Monday, October 30, 2006

Resistance is futile

A blog comment from reader Odette Lussier is perhaps germane. I thought I would repeat it as a full posting. Comments for and against appreciated. Is there any point resisting the forces of obfuscation, or is it a bit like spitting into the mighty sea?


pharmaceutical research misconductOdette writes: Having had some contact with the world of scientific research, I had just assumed that fraud was standard practice and that no scientist would put good money at risk by publicly admitting that his basic assumptions were wrong when he started planning an experiment. You can't just lose money in blind alleys and you can't be at the mercy of your data. Time and again, I have seen researchers replacing missing data cells with the group average, removing outliers until they get the variance they want, doing linear transformations and even using mind-boggling statistical techniques of their own invention to get a p-value worth publishing.

As one student told me, everybody does it and she has worked hard to get her doctorate. She had no control over the experiment or the technicians doing the analysis and there is no degree for work done, just one for results obtained. That science is a corrupt field populated by frauds, psychopaths, hucksters and hustlers is not news. It just surprises me when someone comes out of the woodwork to complain because I wonder how a person could get their degrees and spend years surrounded by such colleagues without noticing something amiss before now. As another student told me, "Why can't you just play the game?"

And why not? I know someone who bucked the system like you and as a result, the researcher he was complaining about colluded with the university rector to falsify results in order to hide the original delinquent data. He was dismissed from his doctoral studies and threatened with a libel suit. Can't blame everyone else for keeping quiet.

My attitude towards research now is you find what you're being paid to find and if ten years from now someone finds something different, no one will take away your diplomas, awards, funding etc. retroactively. Besides, theories go in and out of fashion and even if you take the pains to do ethical research, it doesn't mean that anyone will even consider it relevant by then.

Furthermore, the moral argument that human lives are at risk is getting shakier every day. This is not a position based on reason, but on an ancient moral code involving notions of sacredness and higher power that have been discredited by liberalism for some time now. Inasmuch as liberalism seeks to subsume all aspects of human life to the power of reason, it is to be expected that those who operate from this framework desire to exercise the power they devoted their mental abilities to obtain. The ultimate power, that formerly reserved for the gods, is the power over life and death. Thus, having stripped the gods of their moral authority via reason, why would one hesitate to appropriate their ultimate power over human life as one's own because a few faceless individuals are standing in the way of boundless good fortune, prestige and even more power. This is the final power that religion refused us and that rationalism can confer, that it is not rational to let a few lives matter more than all that can be obtained by possibly putting them at risk. And that's why we have unsafe products, bad meds, pollution and a host of other ills that actuarial bean counters allow to be foisted on the public because in their estimation, a few faceless lives that could be lost are not worth the cost of doing things "right".

It also helps to remember that "In the long run, we'll all be dead." It's not like there's someone waiting on the other side to hold you to account because you colluded with a pharmaceutical firm in putting out a bad product that harmed someone. These companies have enough money to keep people tied up in court for a long time, especially if they are poor or indigent, which is why product testing in the developing world is such a good idea. Thus, you could probably escape the negative moral consequences of your rational course of self-interest completely, whereas your irrational devotion to a moral position that would keep poor people picking through garbage in Brazzaville while you have an obscure career with little fame and even less money seems to no one's advantage.

If you think the game is fun now, wait 'til all those Chinese researchers who were trained in the west start churning out publications back home with a trillion-dollar economy to back them up. They can drown us in normal curves and powerpoint presentations and we'll never be able to separate the wheat from the chaff.

As it is, why would we believe any white-coated pharmaceutical/government research apparatchik about anything? These people have secured their position over the rest of us for a hundred years by touting their greater capacity for reason. Problem is, I have lost faith in the power of the white coat and the fancy diploma to know better than me. I just expect them to be more arrogant about it, that's all. So, call me superstitious, call me irrational if you like, but my years in data analysis have taught me that I can demonstrate that astrology works, that homeopathic medecine is a panacea, that aliens communicate with us or any else I want, as long as I am financed by deep pockets who find it in their interest to popularize these beliefs. By the way, you might want to keep all this in mind when you see the bible beaters attacking science. The way I see it, scientists brought it on themselves. Now, if they could only figure out how to get research grants from these people, think what amazing new "facts" they could discover.

Odette Lussier

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Tuesday, October 17, 2006

Pharmaceutical research games

For researchers and the public

  1. You be the researcher
  2. Follow the path researchers face
  3. Make your own choices along the way

For the pharmaceutical industry

  1. Babble about the free market
  2. Claim that you are operating within that free market
  3. Next pressurise government
  4. Ensure that the regulatory body you run immunises you against litigation
  5. Hide undesirable data from researchers and regulators
  6. Employ public relations firms to spy on critical scientists
  7. Silence critical scientists and Journals with the threat of litigation
  8. Use the resulting cloud of hilarity to publish falsified findings
  9. Mention the "free market" again

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Monday, October 16, 2006

Ghosts in the machine

The American Association for the the Advancement of Science:
Professional Ethics Reports Volume XIX (3) Summer 2006

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

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State Secrets and the MHRA (Secret 1)

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

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.

MHRA guardOulsnam 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

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Monday, October 09, 2006

Watchdogs and Fig Leaves

Many government, professional and private organizations claim to support ethical conduct in research.

Some of these organizations pontificate and write guidelines, but remain completely silent and unsupportive when those guidelines are breached.

Others are used as a smokescreen allowing "virtuous protestations from those whose success is based upon systemic failures" (1).

They can also be used to create a false impression that "all is well", that "there are safeguards" out there, and that "whistleblowers are supported" - when no plausible safeguards exist.

Sometimes these organizations are completely subverted by those with different aims, and used as a Fig-Leaf to hide systemic failures.

A report in The Times describes just such a Fig-Leaf (Drug trials and errors : An expert watchdog is disbanding in protest. The Times. 7 Oct 2006 Link).

"an expert watchdog has announced that it is to disband, claiming it has been used as a fig leaf for the Government’s failure to provide volunteers with independent advice or support. The watchdog CERES (consumers for ethics in research) launched itself as “the voice of the guinea-pig” in 1989. For the past three years this group of academics and health service experts has lobbied for funding to run helplines for drug-test volunteers. But it is to disband on December 31, claiming that the Government’s clinical ethics committee has been advising drug-trial researchers that simply showing volunteers a leaflet from CERES will satisfy the EU requirement. CERES says this has been done “without our permission or recognition"

Here is how CERES was represented in the Consent form for the ill-fated TGN1412 trial. I hadn't read this consent form before, and I am shocked by it's complacent and misleading content.

It remains to be seen whether the new UK Panel for Research Integrity will turn out to be any less of a Fig Leaf for research misconduct.

Girard,M. (2005) Reformulating the principles of Hippocrates. Medical Veritas 2:682.

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Sunday, October 08, 2006

Announcing the Drug Regulatory Logo competition

We have a competition as diversion from the main and serious remit of this blog.

Drug regulatory bodies have become experts at shielding their corporate masters by baffling and misleading the public and doctors instead of protecting and informing them (see ducking and weaving, thank you Health Minister, why is the government not acting?, and the FDA halo effect). Following the success of the Science Idol Cartoon Contest (the Union of Concerned Scientists) you are invited to help defend medicine and pharmaceutical science from manipulation and to work for a healthier world by :
Designing a new logo or mission statement for the FDA, the MHRA, Health Canada (or your very own drug regulatory body).
All entries will be posted on this blog as they are received.
The closing date is 01 December 2006.
The first prize is 10,000 Sudanese Pounds.
Entries by Email (can be posted without your name if you wish).

To set the ball rolling we have a logo for the MHRA courtesy of the Seroxat Users support group


Although intended to be a lighthearted diversion from a personal battle to prevent obfuscation of ethical and scientific problems in clinical studies involving Actonel, there is a serious purpose. If drug regulation is required, then our patients deserve that it should be honest and transparent. Our patients also deserve that all those who choose to lead our noble profession should do so because they have the interests of patients at heart. A little humour or sarcasm might help to place a tiny spotlight on this particular disease. As with any problem facing our patients, we have to do what we can:
"You've got to do what you can,
and let Mother Nature do the rest."

MeatLoaf - Paradise by the dashboard light

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Thursday, October 05, 2006

Drug watchdog fails the public

The highly respected UK publications Which (formerly the Consumer's Association) and its sister publication Drug and Therapeutics Bulletin (DTB) have long pointed out the failure of the MHRA (the UK drugs regulator) to act in a transparent manner or to provide reliable and timely information to doctors. DTB has always been wholly independent of the pharmaceutical industry, Government and regulatory authorities. Earlier this year, the Labour government pulled funding for distribution of DTB to doctors without any consultation (Hansard) attenuating this reliable information source. Why it did so can only be guessed.

Which? (October 2006 issue) continues to highlight the problems, touching also on the Sheffield MHRA "investigation". At least someone is stating the obvious.

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Tuesday, October 03, 2006

Union of Concerned Scientists Cartoon Competition

A winner has been announced.

Please support the Union of Concerned Scientists

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Thank you for the praise Health Minister Burnham

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

blumsohn gets praise from ministerI don't really need praise Health Minister Burnham. I would however be appreciative if you could reassure me you are doing all you can to ensure that the system designed to ensure integrity in medicine is operating as doctors and patients would imagine it should: - honestly, without intimidation and in a transparent manner. You will be aware of serious concerns that have been raised by others about the Medicine and Healthcare Products Regulatory agency - MHRA (1, 2, 3, 4) the General Medical Council, and the influence of the pharmaceutical industry on scientific debate (3, 5).

For your information I reproduce a paragraph of text from a forthcoming Journal article (6) about the functioning of the MHRA in the Sheffield case. It has also appeared in abbreviated form in Healthwatch (7) this week. I will be writing to you about this with further details shortly.

"The Sheffield dispute was discussed in the UK parliament in December 2005 and was transmitted by the Health Minister to the UK drugs regulator (the Medicine and Healthcare Products Regulatory Agency, MHRA) for "investigation". The MHRA is itself accused of failing to examine or to secure raw data in drug licensing applications, simply accepting the word of industry with blind faith (8,3). Since this was precisely the problem in Sheffield, its disinclination to investigate was hardly surprising.

No investigation (or at least anything fitting that definition) took place. The MHRA failed to produce any report, declined to accept any documentary evidence (9, MHRA response to FOI request #06/115), stated that the matter was of "low priority" (9), and that the agency does not have any procedure for investigating research misconduct (MHRA response to FOI #06/188). Further, it claimed that the drug regulator has no remit, nor any necessary obligation to be interested in the integrity of the scientific literature about drugs (9, MHRA FOI #06/188) unless related to licensing (and collected using documentation appropriate for licensing). It even argued that it is "illegal" for a scientist to have data pertaining to information written in his name without the consent of the company "owning" that data (9,MHRA FOI #06/115). It refused to compare data it was sent from Sheffield with the original data it should have received and examined as part of the licensing process for Actonel. Initially, this refusal was on the basis that it would be "too much work" (MHRA FOI #06/059). Later, it admitted that that it had not in fact seen or retained raw data prior to approving the drug (MHRA FOI #05/404). With governments setting the standard for scientific conduct, it is hardly surprising that independent science has encountered such difficulties. "

Yours Sincerely

Dr Aubrey Blumsohn

  1. MHRA continues to duck weave and delay
  2. MHRA -Why is the government not acting
  3. House of Commons Health Select Committee Report, April 2005
  4. Did MHRA Collude over SSRI's
  5. Evans and Boseley, The Guardian, September 28, 2006
  6. To follow
  7. Healthwatch Highlights
  8. Healy,D. Did regulators fail over selective serotonin reuptake inhibitors? BMJ 2006:(333):92-5
  9. Collated media reports, Sheffield case

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