The European Alliance for Access to Safe Medicines – a confused attempt at astroturfing

At last – we find out a little more about the EAASM – and I have to say it’s all most confusing.

From their website we learn:

The European Alliance for Access to Safe Medicines (EAASM) is a new pan-European patient safety initiative campaigning for the exclusion of counterfeit and substandard medicines from the supply chain.

The EAASM is an independent, cross-sector voice representing European patients’ rights to access safe medicines. Raising public awareness of the issues and addressing the shortcomings of current legislation and enforcement forms a key part of the activities of the European Alliance for Access to Safe Medicines.

Combating counterfeit medicines requires the coordinated effort of all the various public and private stakeholders who are affected and are competent in addressing the different aspects of the problem. Wherever this problem is discussed, the call has been for co-ordination and collaboration. The EAASM aims to make that happen.

That’s what they say. What they actually do is not quite the same.

The first major report from the ‘Alliance’ was the Harper report, an expensive tome (€595/£410) entitled European patient safety and Parallel Pharmaceutical Trade – a potential public health disaster?

It’s a wonderful piece of black propaganda which claims that parallel pharmaceutical trade (PPT) represents “a clear and present danger to the safety of every European patient”. In the report, which has been presented to the European Parliament, author Jonathan Harper alleges that parallel traders’ practice of repacking and relabelling medicines undermines supply chain security, and says there is evidence of PPT being an entry point of counterfeit medicines in to the legitimate supply chain.

So there you have it – in one mighty leap the connection has been made between illegal counterfeit medicines and the wholly legal parallel pharmaceutical trade. Very handy indeed, as the pharmaceutical industry does not like losing profits to the parallel trade. The cynical amongst you might think that the EAASM only link the parallel trade with counterfeit drugs because the EAASM has actually been set up with pharmaceutical money in order to play its part to tarnish a legitimate and safe practice (parallel trading) that poses competition to the major pharmaceutical industries.

So who controls the EAASM?

Do you know, we have no idea… all we know is that “The actions of the EAASM are approved by the executive board which consists of seven members: four independent and three pharmaceutical industry representatives. They ensure that the European Alliance for Access to Safe Medicines remains focused on its stated objectives. ”

No more than that… no names, no details – except for one name – Jim Thomson.

For more about Jim and his previous good works please read on:

What a tangled web we weave…

National Depression week 2005…

Depression Alliance…

Yet more on Cymbalta marketing…

The EAASM is funded by Bayer, Boehringer Ingelheim, Lilly, Pfizer and Wyeth.

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An insider explains why Glaxo bought Reliant Pharma…

More from Cafe Pharma here.

The inside track?

“Talked with a home office insider he said that the main reason they went after Reliant is to postpone layoffs until the fall of 2009 when we lose a ton of patents. They want to squeeze every dollar out of the portfolio and keep the reps focused for the next 2 years. Just be prepared for late 2009, if nothing new gets approved it will all hit the fan.”

and another sales rep comments:

“Hey idiots – Lovaza is only indicated for patients with TGs greater than 500. How many patients actually fit this description? approx 5-15% of the cholesterol market, so any doc RXing it for tgs below 500 is ‘going off label’ (which is their right). The problem you will face at GSK is that your reps have the high power microscope of the gov’t on them and Reliant did not. Reliant was a scumbag company which openly promoted off label usage and was not a part of Phrma (even selling it for the pleotropic effects is off label). What does this mean? Well the GSK reps will have to watch what they say even more carefully and any reliant reps (all 4 of them) who manage to pass a competency test will find themselves held to a higher standard and be washed out. Unless you garner another indication your sales will soon plateau and eventually decline once Reliant is out of the picture.”

So now that Glaxo has bought Reliant (and Lovaza), I wonder how long it’ll be before we discover that Lovaza can treat many other illnesses.

How long until the rigged clinical trials start appearing that demonstrate just that?

JP Garnier – will he get away with it?

“Jack Peter Garnier is the most corrupt CEO on the planet—he has lied to save his own ass for years…will he get away with it, let’s hope not”.

So says part of the thread of an interesting topic over on Cafe Pharma.

Who knows? I certainly don’t like what I’ve found out about him.

Oh the irony of it – Glaxo buys Reliant Pharma for $1.65billion…

I see that GlaxoSmithKline is going to pay $1.65 billion to buy U.S.-based Reliant Pharmaceuticals, a privately held drug maker that specializes in cardiovascular remedies…

That’s handy, because Glaxo’s drug Avandia seems to cause heart attacks – at least that’s what the FDA thinks and it has recently forced Glaxo to amend Avandia’s existing black box warning to add the FDA’s conclusion that a meta-analysis of short-term studies showed an association between Avandia and an increase in myocardial ischemic events – that’s heart attacks in plain English.

That all gives the Reliant deal a kind of symmetry, don’t you think?

Sufferers in the UK sue ‘happy pill’ firm GlaxoSmithKline for £30million

This from the Daily Mail:

Pharmaceutical giant Glaxo-SmithKline is facing a £30million damages claim from users of its anti-depressant Seroxat.Lawyers representing patients who insist the bestselling drug is addictive have issued the first of 600 High Court writs against the company, each seeking compensation of up to £50,000.

Since first prescribed in Britain in 1990, Seroxat has been linked to at least 50 suicides of adults and children.GSK, which makes up to £1billion a year from the drug, is already embroiled in lawsuits with American users, and has been accused of failing to act on warnings that it could have serious side-effects, including mood swings and personality changes.

Mark Harvey, of law firm Hugh James, claims Seroxat is “defective” under the 1987 Consumer Protection Act.He said: “When patients took the drug, not only was there no warning of withdrawal problems, there was also a statement on the data sheet until about 2003 which said you cannot be addicted to Seroxat.

“Unfortunately many people are having difficulties as they try to withdraw from the drug, and there are a few who have not been able to stop taking it.”Earlier this year the BBC’s Panorama programme alleged that GSK had covered up fears about Seroxat’s safety, which the firm strongly denied.

The drug was banned for under-18s in 2003 amid concerns that it contributed to suicide among adolescents with depression, and adult patients have reported that, when they stop taking it, they feel aggressive, reckless and violent towards themselves.

Four years ago a man arrested for armed robbery was cleared after medical experts concluded that his behaviour could have been altered by severe withdrawal symptoms from Seroxat.GlaxoSmithKline said: “Seroxat has benefited millions of people worldwide.“We believe the product is not defective and that there is therefore no merit in this litigation.”

Well, I’m not letting Glaxo get the last word – do you know what I believe? –

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden clinical trial data that shows exactly how dangerous a drug it is.

I believe that something must be done to help people who suffer terrible problems with withdrawal, as they desperately try to stop taking Seroxat.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Believe me – I know what I’m talking about.

GSK and its approach to litigation… in Canada

This is a post from Paxil Progress:

GSK has met with, and settled with many children who suffered side effects from paxil. The legal system in Canada stinks, and the lawyers won’t go up against the pharmaceuticals here. I know, I phoned every firm.

I obtained a high profile US lawyer. He is a wonderful man, one who is aware of the extent of suffering the children go through.

Last November (2006) was a very difficult month for my daughter. She had to meet with a GSK lawyer and discuss what she went through due to paxil. Before meeting with their lawyer we had a coffee with our US lawyer. My daughter does not like to discuss her paxil experience with anyone. She spoke with him openly, because she ‘knew’ he truly understood. She spoke about waking up each morning, her first thought being wanting to die. She would take a pin, something sharp and tear her skin. She rode her bicycle down stairs to harm herself. I won’t go on, you all get the picture…

Anyhow, at the end of the meeting I was asked what it would cost for private schooling to get her caught up-to-date. We discussed financial amounts. The GSK lawyer then turned to my daughter and said “we’re sorry this happened to you, but know it wasn’t done deliberately”. Ok, so that is where I spoke up. “Excuse me, don’t lie to her, GSK was very aware, the facts were hidden from the public, that’s why we’re here today”

GSK is aware I post on paxilprogress, but I was then asked if I personally knew Laurie Yorke, Rob Robertson, and Lisa Vansickle, as well as a few others I didn’t know of. “Hell yes!! Laurie is my adopted sister”, were family, as for Rob Robinson, sorry I could not afford the trip to the paxil protest.”

Interesting… what the hell does Laurie Yorke or Rob Robinson have to with my daughters suffering anyways? I shouldn’t have to lay out who I talk to, what we talk about, if it was via telephone, or in person. Anyway, we left the meeting and returned home. Since then, Skye researched schools she wished to attend when she received her settlement from GSK. She talks of going to New Jersey to meet Ryan, the desire to meet another child face to face that understands the suffering she went through.

A year has passed, Skye has received not a dime. Does anyone know why? Not because she hasn’t suffered or doesn’t deserve a settlement like the other children. But in paying her, they may have to pay other Canadian children. Once again it is all about the almighty dollar! They do not give a damn that they withheld information that ended up causing my child so much grief.

The following paragraph is for GSK, everyone that is in litigation with them have their posts from paxilprogress printed off. So by posting this here, I know they’ll get my message.

GSK, the pain and suffering a child suffers on paxil is the same, no matter the location. Place of birth should not matter. Saying that, my daughter’s father was born on US soil, because she resides with her mother in Canada should not make a difference.

I will continue doing what I am, I will provide for my child’s needs. In the mean time, you paid her nothing. I am free to speak openly about GSK litigations. Why the hell would you meet with my child and make her rehash a horrific experience when you have no intention of doing anything about it? Was her experience not enough the first time around? How dare you play with my child’s emotions like that!!

Stay tuned, I need some closure to enable m e to move on from this. A new website is in progress, one that will be getting media coverage, and will also be linked to every website available to me.

Rita

I think we could all do with some closure.

I’ll link to the website as soon as it goes live.

Finnish gunman said he used antidepressants

This from a Finnish news source :

The Jokela gunman Pekka-Eric Auvinen is very likely to have used anti-depressant drugs, which have been linked with school massacres in the United States. A message written by “Sturmgeist89”, a pseudonym used by Auvinen, appeared on the Internet a short time ago stating that he took the mood-enhancers, although he hated them.

In a video that he placed on YouTube, Sturmgeist89 displays packages of Cipralex, Zoloft, Luvox, and Prozac pills. The video “SSRI-One Pill A Day Makes You Happy” criticises medicalisation. The drugs in question are Selective serotonin reuptake inhibitors (SSRIs). Eric Harris and Dylan Klebold, the perpetrators the massacre at Columbine High School in Colorado in the USA, had said that they took pills in the same class of drugs. There is disagreement among experts as to whether or not the drugs can provoke destructive aggression. In a message he put on an Internet chat room Pekka-Eric Auvinen suggests that he had started using anti-depressants during the past year.

“StormSpirit”, another pseudonym used by Auvinen, wrote on the Peliplaneetta.net website that he had suffered “from some degree of depression for about a year”.

Sturmgeist89 told a Danish former female acquaintance that he felt frustrated and aggressive because of the drugs. On the other hand, in his English-language message he said that he had stopped taking the pills, at least temporarily. At Thursday’s press conference police said that Auvinen’s autopsy had not been completed, and that it was not yet known if he was under the influence of any medicines. The police are checking with Auvinen’s parents and health care officials to see if he had been prescribed antidepressants. He also may have acquired them illegally or over the Internet. The National Agency for Medicines recommends against prescribing SSRIs for people under the age of 18, because of the self-destructive or hostile emotions that they have been known to provoke.

No mention of this at all in the UK press.

SSRIs and the Finland massacre

In my previous post, I wondered about the story of Finnish student Pekka-Eric Auvinen who killed six students, a head teacher and a nurse, before turning the gun on himself. You see the Finnish news organisations had picked up on a strong SSRI connection in this story, and indeed I have found out today that among the many videos allegedly posted on YouTube under Auvinen’s two account names (all posted within the last 2-3 weeks) were clips professing interest in various serial killers, atheism and Nazi eugenic themes, with one single, seemingly out of context clip regarding SSRIs titled “SSRI – One Pill A Day Makes You Happy… …or then not!” Auvinen himself indicated that he “ate SSRI antidepressants”.

OK – not scientific – nothing proved – but I have to ask when is someone going to put 2 and 2 together and undertake some serious research into SSRIs and their link with violence and homicide.

For more information, read A brief history of School Shootings and Seroxat and Violence – the link is made.

Sadly, there is also the SSRI Stories website to take a look at…

Glaxo and all the other drugmakers would have us believe that’s it’s all just a coincidence –  I defy anyone to read SSRI Stories and come to the conclusion there’s no connection here that nothing needs to be done.

Lost in translation – were Anti-Depressants Involved In Finland School Massacre?

Very interesting… the recent tragic massacre at a school in Finland, that left eight dead plus the shooter has been reported in VERY different ways around the world.

According to AHRP, there’s evidence that the young shooter was on SSRIs and that they made him “aggressive,” a well-documented but often overlooked problem with these drugs. AHRP reports that, although Finnish press accounts include the SSRI information, the possible SSRI connection was stripped from British and American press accounts of the shooting.

Here is the start of the Finnish article:

SSRI-lääkitys voi aiheuttaa levottomuutta
8.11.2007 13:32
Jokelan ampuja saattoi käyttää SSRI-lääkkeitä, joilla lievennetään masennuksen oireita.

Suomessa myynnissä olevat SSRI-lääkkeet
SSRI-lääkitys voi aiheuttaa levottomuutta
Vihamielisyys seurausta lääkityksen lopettamisesta?
Jokelan tappaja: Lääkitys tekee minut aggressiiviseksi
Pekka-Eric Auvinen on nettikeskusteluissa viitannut käyttäneensä SSRI-lääkeryhmään kuuluvaa, yhtä tai useampaa masennuslääkettä. SSRI-lyhenne tulee sanoista “selektiiviset serotoniinin takaisinoton estäjät”.

SSRI-lääkitystä ovat oman kertomansa mukaan käyttäneet muun muassa Yhdysvaltain Columbinen kouluverilöylyn tekijät.

SSRI-lääkkeet ovat Suomessa tavallisimpia masennukseen käytettyjä lääkevalmisteita.

I think it’s pretty clear what connection is being made…

The headlines in the Finnish Press discussed a shooting rampage by an 18-year old High School student, Pekka-Eric Auvinen. Before killing six students, the head teacher and a nurse, and turning the gun on himself, Auvinen indicated that he “ate SSRI antidepressants”. SSRI antidepressants and antipsychotics both can sweep away self-regulating internal inhibitions while triggering explosive acts of violence and murderous behavior. which, he said, made him feel “aggressive.”

One can only speculate why major news outlets outside of Finland–CNN, Yahoo, Reuters, BBC–failed to report all facts provided by the Finnish sources–including Auvinen’s own statements in a video on YouTube about his unsuccessful treatment with SSRIs.

What is going here? Protection of advertising revenues maybe?

For more information you might to read A brief history of School Shootings and Seroxat and Violence – the link is made.

Sadly, there is also SSRI Stories to take a look at.

Glaxo brands gepirone ER as ‘Velexity’ – then gets the drug rejected AGAIN by the FDA

It just goes from bad to worse for Glaxo.

On October 18 I saw a news item – Gepirone ER branded Velexity® It seemed that McCann Humancare in New York had landed creative duties on the launch of a new antidepressant from GlaxoSmithKline known as Velexity. It was going to be BIG with billings estimated at more than $40 million.

However, today I have found out that geprirone ER has been rejected AGAIN by the FDA. This from the Washington Post:

U.S. regulators have rejected GlaxoSmithKline Plc’s (GSK.L) experimental drug gepirone ER for adults with major depression.

The U.S. Food and Drug Administration (FDA) issued a not approvable letter for the extended-release tablets, which Glaxo had licensed from privately owned Fabre-Kramer Pharmaceuticals Inc in February, Europe’s biggest drugmaker said on Saturday.

The news is a blow to Glaxo, which needs new drugs to make up for pending patent expiries on key blockbusters and a recent slump in sales of its second-biggest seller, the diabetes pill Avandia, which has been hit by fears over a possible link to heart attacks.

Industry analysts had forecast that gepirone ER, if successful, could eventually have sold between $800 million and $1.6 billion a year. But the product was always viewed as high risk, following a chequered history in development.

Akzo Nobel NV (AKZO.AS) of the Netherlands had originally been developing gepirone ER with Fabre-Kramer but the Houston-based drug company bought back rights to the drug in June 2005 after Akzo abandoned development in the wake of two earlier rebuffs from the FDA.

Despite these setbacks, Glaxo had hoped that gepirone ER might still be approved if it provided data from an additional positive clinical trial. Those extra results were submitted to in May 2007 but, in event, proved insufficient to sway the U.S. regulator.

Glaxo and Fabre-Kramer said they were now evaluating the response from the FDA to determine appropriate next steps.

The financial terms of February’s deal between Glaxo and Fabre-Kramer were never disclosed but Moncef Slaoui, Glaxo’s head of research and development, said at the time that gepirone ER was an important addition to the company’s late-stage pipeline.

The clinical trail mentioned in the article was by none other than Dr Marty Keller (and he doesn’t come cheap). Keller’s results found “In conclusion, gepirone ER at a dose range of 40 to 80 mg/d is effective for relapse prevention in patients with recurrent major depression. It is well tolerated during long-term treatment for up to approximately one year.”

I’m sure that many of you will know Marty Keller and the work he has done for GSK in the past… those of you who don’t know how Glaxo use data from their clinical trials see Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug and And while we’re talking about Study 329 – here are some real Seroxat Secrets and gepirone ER – enter Marty Keller

Marty Keller? – top professsional and honest as the day is long…