The MHRA, Ian Hudson and the House of Commons

Just to follow on from yesterday’s post about the MHRA and its links to Big Pharma, I thought this might be of interest.

Below is an old post I wrote, specifically about Ian Hudson and the way he avoided giving evidence to the House of Commons select committee – he just didn’t bother to turn up – he said he had a ‘prior engagement’.

How very convenient.

A short while ago, I wrote a post about Dr Ian Hudson. Hudson is currently the MHRA’s Director of Licensing – but the job he had before he joined the agency was at GlaxoSmithKline – he was their Worldwide Director of Safety and we know from his CV that one of the drugs he had “significant involvement with” was, in fact, Seroxat…

In my previous post I bemoaned the fact that Hudson had decided to go elsewhere on the day he was expected to be questioned by the House of Commons Health Select Committee about Seroxat safety and trial data.

The MHRA has been questioned about the secret data that Glaxo kept hidden for more than a decade.

The MHRA replied that they were “confident that neither Professor Breckenridge nor Dr Hudson had prior knowledge of the data discussed in Dr Breggin’s report.”

Does the MHRA really expect us to believe that Glaxo’s Worldwide Director of Safety, who had a “significant involvement in Paroxetine” (Seroxat), did not have full knowledge of ALL the trials and data that appertained to this particular drug?

Does Ian Hudson expect us to believe this?

He was their Worldwide Director of Safety and Seroxat is one of GSK’s biggest ever blockbuster drugs… hmmmm?

This stinks.

Go on… talk to me

Why not?

Why not just leave a comment and explain things to me – tell me how I’m wrong about you and your products, about you and the way you market them, about you and the way you harm people, about you and the data you kept hidden, about you and the regulators, about you and your lies.

Talk to me – I want to hear your side of the story – I really do.

Surely someone from my “visitors’ book” has something to say worth saying [except the Scientologists]:

Abbott Laboratories, North Chicago, Illinois

Abbott Laboratories, Gurnee, Illinois

Abbott Laboratories, Libertyville, Illinois

Accenture, United Kingdom

Adpepper.com

Allegiance Healthcare, Waukegan, Illinois

American Red Cross, National Headquarters, Washington

American Society of Clinical Oncology, Alexandria, Virginia

Amgen, Thousand Oaks, California

Anapharm, Quebec, Canada

Ashurst Morris Crisp, Edmonton, United Kingdom

Astra AB, Södertälje, Sweden

Astra Zeneca, Montchanin, Delaware

Avalanche Strategic Communications, Hackensack, New Jersey

Aventis Pasteur, Maidenhead, Windsor

Aventis Pharamceuticals, New Jersey

AXA Ireland

Bausch & Lomb, Rochester, New York

Bear Stearns Security Corporation, New York

Bayer Corporation, Pittsburgh, Pennsylvania

Biogen, West Roxbury, Massachusetts

Bircham Dyson Bell, London, London

BMG Avocats, Genève, Geneve

Boehringer Ingelheim Limited, Egham, Slough

Boehringer Ingelheim Pharmaceuticals, Danbury, Connecticut

Boehringer Ingelheim Pharmaceuticals, Redding, Connecticut

Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut

Boehringer Ingelheim Pharmaceuticals, Copenhagen

BKD LLP, Springfield, Missouri

Brigham Young University, Provo, Utah

Bristol Myers Squibb Pharmaceutical Research Institute, Monmouth Junction, New Jersey

Bristol Myers Squibb Pharmaceutical Research Institute, Plainsboro, New Jersey

Brown University, Providence, Rhode Island

Burson – Marsteller BVBA, Brussels

Burson Marsteller, New York

Burson Marsteller (SEA) Pte Ltd, Singapore

California State University, Northridge

Capital One Financial, Richmond, Virginia

Carnegie Mellon University, Pittsburgh, Pennsylvania

Charles University, Prague, Czech Republic

Church of Scientology International, Los Angeles, California

Cleveland Clinic Foundation, Cleveland, Ohio

CMP Media LLC, Great Neck, New York

Collective Intellect, Boulder, Colorado

Columbia-Presbyterian Medical Center, New York

Commission Europeenne, Wezembeek-Oppem, Brabant

Corbett Healthconnect, Chicago, Illinois

Cornerstone Partners, New York

Cypress Bioscience, San Diego, California

Debevoise & Plimpton,

DOIM, Laurel, Maryland

Edelman PR, Alexandria, Virginia

Edelman, London

Edelman PR, New York

Edelman PR, Seattle, Washington

E.I. du Pont de Nemours and Co., Wilmington, Delaware

Eli Lilly and Company, Europe

Eli Lilly and Company, Indianapolis, Indiana

Elron Technologies, Israel

Elsevier Science Limited, Bletchingdon, Oxfordshire

Emory University, Atlanta, Georgia

European Parliament, Brussels

Evergreen Medical Group, Kirkland, Washington

Experian Information Solutions, Roswell, Georgia

FDA, Parklawn Computer Center / DIMES HQ, Silver Spring, Maryland

Parklawn Computer Center / DIMES HQ, Rockville, Maryland

Finkelstein, Thompson & Loughran, Washington, District of Columbia

Fisher & Paykel Ltd., Northmead, New South Wales

Foote, Cone & Belding , New York

Forest Labs, New Hyde Park, New York

Genentech, Dixon, California

Genentech, San Francisco, California

General Motors Corporation, Bloomfield Hills, Michigan

Gerson Lehrman Group, Austin, Texas

Gilead Sciences, Boulder, Colorado

Glaxo., King Of Prussia, Pennsylvania

Glaxo, Raleigh, North Carolina

GlaxoSmithkline, Mississauga, Ontario

Glaxosmithkline S.p.A, Verona, Veneto

Group Health Cooperative, Seattle, Washington

Haymarket Media, Garfield, New Jersey

Health and Welfare Agency Data Center, Clarksburg, California

Hearst Corporation, New York

Hikma Pharmaceuticals, Amman, Jordan

Imperial College of Science, Technology and Medicine, London

Internal Revenue Service, Highland, Maryland

James, Houer, Newcome & Smiljanich, Birmingham, New Jersey

Jones, Day, Reavis & Pogue, Cleveland, Ohio

The Johns Hopkins Medical Institutions, Baltimore, Maryland

Josef Nopp KG, Leonding, Oberosterreich, Austria

Johnson & Johnson, Fort Wayne, Indiana

Johnson & Johnson, New Jersey

Johnson & Johnson, Europe

JP Morgan Chase & Co, Columbus, Ohio

JP Morgan Chase & Co, New York

Kaiser Permanente, El Cerrito, California

Kaiser Permanente Medical Care Program, Los Angeles, California

Kendle, Glasgow, Scotland

King & Spalding, Washington DC

Life Science Communications, Upper Holloway, Redbridge

LNS Communications, Brookline, Massachusetts

Loyola Marymount University, Los Angeles

Management Centre Europe, Brussels

Mayo Foundation, Rochester, Minnesota,

McCarter & English, Newark, New Jersey

Marcus Evans, Chicago, Illinois

McCann-Erickson GuangMing Lt, Hong Kong

McCann-Erickson, London

McCann-Erickson, New York

McCann-Erickson/Torre Lazur, Denville, New Jersey

MDE Investors, Washington, DC

Medical Broadcasting Company, Philadelphia, Pennsylvania

Meditech Media, London

Medstat Systems, Ann Arbor, Michigan

Merck and Co., Montgomeryville, Pennsylvania

Merck and Co., Skillman, New Jersey,

Meta Pharmaceutical Services LLC, Conshohocken, Pennsylvania

Microsoft Corp, United States

MORI, London

Morgen Walke Associates, Brooklyn, New York

Mount Sinai School of Medicine, New York

National Institutes of Health, Bethesda, Maryland

Neuronetics, Malvern, Philadelphia

Nelson Mullins Riley & Scarborough, Columbia, South Carolina

News Corporation, New York

Northwestern University, Evanston, Illinois

Novartis AG, Europe

Novo Nordisk Pharmaceutical, Princeton, New Jersey

Organon Pharmacy, Roseland, New Jersey

Otsuka America Pharmaceutical, Gaithersburg, Maryland

Performance Systems International, Toronto, Ontario

Pepper, Hamilton and Sheetz, Philadelphia, Pennsylvania

Pfizer, Australia

Pfizer, New York

Pfizer, Quaker Hill, Connecticut

Pfizer, United Kingdom

Phillips Lytle LLP, Buffalo, New York

Porter Novelli, New York

PricewaterhouseCoopers GTS UK, London

Publicis & Hal Riney, El Cerrito, California

Quintiles, Raleigh, North Carolina

Regulatory Affairs Professionals Society, Rockville, Maryland

Research Triangle Institute, Durham, North Carolina

R G C Jenkins & Co, London

R I S Christie, Toronto, Ontario

Rosen & Livingston, Brooklyn, New York

Ruder Finn, London

Sankyo Pharma, Parsippany, New Jersey

Sanofi Synthelab(s) PTE LTD, Singapore

Sanofi Techniques, Bourg-la-Reine

Schering-Plough Corporation, Plainfield, New Jersey

Scientific American, New York

Semyung University, Chungbuk, Kyongsang-bukto, Korea

Shire US, Wayne, Pennsylvania

Shock Hardy & Bacon, Overland Park, Kansas,

Smith Hanley, Indianapolis, Indiana

SmithKline Beecham, Ickenham, Slough, United Kingdom

SmithKline Beecham, North Weald, Havering, United Kingdom

St. John Medical Center, Tulsa, Oklahoma

St Josephs Health System, Anaheim, California

State of CA, Dept. of Consumer Affairs (DCA), Sacramento, California

Steptoe & Johnson, London

Steptoe & Johnson, Washington, District of Columbia

Syntex USA, Livingston, New Jersey

Syntex USA, Switzerland

Syracuse Research Corporation, Syracuse, New York

Takeda Pharmaceuticals A, Chicago, Illinois,

Takeda Pharmaceuticals North America, Lincolnshire, Illinois

Takeda UK Ltd, High Wycombe, Buckinghamshire

Texas A&M University, Corpus Christi, Texas

The Bill & Melinda Gates Foundation, Newington, Virginia

The McGinn Group, Fredericktown, Ohio

The Nielsen Company, New York

The Procter and Gamble Company, Cincinnati, Ohio

The United States Centers For Disease Control, Atlanta, Georgia

Trinity Mirror Group, London

TRW Space and Defense Sector, Torrance, California

Ulmer Berne, United States

University of California, Irvine, Irvine

University of Manchester, Manchester, England

University of Newcastle upon Tyne, United Kingdom

University of New Hampshire, Durham, New Hampshire

University of Portsmouth, Portsmouth, United Kingdom

University of Westminster, London

USA TODAY, McLean, Virginia

U.S. Dept. of Commerce – ITA, Cheltenham, Maryland

U.S. Dept. of Health and Human Services, Washington, District of Columbia

U.S. Department of State, Arlington, Virginia

U.S. Senate Sergeant at Arms, Arlington, Virginia

VJIL Consulting, Hyderabad, India

Waggener Edstrom, Portland, Oregon

Walgreens, Arlington Heights, Illinois

Warner-Lambert Company, Morris Plains, New Jersey

Wiley, Rein & Fielding, Washington, District of Columbia

WPP Group, New York

WPP Group U.S. Investments, Miami, Florida

Wyeth-Ayerst Research, Horsham, Pennsylvania

Wyeth-Ayerst Research, Waldwick, New Jersey

Young & Rubicam-Media Edge, San Francisco, California

What about you guys at Ogilvy and Mather Worldwide in New York? Who’s your client? What do they want to say?

MHRA – Breckenridge – Seroxat withdrawal problems

I’ve just read a piece at Seroxat Sufferers – Alasdair Breckenridge (head of the MHRA) is speaking about Seroxat, from The New Statesman in 2005.

It seems Breckenridge was happy that the MHRA had been up to speed on the Seroxat scandal from the very beginning: “If you go back – and I read this out to the Health Select Committee – to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

And here is what Breckenridge actually said to the Health Select Committee: “…What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, ‘As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion’. That was in 1990″.

I think the questions that arise are as follows: what exactly is a “data sheet” and how was it published and provided to patients in 1990? – because I can tell you that there was NO mention at all of withdrawal problems on the Patient Information Leaflet (PIL) that was provided in each box of Seroxat. Neither was there any advice to “discontinue therapy gradually”.

Also, given that the MCA (today’s MHRA) was aware that Seroxat caused withdrawal problems and one should “discontinue therapy gradually”, then please please tell me why there was no mention of these matters in the PIL. No one in their right mind could argue that the MCA had “nailed” the “so-called scandal of Seroxat”.

If the PIL did not inform patients about how to stop taking Seroxat and about the severity and frequency of withdrawal problems, then what did?

Breckenridge: where now?

And so, once again, I find myself writing about the MHRA and one of its most senior figures – in fact THE most senior – its Chairman, Professor Sir Alasdair Breckenridge.

I think that Charles Medawar has pointed out that Breckenridge has a lot of explaining to do… if I can join the queue I’d like him to explain to me why he has not resigned yet and why he has not done anything to protect the public from Seroxat.

Anyone looking in from the outside can see there is something wrong with the MHRA – what it says, what it does and the relationship that it has with the Pharmaceutical industry.

At this point, I’ll hand you over to Charles Medawar:

BRECKENRIDGE: WHERE NOW?

The question then is about Breckenridge’s fitness for purpose in leading the MHRA, not his fitness in medical practice. In his official capacity, he seems to have compromised and exploited his status as a doctor and scientist – making and now casually ‘standing by’ a number of too rash and sweeping statements about the safety of antidepressants in general, and Seroxat® (and Zyban®) in particular. The fact that Breckenridge was for many years a paid consultant to the manufacturers of those drugs doesn’t help. However, impropriety is not the point: it’s about being seen to be unbiased, transparent and committed to doing no harm.

In his public pronouncements on these drugs, Breckenridge seems to personify what the Parliamentary Health Committee (2005) said about the MHRA: “some complacency and a lack of requisite competency … oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings… ” These would be poor qualities in any doctor, and there are too many examples on this [Social Audit] website of Breckenridge leading the regulatory charge. Consider, in particular, what Breckenridge said in the third of the four Panorama programmes (Taken on Trust, October 2004).

In his interview, (including the bits that weren’t broadcast), he bent over backwards to defend Seroxat® and other antidepressants – and by extension, his own record and reputation. More than anyone, Breckenridge led the Agency’s many investigations of these drugs, and repeatedly they emerged with a positive bill of health. Time and again, his judgements later proved wanting – all the more reason to examine the evidence he relied on. Here, for example is Breckenridge on Panorama, shooting from the hip:

Breckenridge: “In fact, what you can say is that the prescribing of SSRIs has increased dramatically since the 1980s, (the) end of the 1980s (and) the risk of suicide has fallen dramatically in that period of time.”

A few weeks later, the MHRA published the conclusion of its Expert Working Group: “Studies generally indicate that increases in the prescribing of SSRIs have not been associated with an increase in population suicide rates, although interpretation of these findings is difficult …”

In these circumstances, one might well ask why Professor Sir Alasdair Breckenridge should now entrust his professional reputation to an MHRA Media Relations Manager. The original questions were surely reasonable: why did he say such things and do they now seem justified? But the answers come from a functionary who is professionally committed, if not exploited, to protect top reputations. She assures us that: “Sir Alasdair stands by the comments he made in the full pre-recorded show”. Her letter concludes: “I would like to reassure you that our Chairman and other spokespeople for the MHRA always ensure that they give robust and fact based judgements to ensure that benefits to patients and the public justify the risks.” I bet she would, but she is far off the mark.

The Agency’s posture seems to illustrate another fatal flaw in the drug control system – the conflict between political and scientific correctness – and Breckenridge never quite managed to reconcile the two. All too often he relied on insufficient or inadequate evidence and put the precautionary principle aside. For years he maintained that Seroxat® withdrawal symptoms were rare and typically mild; now he would have to accept that they were very common and often quite severe. Nor could he now sustain the categorical assurances he gave on Panorama, that such drugs “do not cause suicide, they do not cause suicidal thoughts in adults”. They can and sometimes do.

….some guidance from the GMC would be welcome here. In the meantime, such is the state of the UK medicines’ control system, that Breckenridge can rely on Agency procedures and staff to protect himself against even a catalogue of evidence of ‘conduct unbecoming’. I [Charles Medawar] have previously argued that Breckenridge should resign and increasingly believe that, had he been worth his salt, he would already have done so. Alas, I also have to accept that he will never get the heave-ho: now I just wish that he would quietly go.

Latest from the MHRA to Charles Medawar

“The majority of the enquiry points raised in your letter do not fall within the remit of FOI, as you are not seeking specific items of information… Sir Alasdair stands by the comments he made in the full pre recorded interview… I would like to reassure you that our Chairman and other spokespeople for the MHRA always ensure that they give robust and fact based judgements to ensure that benefits to patients and the public justify the risks”.

Latest from Charles Medawar to the MHRA

Dear Sirs,

Please treat the following as a request under the FOI Act. I am seeking to establish whether and in what way the MHRA defines and requires appropriate standards of behaviour, and levels of personal responsibility, when Agency representatives [a] offer “information and advice to improve public and professional awareness”, when expected to reflect “robust and fact-based judgements”; and [b] are found to have made false, misleading and potentially damaging representations, albeit in good faith.

In this FOI request, I refer specifically to statements made by the MHRA Chairman, Professor Sir Alasdair Breckenridge, in the interview recorded for the BBC-1 Panorama programme, ‘Taken on Trust’, broadcast on 3 October 2004. A transcript of his broadcast remarks is available on the Panorama website, but in framing this FOI request I have also taken account of context, given the reservations expressed by Sir Alasdair in his evidence to the House of Commons Health Select Committee (20 January 2005, at Q815): “The bits of my robust defence of the position of the Agency were not shown and I cringed from behind the sofa when I saw the bits they did show of what I had said. It was very embarrassing”

In the broadcast programme, Breckenridge stated: “There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults”. This claim appears fully consistent with other statements Breckenridge made when interviewed. He was asked: “Why should the public now trust you when you say the benefits outweigh the risks in adults?” He replied: “Because of overwhelming evidence that it does … we have looked at over 300 studies of Seroxat in adults”. Later in the same interview, he emphasised the same point: “There are in over 300 studies which have been analysed and studies using epidemiological databases the drugs do not cause suicide, they do not cause suicidal thoughts.”

The following FOI requests arise in the light of evidence to the contrary that was available at the time this interview took place, notably from data provided to the CSM/MHRA Expert Working Group on SSRI antidepressants. However, the relevance of these FOI requests is underlined by information made available since then – notably in May 2006 by GlaxoSmithKline (GSK), following the independent re-examination of essentially the same data, and in the December 2006 hearings by the US Food & Drugs Administration Psychopharmacologic Drugs Advisory Committee.

1. Does the Agency consider that the categorical assurances given by the Chairman, and his references to “overwhelming evidence” in support of his views, were justified in the light of the conclusion of the Expert Working Group on SSRI antidepressants: “From the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self-harm for SSRIs compared with placebo cannot be ruled out”?

2. In the broadcast interview, the MHRA Chairman sought to explain the linkage between onset of treatment and emergence of suicidal behaviour solely in terms of the delayed onset of drug effect, again wholly discounting the possibility of drug induced suicidal behaviour:
BRECKENRIDGE: There is a period of time when the drug does not act, it takes a period of 3 or 4 weeks before effect.
JOFRE: But it’s in your bloodstream immediately. Are you suggesting it has no effect on you?
BRECKENRIDGE: It has no beneficial effect for some 3 or 4 weeks.
JOFRE: But it might have a detrimental effect.
BRECKENRIDGE: And during that period of time there is a risk of suicide which remains from the period as before, and that is the period when the practitioner must monitor the patient very carefully.

Does the Agency consider that this assumption by Breckenridge was justified in the light of the conclusion of the CSM/MHRA Expert Working Group on SSRI antidepressants? (e.g. “It is very difficult to assess whether these reactions are due to the drug, would have occurred if the person was treated with any antidepressant, or are part of the underlying course of the disease.” And: “This may be suggestive of a causal association but also may be due to the fact that an event occurring shortly after treatment initiation is far more likely to be linked to the treatment by the patient and the prescriber than an event occurring after some time on the drug.”)

3. In the course of the Panorama interview, the MHRA Chairman stated: “In fact, what you can say is, that the prescribing of SSRIs has increased dramatically since the 1980s, end of the 1980s (and) the risk of suicide has fallen dramatically in that period of time.” Does the Agency consider this to be “a reliable and fact-based judgement”, taking into account the conclusion of the Expert Working Group, that: “Studies generally indicate that increases in the prescribing of SSRIs have not been associated with an increase in population suicide rates, although interpretation of these findings is difficult …”

4. In the broadcast interview, Breckenridge stated: “In the adult population the drugs are effective. There are many, many studies to show that.” Does the MHRA accept [i] that of the order of two-thirds of all SSRI prescriptions for depression are written for “mild depression”? [ii] that the EWG was correct in concluding that, “The effectiveness of SSRIs in mild depression has not been clearly demonstrated in RCTs”? And [iii] that the MHRA Chairman therefore failed to comply with the MHRA’s mission, to give “robust and fact-based judgements to ensure that benefits to patients and the public justify the risks”?

In relation to each and all of the above:
5. Does the MHRA now accept that Breckenridge’s assessment of the risk of paroxetine-induced suicidal behaviour in adults was inappropriate and/or unreliable, and therefore did not reflect the “robust and fact-based judgements” that the Agency claims underpins its work?

6. Has either the Agency, or its Chairman, ever withdrawn or apologised for these broadcast remarks? Has any consideration ever been given to doing so? If so, please provide relevant documentary evidence?

7. Did the Chairman undertake any media training, rehearsal and/or formal preparation for this Panorama interview – and please give details if so. Whether or not he did, [i] please identify by date and title any memoranda, briefing notes or advice prepared by or for the Chairman in advance of this interview; and [ii] please disclose the contents of all such documentation.

8. Did the Agency make any assessment either of that Panorama programme and/or of the Chairman’s performance in his broadcast interview? If so, please provide a copy of any appraisal(s) made.

9. Did the Agency, or the Chairman, make any representations to the BBC, following the broadcast interview, to complain of unfair or unjustified treatment of either the subject matter or the Chairman (e.g. relating to his complaint to the Health Committee, referred to above)? If so, please provide a copy of any representation(s) made.

10. Please provide any documentary evidence to show what lessons the Agency learned, following the independent re-analysis of paroxetine clinical trial data, leading to the May 2006 statement by GSK? Specifically, did the Agency consider [i] that the Expert Working Group had been unwise to rely on company analyses of those trial data; and [ii] that Agency representatives should be restrained from making bullish presentations, in the absence of fully reliable analyses and data?

I look forward to receiving the Agency’s response to these questions. In framing them, I have been mindful of the requirements put on pharmaceutical sales representatives under the ABPI Code of Practice for the Pharmaceutical Industry, and specifically clauses 7.2 and 20.2:

7.2 Information, claims and comparison, must be accurate, balanced, fair, objective and unambiguous and must be based on an up to date evaluation of all the evidence and reflect that evidence clearly. They must not mislead, either directly or by implication, by distortion, exaggeration or undue emphasis”
20.2 Information about prescription only medicines which is made available to the public either directly or indirectly must be factual and presented in a balanced way.

I would need some persuading that the MHRA Chairman would have passed such tests. On the other hand, it would be encouraging to find evidence that lessons had been learned. Failing that, I shall seriously consider passing this and further evidence to the Fitness to Practice Directorate of the General Medical Council.

Yours faithfully,

Charles Medawar
Director
Social Audit

[If you want to watch Breckenridge in action – in the very interview cited above, then you can do so here.]

Time to review the MHRA?

In 2005, the Health Select Committee Report outlined the problems with the MHRA. Dr Aubrey Blumsohn (who is not a psychiatrist and yet has similar concerns about the regulation of ‘medical’ drugs) sets this out well, and you can read about it here:

The report did not mince words when it came to the MHRA:

“The Government, like the MHRA, has tended to assume that all is for the best…”

“The MHRA relies on company data, presented as a series of detailed assessment reports, in its decision whether or not to licence a drug. Raw data is very rarely analysed”.

“The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.”

“Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings … The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency…”

Despite this report on the MHRA being published in 2005, as we move into 2007 has any action taken by the government?

None at all.

Download the report here – just scroll down to 5 April 2005, Fourth Report, “The Influence of the Pharmaceutical Industry”

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