Is Medicine in the same boat as the Catholic Church?

This post has nothing directly to do with scientific fraud, science or medicine.

It is about recent reports of corruption and terrible evils that have taken place within the confines of the leadership of the Catholic Church.

A few days ago a long-delayed investigation into Ireland’s Roman Catholic-run institutions was released. It chronicled how priests and nuns molested, abused and tortured thousands of boys and girls for decades. More importantly it documented how those in authority, government officials, and government inspectors failed to stop the beatings, rapes and abuse. The report concludes that church officials shielded their orders' pedophiles from arrest, amid a culture of self-serving secrecy. They turned a blind eye.

In the United Kingdom, we have medical "regulatory" bodies (such as the MHRA and the General Medical Council). We have individuals promoted to positions of professional leadership. These bodies and individuals are supposed to act as guardians of scientific and clinical integrity in medicine. They are supposed to protect the public against quackery, and to uphold the scientific ideals of our profession. Like the corrupt bodies within the Church, these institutions don't always fulfill their stated mission. Too often they act act as protectors of those who are guilty of scientific fraud, of abusing patients and of corruption. Particular individuals within those bodies act to conceal crimes and deception. Rules of conduct are meticulously created and revised, but disobeyed with impunity. The supposed mission of these organisations and the reputation of our profession is brought into disrepute through these actions.

These organisations hide their sins behind a barrrier of secrecy. Names and transparency are important however. The Christian Brothers successfully sued the commission in 2004 to keep the identities of all of its members unnamed in the report resulting in massive backfire and complete loss of any residual reputation. In medicine, bodies such as the General Medical Council demonstrate the same staggering incompetence when they try to get involved in tricky little exercises to protect their friends. Those, like the hilarious exercise to try to hide the scientific adventures of their friend Professor Richard Eastell and his "collaborations" with Procter and Gamble Pharmaceuticals tend to result in a similar outcome for the profession of medicine.

Read the full report of the Commission to Inquire Into Child Abuse report here, or a summary (Associated Press).

The corruption was articulated even more strongly in Milwaukee this week. It is said that retired Archbishop Rembert G. Weakland states that he "did not comprehend" the potential harm to victims in Milwaukee, nor did he understand that what the priests had done constituted a crime (see here and here)

Said Weakland:

"We all considered sexual abuse of minors as a moral evil, but had no understanding of its criminal nature."

I "accepted naively the common view that it was not necessary to worry about the effects on the youngsters: either they would not remember or they would ‘grow out of it’."

Weakland stands accused of assisting in cover-up of the abuse. A 2003 report on the sexual abuse of minors by clergy in the Roman Catholic Archdiocese of Milwaukee revealed that allegations of sexual assaults on minors had been made against 58 ordained men, who were under the direct supervision of the Archbishop of Milwaukee. By early 2009, the Archdiocese of Milwaukee had spent approximately $26.5 million in attorney fees and settlements to victims. Weakland retired in 2002 after it became known that he paid $450,000 to a man who had accused him of date rape.

Why are these men and women not in prison?

See also:

1. Cargo Cult Science : Large Groups of Humans
2. Video Documentary : Deliver us from Evil
3. The Freethinker: ‘We did not know that child abuse was a crime,’ says retired Catholic archbishop
4. Report of the Commission to Inquire Into Child Abuse in Ireland

Earlier|Later|Main Page

A Day of Shame for Science in the United Kingdom

This is the report of the so called "criminal" investigation of GlaxoSmithKline (GSK) by the UK Medicines and Healthcare Regulatory Authority (MHRA). It concerns fakery and misrepresentations of science involving the drug Seroxat/Paxil. Given the close links between the MHRA and GSK this can hardly be regarded as an independent or relevant investigation.

Nevertheless, the MHRA could hardly avoid acknowledging many of the scientific manipulations that took place within their report. Many others are not discussed. These include the apparent "recoding" of clinical records in randomized trials, and the counting of events in the washout phase of trials as events on placebo. There seems very little doubt as to what happened, and the fakery is not denied.

Many children and adults are likely to have died as a result of this fakery.

The upshot of this report is that scientific misconduct is acceptable in the United Kingdom. It is acceptable for doctors and patients to be misled.

The problem is that the MHRA is only concerned about information supplied to themselves by GSK. They are not concerned about the veracity and numeric accuracy of the information supplied by themselves to the public and to doctors. They regard the provision of false or incomplete information to themselves as legal so long as that information does not directly concern licensing. They ignore the fact that doctors and patients make decisions based on information in the scientific literature, and that this literature may be faked. They ignore the fact that they themselves rely on the "peer reviewed" scientific literature to make decisions. Despite this, the MHRA have previously declared that they have no remit to be concerned about the integrity of the scientific literature involving drugs, except where it is related to a licensing procedure. They maintain that the scientific literature is "exploratory" and that fraud in this literature is therefore not relevant.

It took the MHRA four years of "investigating" to reaffirm that fakery involving drugs no longer matters.

It is time for the honest members of the medical profession to say that they disagree.
This is a day of shame for science in this country, for our profession, and for the supine leadership of our profession.

No amount of legal tweaking over issues of data-supply to regulators is going to solve this problem. There are no right answers to the wrong questions.

The government might start by reassessing their failure to respond properly to the issues raised by the Commons select committee report of 2004/5. They might start by examining their refusal to address any of the critical issues raised by that report. They might make a clear statement that honest science matters. They might make it clear that in this country we expect the usual rules of science to be obeyed, and that raw and complete data should be made available both to regulators, authors of scientific publications and to concerned scientists. They might admit that the regulator has failed to scrutinize or retain actual raw data in the past, and has simply accepted the summary claims of industry with blind faith. They might think a little about the conclusions of the select committee concerning the honesty, integrity and independence of the MHRA. They might stop their cozy meetings with industry CEO's.

It was also most unusual that Gordon Brown should have invited the CEO of a company undergoing criminal investigation over the deaths of vulnerable patients to join his International Business Advisory Council.

No, I tell you. No, sir. Corruption charges! Corruption? Corruption is government intrusion into market efficiencies in the form of regulations......We have laws against it precisely so we can get away with it. Corruption is our protection. Corruption keeps us safe and warm. Corruption is why you and I are prancing around in here instead of fighting over scraps of meat out in the streets. Corruption is why we win.
(From the Movie Syriana)

Earlier|Later|Main Page

Fraud in SSRI drug trials - The Gathering Storm Part II

Sometimes there is no other way to say it than through humour. We have taken the most vulnerable in society, and we have lied to them. We have lied as a profession. We have allowed our "regulators" to lie and to collude with lying. The best and most intelligent of our profession have remained silent.

This is the classic description of the research method in these trials:
Monty Python: The Gathering Storm - Part II


"Who's gonna investigate the man who investigates the man who investigates me" was the refrain of "The Investigator's Song", words and music by Harold Rome/Zero Mostel in 1947. The song's final line: "One more problem puzzles me; Pardon my strange whim. But who's gonna investigate the man who investigates the man who investigates... him?"
(The People's Song Book, Waldemar Hille, ed., Boni & Gaer, 1948)

Earlier|Later|Main Page

Memory Hole (12 November): Corruption of medicines "regulation"

Scientific Misconduct Blog Memory Hole: Events of November 12th

Quote of the day

"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."
-Dr. A. DALE CONSOLE, former medical director for drug giant ER Squibb (as quoted in Peretz Glazer and Migdal Glazer, ISBN 0465-09173-3)

3 years ago today: FDA shows "respect for the scientific process" by intimidating scientist

On 12 November 2004 a Food and Drug Administration (FDA) official called the Lancet in an attempt to prevent publication of a study that raised concerns about the drug Vioxx. The article would have embarrassed the FDA

The author, David Graham pulled the paper at the last minute because he feared for his job. The study was due to be posted on the Lancet website on Nov 17th 2004. FDA Acting Commissioner (and convicted criminal) Lester Crawford said that Galson contacted Lancet editor Richard Horton "out of respect for the scientific review process."

Horton responded: "You will not be surprised if I say that I was a little taken aback to get your call on Friday (Nov. 12). It is very unusual indeed for a member of the employing institution of an author to contact us in the middle of the review and publication process of a manuscript."

On November 18th Graham told a Senate panel that the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure". Excess deaths resulting from the use of Vioxx have been estimated at 100,000.

USA TODAY Scientist says FDA called journal to block Vioxx article 28 Nov 2004

3 years ago today: FDA: Being honest is a conflict of interest

On 12 November 2004 the FDA removed Dr. Curt Furberg from an FDA advisory committee for alleged "intellectual conflict of interest" (but more likely to protect Pfizer). Furberg had previously analyzed the data relating to Bextra and had concluded that Bextra carried cardiovascular risk (similar to Vioxx).

Sandra Kweder, acting director of the FDA's office of new drugs, said "If he's already expressed a particular point of view, and especially written a paper on it, would be difficult to expect him to come to such a meeting and be objective about the subject".

What a corrupt muddle. Apparently (but not always) being a scientist and taking a scientific approach is a conflict of interest. FDA's action against Dr. Furberg contrasts sharply with the agency's infinite tolerance of overt and extensive financial conflicts of interest of its advisory panel members.

Sources:

1. WALL STREET JOURNAL, FDA Removes Panel Member From Drug Review, Nov 12 2004
2. http://www.ahrp.org/infomail/04/11/15.php
3. http://www.gooznews.com/archives/000091.html
4. http://www.ahrp.org/infomail/04/11/12a.php

3 years ago today: Sharper teeth for the UK Medicines "Watchdog"

On 12 November 2004 it was reported that the UK government announced sweeping changes to the "independent" and "transparent" medicines watchdog body after years of criticism and pressure, banning those who sit on its central licensing committee from having any personal or financial interests in pharmaceutical companies [Sharper teeth for medicines watchdog, The Guardian, November 12 2004].
(Duh!)

In March 2003 a review committee of the UK Medicines regulator tasked with looking at the safety of GSK's drug Seroxat had to be disbanded when it was revealed that half the members had share holdings in GlaxoSmithKline. Here are some later and ongoing members of the MHRA and their personal interests in just this one company:

Professor A Breckenridge - GSK Fees
Professor H Dargie - GlaxoSmithKline Consultancy
Dr M Donaghy - GSK Shares
Dr J C Forfar - GSK Shares
Dr R Leonard - GSK Fees/ Publicity work
Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares (1)
Professor J F Smyth - GSK Consultancy
Professor Christopher Bucke - SKB Shares
Prof Nicholas Mitchison - GSK Shares
Dr Brian J Clark - GSK PHD student funding
Professor Robert Booy - GSK Consultancy
Professor S M Cobbe - GSK Research grant
Professor J E Compston - GSK Consultancy
Dr A Glasier - GSK Shares (£10,000)
Dr Andrew A Grace - GSK Consultancy
Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now
Professor P D Home - GSK Consultancy - Ex-employee of GSK
Dr R F A Logan - GSK Shares
Professor R MacSween - SmithKline Beecham Shares
Professor J O’D McGee - SmithKline Beecham Shares
Professor David R Matthews - GSK Honorarium for advice
Dr A Smyth - GSK Conference expenses
Professor A D Struthers - GSK Shares
Professor J C E Underwood - GSK Shares
Dr A Gerard Wilson - GSK Consultancy
Dr Rosemary Leonard - GSK Fees/ Publicity work
Mr David P S Dickinson - GSK Fee paid work
Dr Charlotte C D Williamson - GSK Shares
Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products
Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research
Professor Albert - GSK Shares

Professor Alistair Breckenridge [Link][Link][Link][Link] and Dr Ian Hudson [Link][Link][Link] are both former employees/advisors of GlaxoSmithKline, having been involved with GSK's drug Seroxat. Both now work for the MHRA.

The very definition of independence. If any of the above named have ever made any statement about selective reporting in GSK clinical trials, or GSK's study 329, or disputes their GSK funding, I would be pleased to hear from them to correct the record.

"Following the path of least resistance
is what makes rivers and men crooked."

2 years ago today: Scott Gottlieb - what is the half-life of a conflict of interest?

On 12 November 2004 further concerns were raised in the press over the circumstances that led to the appointment of Dr. Scott Gottlieb to the position of deputy commissioner at the Food and Drug Administration. Gottlieb's absurd anti-science and anti-transparency stance, his conflicts of interest, and attempts to interfere with FDA decisions were causing anxiety. He was heavily criticised for attempting to intimidate staff behind the scenes in relation to a Pfizer osteoporosis drug. Gottlieb had also been appointed by one Lester Crawford (who was convicted of criminal offenses relating to his role as FDA Commissioner).

Upon taking his post Gottlieb recused himself for up to a year from any deliberations involving nine companies that are regulated by the FDA, including Eli Lilly, Roche and Proctor & Gamble. (In analogy with radioactive decay, one year is the well recognized decay time for the effect of a conflict of interest after switching off a current income stream).

"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter. Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."

"When asked about his industry connections, Gottlieb said that he complied with all legal requirements".

For some depressing reason the British Medical Journal (a scientific journal?) decided to employ Gottlieb as a staff writer from 1997-2005.

Source:
Henderson, Diedtra. "FDA official recused in flu fight - His ties to drug firms spark questions over agency hiring policies", Boston Globe, 2005-11-12.

Read further:

1. The Scott Gottlieb example - The Carpetbagger Report (2005-09-26).
2. Corporate Crime Reporter: Zheng Xiaoyu Meet Lester Crawford.
3. Henderson, Diedtra. "FDA official recused in flu fight - His ties to drug firms spark questions over agency hiring policies", Boston Globe, 2005-11-12.
4. Mundy, Alicia. "Wall Street biotech insider gets No. 2 job at the FDA", The Seattle Times, 2004-08-24.
5. Blumsohn, Aubrey (2007-09-01). Gottlieb pronounces on pharmaceutical research integrity. Scientific Misconduct Blog.
6. Poses, Roy (2007-08-31). Conflicted View on the Pitfalls of Government-Sponsored Comparative Effectiveness Research. Health Care Renewal.

Earlier|Later|Main Page

Memory Hole (11 November): What else happened?

Scientific Misconduct Blog Memory Hole: Events of November 11th

9 years ago today: New laws and missing raw data

On 11 November 1998 new congressional laws were enacted to deal with access to raw scientific data. This followed refusal by Harvard to release raw data based on a spurious excuse of participant "confidentiality".

"When tax dollars pay for a scientific study, should the public be allowed to see the results? Of course. And now it can, thanks to a provision in the new federal budget law". Read on....

That's good law, but why should it apply only to publicly funded research? Withholding of raw data means that the work is not science in any conventional sense, and should not be published or publicized as science. Science that cannot be scrutinized is not science at all.

3 years ago today: The MHRA: "Shake-up" vs "inaction and cover-up"

On 11 November 2004 the following item appeared on BBC News about the UK drug "regulator". It is reproduced in full.

BBC NEWS: [Link] Shake-up for drug licensing body, November 11, 2004

A reform of the way drugs are regulated has been outlined by ministers to make the system more independent. A new code of conduct has been drawn up for the Medicines and Healthcare products Regulatory Authority (MHRA) body responsible for licensing. It proposes not allowing the members of the body, the Commission for the Safety of Medicines (CSM), to hold interests in the pharmaceutical industry. It also calls for more patient involvement in the process. Two lay representatives will sit on the CSM, the new name for the Committee for the Safety of Medicines, as well as patient representatives on every expert advisory group under the plans. The MHRA has also written to pharmaceutical companies to demand more action on their agreement to publish their clinical trial data. The move comes after heavy criticism at the way the MHRA operates. On Wednesday in a Westminster Hall debate Dr Ian Gibson, chairman of the Commons science and technology select committee, said the MHRA had an image problem. He said it was "gaining a reputation for not giving out information". "I think it is time the culture of secrecy was addressed.

"The damage done by the public believing they have been lied to or defrauded is difficult to repair. "It is the only regulatory agency that is fully industry funded. "It is a difficult task to convince people that a regulatory body entirely funded by the industry is impartial." Last month BBC's Panorama programme criticised the MHRA over its handling of anti-depressant drug Seroxat. The Panorama investigation claimed vital information relating to Seroxat was overlooked.

It suggested the drug could be addictive and increase suicidal feelings in young adults. Health Minister Lord Warner said it was important the MHRA was "open and transparent". He said the changes meant that "everyone can be confident in the impartial and independent expert advice given on the safety of medicines". Professor Sir Alasdair Breckenridge said: "Proposals for the new commission incorporating strengthening of patient and lay involvement, tightening of the rules of interest and increased transparency will move the MHRA forward in its aims of improving public health." And Harry Cayton, the government's patients tzar, welcomed the increased involvement of patients, saying it would increase the agency's "expertise and strengthen its ability to take account of the public interest". "I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions."

No shake-up ever took place. See also:
The MHRA : Why is the government not acting?
1463 days to nothing - the GlaxoSmithKline Criminal Investigation

1 year ago today: Medical Leadership in action

On 11 November 2006 Elizabeth Paice, Chair of the medical forum charged with delivering MMC (Modernising Medical Careers) in the UK stated "MMC is going to be really, really good". (From BMA News 11 Nov 2006)

And it was good, really good.

Read on:

• Fiasco over doctors’ jobs
• Pick a doctor by computer 'fiasco'
• Dr Elizabeth Paice in Article 10 Human Rights Act 1998 Shock
• On Elizabeth Paice

Earlier|Later|Main Page

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:

They 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

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

Earlier|Later|Main Page

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.

Earlier|Later|Main Page

1463 days to nothing - the GlaxoSmithKline Criminal Investigation

It is four years ago this week that the UK drug "watchdog" the MHRA started an "independent" "criminal" "investigation" of GlaxoSmithKline over paroxetine clinical trials. This followed the clear appearance that Britain’s biggest pharmaceutical group had withheld data and had misrepresented clinical trials findings to both patients and prescribers.

Is it likely given the functioning of the MHRA that this will be honest or plausible? That seems almost inconceivable.

I have carefully read the original documents on one part of this problem involving paediatric study 329. It seems to me that four years would not be required to state the obvious. I am wondering why the General Medical Council has not been involved and why it has taken no steps to deal with the company clinicians or the involved medical members of the MHRA itself. After all it does seem likely that patients will have died as a result. This "investigation" has been a joke and a charade from the start. It is almost five years since the first "expert team" assembled by the medicines regulator dissolved after it was discovered that two of the four members held shares in GlaxoSmithKline (The Guardian 26 March 2003).

I am wondering what possible truth can emerge from this all.

It is most unusual that Gordon Brown should invite a company undergoing criminal investigation to join his new International Business Advisory Council. That alone would seem to have preempted any plausible examination.

Read more
http://seroxatsecrets.wordpress.com/2007/10/
http://news.bbc.co.uk/1/hi/programmes/panorama/6291773.stm
http://news.bbc.co.uk/1/hi/programmes/panorama/6298269.stm
http://www.socialaudit.org.uk/6060407.htm
http://clinpsyc.blogspot.com/2007/01/journal-editor-unapologetic-over.html
http://clinpsyc.blogspot.com/2007/01/keller-bad-science-and-seroxatpaxil.html

I think it is time to call this terrible disgrace and coverup by its real name. Again, where are our medical leaders in all this.

Earlier|Later|Main Page

Safe medicine, whistleblowing and the Monogomphe

For anyone interested in integrity in science and medicine, one question looms large. "Where and how can an individual patient or professional ask questions about integrity and public safety?". In the answer to that question lies the most important indicator of good government and of safe medicine.

There are some who are only interested in the appearance of integrity.

Evidence from innumerable cases shows that question-askers are bounced from implausible pillar to post. In my case these pillars included the usual suspects - the General Medical Council (GMC), the discredited Medicines and Healthcare Products Regulatory Authority (MHRA, see here and here), a so called "scientific" Journal (JBMR, See here and here) and sadly also the brand new shiny but toothless UK Panel for Research "Integrity" (at least during our short but vacuous acquaintance). Question askers encounter interminable delay, obfuscation and outright deception. They see their concerns redrafted by others into entirely different ones which are more easily managed. They see their concerns bounced back to organizations who attempted to obscure them in the first place. Everything is shrouded in secrecy. There are legal threats and intimations of bodily harm that question askers may encounter. All this happens with a delay of several years during which time the questioner decides to give up, die or commit suicide.

The basis for these problems lies in the increasingly special relationship between the pharmaceutical industry, a network of powerful colleagues, the government and these very organisations which purport to deal with matters of "integrity" and "professionalism". When those who regulate, those who are regulated and those who scrutinize the regulators become one and the same, alarm bells should be ringing.

Speaking of teeth and of suicide, the story is told of the French academic who found himself facing those four doors. He decided to commit suicide. However he decided first to compose his own epitaph (Ref 1).

The first line was a very fine one-terminated with the word triomphe. To this, after a long search he could find no rhyme, but he could not bring himself to sacrifice his beloved line. Time passed, finding him still in search of his rhyme. He was assisted by a number of friends, but all was in vain. One day he succeeded. The rhyme so zealously sought has been discovered, and the completed epitaph is here as revealed by C.C. Bombaugh (Ref 1):-

Attendre que de soi la vétusté triomphe,
C'est absurde! Je vais au devant de la mort.
Mourir a plus d'attraits quand on est jeune encore:
A quoi bon devenir un vieillard monogomphe?

Monogomphe; a brilliant Hellenism signifying "who has but a single tooth".

The problem is that these monogomphe "integrity" bodies use their single gomphe to chomp away at achieving the very opposite of their stated purpose. They have continued to do this even after the inquiries into their malfunction such as Shipman inquiry, the
Bristol Heart Scandal inquiry, and the House of Commons Select Committee Report into the malfunction of the MHRA. In fact these very inquiries appear to have bolstered their antisocial and anti-scientific behaviour. Witness for example the repeated attempts by the GMC to bully a doctor who has raised concerns or the wholly inappropriate political use of the GMC to discredit Andrew Wakefield. Indeed, the GMC has been bullying one question-asker (Dr Rita Pal) repeatedly, using those very powers granted to it following the inquiries into the deaths caused by the rogue Dr Harold Shipman. The GMC certainly gives the impression that it regards repeated bullying and selective ignoring of problems as is its main role. What a chilling effect on anyone else wanting to ask difficult questions. But chilling appears to be the intent.

Sometimes the plan is to twist the nature of language itself. Any responses or correspondence can be redrafted into something which has the mere appearance of English. I have for example been trying to ascertain the meaning Procter and Gamble ascribe to the words "access", "data", "independent", "confidential" and "sufficient" without any great success. Linguistic trickery to obscure problems is a technique with which the MHRA and GMC will be fully aware.

To get a rhyme in English for the word month was quite a matter of interest with curious people years ago (Ref 1), and somebody made it out (or forced it) by making a quatrain, in which a tooth-challenged little girl is described as saying:-

I can get a rhyme for a month.
I can thay it now, I thed it wunth! (Ref 1)

In the meantime, detailed analysis of the operation of malfunctioning systems is required. Even constructive ridicule may improve public safety. Deconstruction and comparison is also useful exercise. When people behave in one direction when encountering one problem, and in the opposite direction when encountering a very similar problem, questions have to be asked. A brief scientific study of the GMC and MHRA suggests that critical concerns about highly placed individuals and corporations are routinely obscured by a network of powerful colleagues, while punishment is reserved for (generally "overseas") doctors who have supposedly bumped and shouted at a drug representative. The silence within my profession as a whole is worrying, and does not point to the highest of standards.

The next Harold Shipman is on our doorstep.

It is called the MHRA (the FDA for those across the pond).

References

Ref 1. C.C. Bombaugh (1828-1906). Oddities and curiosities of words and literature. Dover Publications Inc. New York.

Earlier|Later|Main Page

On decorum in medicine

A quotation by the Irish priest Steve Gilhooley set me thinking about medicine, and the Alice in Wonderland world of medical leadership in particular. The quotation was delivered as part of a sermon on El Salvador. Gilhooley spoke passionately from the pulpit:

"I said to them, '70,000 people have been butchered and none of you gave a shit.'"

There was silence. A priest had sworn in the pulpit.

"And the reason I know none of you gave a shit," he continued, "was because none of you fell off your seat when I said '70,000 had been butchered', but nearly all of you fell off your seats when I said 'shit'."

For the background to this sermon and its consequences read here. Much of Gilhooley's feelings about the church would apply to the current sad state of medicine.

Says Gilhooley [of the church] "There are those who would rather hide the truth. Those whose priorities have become so skewed that they would protect [sexually] abusive priests before they would protect those who fight for justice and transparency. These are the people who are really in control in the Church. Well, let them get on with it. Let them bury it in the ground, and then we'll all start something else."

The desire to maintain decorum and status in medicine seems also to overwhelm all standards of decency. Our profession is inclined to fixate on the irrelevant while ignoring some very bad things. Does civility matter? In the words of David Kern: When you're in an argument with a thug, there are things much more important than civility. I do not like incivility. Yet, I like thugs even less.

The desire to maintain civility, decorum and status instead of ethics explains for example why we as doctors feel quite comfortable with a drug "regulatory" agency in the UK (the MHRA) that simultaneously

1. conducts a high profile campaign against the nutritionist "Poo lady" Dr Gillian McKeith for selling unproven herbal sex aids [Link]
2. ignores all of the very worrying revelations about the drugs we ourselves prescribe

The need to maintain decorum means that it is hard to deal with the difficult and important problems or to deal honestly with the failures of "important" people. It is a lot easier to think about the "Poo lady" than to explore honestly how we were misled by both companies and regulators over Zyprexa, SSRI's, Vioxx and many other drugs (Link,Link,Link, Link,Link).

The emphasis on decorum and status explains why it is considered by some as "impolite" that I accrued extensive tape recordings (sample here or here) of colleagues and pharmaceutical company executives involved in an unsavory scientific "collaboration" that threatened to damage the science I love and to distort our understanding of a drug [Link]. Does civility matter under such circumstances?

The emphasis on decorum and status explains why the BBC had to conduct it's own investigation [Link] of the worrying events surrounding clinical trials of the drug Seroxat and the company GlaxoSmithKline (GSK) as the medicines regulator (the MHRA) simply dragged it's feet for years conducting an internal investigation of its own collusion with the deception. And to cap it all, key figures within the MHRA are previous employees of GSK.

The need to maintain decorum means that even though it seems very likely that both patients and doctors have been misled, that prescribing decisions have been made on the basis of faulty or hidden data, and that patients have suffered or have died as a result of regulatory malfunction, we doctors remain silent (see extensive discussion here and here).

The need for decorum explains why the General Medical Council (GMC) muttered into their beards when presented with evidence of alleged research misconduct involving Dr David Jefferys. Jefferey's was high in the pecking order, and in a position where the need for integrity was part of the job description. He was former director of the Medicines Control Agency and chief executive of the former Medical Devices Agency (both organisations merged to become the Medicines and Healthcare Products Regulatory Agency, the MHRA). This week the General Medical Council also refused to scrutinise in any way the activities of another very important doctor, Dr. Alastair Benbow of GlaxoSmithKline. This despite obvious public concern and a BBC investigation. The GMC refused on the basis that there has not been a criminal or regulatory investigation of GSK (taking the obfuscation full circle). I have no idea how much Dr Benbow knew and when he knew it, but a proper, open and transparent public investigation is urgently required. The GMC cannot claim to be concerned about the scientific integrity of doctors when it behaves in this manner. Indeed the GMC appears to care nothing about the integrity of the research upon which our patients rely.

At the other end of the pecking scale, the GMC has felt quite happy to persecute whistleblowers such as Dr Rita Pal while hiding reports relating to the very serious problems she raised. The recent suspension of yet another Asian doctor for shouting abuse at a Pfizer drug representative was also easy for the GMC, and was presumably felt to have had less impact on the reputation of anyone who mattered [Link].

Earlier|Later|Main Page

Batman and drug regulation in the UK

Thank you to the Bitter Pill Blog for pointing out the uncanny resemblance between the Right Honorable Andrew Burnham Minister of State at the Department of Health, and the psychiatrist known as the Scarecrow who works at Arkham Asylum (and has developed fear-inducing toxins) in the recent movie Batman Begins.

I have posted about the Right Honorable Andy Burnham previously:

I posted about the documented threats from the pharmaceutical industry to the Department of Health and Minister Burnham that they would withdraw from the UK if not allowed to get their own way [Link].

I posted about his praise for myself -- while he did nothing about the actual problems of research integrity I raised -- and while the MHRA, his government agency, attempted unsuccessfully to collude with others to obscure them [Link].

I posted about his rather interesting redefinition of the word transparency as it pertains to the UK drug regulator, the MHRA [Link].

Below is the previous letter I wrote to him about a trivial but important aspect of transparency. He has not replied, no doubt because he probably doesn't read about the concerns raised by us the people, or my blog.

Anyway, here is that letter again. I'll send it by mail, and we will see if we can find out why we are not allowed to know anything at all about those who make decisions about our health and about honesty in drug regulation.

Despite the frivolity, there is a serious intent. It is clear that many patients have died as a result of a complete lack of regulatory transparency, gobbledegook regulation, and government failure to implement recommendations of the Health Select Committee report on the malfunction of the MHRA [Link].

To: Mr Andy Burnham
Minister of State, Department of Health
The House of Commons
UK

Redated 8 April 2007

Dear Minster Burnham

I wish to let you know about a state secret, and to seek your opinion about it.

I should declare a conflict of interest. I was born in a country where a state secret involved brutal policemen and barking dogs. Secrets which could cause doctors or patients to make incorrect decisions because they have been misled (in even the tiniest way) are not legitimate secrets.

I was therefore delighted to note your letter to Stewart Hosie MP (5/9/06) about the UK drug regulator (MHRA) in which you write: "it is important for the [drug] regulatory system and indeed the regulator to operate in as transparent a way as possible".

Your comments relate to urgent concerns raised by many including The Health Select Committee 18 months ago. MP Hosie seemed upset by the rest of your response, since you suggested no time-scale to implement any sort of plausible or honest review of the MHRA. Given your emphasis on transparency Minister, might we consider the legal and moral implications of a small state secret.

Let me paint a picture: Let us suppose you were a doctor Mr Burnham. You are standing there, syringe in hand, about to inject a potentially toxic drug into a patient. You do so in the knowledge that the MHRA, your government agency, has given a stamp of approval. It would be your fundamental right to know why the MHRA approved that drug before inflicting potential harm on a fellow human being. You might imagine you would have a right to know that the MHRA scrutinised evidence, what named persons were involved, and how precisely those persons were qualified. You might imagine that it should be your moral obligation to know these things.

So let us consider a small secret. Mr Ian Oulsnam is operations manager of the GCP inspectorate of the MHRA. This is a key role in this public body. He makes pronouncements about matters of science and medicine. He makes decisions which impact on life and death. He "investigates" matters upon which patients and doctors depend. He was involved in the MHRA self-"investigation" of the TGN1412 disaster. He makes public statements to the press on behalf of the MHRA. He received parliamentary instruction to conduct the fascinating "investigation" of P&G's conduct in Sheffield. He informed me that he "has a "relevant" university degree and a postgraduate degree in statistics.

I was thus surprised to note on the MHRA website a Freedom of Information request from Mr RC (MHRA FOI 06/185). The MHRA declined to convey a list of Mr Oulsnam's scientific publications [on Pubmed there are none]. The MHRA declined to say what university degrees Oulsnam has (if any). It was stated this is personal information. In the same spirit of transparency, the MHRA refused to sign this FOI response. When asked repeatedly to reply in writing, they posted an unsigned printout of their Emailed response to RC.

Oulsnam then made a scientifically incorrect and bizarre statement to the press about a drug. That statement was reproduced by yourself in correspondence to a MP. I therefore repeated the FOI request. I did not ask whether Oulsnam felt himself qualified to do his job. I simply wished to know what precise university degree(s) Oulsnam has (if any), and at which University. This was again refused on the basis that it is "personal information".

The REQUEST (FOI 06/303): "Mr Oulsnam stated to me that he has a degree, and that he also has postgraduate degree in statistics"..... "it is not clear whether I was misled. I request under the FOI a list of the university degrees and postgraduate university qualifications held by Mr Ian Oulsnam of the MHRA (and the names of awarding institutions)."

The MHRA RESPONSE (FOI 06/303): "The full details of Mr Oulsnam's qualifications are not released as this is considered to be personal information." [the absence of "full details" in MHRA language = "no details"]

Given Mr Oulsnam's job and public scientific pronouncements, this is not personal information. My refusal to convey my degree(s) would be a disciplinary offense. The DoH website urges patients to insist that surgeons, doctors, dentists, nurses and beauty therapists disclose their qualifications. Universities themselves consider degree awards to be public information (eg here, here, here, here, here). Even professional hypnotists are required to make their qualifications available upon request!

Question 1 Mr Burnham: Would YOU inject the drug Mr Burnham?

Question 2 Mr Burnham: Is this behaviour restricted to the MHRA?

A similar FOI request to the Water Inspectorate (DEFRA) requesting degrees of an official yielded a remarkably comprehensive response within 2 days listing all degrees, Universities, subjects taken and dates. I feel strangely confident when I drink water.

Yet the MHRA, which (unlike the Water Authority) uses an intermediary - doctors - to administer potential harm to other humans is as transparent as mud. In another instance the MHRA refused to provide any names of officials who had made decisions about Vioxx on the laughable basis that this might expose them to animal rights activists!

There will always be potential concerns about the training, common sense and conflicts of interest of public officials. But the point is that you, as that syringe-holding doctor are not even allowed to know.

Something is wrong Minister Burnham.

Yours Sincerely

Dr Aubrey Blumsohn
and if it matters .... MB BCh, PhD, MSc, BSc hons, MRCPath

Earlier|Later|Main Page

Am I Normal? More on the case of Lisa Blakemore Brown

Many bloggers have been writing about the case of Lisa Blakemore Brown and the shameful attempt by the British Psychological Society to have her pronounced "mentally disturbed" and "unfit to practice" (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22). My collated postings on this topic are here.

The psychiatric transcript of LBB's "trial" has now appeared online here. I will be analyzing this part of her "trial" in detail over the next few days. What happened to Blakemore Brown must never happen to any other commentator on science. The BPS approach to debate is absolutely wrong and against the public interest.

Worse still, the BPS have shrouded the issue in secrecy [Link]. They have allowed the nature of the "charges" to be misrepresented in public while refusing to allow Blakemore Brown to i) discuss her own case, ii) present her case at an international meeting, or iii) publish the transcripts of her trial. The BPS have threatened legal proceedings if Blakemore Brown breaks their "copyright" on what they have done to her.

If Blakemore-Brown did do anything seriously wrong in terms of patient care, then charges should be examined in detail, and criticism should be transparent - but we have seen no evidence of this in her "trial". These procedures have been likened to a Salem Witch Trial and threaten to shut down all debate. I don't have to agree with her in order to be repelled by what is happening. This is not how debates about policy or science should work.

Blakemore Brown appears as sane as the next person working in this controversial area. Having spoken extensively with her, her colleagues and some of her patients, it would be hard to describe her as having a paranoid illness. Even harder since those of us who have investigated the facts of her case know that all of her so called "paranoid delusions" appear to have a solid foundation in fact. The British Psychological Society don't appear to be too concerned about facts. Blakemore Brown claimed that:

1. there were successful attempts to hack into her computer.
2. named parties in communication with the BPS had admitted to computer hacking.
3. documents had been stolen from her home (by an individual known to the BPS).
4. this individual had altered the address of her bank account.
5. a patient had been coached to make an earlier "complaint" by a patient "support group".
6. this support group subsequently received a large injection of funding from a pharmaceutical company.
7. some E-mail and written correspondence had been forged.
8. the BPS lied that they had not been approached repeatedly by a third party to report that a patient had been coached to complain.
9. the BPS transmitted correspondence of dubious provenance (supposedly written by herself) to a psychiatrist for "review" without checking whether she had in fact written it.
10. critical background regarding the source of the correspondence and the stated intentions of the individual who provided it was not conveyed to the assessing psychiatrist.
11. the BPS had continued with their procedures taking no cognisance of the fact that her daughter was desperately ill.
12. the "panel" judging her mental state was composed of an accountant, a physiotherapist, and Dr Pat Frankish.
13. the medical assessor to the panel (qualified in medicine in 1953, was a Consultant Psychiatrist at King's College Hospital), is author of these books on Christianity and psychiatry and has accused her of "grandiosity" (presumably of a non-religious type). This is on the basis of her involvement in parliamentary reports - unfortunately senior parliamentarians have declined to agree with this interesting assessment (see letter from Lord Earl Howe)
14. that the Psychiatrist chosen to assess her mental state and paranoia from her E-mail syntax (including falsified E-mails) is Deputy Director of the UK Mental Health Research Network which aims to provide "a better environment for pharma industry-sponsored research in the UK" [Link].
15. that the psychiatrist "forgot" to include this appointment on his supplied CV
16. that a number of anonymous and named parties had conducted a deliberate and protracted campaign (between 2002 and 2006) to induce a "flame war" on an Internet bulletin board to defame her -- and that she knew the identity of at least one of the anonymous posters (that bulletin board is there for all to see - as is an archive of an earlier postings - but the BPS have not thought to ask for it).
17. that one of those parties defaming her anonymously was in communication with the British Psychological Society.

Unfortunately for Blakemore Brown, she also claimed (amongst many other excellent writings) that thimerosal in vaccines might not be such a great idea. Furthermore she claimed that some prominent paediatricians might have misled the scientific community in terms of the strength of science relating to the diagnosis of Münchhausen's Syndrome by Proxy (MSbP) and supposed murders and injury of children by their mothers. I have no idea at all about this aspect of science. I have no idea whether there is any credible scientific evidence to indicate the specificity and sensitivity of indices for diagnosis of MSbP. I have no idea whether vaccines are always helpful. Lisa Blakemore Brown may well be wrong - but I am starting to wonder why those in power feel the need to stifle debate in this most controversial and scientifically blurry area of medicine.

There are of course never conspiracies to discredit those who forward unpopular, embarrassing or potentially costly scientific viewpoints. Those who believe in conspiracies must be mentally ill. See the next posting on querulous paranoia, and more about the Mental Health Research Network.

Earlier|Later|Main Page

Ghosts in the machine

The American Association for the the Advancement of Science:
Professional Ethics Reports Volume XIX (3) Summer 2006
http://www.aaas.org/spp/sfrl/per/per46.pdf


(Part 1 - the Sheffield Procter and Gamble MHRA "investigation")

Earlier|Later|Main Page

State Secrets and the MHRA (Secret 1)

To: Mr Andy Burnham
Minister of State, Department of Health
The House of Commons
UK

Dear Minster Burnham

I wish to let you know about a state secret, and to seek your opinion about it. I should declare a conflict of interest. I was born in a country where a state secret involved brutal policemen and barking dogs. Secrets which could cause doctors or patients to make incorrect decisions because they have been misled (in even the tiniest way) are not legitimate secrets. I was therefore delighted to note your letter to Stewart Hosie MP (5/9/06) about the UK drug regulator (MHRA) in which you write: "it is important for the [drug] regulatory system and indeed the regulator to operate in as transparent a way as possible".

Your comments relate to urgent concerns raised by many including The Health Select Committee 18 months ago. MP Hosie seemed upset by the rest of your response, since you suggested no time-scale to implement any sort of plausible or honest review of the MHRA. Given your emphasis on transparency Minister, might we consider the legal and moral implications of a small state secret.

Let me paint a picture:

• Let us suppose you were a doctor Mr Burnham:
• You are standing there, syringe in hand, about to inject a potentially toxic drug into a patient.
• You do so in the knowledge that the MHRA, your government agency, has given a stamp of approval.
• It would be your fundamental right to know why the MHRA approved that drug before inflicting potential harm on a fellow human being. You might imagine you would have a right to know that the MHRA scrutinised evidence, what named persons were involved, and how precisely those persons were qualified. You might imagine that it should be your moral obligation to know these things.

So let us consider a small secret

Mr Ian Oulsnam is operations manager of the GCP inspectorate of the MHRA. This is a key role in this public body. He makes pronouncements about matters of science and medicine. He makes decisions which impact on life and death. He "investigates" matters upon which patients and doctors depend. He was involved in the MHRA self-"investigation" of the TGN1412 disaster. He makes public statements to the press on behalf of the MHRA. He received parliamentary instruction to conduct the fascinating "investigation" of P&G's conduct in Sheffield. He informed me that he "has a "relevant" university degree and a postgraduate degree in statistics.

I was thus surprised to note on the MHRA website a Freedom of Information request from Mr RC (MHRA FOI 06/185). The MHRA declined to convey a list of Mr Oulsnam's scientific publications [on Pubmed there are none]. The MHRA declined to say what university degrees Oulsnam has (if any). It was stated this is personal information. In the same spirit of transparency, the MHRA refused to sign this FOI response. When asked repeatedly to reply in writing, they posted an unsigned printout of their Emailed response to RC.

Oulsnam then made a scientifically incorrect and bizarre statement to the press about a drug. That statement was reproduced by yourself in correspondence to a MP. I therefore repeated the FOI request. I did not ask whether Oulsnam felt himself qualified to do his job. I simply wished to know what precise university degree(s) Oulsnam has (if any), and at which University. This was again refused on the basis that it is "personal information".

The REQUEST (FOI 06/303): "Mr Oulsnam stated to me that he has a degree, and that he also has postgraduate degree in statistics"..... "it is not clear whether I was misled. I request under the FOI a list of the university degrees and postgraduate university qualifications held by Mr Ian Oulsnam of the MHRA (and the names of awarding institutions)."

The MHRA RESPONSE (FOI 06/303): "The full details of Mr Oulsnam's qualifications are not released as this is considered to be personal information." [the absence of "full details" in MHRA language = "no details"]

This is bad

Given Mr Oulsnam's job and public pronouncements, this is not personal information. My refusal to convey my degree(s) would be a disciplinary offense. The DoH website urges patients to insist that surgeons, doctors, dentists, nurses and beauty therapists disclose their qualifications. Universities themselves consider degree awards to be public information (eg here, here, here, here, here). Even professional hypnotists are required to make their qualifications available upon request!

Question 1:

Would YOU inject the drug Mr Burnham?

Question 2: Is this behaviour restricted to the MHRA?

A similar FOI request to the Water Inspectorate (DEFRA) requesting degrees of an official yielded a remarkably comprehensive response (within 2 days) listing all degrees, Universities, subjects taken and dates [pdf][image]. I feel strangely confident when I drink water.

Yet the MHRA, which (unlike the Water Authority) uses an intermediary - doctors - to administer potential harm to other humans is as transparent as mud. In another instance the MHRA refused to provide any names of officials who had made decisions about Vioxx on the laughable basis that this might expose them to animal rights activists!

There will always be potential concerns about the training, common sense and conflicts of interest of public officials. But the point is that you, as that syringe-holding doctor are not even allowed to know.

Something is wrong Minister Burnham.

Yours Sincerely

Dr Aubrey Blumsohn
and if it matters .... MB BCh, PhD, MSc, BSc hons, MRCPath

Earlier|Later|Main Page