trials yet completed, reliance was exclusively on various surrogate end points"
  • "the company" has chosen to market rosuvastatin by "applying adventurous statistics to an overinterpreted syllogism".

The rebuttal from AstraZeneca and some scientists was to the effect that:
  • "Rosuvastatin is an extensively studied and well-tolerated drug with a safety profile comparable to other marketed statins combined with a greater ability to get patients to their cholesterol goals than any other single product".
  • That evidence underlying the use of other drugs is even worse. "Lipitor went to 53% of the market without a single long-term clinical trial. How can you say this to AstraZeneca when its competitors have done exactly what it's now doing?"

High quality thinking and scientific debate all round.

The clinical pearl of the day : use a new drug while it is still effective.

Source: The statin wars: why AstraZeneca must retreat. Lancet. 2003 Oct 25;362:1341.

Fardin Oliaei

2 years ago today: High science and bullying in Minnesota

On 25 October 2005 a scientist Fardin Oliaei at the Minnesota Pollution Control Agency testified that she had been reprimanded for studying a chemical once manufactured by 3M. Furthermore her bosses had blocked her work.

3M had stopped making the chemical after previous studies had shown that it was accumulating in water and human tissues. Oliaei began looking again in 2002 when 3M said they found further contamination.

"At every turn, this MPCA management has tried to hinder my work in investigating the PFC problem," Oliaei said. "The managers became totally blind of their professional obligation."

Commissioner Corrigan of the MPCA was quoted as saying: "the MPCA is not a place for scientists. It is not a research institution". And I should look for another job."

Oliaei was then disciplined for talking to Minnesota Public Radio.

"It's clearly retaliation to me," said Senator Marty. "She's been doing work that a company doesn't like, certain senior managers don't like, and they're treating her like dirt."

High science in Minnesota. So Minnesotans, next time you find a crack in a bridge you know what to do.

Source: "MPCA scientist tells lawmakers her research on 3M chemicals was blocked" Minnesota Public Radio, Oct 25 2005

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Wednesday, October 24, 2007

Memory Hole (24 October): Everyone is fooled

Scientific Misconduct Blog Memory Hole: Events of October the 24th

Houdini patent

81 years ago today: Houdini's last performance

On 24 October 1926 Harry Houdini the famous escapologist gave his last performance
(at the Garrick Theatre in Detroit).

His escapes relied on trickery and misdirection.

Not unlike the nimble evasions and circumlocutions, and the Houdini-like scientific escapes discussed here.
It is about those scientific fraudsters and fakers who slip through the loopholes. Everyone is fooled.

He was also a genius.

The picture is a detail from his 1 March 1921 patent application for a diving suit.

#1370316 signed "H Houdini, Inventor".

Serious science and engineering underlying the tomfoolery.

78 years ago today: Stock market crash

24 October 1929 was the "Black Thursday" crash on the New York Stock Exchange. I am interested in the functioning and malfunctioning of government and "regulators" (including drug "regulators") in a supposed free market - hence this entry.

60 years ago today: Walt Disney and the "communists"

On 24 October 1949 Walt Disney testified to the House Un-American Activities Committee naming Disney employees he believed to be communists. Ditto above.

scientific authorship

5 years ago today: Imperial College London and the mystery publication

On 24 October 2002 a mysterious paper appeared in the New England Journal of Medicine about hypertrophic cardiomyopathy (W. Shamin et al. NEJM. 347, 1326 1333, 2002)

There were eight authors. The signatures of all eight appeared on the original submission and the three revised versions. Over the weeks following publication it emerged that several of these signatures were forgeries. Indeed most "authors" had never seen the manuscript, nor the original data.

Six "authors" had affiliations with Imperial College. Two authors, Waqar Shamin and Mohammed Yousufuddin appear to have chosen six other authors at random to lend prestige to their paper. One author stated "The first thing I knew of it was when Yousufuddin rang me two days before its publication to congratulate me, and to ask me about the method involved in case journalists questioned him".

Having said that, authors in the NEJM and elsewhere are often not authors at all.

This is a good quote about the importance of authorship:

"the integrity of a body of literature is our society’s ultimate temporal forum for negotiating life and death, suffering and wellness... the medical well-being of the society it serves is dependent on the question of who stands behind the word."
-Fr. Mark Gruber, 1999 (cited in ref)

Source for main story: "Paper Retracted as Co-Author Admits Forgery," Nature 421: 77.

3 years ago today: Bullying of doctors in the USA for raising patient welfare concerns

On 24 October 2004 the Association of American Physicians and Surgeons passed a resolution to investigate what they describe as "bad faith" peer review (basically use of hospital "peer review" proceedings to bully doctors who advocate too loudly or too persistently for better patient care).

One year earlier in October 2003, the same newspaper, the Pittsburg Post Gazette published an excellent series of articles over four days dealing with the abuse of doctors who had voiced concerns over patient welfare in the United states. Some of the articles in this "Cost of Courage" series are below:

Part 1: How the tables turn on doctors
Part 2: When right can be wrong
Doctors who spoke out: part A
Doctors who spoke out: part B
Doctors who spoke out: part C
Doctors who spoke out: part D
Extra: Rules of fair play don't always apply
Extra: Centre County hospital critics soon unwanted
Extra: Doctors pay for reporting suspicions

Source main story: Medical groups look into 'bad faith' peer reviews, Pittsburg Post Gazette, Oct 24, 2004

2 years ago today: Cylert discontinuation

On 24 October 2005 the FDA announced that "the overall risk of liver toxicity" from Cylert (Pemoline, an ADHD drug) "outweighs the benefits of this drug". It was linked with 21 cases of liver failure, of which 13 resulted in liver transplantation or death (incidence 10 to 25 times greater than the general population). Abbott Laboratories had already discontinued production.
Source: FDA Alert: Cylert

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Tuesday, October 23, 2007

Memory Hole (23 October): Deja vu all over again

Scientific Misconduct Blog Memory Hole: Events of October the 23rd

Quote of the day

Insanity: doing the same thing over and over again and expecting different results.
Albert Einstein

34 years ago today: Those damn tapes again

On 23 October 1973 President Richard Nixon eventually agrees to turn over subpoenaed audio tapes of his Oval Office conversations about the Watergate scandal.

Office espionage kit

Those damn tapes again.

14 years ago today: A prelude to TGN1412 (sort of)

On 23 October 1993 it was revealed that a patient in a clinical drug trial who had raised concerns about serious side effects in participants was told he would no longer receive any medical care because of his criticisms. The trial then ended in catastrophe - with the iatrogenic deaths of five participants. The NIH Doctor involved is named as Jay H. Hoofnagle. The drug was fialuridine, to treat hepatitis B. 5 of the 15 patients who took the drug died, and two more required liver transplantation. Shades of TGN1412 (where the MHRA approved a protocol giving an entirely novel drug to six participants within a short time - and then declared themselves innocent of something).
Source: "Doctor Drops Patient For Criticizing Drug Trial," New York Times, 23 Oct 1993

5 years ago today: Research contracts fail to adhere to guidelines

On 23 October 2002 the results of an important study of scientific contracting in biomedicine were released. The study examined legal provisions in 108 contracting arrangements between academics and corporate sponsors. Contracts failed to adhere to guidelines designed to protect integrity.

The study was led by researchers at Duke University Medical Center and the Duke University School of Law. Compliance with three key provisions International Committee of Medical Journal Editors (ICMJE) were examined. ICMJE guidelines are used by more than 500 medical journals as a standard for scientists submitting research for publication.
  • If researchers had proper access to trial data;
  • If researchers could control publication decisions; and
  • If researchers were involved in the design and protocol
The investigators found academic institution contracts with corporate sponsors rarely included these provisions.

"How low the level was kind of surprising and also what was surprising was how powerless the institutions felt in negotiating" [for honest science] Schulman said. "There's a failure of protections." "The problem is one of misrepresenting the data. Data interpretation is key and how the data are interpreted can skew the results".

"Any study that has strong pharmaceutical backing is highly likely to be defective," said Drummond Rennie. "You get the data the drug company wants you to have." "I'm not surprised because this shows what an appalling state everyone was in." "If the same study was conducted in five years time, I would hope there would be a huge difference."

Well that 5 years is up today Drummond.

2002 "Research contracts violate guidelines" 23 Oct 2002 United Press International

Professor Sir Graham Catto

1 year ago today: The General Medical Council - Action through Inaction

On 23 October 2006 Reuters reported that "the UK General Medical Council has re-drafted the Good Medical Practice guidelines which, amongst other measures, include the provision for raising concerns about patient safety. This follows an extensive consultation by the GMC following the Harold Shipman Inquiry. The Guide demonstrates how far the medical community and its professional body has come in recognising and emphasising the importance of raising concerns where patient safety may be at risk. Public Concern at Work is clearly identified as a source for confidential and independent advice for doctors." Public Concern at Work

Hard to say anything other than ha ha ha.

The threat to those raising concerns has never been greater, thanks in no small part to these two self congratulatory organizations.

They need to examine what actually happens to concerns when they are raised, and discuss what they plan to do about it.

My letter to Professor Graham Catto is alongside. I eventually received a "reply" from an underling admitting system failure (to follow). Read about the GMC here or Wilmshurst's excellent discussion of their miserable lack of integrity here.

Why are there so many problems involving this body? Why would a so called "whistleblower" support group not make any comment about this at all yet wholeheartedly accept a role providing "confidential and independent advice for doctors", while supporting legislation that insists that concerns are raised through such routes. Have they spoke with a reasonable selection of patients and doctors who have tried - and failed - to discuss serious concerns about patient welfare?

Why would anyone bother?

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Monday, October 22, 2007

Memory Hole (22 October): What happened this day?

Scientific Misconduct Blog Memory Hole: Events of October the 22nd


97 years ago today: Dr Crippen found guilty - wrongly

On 22 October 1910 Dr. Crippen was convicted at the Old Bailey of poisoning his wife and was later hanged in London. In England, Crippen worked for a homeopathic pharmaceutical company. This month Science Magazine reported that based on mtDNA comparison with matrilineal relatives, the body found beneath Crippen's home was definitely not that of Cora Crippen.
Reference: Notorious Dr Crippen wrongly hanged, Science 16 Oct 2007


70 years ago today: Dr A.S Calhoun on responsibility

On 22 October 1937 this letter was written by Dr. A.S. Calhoun. It was part of a key incident leading to a change in medicines regulation:

"But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony."
(Letter from Dr. A.S. Calhoun, October 22, 1937)

The medicine that killed Dr. Calhoun's patients was Elixir Sulfanilamide (Read more here).

The question is whether our sense of personal responsibility for failing to examine science and integrity should be any different in 2007 given a semblance of "regulation". I like this quote from Dr. A. Dale Console, former medical director for drug giant ER Squibb:

"We could make no greater mistake than to be lulled into a sense of false security by believing that some disembodied force called the government will act like a beneficent big brother and make certain that the special interests will not predominate. If the general welfare is to be protected, it will be protected by the actions of people, not the government."

13 years ago today: More non-consensual radiation experiments disclosed

On 22 October 1994 it was reported that the US President's Advisory Committee on Human Radiation Experiments admitted that many more radiation had been conducted by the Government and the military from 1944 to 1974 than previously suggested. These included injection of plutonium and deliberate release of large amounts of radioactivity into the environment.

The number of human experiments were said to be in the thousands. Most were conducted without consent, and some on retarded and "incorrigible" children in institutions.

A decade ago I was involved in conducting a limited low-dose isotope experiment in osteoporosis (reference below). I had read many of the original studies of skeletal metabolism that were carried out in the 1950's. Some of these were interesting. I had thought little about their origins and will discuss one particularly problematical bone radiation study in a later posting. It's about trust.

  • "Panel Says U.S. May Have Done Thousands of Human Radiation Experiments," New York Times, 22 October 1994
  • Blumsohn A, Morris B, Eastell R (1994). Stable strontium absorption as a measure of intestinal calcium absorption: comparison with the double-radiotracer calcium absorption test. Clin Sci. 1994 Sep;87(3):363-8. [Pubmed]
  • Panel Releases Report on Human Radiation (the US government view)

Tip of the iceberg

7 years ago today: Another easy case - Fujimura the archaeologist

On 22 October 2000 a renowned archaeologist Shinichi Fujimura dug some holes in Japan. He arranged some ancient stone tools in a symbolic pattern, and covered them with soil. He and his team then invited journalists to see this important discovery in progress.

Fujimura’s findings had led to the idea that the earliest human habitation of Japan was 600,000 years ago instead of a mere 30,000.

As it happens, reporters suspicious of his previous work had filmed the burial. Fujimura admitted to his fraud. Most of his earlier discoveries also proved to be forgeries.

Another nice cozy case of fraud for those want easy definitions of integrity.

BBC: Archaeologist exposed as fraud (with nice photographs)
Harvard Asia Quarterly Volume VI (3) 2002

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