Can you believe they really said this… reprise

Here are all those great quotes brought together in one huge post for us all to consider once again…

I have no trouble making difficult decisions. I do not agonize too much just ask around. I sleep well at night.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
4/5/2004

I do not need to take anything. I am fortunate to be in very good health. And you have to be well in your head. You have to enjoy not the destination, but the journey.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
4/5/2004

I can’t count on people just to trust us as a company to do the right thing, even though they should.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
10/4/2004

I think you have to develop a culture where if there is bad news you don’t sit on bad news. Bad news does not get any better. It can only get better if it’s admitted, understood and addressed.
Robert (Bob) Ingram
Vice Chairman, GlaxoSmithKline Pharmaceuticals
8/25/2002

We’re reviewing every single process at the company. The environment of the business has changed after Enron. I believe that there was a lack of trust [on the part of] the public for big business, and that lack of trust has been amplified by a few bad apples in the cart. And because of that, there has been a tremendous loss of trust in all big business not just pharma and that has implications to me as a CEO.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
10/4/2004

Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.”
Mary Ann Rhyne
GlaxoSmithKline spokesperson
11/11/2002

We don’t want to be accused of anything about the way we deal with trials.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
6/21/2004

As a knowledge-based industry we understand full well the value of information, and we want to create a climate of openness where the evidence for prescribing our products is clear.
Richard Sykes
Chairman of Glaxo Wellcome
6/19/2004

I think if, if we’ve been guilty of anything over the past few years, perhaps, um, emphasizing entertainment over education, um, we know that’s what patients really want.
Christopher Viehbacher
GlaxoSmithKline U.S. President
8/16/05

Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
10/13/02

My wife thinks J.P. [Garnier] is the best thing since sliced bread.
Christopher Viehbacher
GlaxoSmithKline U.S. President
7/21/03

….there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
10/19/2000

No, we are not misleading them [patients]. The information in the patient leaflet and in the information we supply to doctors, is based on fact.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
10/13/02

We are a high-integrity company. We know what the rules are and we follow them.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
6/6/2004

The vast majority of drugs more than 90 per cent only work in 30 or 50 per cent of the people, I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody.
Dr. Allen Roses
GlaxoSmithKline Senior V.P.
Genetics Research
12/8/2003

It’s not possible really to measure total serotonin. We do not know with absolute certainty about how any of the antidepressants work.
Alan Metz
Glaxo Vice President for Clinical Development
source: Generation RX

If anyone thought drugs were without side-effects, hopefully that’s over. All drugs have side-effects. We are having to spend hundreds of millions of dollars on lawyers.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
4/23/2005

We follow the law, and we follow government guidelines.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
8/26/2005

This is a company that is reinventing itself … possibly creating a model for pharma companies.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
7/21/03

The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm.
Dr. Alastair Benbow

GlaxoSmithKline’s European Medical Director
10/3/2004

So we always want to make sure we are serving the good, the right purpose….
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
9/9/2004

I’ll be a hero in three years.
Jean-Pierre Garnier
Chief Executive Officer GlaxoSmithKline
4/5/2004

I am sure it happens because academics are very, very busy people, and they prefer to do research than spend a lot of time writing papers. If the industry puts forward a method of relieving them of that chore, then I am sure that that does happen throughout the industry. That would be true generally. Is it a good idea? I think it can be, as long as everybody is in agreement with what is written at the end of the day, the results and what they are.
Sir Richard Sykes
former Chairman of GlaxoSmithKline
On the industry practice of “ghostwriting medical reports” and “gift authorship.” 12/7/2004


We have acted responsibly in conducting clinical studies in pediatric patients and the dissemination of the results. We would strongly disagree with any allegation that we have done otherwise.

Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
6/19/2004

You can experience symptoms, as you can with other SSRIs and as you can with other kinds of medicines as well.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
12/13/2003

What we have seen in terms of the anecdotal reports [of Paxil withdrawal] is that it happens very rarely.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
8/25/2000

While GlaxoSmithKline strives to produce medications that safely and effectively treat medical conditions, we’re also committed to protecting the environment.
Dr. Anne Phillips
Chief Medical Officer of GlaxoSmithKline
source: GlaxoSmithKline

As you can see here, few numbers of patients experienced any adverse event after being randomized off [Paxil] into the placebo group and the percentages are certainly very small. But these were the common adverse events seen in that small population in our attempt to systematically assess a discontinuation syndrome.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services Excerpt from a transcript of the FDA Review of Paxil
10/5/1992

I have my iPod and my Bose headphones. You can run anywhere. I’m in a bubble. When I go home I don’t talk about my job. It drives my wife crazy because when we go out she doesn’t know anybody. Socially we see politicians we have to and she knows nothing about the issues. But that’s the way I like it. I want to go home and say, ‘hey what happened to you?’ I have a very demanding job and I don’t want to go home and discuss the same stories.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
4/23/2005

We feel strongly that we have an obligation to speak up both for the millions of patients that Seroxat allows to lead a normal life, and for our employees whose commitment to this important medicine has made such a positive difference to so many people.
Eddie Gray
General Manager
GlaxoSmithKline UK
10/10/2002

My mum, you know, she thinks her son walks on water…..
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
4/23/2005

….recognize that in the final analysis success rests on selecting the right people to work with. If you have the right people, the rest will follow.
Jan Leschly
Former CEO of SmithKline Beecham

If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
2005

Drugs like Seroxat [Paxil] have been around for almost a decade and help millions of people fight depression. There’s no reliable scientific evidence to show they cause withdrawal symptoms or dependency.
Alan Chandler
GlaxoSmithKline spokesperson

These problems [’discontinuation reactions’] are just the body’s adjustment when you stop taking medicines. It takes more than that to be addictive.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
8/21/2002

The side effects [of Paxil “discontinuance”] are things like dizziness, nausea, headache, um, and are clearly labeled in the information made available to doctors and patients.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

I think patients have nothing to fear from taking Seroxat.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
6/13/2002

Experts including the FDA and leading physician and mental health organizations agree that antidepressant medications like Paxil are non-habit-forming.
David Stout President
US Pharmaceuticals
GlaxoSmithKline
10/10/2002

It was quite clear from talking to patients and as a doctor that’s very, very important to me, it’s quite clear that the phrase “Seroxat is not addictive” was poorly understood by them.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
5/11/03

It’s becoming too easy for many people to attack the pharma industry and hold the pharma industry to standards that are higher than anywhere else. I don’t have a problem with the standards….
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
6/6/2004

Of course we didn’t follow this advice. Of course we didn’t selectively publicize the data. This is not a smoking gun. It’s a stupid memo and there are lots of stupid memos in every company’s file and it is really unfair to look at the company’s action through the small hole of one memo written among thousands and thousands in 1998. I do regret that those memos exist but I’m not going to lose sleep over the fact.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
6/6/2004

I utterly refute any allegations we are sitting on data, that [we] have withheld data or anything like that. We have provided all the data both relating to safety and efficacy in the pediatric population to the regulatory authorities around the world and have hidden nothing.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
6/15/2003

Corporate responsibility is not just a job for selected people at GSK, it defines the way we do business. Our ten corporate responsibility principles set thestandard for everyone, since responsible business is only a reality if it is practised by all employees at all times.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

The overwhelming view of independent medical experts and regulatory bodies around the world who have seen the data, is that Seroxat has a well established safety profile and is an effective treatment with experience in tens of millions of patients worldwide since launch in the UK over ten years ago.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline 10/10/2002

Human behavior is we know so little about it, and therefore, to try to speculate on a mechanism for human behavior is very difficult.
Dr. Tadataka Yamada
Chairman of Research and Development GlaxoSmithKline 1/24/2001

Sometimes a system indeed hinders your rise up the ladder but you also have to accept personal responsibility. That translates into realizing that it’s not always someone else’s fault that you didn’t get promoted. You have to ask some serious questions of yourself before you point the finger at someone else. Ask yourself, `What have I done?’ ‘What is my role in this?’ ‘What am I willing to do?’
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
10/26-27/1995

If we meet the test of our highest purpose nothing less than making historic contributions to human welfare then we will surely meet our important responsibilities to other GlaxoSmithKline stakeholders, to the investors who put their trust in our performance, to the communities in which we operate, to our colleagues and to ourselves.
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline from GSK’s web site

We are all in favour of this being scrutinized all the time, because it is not in our interests to have a product on the market that is not safe or effective.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline 2/15/2002

I think fundamentally the public needs to be reassured that multinational companies and globalisation are not bad quite the reverse.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
2/18/2003

We take the safety of our medicines extremely seriously….
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

First of all let me say that we, as a manufacturer of pharmaceutical products and vaccines, take any report of an adverse event on any of our products, seriously.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
1/31/2001

If you pay peanuts you get monkeys and we cannot have monkeys running this company.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
1999

Great [GSK] products, however, are not the whole story society expects companies to act responsibly in their pursuit of success. If anything, the fact that our business is about human health makes it even more important that we operate to the highest standards.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

I think to focus on safety is important.
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
3/01/05

….my experience is that most physicians don’t look at the [a drug safety] label very carefully. And I’m not certain. I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section….
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
1/24/2001

Responsible business practices are also the key to a good reputation. In 2004, the pharmaceutical industry and GSK continued to come under public scrutiny on how medicines are developed, tested and marketed. To meet this challenge we must act with integrity and be open about our approach to these important issues.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

Our concern is people’s safety.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
3/1/2003

Anybody who suffers side effects of any sort I feel every sympathy for….
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
5/11/03

Everybody who has looked at this the FDA, American Psychiatric Association, National Mental Health Association all those groups agree that SSRIs, like Paxil, are not addicting and not habit forming.
Andrew T. Bayman
attorney for GlaxoSmithKline
King & Spalding

GSK strongly stands behind the safety and efficacy of Paxil. Physician organizations, like the American Psychiatric Association, have stated that antidepressants are not habit-forming.
David Stout
President of U.S. Pharmaceuticals, GlaxoSmithKline

GlaxoSmithKline is proud to offer physicians Paxil CR the latest treatment advance in the SSRI class.
David Stout
President, US Pharmaceuticals, GlaxoSmithKline
4/19/2002

We missed something big we missed the fact that the public wasn’t going to necessarily trust us.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
8/13/2005

Talk is cheap.

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Long-term Seroxat use and its associated health problems

Have you been taking Seroxat for 5 years or more?

Suffered health problems that you think could be caused by Seroxat?

Then don’t tell me, but go to – ‘Seroxat: Ups and Downs’ – and let them know.

It’s new forum and we all have to start somewhere, so get over there and start posting!

The forum has been started by Shutah, whose signature runs like this:
Prescribed 20mg Seroxat 1996 for migraines!! WHY???
Divorced 1997.
Doolally 1997 onwards.
Escaped to USA 1999.
Completely barmy 1999 onwards.
Came back to UK 2003 and tried 10mg – OMG!!! Scary time.
Back up to 20mg. Ahhhhh calm again.
2004 tried 10mg again – MANIC!! Murderous!! Frightened!!
2005 put up to 30mg – wahay!! Fairyland!!
2006 down to 20mg.
2007 still on 20mg – too darn scared to try again!!!

I should also perhaps mention Shutah’s blog while I’m at it – the Seroxat Weblog

Everything you ever wanted to know about… ‘patient groups’

Well, not EVERYTHING of course! This is the fourth post in a series that recaps (in one handy place) all I’ve written so far about a particular subject. The first three ‘everythings’ have been about Alastair Benbow, Ian Hudson and Serotonin.

But what about these patient groups I hear you ask…

I’ve written quite a lot on this subject, as I feel strongly about it. The collected posts run to four pages. You’ll learn about a complex cast of characters and organisations that include:

Jim Thomson & Amelia Mustapha, Rodney Elgie, Neil Bindemann, Dr Chris Manning, Innervate Ltd, The Centre for Mental Health, The Healthwell.org, The European Alliance for Access to Safe Medicines, Depression Alliance, The Diabetes Monitoring Forum, Primhe, the antidepressant Cymbalta, Eli Lilly, Boehringer Ingleheim, National Depression Week, MediSense, a division of Abbott Laboratories, GAMIAN-Europe, the European Patients Forum, the International Alliance of Patient Organisations, The European Patient Information Channel, Packer Forbes, the Medicom Group, the (non-existent) All Party Parliamentary Group on Depression, the Partnership for Safe Medicines, The National Alliance for the Mentally Ill, the Alliance for Better Medicare, Citizens for Better Medicare, Action for Access, Breaking through Barriers – Depression: The Painful Truth, Astroturfing, European Depression Day and the European Depression Association.

Jim Thomson himself has told me “What you have “uncovered” is a tissue of conjecture and you are, clearly, a master at putting two next to two and seeing several dozen.” He says it’s all a “fifth-form conspiracy theory.” That might be the case – please follow this link to the four pages of collected posts and you can make your own mind up… I suggest you read from page four backwards to page one to get the full chronological flow!

I think there are a lot of questions to be answered and as you read about these people and organisations just remember Jim’s own words “…ask yourself one question… What does this person, or this organisation, have to gain from taking this position?”

“Continuing medical education – a great way to educate physicians”…!

I kid you not – someone out there really said that – but it was Scott Lassman and he’s senior assistant general counsel at Pharmaceutical Research and Manufacturers of America (PhRMA) – so we can all trust what he says… NOT.

He went further and defended the practice of discussing off-label uses for drugs — uses not approved by the Food and Drug Administration — in the courses. “A lot of times, the regulatory process lags behind the science,” he said. “I think it’s a benefit for physicians…”

But what about the patients, Scott?

“Most of what doctors know about drugs comes from the industry, and that’s not healthy,” said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. “Academic organizations lend their names to courses that are nothing more than infomercials.”

For doctors, though, drug company funding “makes it very difficult to know what research to believe,” said J. Gregory Rosenthal, an Ohio retinal surgeon and a founder of Physicians for Clinical Responsibility, a group pushing for tighter controls on conflicts of interest in medicine. “Even at the (specialty) academy level, you can’t go onto a Web site without being confronted by sponsorship logos.”

Rosenthal will testify today in a hearing before the Senate Special Committee on Aging, which is looking into physician links with the drug industry. Sen. Herb Kohl (D-Wis.), the chairman, said the commercial sponsorship of courses creates a conflict of interest.

“It appears that everyone profits from this pervasive system of gifts and payments, except the consumer,” Kohl said.

Read the entire article here (by Elizabeth Williamson and Christopher Lee in the Washington Post).

You can learn more about Shire Pharmaceuticals and the latest Continuing Medical Education (CME) scam here at The Carlat Psychiatry Blog.

[Thanks to Ken K for alerting me to this.]

Psychiatrists Top List in Drug Maker Gifts

From the New York Times:

As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.

How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved.

Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.

Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.

Still, a similar pattern was evident in a Minnesota database that was the subject of a series of articles in The New York Times this year. As in Vermont, psychiatrists earned on aggregate the most in Minnesota, with payments ranging from $51 to $689,000. The Times found that psychiatrists who took the most money from makers of antipsychotic drugs tended to prescribe the drugs to children the most often.

Read the whole story by Gardiner Harris here

More PhRMA rubbish about CME – and this is good

Daniel Carlat – he of The Carlat Pyschiatry Blog – is well placed to comment on continuing medical education (CME) as he’s a Doctor himself.

He writes (read the whole article here):

Marjorie Powell, Esq., the head lawyer for PHRMA (Pharmaceutical Research and Manufacturers of America), has just made it official: your drug rep can’t buy you more than one glass of wine at the educational dinner meeting you attend. This pronouncement was made today at a Senate Hearing entitled “Paid to Prescribe? Exploring the Relationship Between Doctors and the Drug Industry.”

Senator Claire McCaskill (R., Missouri) elicited this embarrassing lie after she told a story about how her brother, who owns a restaurant, said that his biggest profits came from renting out a private room to pharmaceutical companies giving dinner programs for doctors. The amount of expensive wine consumed at these dinners was astonishing, said Senator McCaskill. How could PhRMA claim that this money is spent for medical education, she asked Ms. Powell, when it appears to be nothing more than a lobbying tactic?

In response, Ms. Powell attempted to deflect the question, but the Senator was relentless: “Do you pay for alcohol?” Finally, cornered, Ms. Powell fumblingly outlined the official policy of PhRMA: “Maybe one glass of wine,” she said, and she then admitted that any amount of wine was not ideal for promoting medical education, or for improving patient care. “Much better would be to provide some pizzas for the nurse practitioners, who are the ones seeing many of the patients,” she said.

I urge interested parties to watch the hearing via webcast, as I did. Unfortunately, I just tried the webcast link and it appears to be broken. The written testimony is available, however, and includes some interesting comments from Jerry Kassirer (former editor in chief of NEJM), Peter Lurie of Public Citizen, Gregory Rosenthal (a retinal specialist who describes a $5 billion treatment pushed by the retinal industry), and Rep. Sharon Treat of Maine.

And if you want to hear our own AMA’s bland party line, cue up the testimony of Robert Sade, the Chair of the AMA’s Council on Ethical and Judicial Affairs. This makes for great bedtime reading, since you won’t get too far before slow wave sleep kicks in. Poor Dr. Sade had nothing to say for himself. When Senator Herb Kohl, the Chairman of the Committee, asked Dr. Sade how he felt about Minnesota’s law requiring disclosure of drug company payments to physicians, he responded, “The analysis of that data is incomplete”, and that “the AMA will be developing a position on that soon.” Thanks for representing the ethics of America’s physicians, Dr. Sade!

CIA’s release of documents implicates drug industry

This is lifted straight from Peter Rost’s excellent blog – he’s said it all, I think:

CIA yesterday released some pretty amazing documents about an agency spying on everyone in a most un-american way and the New York Times wrote a front cover story with the headline Declassified CIA Archives Detail Illegal Activities.

But there was one section New York Time missed, which New Scientist picked up, and this excellent magazine writes:

“Go to page 416, and you will learn of a behavioural drug screened as part of “larger programme, in which the Agency had relations with commercial drug manufacturers, whereby they passed on drugs rejected because of unfavorable side effects”. Drugs deemed interesting were later tested on “volunteer members of the Armed forces”. The programme was apparently considered “defensive, in the sense that we would recognize certain behavior if similar materials were used against Americans”.

It’s the complicity of the pharmaceutical industry, passing on drugs known to be harmful, that I find most disturbing. Any ex-spooks or pharma executives care to comment?”

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