A Blogger's Manifesto: A new book and the interesting story of Eric Ringmar

This post is about Eric Ringmar and an excellent little book about blogging, Universities and Free Speech that is on sale as of today:

Eric Ringmar: A Blogger's Manifesto - Free Speech and Censorship in the Age of the Internet. ISBN-10: 1843312883. The book is available at Amazon (Amazon USA, Amazon UK). You can also download it, but I would encourage that you read part of it today, and then buy it.

The book is great. What happened to Eric is important and infuriating.

Eric is a Swede, and was up until recently a Senior Lecturer in Government studies at the London School of Economics (LSE). He writes complicated and interesting-looking books about political history (like this one or this). He spent 20 years at prestigious universities, first Yale and then the LSE. Now he is at a "non-prestigious" one : National Chiao Tung University.

Eric resigned from the LSE on the 1st of February 2007. His resignation letter is here. It reads simply:

"Freedom of speech is important to scholarship. It is also important to me. I cannot go on working at an educational institution which does not protect and share this value."

Now read Chapter 3 of Eric's book. It describes what happened to him (For press coverage see Guardian, THES).

To enhance the sense of incredulity while reading, it will help to look at the open day speech he gave to prospective students at the LSE before the trouble started, and the blog that infuriated the LSE. For a rapid tour, some posts are gagging orders, should you do a PhD in the UK, English Professors, Potentially defamatory blogs, and the Muslim Danish Cartoons

Then read Chapter 8: The bloggers manifesto, peruse the other chapters here, and buy it.

I give it 9 out of 10 for insight and amusement.

Previous book reviews on this blog:

• Shuchman, Miriam. the Drug Trial: Review| Rating 0/10
• Shuchman, Miriam. the Drug Trial: Review| Rating 0/10
• Washburn, Jennifer. University, Inc.: The Corporate Corruption of American Higher Education: Review| Rating 10/10
• Rivlin, Solomon. Scientific Misconduct And Its Cover-up: Review| Rating 7/10
• Ringmar, Eric. A Blogger's Manifesto - Free Speech and Censorship in the Age of the Internet: Review| Rating 9/10

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

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

Quote of the day

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

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

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

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

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

7 years ago today: William Simmons admits faking results

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

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

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

All nice and tidy.

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

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

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

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

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

Source: BBC

5 years ago today: More troubles for Seroxat/Paxil

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

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

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

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

Sources: BBC, AHRP, Social Audit

4 years ago today: PLoS commences publication

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

See complete interview here

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

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

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

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

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

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

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

Source Philadelphia Inquirer

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Memory Hole (12 October): Efficacy

Scientific Misconduct Blog Memory Hole: Events of October the 12th

Quote of the day

Efficacy, n. Tendency of pharmaceuticals to produce salutary results. Attributable to extensive research, exacting experimentation, elaborate lawyering, pervasive marketing, gullible physicians, and a sales representative in a short skirt and high heeled shoes.
(From the Prattler)

Wyeth and HRT

Today (12 October 2007) Wyeth was hit with $134.5 million verdict. A Nevada jury awarded $134.5 million to three women who claimed Wyeth's hormone-therapy drugs caused their breast cancer. Jurors agreed that the company "concealed a material fact about the products' safety".

12 years ago on 12 October 1995 the information leaflet for Prempac-C read:
"Some studies with HRT have shown a small increased risk of breast cancer when HRT has been used over a long period of time."

I suppose the question is "what constitutes a warning?" and "what constitutes efficacy?" and whether these were adequately and honestly conveyed. Warnings without numbers attached are meaningless.

A BMJ Editorial from 2003 is worth reiterating:

"HRT promotion has depended heavily, although covertly, on industry involvement with scientists. In the 1960s American physician Robert Wilson wrote the influential Forever Feminine, extolling the virtues of HRT as a virtual fountain of youth for the "dull and unattractive" ageing woman. In an article in the New York Times last year (10 July 2002), Wilson's son conceded that Wyeth paid for his father's book and promotion of HRT.

In 2002 the powerful New York based Society for Women's Health Research, whose "sole mission is to improve the health of women through research," held a celebrity gala ostensibly celebrating women's "coming of age." It was entirely underwritten by Wyeth. In a Washington Monthly article entitled "Hot Flash, Cold Cash," journalist Alicia Mundy reported that only a few days after the Wyeth themed gala the company donated a quarter of a million dollars to the society.

Several weeks later, the WHI study results were made public. Wyeth was in a tailspin. They found support from the society, whose high profile chief executive, Phyllis Greenberger, and her staff went on national radio and television talk shows attacking the findings of the WHI study and its authors. "Instead of taking the side of its constituents," The society's staff failed to disclose their substantial links to Wyeth and other drug companies."

398 years ago today: Three Blind Mice

398 years ago on 12 October 1609 London songwriter Thomas Ravenscroft published ""Three Blind Mice".

8 years ago today: Lancet in a furious row

On 12 October 19999 the Lancet was "embroiled in a furious row with its own advisers over a decision to publish the controversial research on genetically-modified (GM) potatoes by Dr Arpad Pusztai."
Source: BBC

2 years ago today: Zimbabwe praised for rejecting food

On 12 October 2005 Zimbabwe was praised for rejecting food.

"INTERNATIONAL scientists, including those from the United States, have praised Zimbabwe and Zambia for rejecting genetically-modified food donations from the West to feed scores of their rural folk facing drought-induced food shortages. By standing firm against GMOs, said the scientists, the two governments avoided manipulation and deception, which could have resulted in their vulnerable poor being used as guinea pigs."
Source: Zim, Zambia stance on GMO food hailed, The Herald, Zimbabwe, by Wisdom Mdzungairi


A reminder that Zimbabwe is not London. The world loves to simplify. Problems are framed as left versus right, excessive regulation versus free enterprise. I wonder who made this decision.

2 years ago today: Angry response to Advisory Committee on Human Radiation Experiments

On 12 October 2005 it was reported that "Groups representing individuals who were the subject of human radiation experiments in the United States after the Second World War have reacted angrily to the main findings of the President's Advisory Committee on Human Radiation Experiments, which reported to President Bill Clinton last week."

They are "planning to formally reject an apology that was issued by Clinton when the report was released". "Clinton had offered "sincerest apologies to those citizens, their families and their communities" on behalf of the U.S. government." "Responding to the committee's findings that existing protections for human research subjects are "seriously deficient," Clinton asked all the federal agencies involved to review procedures for protecting the subjects of experiments, and to report back within three months to the planned National Bioethics Advisory Commission (NBAC)"
Source: Nature 377 (12 October 1995), p. 470.

2 years ago today: Science "at your peril"

On 12 October 2005 nearly 30 builders and decorators were reported to have received threatening letters from animal rights activists warning them not to work for Oxford University. Signed by the Animal Liberation Front (ALF), the letters tell the firms that work will be done "at your peril".

Is this appropriate?

Source: " Animal rights group threatens builders over new Oxford labs", Telegraph, 12/10/2005

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Memory Hole (11 October): Who will guard the guards?

Scientific Misconduct Blog Memory Hole: Events of October the 11th

Quote of the day

Sed quis custodiet ipsos custodes? (But who will guard the guards?)
Juvenal

70 years ago today: The Sulfanilamine disaster and regulation

11 October 1937 was a landmark day in the history of drug safety. On that day, the American Medical Association received reports from doctors in Tulsa suggesting that a formulation of sulfanilamide was responsible for the deaths of patients deaths. It was discovered that the Elixer contained large amounts of the toxin diethylene glycol. Elixir of Sulfanilamide eventually killed 107 patients. One doctor who had six patient deaths resulting from his prescribing of the Elixir stated "I have spent hours on my knees . . . I have known hours when death for me would be a welcome relief from this agony." Other doctors tried to avoid responsibility by denying they had prescribed the drug.

In fact, the company that produced the Elixer had not broken any laws and there was no basis for prosecution. The only charge that was possible was an obscure "mis labeling" charge (that the word "elixir" implied alcohol content, but that the Elixer contained no alcohol). In 2007, I am not sure that anything has changed, even when science is deliberately misrepresented. The chemist who had compounded the Elixer committed suicide. He had made a mistake.

Public outrage led to the signing of the USA Food, Drug, and Cosmetic Act on June 25 1938. There is a counter view that this connection between a crisis and regulation is overly simplistic. "Industry capture" explanations propose that established drug firms supported new regulation as a way of driving away competition and gaining control of the rules of regulation. There may be some merit in that view.

Sed quis custodiet ipsos custodes? (But who will guard the guards?)
Juvenal

Read more: FDA view of the incident, and another view

40 years ago today: Harold Wilson and the nude postcard

On 11 October 1967 the British Prime Minister won a libel case against the pop group The Move after they published a promotional postcard featuring a cartoon of the Prime Minister in the nude with his female assistant Marcia Falkender. Wilson also sued journalists for libel and Lady Falkender sued the BBC over other matters.

The only reason for including this here is that legal threats and UK libel law have a chilling effect on science. Prime Ministers should not sue for libel. After all, Wilson's election campaign was aided by another nude.

Oh what have you done cried Christine,
You've wrecked the whole party machine!
To lie in the nude may be terribly rude
But to lie in the House is obscene
Anon
Source: Harold Wilson and the nude postcard

19 years ago today: AIDS activists challenge regulation

On 11 October 1988, the group ACT UP (AIDS Coalition to Unleash Power) held a public demonstration to voice "their concern about the availability of drugs and other therapies to combat AIDS". The FDA and clinical trials were perceived to be the roadblock in the way of access to AIDS drugs. Protesters held mock tombstones with inscriptions: "I got the placebo - R.I.P."

While there may have been merit in these concerns, the crisis was used by industry to create an argument that science should be abandoned, denying patients and doctors critical information that can only be obtained through properly conducted trials. The debate about sulfanilamide (above) applies here.

Read: FDA view of demonstration. This August 2007 court decision is also of relevance.

4 years ago: 200 000 euthanasia files from the Nazi regime made available

Around 11 October 2003 documents pertaining to Nazi euthanasia (medically approved murder) were made available. These had been concealed for half a century by the former German Democratic Republic. Victims were mostly mentally and physically disabled adults and children.

"Eighty eight year old Rosemarie Albrecht, former director of the Ear Nose and Throat Hospital and former dean of the medical faculty in Jena is accused of taking part in the killing of at least 159 women and 11 children when in 1940 she worked as a junior doctor in a psychiatric hospital in Stadtroda, Thuringia."

Sources: British Medical Journal 2003;327:832 (11 Oct), The central databank of the German Federal Archives

2 years ago today: Arrest of 4 Israeli doctors for research violations

On 11 October 2006 four Israeli doctors were arrested for carrying out illegal, non-consensual medical experiments on their patients.

"the hospitals in Gedera and Rehovot conducted illegal and unethical testing on thousands of elderly patients for years." "During one of the incidents described, twelve patients died either during the experiments or shortly after they took place, but these incidents were not reported".

Source: AHRP

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Memory Hole (10 October): A society of sheep

Scientific Misconduct Blog Memory Hole: Events of October the 10th

Quote of the day

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

63 years ago today: 800 Gypsy children gassed at Auschwitz

On 10 October 1944 800 Gypsy children were gassed to death at Auschwitz. Many children were subjected to medical experiments before they were exterminated. Some Gypsies used in experiments by Mengele at Auschwitz were twins (two pairs of twins at right). Approximately 300,000 Gypsies were murdered in all. Almost all German and Austrian Gypsies (about 30,000) were murdered. The rationale for murder was based in part on the academic "research" of racial scientists Dr. Robert Ritter (a psychiatrist), Dr. Adolf Wurth and Dr. Sophie Ehrhardt (anthropologists) and Eva Justin (a nurse). At the end of the research projects most of their subjects were killed.
Sources: The Nazi Doctors, O Porrajmos - the Gypsy Holocaust, Sinti and Roma Victims of the Nazi era

50 years ago today: Coverup of a UK Nuclear disaster at Windscale

On 10 October 1957 Britain suffered its worst nuclear accident. On that night, a fire began to spread throughout the core of the Windscale nuclear reactor (now Sellafield), sending radioactive dust across Britain."

"Radioactive leaks were found and the core of the reactor began dangerously overheating. Some scientists warned that radioactive materials inside could catch fire. But the leaks were hushed up and the warnings ignored. Instead, Windscale was ordered to achieve even greater increases in output to meet a political deadline to explode Britain's first H-bomb. The result was potential disaster - the core of the reactor caught fire and radioactive dust began spreading over the country. Windscale workers faced a terrible dilemma - if they tried to put the fire out with water they risked turning the reactor into a gigantic nuclear bomb, and if they let the fire burn, it could contaminate people across a huge area. Risking death from explosion and radioactive poisoning, the Windscale men averted a major tragedy. The inquiry revealed that the warnings about the risks had been hushed up or ignored. But the government kept its findings secret, and instead blamed the fire on an "error of judgement" by the very workers who had first warned of the potential problems and then battled so heroically to prevent tragedy." A new BBC broadcast discusses the disaster and the coverup: (Read more). See also here and here.

28 years ago today: Pac-Man is born

On 10 October 1979 Pac-Man was released in Japan. It involved ghosts and all sorts.

Source: Pac-Man

27 years ago today: Philip Felig's loss of the Chair of Medicine at Columbia

On 10 October 1980 the journal Science reported on the ongoing saga of Philip Felig, his rogue co-author Vijay Soman, and the problem at Yale. It is an interesting story and involves the responsibility of coauthors, the reluctance of institutions to investigate themselves, and a lot more. The New York Times has a good summary.

Source: "Imbroglio at Yale (II): A Top Job Lost," Science 210 (10 October 1980), pp. 171-173.

18 years ago today: Dispute over David Baltimore presidency of Rockefeller University

On 10 October 1989 the New York Times reported on the dispute over the invitation to David Baltimore to presidency of Rockefeller University. The New York Times had a "conversation . . . with 15 of the university's 42 full professors . . . All said they opposed the Baltimore candidacy, for various reasons and in varying degrees, and they added that informal polls indicate that perhaps half the full professors oppose him too."

For more on the Baltimore affair see:
Serge Lang QUESTIONS OF SCIENTIFIC RESPONSIBILITY: THE BALTIMORE CASE, Ethics and Behavior Vol. 3 No. 1 (1993) pp. 3-72

Source: New York Times 10 October 1989 (p. 1): "Dispute on New President Shatters Tranquil Study at Rockefeller U."

5 years ago today: Dr. Alastair Benbow of GlaxoSmithKline asserts safety of Seroxat/Paxil

On 10 October 2002 Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline made the following statement:

The overwhelming view of independent medical experts and regulatory bodies around the world who have seen the data, is that Seroxat has a well established safety profile and is an effective treatment with experience in tens of millions of patients worldwide since launch in the UK over ten years ago.
Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline, 10/10/2002

He later stated:

"I utterly refute any allegations we are sitting on data, that [we] have withheld data or anything like that. We have provided all the data both relating to safety and efficacy in the pediatric population to the regulatory authorities around the world and have hidden nothing."
Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline, 6/15/2003

It is not clear that these statements were true, but that is perhaps a matter involving the redefinition of words. It is also not clear what data "independent medical experts" have seen, the independence of those experts, or the definition of "all the data". Perusal of some of the evidence makes very worrying reading. Everything is not OK.

It is said that when your taxi driver starts talking about the stock market, it's time to think again about your finances. The same might apply to medicine. Patients are asking the scientific and ethical questions we should be asking.

For some patient writings see:
Seroxat Secrets
Furious Seasons
It's Quite an Experience
Bob Fiddaman Blog

3 years ago today: Anthrax documents show pentagon lied

On 10 October 2004 US "Government officials have acknowledged that the Department of Defense secretly tested squalene on human beings in Thailand. [Col. Felix] Grieder believes they did the same in Dover."

"A former Dover Air Force Base commander says military officials used his troops as guinea pigs in illegal medical experiments under the government's controversial anthrax vaccination program."

"The Delaware News Journal has uncovered documents and videos that reveal that Pentagon officials lied; that US troops were given an experimental concoction of anthrax vaccine laced with squalene. Many soldiers have suffered permanent harm as a result."

"The military's anthrax Web site claims the vaccine is safe, because "The Food and Drug Administration individually approves each lot before release." But FDA documents obtained under the Freedom of Information Act show that the FDA no longer tests the lots for squalene." "The FDA gave limited approval for the Defense Department to test vaccines boosted with squalene during the 1990s. The results of those tests are confidential."

There seems to be a dispute about the science, but how can science function when there is government sanctioned lying? And why should the results of such research ever be confidential?

Source: "Ex-DAFB commander says troops used as guinea pigs" Delaware News Journal, 10 Oct 2004

2 years ago today: Safety of long-term PPI acid-suppressing drugs

On 10 October 1947 questions over the safety of long-term use of proton-pump inhibitors (PPIs) hit the Wall Street Journal.

The long-term safety of PPIs is not completely known. PPIs include Nexium, Protonix and Prevacid. They account for $13 billion in sales each year, making PPIs the second most popular drug after statins. Stomach acid clearly serves a function. Given widespread use we need to know a bit about long term effects. The reports suggested that preliminary research links PPIs to a rising incidence of esophageal cancer. Concerns are also expressed about "overgrowth of bacteria in the digestive tract" and possible rare cases of life threatening Clostridium difficile colitis. All these things are disputed. PPIs seem to be a risk factor for osteoporosis and fractures.

The fact remains that we really know rather little about the long-term balance of risks and benefits for the most widely used drugs. We may be asking the wrong questions and designing the wrong studies. Watch this space.

Source: "The hidden dangers of heartburn" Oct 10 2005, Wall Street Journal

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Memory Hole (9 October): When white is black and black is white

Scientific Misconduct Blog Memory Hole: Events of October the 9th

Quote of the day

"There was a society of men among us,
bred from their youth in the art of proving,
by word multiplied for the purpose,
that white is black and black is white
according to how they are paid"
Jonathan Swift

20 years ago today: Cornell whitewash is undone

On 9 October 1987 final resolution of a dispute involving Cornell Medical center was announced in the journal Science.

The story began in 1981 when a prominent cardiologist, Dr. Jeffrey Borer was accused of making several misstatements in a scientific paper. the whistleblower was Dr Jerome Jacobstein. Jacobstein said that Borer had falsely declared that there were two observers in the experiment (there had only been one), and that subjects had not been chosen randomly as the paper had stated.

The committee criticised Cornell for not treating Jacobstein's initial charges properly.

Jacobson states that it is hardly surprising that cases of proven scientific misconduct are so rare, that the costs of raising it are too high and that Cornell whitewashed his concerns. "Everybody concerned dragged their feet".

Borer had served on the Cardiorenal Advisory Committee of the FDA.

Source: "NIH Finally Resolves 7-Year Dispute," Science 238 (9 October 1987)

15 years ago today: Public learns of Bristol Heart Scandal through a satirical magazine

On 9 October 1992 the British satirical magazine "Private Eye" revealed that mortality rates for infants undergoing certain cardiac procedures in Bristol was unacceptably high and that operations were still being carried out despite concerns raised by staff.

The article read:

"The sorry state of paediatric cardiac surgery at the United Bristol Healthcare Trust has been confirmed by an internal audit over the last two years' operations. The results of procedures to correct two congenital heart abnormalities (Tetralogy of Fallot and transposition of the arteries) were especially poor.

James Wisheart, chairman of the hospital management committee and medical advisor to the trust board, is required to maintain standards of medical practice at UBHT. Curiously he has not felt it necessary to inform the trust board or the trust's purchasers of these findings. Could it be because he is also associate director of cardiac surgery?"

Thus began the public exposure of what became known as the "Bristol heart scandal" as well as the institutional cover up and the ignoring and bullying of the whistleblower anaesthetist Stephen Bolsin. Between 30 and 50 babies died unnecessarily at the Bristol Royal Infirmary between 1984 and 1995. In 1992 it needed a satirical magazine to take notice. The report into the scandal made more that 200 recommendations but the real problems were not addressed. Raising concerns about patient safety and scientific misconduct is more difficult than it has ever been. The cover up culture has persisted and has been reinforced through legislation such as the Public Interest Disclosure Act. There is an illusion of change.

15 years ago today: Death of Dr Joseph Mengele confirmed

On 9 October 1994 a report confirmed that bones in a grave at Embu near Sao Paolo in 1985 were authenticated by forensic experts as belonging to Mengele. On 1943, he became medical officer of Auschwitz-Birkenau's "Gypsy camp." Mengele supervised many sadistic experiments on Gypsies and Jews.

Source: "U.S. Report on Mengele Reaffirms His Death," New York Times, 9 Oct 1992

10 years ago today: Delayed release of report into the effect of above-ground nuclear tests

On 9 October 1997 it was reported that the US National Cancer Institute (NCI) admitted they should not have avoided releasing a study of exposure to radioactive iodine from above-ground nuclear tests in the 1950s.

The study reported that up to 75,000 additional cases of thyroid cancers in America were probable given the amount of radioactive iodine to which Americans on average were exposed.

Joseph Lyon, a professor of family medicine at the University of Utah suggested that funding for follow up studies had been blocked by Bruce Wachholz, chief of NCI's Radiation Effects Branch.

(I note in Pubmed a cohort study authored by the above Lyon some 10 years later. Life near a nuclear blast site doesn't sound too bad)

Source: "NCI Apologizes for Fallout Study Delay," Nature (9 October 1997) p534.

10 years ago today: African HIV experiments criticised

On 9 October 1997 the New York Times reported on the ethics of HIV experiments in Africa. It turns out that individuals studied were given placebo and didn't grasp "what exactly a placebo is" or why they "might have been given one instead of a real medicine". It would have been virtually impossible to get approval for placebo controlled studies of HIV in the United States. There is much more to this story.

Source: " AIDS Research in Africa: Juggling Risks and Hopes" New York Times, 9 Oct 1997

5 years ago today: Declassified documents reveal further unethical toxicology experiments on military recruits

On 9 October 2002, The New York Times reports that 16 newly declassified reports from the Pentagon describe experiments conducted on soldiers without consent between 1962 and 1971.

Ships and sailors had been sprayed with sarin gas and other chemical and biological agents. An estimated 5,500 persons were involved.

Tests conducted together with the Canadian government used VX, and tests with Britain used sarin and VX, the documents show.

It took 40 years to disclose these experiments.

Source: "U.S. Troops Were Subjected to a Wider Toxic Testing" New York Times Oct 9 2002

2 years ago today: Secret funding to ADHD patient "support" groups

On 9 October 2005, a newspaper article in the UK Telegraph revealed that UK patient "support" groups for parents of children with ADHD were being secretly funded by pharmaceutical companies with an interest in selling drugs for ADHD.

In particular, the "Attention Deficit Disorder Information and Support Service" (ADDISS), a Department of Health-funded "charity" had been providing details of drugs to parents. Andrea Bilbow, chief executive of ADDISS, admitted that ADDISS had solicited and received funding from Janssen-Cilag, which makes Concerta, UCB Pharma, and Eli Lilly, which makes Strattera (an ADHD drug linked to an increased risk of suicide in children). Bilbow maintains that "not enough children are given the drugs" and that at least 700,000 children in the UK should be taking Ritalin.

Whether that is a reasonable belief or not, the drug firms' financing was not acknowledged on ADDISS website and nor did their names show up on the accounts lodged with the Charity Commission.

Bilbow stated: "If we put the names on the site that would be promoting the companies and I've told them I won't do that" and "That would be advertising and I'm not getting enough money from them for that."

Although such secret funding might not cause surprise outside of the UK, it was a shock. The funding also assumed importance because a psychologist Lisa Blakemore Brown had maintained that ADDISS had been receiving such funding. Furthermore, she maintained ADDISS had coached a patient to place a spurious complaint about her to the British Psychological Society. In leaked transcripts of the case, it appeared that the BPS had then accused Blakemore Brown of being paranoid (and hence not fit to practice). As part evidence for this supposed paranoia, Dr Friedman (a psychiatrist who had not examined her) felt such as idea would be "amazing" and "extremely unlikely". Friedman also works as psychiatric assessor for Doctors facing fitness to practice tribunals with the GMC.

Source: ADHD advice secretly paid for by drugs companies", Telegraph, 9 Oct 2000

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Memory Hole (8 October): Illusions of due diligence

The Scientific Misconduct Blog Memory Hole: Events of October the 8th

This quotation from the movie Syriana is appropriate to many of these events:
"We're looking for the illusion of due diligence, Mr. Pope. Two criminal acts successfully prosecuted -- it gives us that illusion."

60 years ago today: Attempt to hide secret human radiation experiments

On 8 October 1947, J.C.Franklin, operations manager of Oak Ridge, wrote to the general manager of the US Atomic Energy Commission: "There are a large number of papers which do not violate security but do cause considerable concern to the Atomic Energy Commission insurance branch, and may well compromise the public prestige and best interests of the commission". He added that such documents "are definitely prejudicial to the best interests of the Government" and ordered that "any such documents be edited or kept secret".

He was writing about the need to keep secret many research experiments involving radiation in humans. These had been carried out without consent or public knowledge.

Source: "Inquiry Links Test Secrecy To A Cover-up," New York Times, 15 December 1994

8 years ago today: Further adventures of Professor Martin Keller

On 8 October 1999 it was reported that Professor Martin Keller of Brown University had received "hundreds of thousands of dollars from drug companies" while he was receiving federal funds to test new drugs, and then provided favorable reports on those drugs without notifying the payments. Keller was paid more than half a million dollars in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted.

Scientists seeking US funds are required to disclose to their research institutions any "significant financial interests" that could be affected by the proposed study. Then it's up to the institutions to assess the financial interests. If the institutions find a conflict, they must report it to the US funding agency and protect the research from bias. According to the newspaper report, Brown University appeared unconcerned about the regulations or the conflict of interest. The American Psychiatric Association announced that they were "investigating". For Keller's later involvement in shonky research see here or here or read about his depressing involvement in GSK's study 329 here.
Source: Boston Globe 8 October 1999, page B01

8 years ago today: London professor struck off for bullying and dishonesty

On 8 October 1999 A British professor of respiratory medicine with an international reputation in asthma research was struck off the medical register for bullying and threatening a junior colleague to cheat in a drug trial. See report of the case in the BMJ here and here.

Former Professor Robert Davies had threatened and abused a young doctor and tried to persuade him to break the trial code in order to fiddle the results. Davies threatened that Ramsay's career would be "finished" if he told anyone about the request to break the code blinding the study of the SmithKline Beecham drug Prankulast.

• The case involved tape recording of Professor Davies by Dr Ramsay. It is likely that without that recording the incident would have ended the career of Dr Ramsay instead of his senior "old-tie" boss. Davies told another colleague that he did not "know a microscope from a fucking hole in the ground". On the tape, Professor Davies is heard saying: "If I hear you speak to anybody you’re finished, OK." Davies said he had been "flabbergasted" to learn Ramsay had taped their conversations. He said when he had told Ramsay he would be finished if he spoke out, it was "in no way a threat to his career".
• The case included a strange comment from Joanna Glynn, counsel for the GMC. She said that "there was no body, other than the General Medical Council on which the pharmaceutical industry could rely to regulate doctors' activities in clinical trials". Kindly contact me for some education Ms Glynn or read this or this about the corruption of the GMC.
• The case is important in terms of definition of research misconduct. According to the current tortuous definition promulgated by the ORI and others, the actions of Professor Davies would not constitute research misconduct. Bullying with intent to disrupt the scientific record is not so defined.

Reference: BMJ 1999;319:938 London Professor struck off for bullying and dishonesty

5 years ago today: Pioglitazone data - when all 30 authors are wrong

On 8 October 2002 Nick Freemantle (University of Birmingham) reported in the BMJ (BMJ 2005;331:836-838) that clinical trial findings involving the drug Pioglitazone (the PROactive trial) had been misrepresented and that the conclusions were unsafe.

A response by a reader (Dr James Penston) was pertinent and bears on the responsibilities of authorship. His letter was entitled "When all thirty authors are wrong".

Penston writes: "Perhaps this was simply an innocent error. But it is hard to believe that none of the thirty authors – including 27 professors – were aware that it would be misleading to interpret the data as showing that pioglitazone reduced macrovascular events. Given that 28 of the 30 authors had financial links with the pharmaceutical industry and that the study was funded by Takeda and Eli Lilly, it would have been prudent to avoid at all cost the charge that this manipulation of data stemmed from a conflict of interest."

4 years ago today: Nigeria versus Pfizer

On 8 October 2003 the US Court of Appeals reinstates a Nigerian research case against Pfizer.

"The central events at issue in this lawsuit occurred in 1996, not long after epidemics of bacterial meningitis, measles and cholera broke out in Kano, Nigeria. Pfizer established a treatment center at the Infectious Disease Hospital in Kano to treat victims of the meningitis epidemic.

Plaintiffs allege that Pfizer, instead of using safe and effective bacterial meningitis treatments, used the epidemic as an opportunity to conduct biomedical research experiments on Nigerian children involving Pfizer's "new, untested and unproven" antibiotic, trovaflozacin mesylate, better known by its brand name, Trovan."

Plaintiffs claim that Pfizer failed to obtain informed consent, and that some children were deliberately given inadequate doses of ceftriaxone so that Trovan would look more effective by comparison. Several children died. The case is ongoing (see AHRP or here).

What is the chance that justice will be served under the circumstances?

Four years later it seems that Pfizer is going to try to keep the whole thing quiet through some form of payment of money or perhaps a large bribe.
Source: AHRP http://www.ahrp.org/infomail/03/10/14.php

3 years ago today: FDA officials attempt to soften a report by Dr David Graham about Vioxx

On 8 October 2004 it was revealed that FDA officials had attempted to soften the conclusions of a scientific report about the drug Vioxx produced by Dr David Graham. Senator Grassley was reported as saying "Instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert" “Dr. Graham described an environment where he was ostracized, subjected to veiled threats and intimidation".

Vioxx was later withdrawn. It is estimated that the use of this drug has resulted in at least 100,000 deaths worldwide.
Source: "FDA Officials Tried To Tone Down Report on Vioxx" Wall Street Journal, 8 October 2004

2 years ago today: MHRA leadership asserts its integrity, but with what evidence

On 8 October 2005 Professor Alasdair Breckenridge and Professor Kent Woods coauthored a strange paper in the BMJ (BMJ 2005;331:834-836) subtitled "How does an agency funded by user fees make impartial decisions about the safety of new and licensed drugs?". Breckenridge and Woods are important people. Breckenridge is the chairman of the UK drug regulator (the Medicines and Healthcare Products Regulatory Agency, MHRA) and Woods is the chief executive of the agency.

And the answer to the question is?

Some have asked these gentlemen about the ongoing "independent criminal investigation" of GlaxoSmithKline (see see 1463 days to nothing).

Breckenridge sat on GSK's scientific advisory committee for years before taking up his post at the MHRA (reference). Ian Hudson, who was the worldwide safety director of GlaxoSmithKline (GSK) until 2001, is now director of licensing at the MHRA (reference). As Charles Medawar has pointed out here or here there is a lot of explaining to do.

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