Seroxat comics… back by popular demand – but what’s happened to Pharma Giles?

So farewell then Pharma Giles… does anone know what has happened to the excellent (and oh so funny) Pharma Giles blog?

Was Giles paid off?  Was he threatened?  Why no explanation?

Maybe the answer lies over at Pharma Gossip?

Anyway, as it seems that Big Pharma doesn’t like being made fun of, here are the Seroxat comics once again!

Although the wonderous ego that is JP Garnier has left Glaxo now, I for one will never forget the caring, sensitive man who watched as Glaxo’s share fell by 40% during his leadership. And what about the MHRA investigation that this year found Glaxo had withheld evidence that the controversial drug, Seroxat, increased the likelihood of suicide among teenagers?

Way to go, JP…

Comic 1

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Comic 2

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Comic 3

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I’m not sure which one I like best – it’s maybe a bit unfair to pick on poor Alastair Benbow quite so much because Breckenridge of the MHRA was just as useless when he was interviewed on Panorama.

OK – I’m sorry, I’ve had a chance to reconsider that last remark – I take it back. Pick on Benbow as much as you like, he deserves it!

You’ll remember that Benbow is the man, who, when asked on television by pharmacology expert Dr Andrew Herxheimer about why GSK had given no warning about the severe reactions from Seroxat despite knowing about it for 5 years… simply replied “Seroxat has provided countless benefits to many people and enabled them to do more, live longer and feel better… and I think that speaks for itself…”

That reply certainly does speak for itself – Glaxo’s corporate mission statement is “… enabling people to do more, feel better and live longer.” In fact, you can download GSK’s corporate brochure here – it’s entitled “Do more, feel better, live longer”.

Good to know we can rely on Dr Alastair Benbow to seriously address patient concerns about one of Glaxo’s drugs without even bothering to consider the direct question that had been asked.

Watch Benbow in action here and marvel at the way he continually avoids questions.

Please remember Alastair – it’s just a little bit of fun!

GSK Lawyers target Seroxat campaigner Bob Fiddaman – see the video they wanted banned!

Well, then… isn’t the internet a wonderful thing.

The video that Glaxo thought they’d had taken down can still be seen thanks to the magic of the internet!

You can read a full description of the contents of the video here

… but perhaps you just want to go and watch it at Furious Seasons: Glaxo Goes After British Blogger’s Video.

Or maybe you prefer to watch it on YouTube

Here’s what Phil Dawdy at Furious Seasons has to say on the matter:

I learned yesterday that attorneys representing GlaxoSmithKline in the UK had sent a letter to Bob Fiddaman, who writes the Seroxat Sufferers blog. Seroxat is Paxil’s brand name in the UK. As a result of the letter, Fiddy felt compelled to remove a video he created and posted to his website in February. It’s not clear to me what specific legal action the lawyers threatened.

I linked to the video when it was originally posted in February since I felt it got at some of the issues that had just been aired in the British and American press concerning accusations that GSK had hidden suicidality data connected with the use of Paxil. The person making that accusation was none other than Harvard clinical psychiatry professor Joseph Glenmullen who had reviewed clinical trials data in connection with a California lawsuit. Fiddy’s video presented statements made by Alistair Benbow, a GSK UK official and medical doctor, concerning the drug’s suicidality profile and contrasted them with statements in the British press about Seroxat’s suicidality profile as well as interspersing all of that with information about select patients who had experienced some of the drug’s rotten side effects. There was even background music.

Fiddy, in essence, posed the question of whether Benbow was a liar.

The whole thing seemed innocent enough since Fiddy was working with known facts and seemed to be presenting them in a reasonable fashion. But GSK’s attorneys, apparently writing to Fiddy on behalf of Benbow, objected to the fact that Fiddy had employed GSK’s logo in his video. What’s more, the video was posted to YouTube and in the comments section someone asked Fiddy a question and Fiddy compared Benbow with Hitler, as I understand it. The attorneys apparently complained to Fiddy that Benbow was feeling harassed as a result of the video. And they also took umbrage that Fiddy has implied that Benbow was a liar.

Fiddy explains his view of the situation here. He took the video off of YouTube recently and issued an apology to Benbow. Fiddy, most of you know, had some rotten experiences on Seroxat (Paxil).

Going after Fiddy for comparing Benbow to Hitler shows an incredibly thin skin on Benbow’s behalf and how silly British press laws are (the subject for another day perhaps). It’s also a move that Fiddy should regard as a backhanded compliment and a badge of honor. He’s being targeted because he is one of the loudest voices on the Internet denouncing GSK and how it’s handled Paxil/Seroxat and he’s clearly gotten under Benbow’s skin. Basically, GSK used lawyers to intimidate an activist into shutting up, especially in light of the fact that there are many, many others on the Internet who have talked serious trash about Benbow. Unless GSK plans to go after everyone who’s said anything sharp about Benbow, then they have singled out Fiddy.

Beyond that, this kind of behavior on GSK’s part chaps my hide, as the saying goes, because GSK has had run ins with academics before and attempted to stifle their views. I simply won’t tolerate this sort of nonsense and since I have obtained a copy of the video thanks to the magic of the Internet, I am posting it here, unedited.

The video is also on YouTube here. You can comment on it here or on YouTube. I know that Paxil/Seroxat stirs passions like few other psych meds, so I’d simply ask that people who feel compelled to comment on this matter in any fashion keep their rhetoric reasonably decent.

Learn more about Benbow here:

Seroxat increases suicidal thinking – it’s official – 2: Alastair Benbow weighs in

Panorama interactive forums

Benbow – “Science, not hype, will be the king here…

Alastair Benbow and the General Medical Council – are the GMC protecting Benbow?

The magnificent Alastair Benbow in full flow…

Seroxat comics once again – given the findings of the MHRA’s investigation into Glaxo they’re quite current once more:

Comic 1

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Comic 2

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Comic 3

buying_our_silence_1.jpgbuying_our_silence_2.jpgbuying_our_silence_3.jpgbuying_our_silence_4.jpg

I’m not sure which one I like best – it’s maybe a bit unfair to pick on poor Alastair Benbow quite so much because Breckenridge was just as useless when he was interviewed on Panorama.

OK – I’m sorry, I’ve had a chance to reconsider that last remark – I take it back. Pick on Benbow as much as you like, he deserves it!

You’ll remember that Benbow is the man, who, when asked on television by pharmacology expert Dr Andrew Herxheimer about why GSK had given no warning about the severe reactions from Seroxat despite knowing about it for 5 years… simply replied “Seroxat has provided countless benefits to many people and enabled them to do more, live longer and feel better… and I think that speaks for itself…”

That reply certainly does speak for itself – Glaxo’s corporate mission statement is “… enabling people to do more, feel better and live longer.” In fact, you can download GSK’s corporate brochure here – it’s entitled “Do more, feel better, live longer”.

Good to know we can rely on Dr Alastair Benbow to seriously address patient concerns about one of Glaxo’s drugs without even bothering to consider the direct question that had been asked.

Watch Benbow in action here and marvel at the way he continually avoids questions.

Please remember Alastair – it’s just a little bit of  fun!

Seroxat increases suicidal thinking – it’s official – 2: Alastair Benbow weighs in

I am getting VERY confused by all this…

Just a few days ago, we had this news:

WARNINGS of the dangers of suicidal thoughts and behaviour are to be
included in the packages of anti-depressants in the UK. Warnings will be
carried in the patient information leaflet in the packets from October this
year (2008).

The direction was issued yesterday (Tuesday 5 February 2008) by the Government’s
Medicines and Healthcare Products Regulatory Agency (MHRA).

So it’s official then – Seroxat/Paxil is linked to suicide.

But wait – in a Panorama interview in April 2003, GlaxoSmithKline’s own spokesman, the one and only Alastair Benbow told us (in no uncertain terms):

“The evidence, however, is clear, these [Seroxat/Paxil] medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm.”

And in ‘E-mails from the edge’ a Panorama programme broadcast in May 2003, Benbow once again defended Seroxat. He said “Whilst self-harm and suicidal thoughts are clearly a feature of depression, they have not been shown in carefully done studies to be a feature of treatment with these [Seroxat/Paxil] medicines.”

Now, remind me again Alastair – where did you put those “carefully done studies” that show Seroxat treatment is not associated with suicidal thoughts.

I think we would all like to see them – in fact, why didn’t you show them to the MHRA before it decided to add the new warnings to the patient information leaflet?

Panorama interactive forums

The links below will take you to three Panorama interactive web forums that took place after broadcasts of the Seroxat programmes.

They’re worth watching to see our good friend Alastair Benbow in full flow defending Seroxat as only he can… you also get to see Charles Medawar, David Healy and Andrew Herxheimer.

14 October 2002

11 May 2003

11 July 2003

Seroxat Comics – reprise

When I was young a big part of my summer holiday were the comics I bought. So in the spirit of times past, here are the Seroxat comics yet again:

Comic 1

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Comic 2

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Comic 3

buying_our_silence_1.jpgbuying_our_silence_2.jpgbuying_our_silence_3.jpgbuying_our_silence_4.jpg

I’m not sure which one I like best – it’s maybe a bit unfair to pick on poor Alastair Benbow quite so much because Breckenridge was just as useless when he was interviewed on Panorama.

OK – I’m sorry, I’ve had a chance to reconsider that last remark – I take it back. Pick on Benbow as much as you like, he deserves it!

You’ll remember that Benbow is the man, who, when asked on television by pharmacology expert Dr Andrew Herxheimer about why GSK had given no warning about the severe reactions from Seroxat despite knowing about it for 5 years… simply replied “Seroxat has provided countless benefits to many people and enabled them to do more, live longer and feel better… and I think that speaks for itself…”

That reply certainly does speak for itself – Glaxo’s corporate mission statement is “… enabling people to do more, feel better and live longer.” In fact, you can download GSK’s corporate brochure here – it’s entitled “Do more, feel better, live longer”.

Good to know we can rely on Dr Alastair Benbow to seriously address patient concerns about one of Glaxo’s drugs without even bothering to consider the direct question that had been asked.

Watch Benbow in action here and marvel at the way he continually avoids questions.

Benbow – “Science, not hype, will be the king here…

 Comedy Gold…

Dr Alastair Benbow, GSK’s European medical director, weighs in on the Avandia debate with all his authority…. Ali B tells us that “… Avandia’s risks have been overblown: Science, not hype, will be the king here.” He went on “Patients don’t necessarily understand the science behind these figures. You can blame the way it [the 43 per cent excess risk of heart attack] is presented as a big-ticket number when the actual numbers [the increase in risk] were very small.”

Good. Fine. That’s clear then Dr Benbow… er, sorry, but what are you actually trying to say here?

Read this recent complaint to the General Medical Council about Benbow and see if you think he’s up to his old tricks again, but this time with Avandia

This from The Times July 9:

Big Pharma’s bitter pill

A £9bn controversy over a diabetes pill raises vital questions about the future of blockbuster drugs

It may rank as one of the costliest sentences to run in a medical journal. On May 21, The New England Journal of Medicine broke its usual embargo and posted online a paper by scientists who had been studying data on a diabetes drug, rosiglitazone.

Dr Steve Nissen and Kathy Wolski’s summary of 42 patient trials into rosiglitazone, sold under the name Avandia by its makers GlaxoSmith-Kline (GSK), had a devastating pay-off: “Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had border-line significance.”

In other words, diabetics who took the drug ran a 43 per cent higher risk of heart attack (a 1 per cent risk rose to 1.43 per cent) and, possibly, a 64 per cent higher risk of death from cardiovascular disease (a 1 per cent risk rose to 1.64 per cent) than patients who took a placebo or an alternative medicine, according to Dr Nissen, a cardiologist, and Wolski, a statistician. Within days of publication, £9 billion had been wiped off the value of GSK.

The company fought back with a letter to The Lancet, deriding Nissen’s meta-analysis methodology and claiming that the side-effects of Avandia, approved for use in the US and Europe in 1999, were comparable to those of rival diabetes medications. GSK’s letter, written by Dr Ronald Krall, the company’s chief medical officer, revealed that its own studies were beginning to point the same way, findings that the company had passed to regulators. GSK’s Avandia-induced headache was exacerbated last week by a small study published in the journal Diabetes Care, linking the drug to a loss of bone density in men. A possible similar effect in women had already been reported.

Whether fairly or not, Avandia risks joining Vioxx – a painkiller voluntarily withdrawn by Merck after being linked to heart attack and stroke – as a totem of the darker practices in the world of Big Pharma: the dogged pursuit of remedies for the ailments of an indulgent West (obesity, diabetes, heart disease); the relentless research and marketing campaigns devoted to me-too medications that offer no substantial benefit over existing therapies; the steep prices charged for branded drugs; the perceived financial cosiness between companies, regulatory agencies and researchers; the selective disclosure of information that shows off experimental therapies in the best possible light; the heavy-handed tactics allegedly employed to silence critics.

Nissen, a heart specialist at the Cleveland Clinic in Ohio, is a seasoned whistle-blower: he wrote a key paper that led to the withdrawal of Vioxx, and has previously criticised the FDA for what he regards as a lax attitude towards drug safety. GSK has speculated that the timing of Nissen’s paper is suspicious (it coincided with US government meetings on the FDA’s future), and may have more to do with politics than patient safety.

Why would GSK question Nissen’s motives? Benbow insists it is patient welfare. But it would be naive not to mention the bottom line – profits.

Until 2003, pharmaceuticals was the most profitable industry in the world (it now comes third, behind crude oil production and commercial banking). Pfizer is at the top of the food chain with its cholesterol-buster Lipitor. It is by far and away the world’s bestselling drug, reeling in $12 billion (£6 billion) in sales a year.

Every pharmaceutical company dreams of enjoying a comparably large slice of the healthcare pie, estimated to be worth $660 billion (£328 billion) by 2020, which is why companies like developing “blockbusters” – defined as drugs expected to reap at least $1 billion in sales a year. These tend to be for common complaints, such as heart disease, asthma, diabetes, arthritis or depression. GSK’s biggest hitter is Advair, an antiasthma medicine, which brings in $3.2 billion (£1.6 billion) annually. Avandia was second with $1.3 billion (£0.65 million).

On average, blockbusters take about 15 years to travel from laboratory to market, a journey that costs around $1 billion. Around four in ten medicines fail at the final hurdle, the Phase 3 clinical trial (when tested in patients against placebo or another drug). Because of this, companies spread their bets by having several therapies in development at the same time. This costly approach is used by Big Pharma to justify high prices on the market.

The blockbuster approach, however, is under attack. According to a report by the accountants PricewaterhouseCoopers published this month, the pharmaceutical industry business model is “economically unsustainable”. Drug companies, the report noted, spend twice as much on research and development than ten years ago but produce half as many drugs.

Share prices have suffered on the back of leaky drug-development pipelines, soaring sales and marketing costs, the prospects of lawsuits (Merck faces more than 11,000 patient lawsuits over Vioxx) and the appearance of the National Institute for Health and Clinical Excellence (NICE), which vets drugs to ensure that they deliver value for money in a cash-strapped NHS. In addition, the finding that not all patients respond similarly to drugs is driving research towards personalised medicines and away from a one-blockbuster-treats-all philosophy. These challenges are, slowly, leading Big Pharma to expand its horizons beyond blockbusters. This month, GSK opened a £50 million imaging centre, a collaboration with Imperial College and the Medical Research Council, which is designed to speed up (and cut the cost of) drug development. It is a tacit admission that companies are finding it harder to go it alone in the hunt for innovative new medicines.

“GlaxoSmithKline – You Bastards!”

So says Bob Fiddaman at Seroxat Sufferers.

“The gloves are off Glaxo.

I have just watched a video of Manie who at only 8 days old had to undergo surgery because the drug YOU manufacture and ‘push’ was prescribed to his mother whilst she was pregnant.

Manie had an arterial switch. Because of the surgery Manie has a leaky valve. Manie’s surgery lasted 12 hrs.

I want YOU GlaxoSmithKline… in particular Alistair Benbow… to watch this short video clip of Manie after surgery. I want to know if YOU feel any sense of shame at what YOU allowed to happen.”

I couldn’t agree more – go here to read the rest of Bob’s post and see the video.

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?

Alastair Benbow and the General Medical Council – are the GMC protecting Benbow?

Below you will find a sequence of correspondence between Charles Medawar of Social Audit and the General Medical Council. It seems the GMC does not want to investigate Dr Alastair Benbow, despite what he has said in public, on more than one occasion regarding the safety and side effects of Seroxat “…In short, and in the light of the evidence that has since become publicly available, this man’s statements on television leave the impression that he conceived his primary duty of care to be to his employers, rather than to the many people (including health professionals) likely to have trusted his judgment as a doctor…”

Now read on:

1 February 2007
Dear Sirs,

I am writing to enquire about the possibilities and appropriate procedures for making a complaint about a registered medical practitioner, in circumstances which do not appear to be covered by the guidance given on the GMC website. I should be grateful for your advice about how to proceed, in the light of the following possibly complicating factors:

1. The complaint I seek to bring does not directly relate to standards of treatment or practice by the individual concerned. I am not a patient of the doctor in question, nor do I have reason to believe that he lacks qualities that would call into question his fitness to practice medicine in a clinical setting. My concern is about the conduct of medically qualified individuals in an institutional/organisational setting.

2. The subject of this prospective complaint is a well qualified physician who acted as the principal spokesperson for the manufacturers (his employers) of a widely prescribed antidepressant drug. I would wish to allege that, in that capacity, and on several occasions, he offered inappropriately reassuring advice about the safety profile (benefit-to-harm ratio) of that drug, in programmes broadcast on television (Panorama: BBC-TV), distributed worldwide. I would wish to allege [a] that his statements were (by omission and/or commission) inaccurate, misleading and possibly reckless; [b] that the statements he made did not reflect the evidence to which he had unique access, whether or not he availed himself of those data. (It is relevant to note here that some submissions to the UK drug regulatory authorities were made in his name); and [c] that substantial harm very probably resulted from his failure either to critically assess the evidence available to him, and/or to his presumption that there was no cause for concern.

In short, and in the light of the evidence that has since become publicly available, this man’s statements on television leave the impression that he conceived his primary duty of care to be to his employers, rather than to the many people (including health professionals) likely to have trusted his judgment as a doctor, and to have been influenced by the reassurances he gave. (Panorama has broadcast four programmes on this subject and this man was interviewed for the first two, but made appearances in all four). I believe that, in the UK, the audience for each of these programmes has been over 3.5 million viewers).

3. My status as a prospective complainant is untypical. The complaint I would wish to bring would and should be in my name – but in my professional capacity as a medicines policy analyst and reporter, with a particular interest in the marketing and effects of this (and related) medicinal products. Therefore it would also seem most appropriate to bring forward any complaint under the letterhead of the organisation (Social Audit Ltd) which employs me in this capacity.

By way of background information, I am enclosing a copy of the review posted to the Social Audit website of the Panorama programme broadcast on 29 January: http://www.socialaudit.org.uk now gets >750,000 visits/year.

I understand this review is to also be posted to bmj.com

I would welcome your advice on how best to proceed. Thank you for your attention; I look forward to hearing from you.

Yours faithfully
Charles Medawar
—————————————
From the GMC 22 February
Dear Mr Medawar

Your complaint about Dr Alastair Benbow

Thank you for your letter of the 1 February 2007.

The main statutory objective of the GMC is to protect, promote and maintain the health and safety of the public. One of the ways in which we do this is by maintaining the integrity of the medical register (on which all doctors wishing to practice medicine in the United Kingdom must be included) by ensuring that those doctors on the register are fit to practice and taking appropriate and proportionate action against those whose fitness to practise may be “impaired” (by virtue of misconduct, ill-health, performance, criminal conviction or regulatory determination). Should we continue with your complaint it would almost certainly fall within the misconduct category.

Your complaint appears to relate to statements made by Dr Benbow, in his capacity as head of European clinical psychiatry at GIaxoSmithKline, on two Panorama programmes in relation to the safety (benefit to harm ratio) of paroxetine (seroxat) on depressed adolescents and children. You have helpfully enclosed with your complaint a copy of a review of his and others comments made on the programme(s), which was posted to the Social Audit website following a broadcast of one of the programmes on the 29 January [2007].

In order for the GMC to determine whether Dr Benbow’s fitness to practise may be impaired by reason of misconduct we would need to consider the nature of the allegations you are making (taking into account all the circumstances of the case and our guidance in Good Medical Practice) and whether there is tangible evidence to support a finding of misconduct.

Whilst I appreciate that Dr Benbow’s comments have caused you concern, at present there is nothing in your complaint in its current form to suggest that his medical abilities are affected as a result of the comments you say he made. Therefore, if you wish the GMC to consider this matter further I should be grateful if you would provide me with further details of the allegations you are seeking to make against Dr Benbow, including specific details of exactly which comments you take issue with, when and in what context they were made, and why you take issue with them. If you have any documentation which would support your complaint, then I would be grateful if you could supply this. It would be of particular help if you could provide me with a videotape or DVD of the programmes in question if you are able to do so.

I look forward to hearing from you by Friday 2 March 2007.

Yours sincerely

Anna Neill
Investigation Manager
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From Charles Medawar 28 February 2007

Dear Ms Neill,

Thank you for your letter of 22 February. I’m sorry if I didn’t make it clear in my letter of 1 February that I was not so much bringing a complaint about Dr Benbow, as enquiring about whether and how to do so in the unusual circumstances I outlined.

I mentioned that my search of the GMC website yielded no guidance, nor obviously applicable case law, but thank you for telling me that allegations of misconduct would almost certainly best fit. However, I have checked the GMC website again and have found no pithy judgments, definitions or precise guidance about what misconduct might entail. I would therefore welcome any advice you might give about what might be relevant and appropriate in pursuing the issues in this case.

It might help to clarify these matters at the outset, because preparation of the case would involve me in a lot of work – and a great deal more by the GMC, if the case were to be investigated and pursued. What was said in the broadcast interview would need to be tested against substantial, sometimes detailed evidence, to establish how true, fair and appropriate it actually was. You will appreciate this from the recordings and transcripts of the programme I shall send you, though the gist is clear.

Dr Benbow publicly and emphatically denied the existence of risks with Seroxat® when his employers were in possession of evidence that those risks were substantial and real. The book, Medicines out of Control? gives a summary of events and context, through December 2003, and I shall send you this too. Meanwhile, Panorama specified two main problems:

1. Some users experienced severe and prolonged withdrawal symptoms and felt addicted to Seroxat®; they were unable to stop taking the drug when they very much wanted to. This problem was clearly significant: there were (and are) more such adverse drug reaction reports for Seroxat® than for any other drug. With apparent sincerity, but also quite deviously, Dr Benbow denied their significance. However, within three months of the second Panorama programme, GSK withdrew its claim that Seroxat was not addictive, and radically revised its previous insistence that withdrawal symptoms were rare and mild. They admitted (as they were required to do) that about one-quarter of all users would experience withdrawal reactions, some severely so.

2. Concern was expressed also about the risk of paroxetine-induced violence and self harm including suicidal behaviour, especially in children and adolescents. Again Dr. Benbow denied the available evidence, though a few weeks after the second Panorama programme, the UK regulators required Seroxat® to be contraindicated for use by under 18-year olds. Having seen the relevant data, it took them just two weeks to do so. Independent reanalysis of the original data in 2006 showed the risk for children to be greater still, and that a significant risk existed for adults too.

In my earlier letter, I alluded to the apparent complexity of the issues, but perhaps too obliquely. The prospective complaint is not primarily about Dr Benbow’s abilities as a clinician, the traditional concern of the GMC. Nor is it to do with traditional notions of professional misconduct. The complaint is also very much to do with context: what is proper, or ‘behaviour unbecoming’ or ‘misconduct’, when a doctor assumes responsibility for communicating to millions of people ‘the facts’ about the risks and benefits of using a specified drug, when he also has unique access to the unpublished and most relevant data?

Another complication is that it seems impossible to measure with any precision the health impact of Dr Benbow’s advice – arguably the key indicator of appropriateness of behaviour. My sense is that, if he had been free to reflect what he knew (or ought to have known), and to promote his beliefs and values as a doctor, [a] Dr Benbow would have been very much more circumspect and honest in dealing with Panorama; and [b] this would have spared many people significant injury, loss and distress.

It seems relevant to note that there would be no grounds for complaint about Dr Benbow, had he complied with the terms of the pharmaceutical industry’s codes of practice for drug sales representatives – e.g. “Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication.”

In this connection, you should be aware that, between 2001 and 2003, Social Audit made two separate complaints to the ‘Prescription Medicines Code of Practice Authority’ about gross misrepresentation of risk of dependence by GSK staff. Both complaints were lodged before Dr Benbow’s appearances on Panorama, and both were upheld. As Dr Benbow represented GlaxoSmithKline at the second hearing, he would have been familiar with the issues – including those relating to definition. Dr Benbow’s statements in the first Panorama programme cannot be reconciled with the relevant WHO advice on this subject. See attached letter (20 May 2002) and specifically the section on the definition of ‘dependence’:

Since publication of the ICD-10 guidelines, the World Health Organisation (1998) has published a statement on “Selective serotonin reuptake inhibitors and withdrawal reactions,” which makes it clear: [a] that dependence should be regarded as not an ‘on or off’ phenomenon, but as a condition that should be measured by degree; [b] that on existing definitions, sensibly interpreted, SSRIs can and do cause ‘dependence’; and [c] that in the last analysis, the patient’s experience with the drug is the test of whether or not a drug causes dependence:

“There is obviously some confusion about the concept of dependence … The simplest definition of drug dependence given by WHO is ‘a need for repeated doses of the drug to feel good or to avoid feeling bad’ (WHO, Lexicon of alcohol and drug terms, 1994). When the patient needs to take repeated doses of the drug to avoid bad feelings caused by withdrawal reactions, the person is dependent on the drug. Those who have difficulty coming off the drug even with the help of tapered discontinuation should be regarded as dependent, unless a relapse into depression is the reason for their inability to stop the antidepressant medication.

In general, all unpleasant withdrawal reactions have a certain potential to induce dependence and this risk may vary from person to person. Dependence will not occur if the withdrawal symptoms are so mild that all patients can easily tolerate them. With increasing severity, the likelihood of withdrawal reactions leading to dependence also increases …” (WHO Drug Information, 1998)

Should this case be progressed as a formal complaint, I would need to refer to other relevant documents on the Social Audit website. In the meantime, I hope that the programmes, transcripts and other materials I am sending will help you to determine whether and how you would wish to proceed.

You will appreciate that my underlying concern is about the meaning of being ‘a doctor’, and about the extent to which the public should trust that status, and depend on professional commitment to procuring health and doing no harm. To what extent should the public trust a doctor, when substantial conflicts of interest are involved? Perhaps Dr. Benbow’s fitness to practice is less important than the principle of the thing. I am very much open to suggestion, more concerned about the effective resolution of these concerns than about how this is achieved. I look forward to hearing from you

Sincerely,

Charles Medawar
Director

Attachments: DVDs and transcripts of Panorama programmes, Medicines out of Control? and other relevant materials. The reply from the GMC indicated a reply might be expected “within a couple of weeks”. It took ten.
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From the GMC 11 May
Dear Mr Medawar
I am writing further to your correspondence about Dr Alistair Benbow. I am sorry for the delay in our response.

From the information that you have provided so far, we cannot identify any issues that would enable us to conduct an investigation into Dr Benbow’s practice. In the absence of any clear criminal or other regulatory proceedings relating to the research into, and/or production or marketing of, Seroxat, to which Dr Benbow can be directly linked, there is no information available to us which could amount to an allegation of misconduct capable of calling into question Dr Benbow’s fitness to practise.

We are also of the view that it would be disproportionate and/or premature for us to commence an investigation at this stage for the purposes of searching for information or evidence sufficient to make an allegation regarding Dr Benbow’s fitness to practise.

We do not have information sufficient to make (or support) an allegation that Dr Benbow’s fitness to practise may be impaired. Although our file in this matter is now closed, this will not preclude us from reconsidering this matter in future, should new information or evidence come to light, which indicates that Dr Benbow’s fitness to practise might be called into question.

Please find enclosed your DVD, as requested. We have not taken a copy.

Yours sincerely

Tim Cox-Brown
Investigation Officer
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From Charles Medawar 24 May 2007
Dear Mr Cox-Brown

Thank you for your letter of 11 May (Ref E1-6XK3V) in response to my enquiries dated 1st and 28th February. Thank you too for returning the Panorama DVD that I sent to Anna Neill. I received both on 18 May, several days after I had read the duplicate letter you sent to another complainant, Mr. Derek Brown. He posted your correspondence on the Internet, but you should know that I had no contact with Mr. Brown on this matter: these were independent complaints, albeit prompted by many of the same concerns.

I am now minded to post our correspondence on the Social Audit website (>1m visits/year), to allow others to decide whether my enquiry was handled appropriately. My view is that this response casts doubt on the General Medical Council’s own fitness for purpose. The response to date signals to me lack of competence, capacity, imagination, independence and commitment to health, though in what proportions I can’t be sure.
I was struck by the emptiness of your letter. Everything you wrote emphasised that the GMC believes nothing can or should be done. The available evidence was sufficient to persuade Panorama to complain that Dr Benbow, representing himself as expert, had broadcast false and misleading statements about the safety of Seroxat (paroxetine). Yet the GMC seems unconcerned.

Is this really in the public interest, and in line with public expectations of the GMC? I very much hope not. It seems absurd that the GMC should be satisfied with the conduct of a registered medical practitioner, even when he/she falls short of pharmaceutical industry standards for drug sales representatives:
“Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication.”

I bent over backwards to explain that I don’t have it in for Dr Benbow either as a clinician or personally but – along with many others – I am extremely concerned that any doctor should so uncritically toe the company line, when evidence of drug risk and harm is so strong. The generic issues seem critical: are doctors who speak for drug companies under too much pressure or otherwise professionally compromised? Are they simply to be regarded as company spokespeople, owing correspondingly less to the public by way of duty of care? It seems really feeble that the GMC should conclude so blandly, authoritatively and emphatically that there is nothing to be said, case closed.

The GMC’s position seems all the more unacceptable given that your President recently, if unwittingly, instigated an oppressive investigation of Professor David Healy, on the basis of ropey evidence and dark hints. On that occasion, a bit of deviously orchestrated and nasty gossip was sufficient for the GMC to require Dr. Healy to justify, in some detail, his fitness to practice as a doctor. I suppose it is to the GMC’s credit that they later concluded there was no case to answer; several major pharmaceutical companies would have been well pleased if this monstrous complaint had been pursued.

Here too, the GMC seems to have missed the point. Commercial influence now has profound effects on the ethos of medicine, clinical practice and patients’ health – some undoubtedly welcome, but others unquestionably not. If the GMC wasn’t concerned about the evidence from Dr Benbow, it would strike at the heart of evidence-based clinical medicine. I’d be reassured to think that, as a matter of urgency, the GMC was at least thinking about giving guidance on the subject – strong enough to protect the conscience of honest doctors employed by drug companies.

Both to protect Dr Benbow’s reputation, and to safeguard its own credibility, I suggest that the GMC should now state publicly [a] whether or not Dr Benbow was asked to respond to any allegations? [b] whether and in what manner Dr Benbow explained his position to the GMC? [c] whether or not the GMC accepted evidence from Dr Benbow that he had faithfully described the risks and harms of paroxetine known to him? [d] that the GMC was satisfied that the evidence of risks and harms of paroxetine that were uniquely available to Dr Benbow was satisfactorily communicated and [e] whether he explained to the GMC’s satisfaction that his performance on Panorama was sufficiently guided by the truth, the whole truth and nothing but the truth.

One should expect nothing less from an honourable doctor than from a witness in court, but where does the GMC stand? The question is not rhetorical, but nor am I prepared to fall in with the executive propensity for delay. If you or anyone else from the GMC were to pick up the phone within the next working day or two, I would sympathetically engage in any discussion relating to issues, publicity and engagement – even on off-the-record terms, if that were to serve some greater good. An alternative might be Judicial Review.

Yours sincerely

Charles Medawar
Director
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From the GMC 31 May
Tim Cox-Brown (0161 923 6427)
TCoxbrown@gmc-uk.org

Dear Mr Medawar

Thank you for your letter of 24 May 2007.

We are currently considering your comments and we will contact you again in due course.

Yours sincerely

Tim Cox-Brown
Investigation Officer

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You can find all my previous posts regarding Benbow, collected here for ease of reference.

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