Yet more on Ian Hudson and the MHRA

Another old post here about Ian Hudson playing fast and loose with important public health matters – how that man is still in his job in 2012 is beyond me.

Interestingly, I’ve just found this old article from the BMJ, 29 January 2005

Select committee angry over absence of drug regulator from session

London – by Lynn Eaton

Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry.

Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.

MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.

Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.

“It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible [for drug safety],” said Mr John Austin (Labour MP for Erith and Thamesmead).

The agency’s chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.

The agency’s chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. “However, because of his role in the company [SmithKline Beecham] he doesn’t get involved [in discussions on Seroxat],” said Professor Woods.

Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.

However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.

Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.

Professor Breckenridge admitted that the agency had “suffered from not being professional enough” in its communications. “We are determined to change that,” he said, explaining that the agency has just appointed a communications director.
I hope you noticed the paragraph in bold – “Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend”.

But what I find strange is that if you want to download this PDF – Witnesses for Thursday.pdf – you’ll see that it appears that Lord Warner (then Health Minister) and David Hincliffe had a phone conversation on the Monday morning before the hearing and agreed exactly who was going to attend from the MHRA… and you will see that Ian Hudson is not mentioned as a witness.

I’m confused – who’s lying then – Lord Warner or David Hinchliffe? and why?

I have emailed my concerns to members of the Committee who were there, asking questions that day, but so far I have been ignored – more than once…


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.

Glaxo & the MHRA; the MHRA & Glaxo…

I’ve always questioned exactly where big pharma ends and the regulators begin.

Certainly the MHRA (the UK’s medicines watchdog) has always had VERY close ties to the drug industry, and I mean VERY close.

The revolving door that connects the MHRA and GlaxoSmithKline (in particular) has always been well used.

The Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK (then known as SmithKline Beecham), as is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has a track record of publically supporting Seroxat (but not really very well!)… Hudson is much more interesting – he worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but Hudson is such an authority on Seroxat that Glaxo actually used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon). And to this day we still don’t know if Wheadon was guilty of perjury in that court.

However by 2005, Hudson was not so keen on talking…

A House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had… a prior engagement.

A prior engagement!? Hudson is the one man who knows more about Seroxat’s secrets than anyone outside of GlaxoSmithKline.

A prior engagement? – don’t make me laugh, Ian.

Now, in 2010 we see more evidence of the revolving door between the MHRA and Glaxo in the company’s choice of expert witnesses to appear in the High Court.

The tireless Bob Fiddaman at Seroxat Sufferers has discovered some very interesting facts about Glaxo’s expert witnesses.

One is Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd. Shah was employed by the MHRA between 1987 and 2004. Positions held were: Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

I would be very interested to know 1): who are the current clients of Rashmi Shah Consultancy Ltd and 2): which company was its first client back in 2004…

I’d put money on the answers being – 1): GlaxoSmithKline and 2): GlaxoSmithKline

But this is only the start – Bob Fiddaman is promising revalations about other Glaxo ‘expert witnesses’ in the near future – keep on checking back at Seroxat Sufferers.

You want more evidence of the cosy relationship between the MHRA and Glaxo?

What happened when the MHRA found that Glaxo had hidden negative trial data?… The MHRA announced, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear.”

You want more evidence of the cosy relationship between the MHRA and Glaxo?

How about MHRA staff co-operate with Glaxo to monitor critical comment on the internet..

MHRA and Ian Hudson – still questions to be answered

Things have moved on at the MHRA so they tell us… it wants to be more open, it wants to engage with us…

Well, I’d like it to be more open about one of its employees, Ian Hudson.

I’ve been wanting to get to the truth since January 2005 when the House of Commons Health Select Committee questioned some senior MHRA members about Seroxat (Paxil).

Here’s some background: Ian Hudson worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but Hudson is such an authority on Seroxat that Glaxo used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon).

See below for this entry from the Seroxat Timeline.

June 14 2001:
People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.
For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat – Paxil in the USA – was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK (later to become the MHRA).

What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy? His position is that an individual case cannot tell you one way or the other – only randomised controlled trials will do.

But Dr David Healy says that randomised control trials are the wrong tool to establish whether serious side effects are occurring. The way to investigate what is happening is to carry out a challenge-rechallenge trial, where people are given the drug, taken off it and then put back on.

But GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.

Does Mr Hudson still take that view now he is at the MHRA, which watches over the safety of the British public? “If he takes the position with the MHRA that he took at the trial, then none of us is safe with any drug in the UK at the moment,” says Dr Healy. How would Mr Hudson even be able to blame alcohol for making someone drunk?

So what does Mr Hudson think? As always, the MHRA declines to answer detailed questions.

The MHRA will (?) have been supplied with all the healthy volunteer data before it granted the licence for Seroxat. It doesn’t seem to have been worried then, which makes one wonder who, exactly, was steering them as to what it meant.

More on Hudson here and here.

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

At the time, the UK press reported Ian Hudson’s non-appearance at the House of Commons like this: “Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry. Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division. MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.”

I know someone who attended the hearing that day as well, and he confirms that David Hinchcliffe, the Chairman of the meeting was angry & exasperated “There was a great feeling of cover up, or at least that’s what I felt sitting there nearby Charles Medawar. Charles Medawar’s overall demeanour was one of anger, alongside David Hinchcliffe who was also angry & exasperated…”

The transcript of the hearing is here, read around question 783 for a flavour of how the committee and Chairman felt.

In response to a Freedom of Information request, the MHRA has made public an email, download here – Witnesses for Thursday.pdf – apparently showing that Hudson’s non-appearance was agreed in a phone call between Lord Warner (government Health minister) and David Hinchcliffe (meeting Chairman) just a few days before the hearing. This email was from Neil Townley at the Dept. of Health to David Harrison – the Clerk of the committee (and copied to Professor Sir Alasdair Breckenridge.

However this exchange from the hearing is most interesting:

Q790 John Austin: I think it would have been useful if Dr Hudson had been here because, as far as I understand, he was at SmithKline Beecham and his department was responsible for the collection of adverse reaction information such as there was with Seroxat.
Professor Sir Alasdair Breckenridge: Yes, I know that, but I—
Q791 John Austin: So he would have been a very key witness.
Professor Sir Alasdair Breckenridge: But I have not discussed that with Dr Hudson.
Q792 John Austin: So you must admit that it is very unfortunate he is not with us today?
Professor Sir Alasdair Breckenridge: Well, I apologise for that, but I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be.

Why did Breckenridge reply to Q792 as he did? The email that was copied to him on Monday 17 January clearly states Lord Warner and Hinchcliffe had just agreed that it would only be Breckenridge, Woods and Raine who were appearing. For Breckenridge to say “…I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be…” beggars belief.

Well, I think there was no confusion at all. I think the Clerk was never told that Hudson would appear. I think Breckenridge was lying when he said that. I think it would have been too embarrassing to let Ian Hudson be questioned.

I think this stinks.

Why didn’t Breckenridge simply say that “Ian Hudson is not here today because you, Mr Chairman, agreed his non-appearance with Lord Warner on Monday of this week”… (the hearing was Thursday).

And why, if Hinchcliffe did agree the list of attendees, did he say nothing to explain the confusion to the hearing….

So, the question is just what did Lord Warner say to Hinchcliffe during their phone call on the morning of Monday 17 January 2005?

Come on MHRA – let’s you and me have an open and honest discussion about this then.

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?

So, who’s lying then?

Sorry to go over old ground here, but I still have questions about Ian Hudson and his non-appearance at the Health Select Committee hearing back in 2005. I have written about this before, so if you’re new to this thread or just want a refresher then I suggest you look at this post: More on the MHRA and the House of Commons.

Interestingly, I’ve just found this old article from the BMJ, 29 January 2005

Select committee angry over absence of drug regulator from session

London – by Lynn Eaton

Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry.

Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.

MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.

Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.

“It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible [for drug safety],” said Mr John Austin (Labour MP for Erith and Thamesmead).

The agency’s chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.

The agency’s chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. “However, because of his role in the company [SmithKline Beecham] he doesn’t get involved [in discussions on Seroxat],” said Professor Woods.

Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.

However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.

Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.

Professor Breckenridge admitted that the agency had “suffered from not being professional enough” in its communications. “We are determined to change that,” he said, explaining that the agency has just appointed a communications director.
I hope you noticed the paragraph in bold – “Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend”.

But what I find strange is that if you want to download this PDF – Witnesses for Thursday.pdf – you’ll see that it appears that Lord Warner (then Health Minister) and David Hincliffe had a phone conversation on the Monday morning before the hearing and agreed exactly who was going to attend from the MHRA… and you will see that Ian Hudson is not mentioned as a witness.

I’m confused – who’s lying then – Lord Warner or David Hinchliffe? and why?

I have emailed my concerns to members of the Committee who were there, asking questions that day, but so far I have been ignored – more than once…


Ian Hudson’s “significant involvement” with Paroxetine

Ian Hudson worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had significant involvement a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but he used to be such an authority on Seroxat that Glaxo put him forward as a defence witness in the Tobin/Schell case (in fact, he gave evidence for Glaxo alongside David Wheadon).

See below for this entry from the Seroxat Timeline.

June 14 2001:
People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.
For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat – Paxil in the USA – was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK (later to become the MHRA).

What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy? His position is that an individual case cannot tell you one way or the other – only randomised controlled trials will do.

But Dr David Healy says that randomised control trials are the wrong tool to establish whether serious side effects are occurring. The way to investigate what is happening is to carry out a challenge-rechallenge trial, where people are given the drug, taken off it and then put back on.

But GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.

Does Mr Hudson still take that view now he is at the MCA (later to become MHRA), which watches over the safety of the British public? “If he takes the position with the MCA that he took at the trial, then none of us is safe with any drug in the UK at the moment,” says Dr Healy. How would Mr Hudson even be able to blame alcohol for making someone drunk?

So what does Mr Hudson think? As always, the MCA declines to answer detailed questions.

The MCA will (?) have been supplied with all the healthy volunteer data before it granted the licence for Seroxat. It doesn’t seem to have been worried then, which makes one wonder who, exactly, was steering them as to what it meant.

More on Hudson here and here.

You’ve got to ask what exactly does a “significant involvement” actually mean.

I’d like to know.

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