Can you believe they really said this…6

And still they come…!

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

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Well, the MHRA did invite comments…!

I think you should have a look here at Bob Fiddaman’s comments to the MHRA…

It’s quite a long post, as he has quite a lot to say!

Bob finishes up with:

I doubt very much if my comments will be taken on board because the MHRA, it seems, refuse to accept negativity. Such is the power of the internet though, these comments WILL be posted if no feedback is recieved. The public have a right to know. If the MHRA continue down the path they are going then the Patient support groups will get louder and louder.

There is a cancer running right through the Medicines Regulator – this cancer, however, is treatable – if it goes untreated it will be the demise of you. Remove members from the agency who have close ties with Pharma. Investigate (impartially and independently) every patient report. Set up a team to read patient support groups and to work with them and NOT against them and act with immediate effect when evidence comes to light that a manufaturer has been lying to you.

A comment worth thinking about

I thought I’d pull this comment out (to Buying our Silence) and let a wider audience have a look. It’s from Matthew Holford and I think it sums up things very well.

It’s all too easy to get bogged down in the detail of all this and not see the incongruities in the bigger picture.

“You’ve hit the nail on the head. We have GSK’s original position, which boils down to Seroxat being exceptionally valuable, which has been publicly modified in certain respects (admission of the risk of suicide in anybody under the age of 31, withdrawal symptoms, risk to unborn babies, etc etc). The original position is bolstered by a whole bunch of academics, at least some of whom, we’re reliably informed, didn’t write the articles that have their names on, and a bunch of patients, who swear that the drug has at least permitted them to gain some perspective, while they sorted themselves out. We also have the support of the DoH and regulators for this original view.

We also have a counterproposition, which comes from another bunch of academics, and a different bunch of patients, who argue that they’ve experienced some quite horrific side effects. We’re also starting to see some successful legal actions. And then we have all the failed trials. Above all, we have GSK’s own view of its drug.

Now, when this counterproposition is put to the DoH, the MHRA and GSK we get silence. And thus the status quo is maintained. In the absence of further input from these players, one is left to speculate. Something’s wrong. It must be wrong, because there is a group of people who have assigned to themselves the right to tell a bunch of other people what is true, and have determined not to entertain any alternative positions.

There is nothing particularly complex about this type of analysis. It’s a standard argumentative approach. It’s called dialectic: one takes two apparently opposed propositions, and rather than attempt to demonstrate the truth of one at the expense of the other, one assumes that neither is true, and by analysing the two one may arrive at the truth. However, for this approach to be successful, the advocates of both propositions must be prepared to engage.

What does it tell us, when one of the parties refuses to take part in a discussion? Nothing, or everything? Or some position in between the two? Well, as I wrote before, people go silent when their reality has been confounded: they need time to process the new data, in order to understand how to respond. When it comes , the response is usually an attempt to re-establish their position. That is, can they disprove the evidence that one has put before them?

This is why presenting their own incongruities to them is so valuable: they have to reject something that they have said, in order to proceed, or else somehow try to reconcile two apparently contradictory statements, in order to demonstrate the consistency of their position. Which they choose to reject tells one everything one needs to know about the type of person one is dealing with.”

Gepirone ER – enter Marty Keller

You may remember I wrote about Gepirone ER a while ago. It’s a drug that has been around for a while and in fact it “was determined by the FDA in June 2004 as not approvable” when Organon tried to get a licence for it. Strange how the information below – from the Fabre Kramer website fails to mention the fact it was not approvable in 2004…

Gepirone ER
Therapeutic Area(s): Major Depression
Phase of Development: NDA under review at FDA

Development Status:
NDA Amendment planned for 2007

Product Description
Gepirone extended release (ER) is a 5HT1A partial agonist. Antidepressant effects are believed to be due to an agonist effect on post synaptic serotonin receptors. Gepirone is the first in this class of direct serotonin agonists.

The extended release formulation of Gepirone allows once daily dosing with a favorable side effect profile. Gepirone ER is the first successful extended release formulation of a 5HT1A partial agonist.

Clinical Trials
An NDA was submitted in May 2001. The FDA stated that there was one immediate release Gepirone trial in major depression that was positive and one extended release study that was positive. The FDA requested one further short term efficacy trial. There were no serious outstanding issues on CMC or preclinical data.

Fabre-Kramer initiated two 8 week trials of Gepirone extended release in the treatment of major depression. The results of these trials were positive and will form the basis of the amendment to the FDA.

The accumulated safety data for Gepirone is huge. There have been 850 subjects entered in Phase I trials. In Phase II & III, 1900 patients have been treated with Gepirone Immediate Release and 3100 with Gepirone Extended Release. In addition, 634 children and adolescents were enrolled into pediatric trials in depression.

The extensive clinical experience with Gepirone has shown it free of troublesome adverse events. Common adverse events are limited to transient lightheadedness, nausea, and headache. Sexual dysfunction and weight gain, common problems with other antidepressants, are not found with treatment of Gepirone ER.

Partners
Worldwide commercialization rights licensed to GlaxoSmithKline.

Perhaps you might also remember that Glaxo had bought the rights to the failed drug and Stephen J. Kramer, M.D., CEO of Fabre Kramer said “We are excited about this alliance [with Glaxo] because we are confident that GSK, through its outstanding experience in the depression market will, once approved, successfully commercialise and further develop gepirone ER….”

Clearly in order to get the drug approved by the FDA, Glaxo’s “outstanding experience” decreed there would have to be new clinical trials… and hey presto – enter Marty Keller and his Gepirone ER trials! Who better to ‘prove’ Gepirone ER was actually a fantastic, very safe new drug than the famous Marty Keller of Seroxat study 329 fame.

Glaxo can always rely on Marty to step up and bat for them – you can watch him in action here in the recent Panorama programme, Secrets of the drug trials.

Yep, when the going gets tough, Marty Keller is your man – the cynics amongst you might think he’ll say whatever Big Pharma want him to as long as the price is right.

Back on February 13 I wrote: Glaxo really doesn’t want to let go of trying to connect Serotonin with a cure for depression – even if, in the case of Gepirone ER, they are more than a bit wooly about the truth – “Gepirone ER affects brain serotonin by binding to serotonin 5HT1a receptors.”

Is this a good thing? Who knows, but at least the PR company has got ‘Gepirone ER’ in the same sentence as ’serotonin’. That’s got to be a start, I suppose – perhaps marketing can build on this sentence with a scientific paper from ‘Marty’ Keller to ‘prove’ it is a good thing!

I was a little slow – seems someone had already got Marty on the case….

The MHRA invites your comments!

This just in from Seroxat Sufferers…

How Regulatory Decisions Are Made – Comments Invited – MHRA, UK

28 Mar 2007

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting comments on “Making Regulatory Decisions about Medicines and Medical Devices.” It has written a document that sets out:

— the main regulatory decisions that are made about medicines and medical devices;

— the principles that inform these decisions;

— the questions that are considered to ensure that the decisions are reasonable, and

— who makes decisions about medicines and medical devices – which includes bodies other than MHRA.

MHRA has drafted the document after consultation with a range of external stakeholders, including healthcare professionals, bodies which represent patients and the public, and the pharmaceutical and medical devices industries.

MHRA invites further comments on it. MHRA will consider all comments and expect to publish a revised version in the summer of 2007. Please e-mail any comments to john.watkins at mhra.gsi.gov.uk (at = @. @ was taken out to prevent spammers from picking up the email)

— You may want to mark up your comments on the Word version of the document, save it on your own computer and then e-mail it back to us.

— If you prefer just to use a simple e-mail, please make sure you note the page(s) and paragraph number(s) your comments refer to.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

We should let them know what we think… it’s only fair!

Posted in MHRA. 10 Comments »

What will be the long term effects of taking Seroxat…?

I often wonder this… what’ll happen 10 or 20 years down the line…?

When I look back on my time on Seroxat, with hindsight I can see the terrible harm it did me then. I can see how it slowly changed ME – the person I was, the person I am… it made me someone different. That is scary. It harmed me physically as well while I was taking it, but at the time none of my illnesses were connected to Seroxat by Doctors.

As for withdrawal, that hit me quite badly. My memories are not clear at all, but I kept a diary during that time and it makes for frightening reading. I don’t pour over it but sometimes I’ll have a look and be instantly transported back in time. But that’s not what I want to talk about.

I’m thinking about the future.

In 2007, I hope that we can all agree on a few givens:

Seroxat is a powerful drug…

Even its makers do not fully understand what it does to the brain and body of patients who take it…

Seroxat has many side effects…

Seroxat is addictive – millons of people find it hard to very hard to stop taking it…

Withdrawal can cause physical and mental traumas…

Seroxat can harm babies in the womb…

Seroxat can cause suicidal, homicidal and violent acts…

Seroxat is not a good thing – it’s not Glaxo’s gift to the world…

What long term damage has Seroxat done to the millions of patients who were prescribed it? What’s going to happen to us all in 10 or 20 years?

And what’s Glaxo doing to find out?

As if by magic…

Just when I’d finished a recent post – The caring face of GlaxoSmithKline – I got alerted to a new post over at Seroxat Sufferers – Objection your Honour – which you really should have a look at it. It’s part of an old trial transcript and it kind of underlines what I was saying in The caring face…. why don’t Glaxo admit there’s a problem?

Here are some details:

Q: How many complaints on Paxil withdrawal have you received since January 1, 1993?
A (Glaxo): We object to the question. We don’t know what you mean by “complaint” and “withdrawal”…

Q: What efforts have you made since 1993 to find out about the Paxil withdrawal problem?
A (Glaxo): We object to the question…

Q: What were the symptoms of the 18 Yugoslav patients you claim were suffering “relapse” (and we claim may have been suffering withdrawal)?
A (Glaxo): We object to the question…

Q: In Paxil’s labeling, why did you warn patients that those with a “history of drug abuse” should worry about tolerance for the drug when other patients were not so warned?
A (Glaxo): We object to the definition of “history of drug abuse”…

And so on…

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