GSK ~ A Class Act

Courtesy of Google Images

I had one of those Nescafe down the nostrils moments earlier. Snot accompanied the Nescafe as it projected down my left nostril, much of it spraying the screen of my laptop.

GSK, it appears, have been implementing ethics into the way they give incentives to sales staff by rolling out new sales training, performance review and bonus structure.

In an interview with HR Magazine, GSK's Dannii Portsmouth, (Pictured top of post) said, “We don’t think we've done anything inappropriate in the past, but we think the expectations of society have changed.”

(Insert laughter here)

Portsmouth is GSK's Director, HR Business Lead, UK & Ireland Pharmaceuticals - to suggest that; a) the company who employ her have done nothing inappropriate in the past and b) it's down to the expectations of society, is classic GSK spin.

Here we have a company spokesperson trying to put right many wrongs but she fails at the first hurdle with a statement of denial. "We don’t think we've done anything inappropriate in the past."

Really?

So, why plead guilty then?

One word: Incredulous!

GLAXOSMITHKLINE SETTLEMENT FACT SHEET 

GSK has agreed to plead guilty and pay $3 billion as part of this criminal and civil resolution.

GSK has agreed to plead guilty to three misdemeanor violations of the Food, Drug and

Cosmetic Act:

Regarding Paxil, GSK will plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.

Regarding Wellbutrin, GSK will plead guilty to distribution of a misbranded drug due to inadequate directions for use, in violation of 21 U.S.C.

Regarding Avandia, GSK will plead guilty to failure to report data to the FDA, in violation of 21 U.S.C.

So, nothing "inappropriate " huh, Dannii?

Oh, and what about the statement of apology to the Chinese government and its people?

You remember that, right Dannii?

The fine of  $490m (£297m) after a court found your company guilty of bribery after having made an estimated $150m in illegal profits.

Still,  nothing "inappropriate. " 

What about the out-of-court settlements made to over 3,000 claimants who were addicted to your company's antidepressant, Seroxat?

Or the countless settlements made with mothers who, as a result of ingesting Seroxat during pregnancy, gave birth to children with birth defects or had to abort their foetuses because the chances of survival after birth were slim, to say the least. Case in point, Joanne Thomas from Pennsylvania. You, or rather your company, gave her the run-around, she lost her case against you, appealed, lost that too - then, miraculously your company settled with her after your law team messed up by not disclosing everything to her attorneys - naughty Glaxo - (see here and here)

Still, nothing "inappropriate. " - I mean, what's 800 or so kids being born with severe heart or cranial defects? Just part of the business, huh Dannii?

Don't even get me started on Study 329, Dannii!

I could go on and on to show you exactly where GSK have been inappropriate but what's the point?

Glaxo employees, Portsmouth included, have a knack of burying their heads in the sand when it comes to Glaxo's dark history - Maybe that's the only way they get to sleep at night, who knows?

First rule of ethics, admit to your inappropriateness then seek to make sure it doesn't happen again.

The expectations of society have always been the same, we expect you to be honest and truthful, we expect to live and not suffer at the hands of your drugs.

End of rant.

Dannii Portsmouth's musings can be read, in full, here.


Bob Fiddaman.


*Disclaimer*

This blog post was not sponsored or endorsed by Nescafe.

The Homicide Files: "We Want Our Documents Back"

This is the final post in the series of the Homicide Files, and probably the most important - moreover, it's one that I'd like shared far and wide. Facebook, Twitter, and other social media outlets. If you, like me, are a blogger then please share these very important set of documents, even if you blog about cooking, gardening, music, or whatever it is you happen to be passionate about. Even if you don't quite understand what it all means, just blog or share the files or this blog post. The FDA don't want you to ~ that should be as good a reason as any to share, right?

The following documents are, according to the FDA, not supposed to be made public. They cited an apparent privacy exemption under the Freedom of Information Act (FOIA).

One can see, when looking through the documents, exactly why the FDA have thrown their dummy out of the pram with these documents as they reveal information that the public need to know. Let's face it, the FDA are about as transparent as the MHRA, who, in turn, are about as transparent as a polluted river.

I'm going to highlight just one of those documents and then add links to the others. Please, if sharing on Facebook and Twitter, highlight the importance. The public have just as much right to see these documents as the medicine regulators and pharmaceutical companies do.

It's an embarrassment for the FDA ~ they sent the files to investigative reporter, Andrew Thibault, then relaised they had ballsed up on a humungous scale.

As the Russian wrestler once said, Tufty Shitski.

The following document features the tricyclic antidepressant, Nortriptyline hydrochloride. The information contained within this document shows, without doubt, that the drug caused  a 35 year old female Akathisia, Homicide, Suicidal ideation and Delirium.

The reason she was prescribed this powerful antidepressant wasn't because she had a mental disorder or that she was suffering a breakdown of some kind. She was prescribed it because she was distressed due to husband's drinking.

Let's take a closer look. There's a lot of talk about metabolism, much of which will be explained in a future post by a special guest and friend. (CLICK ON IMAGES TO ENLARGE)

This woman, according to the document, pleaded mental illness, yet, all she had before she was prescribed this antidepressant was distress over her husband's drinking. The Medical Reviewer considered the case to be possibly related to the suspect drug.

Not yet curious as to why the FDA want this particular case file returned and not made public?

Here's the other files they want back from Andrew Thibault.

Vyvanse-Safety-and-Drug-Utilization-Review-Unredacted

rev2_Vyvanse Safety and Drug Utilization Review_Redacted (2)

FDA letter 100815 original

Adzenys_PI

10213469v2

10213469

8464514v2

7979016v4

7979016v3

7979016v2

6179785

204326 amphetamine clinical prea

Do what you can folks and SHARE, SHARE SHARE!

Bob Fiddaman.

Previously in the Homicide Files series.

The Homicide Files: Paxil/Seroxat

The Homicide Files: Celexa & Lexapro

The Homicide Files: Cymbalta

The Homicide Files: Effexor

The Homicide Files: Prozac Prescripticide

The Homicide Files: Zoloft

The Homicide Files: The Interview

The Homicide Files: Age 8 - 17

The Homicide Files: Age 8 - 17

The following information has been taken from the brilliant Murder Meds database. The database contains over 3,000 documents recently attained from the American drug regulator, the FDA. The documents are adverse events, in particular, where homicide has been committed whilst patients have been on (or withdrawn from) one or more psychiatric drug.

Today I'm focusing on those FDA files where children are concerned, namely 8-17 year-olds. Remember, these are adverse events initially reported to the FDA because a doctor, family or member of the public suspected the homicide may have been caused by the drug/s. There could very well be many more of these types of incidents that have never been sent to the FDA ~ If the FDA had gone public with the documents below then I'm almost certain that they would have been inundated with similar adverse events, which would have been really bad for business, right?

This is drug induced homicide. This is prescripticide.



AERS Case Number 5749577

10 year-old boy. PROZAC

Notice how the FDA allow every adverse event to go unredacted, apart from the death. A description of events has also been redacted by the FDA.

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AERS Case Number 6296459

12 year-old boy. Prescribed sertraline and paroxetine, better known by their brand names ZOLOFT and PAXIL. The adverse events listed include abnormal behaviour, mania, aggression, restlessness, psychotic disorder, hallucinations and homicide. A description of the homicide has been redcated by the FDA.

--

AERS Case Number 5801931

8 year-old girl. Was taking a cocktail of RISPERDAL, ZOLOFT and PAXIL - these were, according to the document, prescribed to her for "anxiety". Listed in the adverse events, amongst other side effects, are anxiety and homicide. So, here we have an 8 year-old little girl, prescribed mind altering drugs for anxiety and the drugs she was prescribed make her anxious. It appears that the 8 year-old child attempted homicide by picking a knife up. The important part of this actual event has been redacted by the FDA.

The 8 year-old was admitted to a psychiatric unit where they weaned her off her final drug, Zoloft. An update shows that the child, as of Feb 2004, was happy at home and school. Miraculously after stopping all medications her anxiety and homicidal thinking stopped.

--

AERS Case Number 10213469

10 year-old girl. Prescribed VYVANSE for ADHD. Vyvanse (Lisdexamfetamine) is a central nervous system (CNS) stimulant. The report regarding the homicide event have been redacted by the FDA.

During an FDA Pediatric Postmarket Adverse Event Review it was found that... “The majority of the psychiatric adverse events (n=27) were homicidal or suicidal ideation, self-injurious behavior or ideation, or suicide attempt." Begs the question why this young girl was ever prescribed Vyvanse.

Today the Vyvanse website claims...

Vyvanse® (lisdexamfetamine dimesylate) is a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and above.

To date there has been no scientific evidence to prove that he condition, ADHD,  is a mental disease of the brain.

--

AERS Case Number 3973882

16 year-old boy. PAXIL and RISPERDAL. The boy carried out a murder. During his trial his mother stated that her son became "more defiant and aggressive after taking Paxil." - Furthermore, his psychiatrist testified that he treated the patient after the murder and had to lower his dosage because it made him "violent and delusional."

Patient was found guilty of murder and sent to prison.

--

AERS Case Number 4078438

15 year-old boy. Prescribed PAXIL.  Weaned of Paxil whilst spending time at a juvenile detention centre for committing an unknown crime. Some time after halting Paxil the 15 year-old boy committed homicide.  He pleaded guilty to murder. At the time, the media reports indicated that the 15 year-old's tendency to commit homicide may have been influenced by a "video game."

--

AERS Case Number 4223728

17 year-old boy. What's remarkable about this adverse event report is the diagnosis of "loneliness" - Loneliness, it seems, is now deemed as a mental disorder. The claim, it appears, was made by Wyeth, the pharmaceutical company that market and manufacture the antidepressant in question.

The 17 year-old boy was prescribed EFFEXOR XR. When on Effexor his depression worsened, he felt everyone hated him, in particular his best friend. His dosage of Effexor was increased from 75mg per day to 300mg per day. On an unspecified date he killed his best friend.

--

AERS Case Number 5935626

16 year-old boy. Prescribed PAXIL. His parents and friends said that he had no history of violence or aggression  He was given a three week supply of Paxil by his family physician. Ten days later he stabbed (REDACTED) to death.

--

There are many more cases in the database. 

If the FDA have been sitting on files like the ones you have seen above then maybe, just maybe, a lot of children would never have had to endure the horrific side effects caused by these drugs. The increase in prescription rates is quite alarming - yet the FDA, armed with this information and many more cases like it, have just sat back and done nothing. It took a Freedom of Information request to get this information out into the public domain. For that we should all applaud Andrew Thibault.

Bob Fiddaman.

Previously in the Homicide Files series.

The Homicide Files: Paxil/Seroxat

The Homicide Files: Celexa & Lexapro

The Homicide Files: Cymbalta

The Homicide Files: Effexor

The Homicide Files: Prozac Prescripticide

The Homicide Files: Zoloft

The Homicide Files: The Interview

The Homicide Files: The Interview

Over the past week I've been showcasing a series of files that were requested under the Freedom of Information Act from the FDA by investigative reporter, Andrew Thibault. Those series of posts can be found at the foot of this post.

The following audio is an interview with Andrew Thibault where he describes, in detail, how the American Medicines Regulator, the FDA, have been witholding important information back from doctors and the public with regard to the role psychiatric medication has played in documented acts of homicide.

It's a fascinating interview and deserves to be spread far and wide.

Bob Fiddaman.

Previously in the Homicide Files series.

The Homicide Files: Paxil/Seroxat

The Homicide Files: Celexa & Lexapro

The Homicide Files: Cymbalta

The Homicide Files: Effexor

The Homicide Files: Prozac Prescripticide

The Homicide Files: Zoloft

The Homicide Files: Zoloft

The is the sixth in the Homicide Files series (previous 5 are at the foot of this post)

Today I focus on Zoloft (sertraline), an antidepressant of the selective serotonin reuptake inhibitor family.

Zoloft is manufactured and marketed by Pfizer and is the subject of many lawsuits in the United States, alleging, amongst other things, that Zoloft is ineffective (doesn't work), that it causes birth defects and that it causes violence and suicide.  It is known as Lustral in the UK.

The first file today is 99 pages in length and concerns a 27 year-old male. I'm not going to publish all the 99 pages, if you want to view the whole document then you can do so here.


AERS Case Number 4073159

27 year-old male, prescribed 100mg Zoloft per day between 1996-1998. Patient, according to the first page of the document, murdered an acquaintance of his. Moreover, the report says, "Either chronic use or sudden involuntary withdrawal caused a major psychotic event where "patient" murdered an acquaintance of his.

http://www.murdermeds.com/index.php/2016/01/14/aers-case-number-4073159/

--

AERS Case Number 4088468

20 year-old male prescribed 50mg of Zoloft per day between Oct 24, 2003 - January 23, 2004.

The report was sent to Medwatch by the parents of the 20 year-old who state that their son experienced an adverse reaction to Zoloft and killed a "friend of a young woman" in their home.

http://www.murdermeds.com/index.php/2016/01/14/aers-case-number-4088468/

--

AERS Case Number 5838493

19 year-old male. Prescribed Zoloft between 2003-2004. The report was sent in by a psychologist who said, "The patient started taking Zoloft (50mg) for one week then 25mg daily for two weeks." The psychologist also states, "On day 13 of his Zoloft therapy he decided it was not working and stopped taking in for 3 days, then he restarted Zoloft at 25mg daily."

Days later he killed someone.

His parents said, he committed the murder because of persistent severe agitation and aggression from Zoloft.

http://www.murdermeds.com/index.php/2016/01/16/aers-case-number-5838493/

--

AERS Case Number 6100809

Homicide by a 32 year-old female who was taking Zoloft (dosage unknown) because she was having 'mental problems' for 3 to 4 months.

http://www.murdermeds.com/index.php/2016/01/18/aers-case-number-6100809/

--

AERS Case Number 5837912

37 year-old female. Prescribed 200mg of Zoloft per day. She killed her son then attempted to kill her daughter. You'll note in this document how the reporter makes claims that the female patient may have been taking another prescription drug at the time of the murder. This, according to the document, was never proven. 

http://www.murdermeds.com/index.php/2016/01/16/aers-case-number-5837912/

--

AERS Case Number 5668352

70 year old male. Was taking Zoloft (date unknown)  - He killed his wife and them himself. The report was sent in by one of the children. It states, "He did not have a history of depression... we all knew it was the drug when this happened"

http://www.murdermeds.com/index.php/2016/01/15/aers-case-number-5668352/

--

So, six more cases of prescripticide. Feel free to read the links below to cases of other antidepressant medication.

Bob Fiddaman.

Source - Murder Meds Database.

Previously in the Homicide Files series.

The Homicide Files: Paxil/Seroxat

The Homicide Files: Celexa & Lexapro

The Homicide Files: Cymbalta

The Homicide Files: Effexor

The Homicide Files: Prozac Prescripticide

**Prescripticide is defined as a death that is caused by an adverse reaction to a prescription drug.

The Homicide Files: Prozac Prescripticide

This is the fifth in the series of the homicide files. My attention was to throw light on the homicide cases that have been reported to the FDA where the antidepressant, Prozac (fluoxetine) has been associated.

As you will see from the reports, the FDA have redacted all the vital information, particularly where the reported homicide was carried out by a child or person under the age of 25.

Prozac is marketed and manufactured by Eli Lilly.

An FDA advisory panel was convened in 1991 to review the fluoxetine data. It concluded that fluoxetine was safe despite the concerns raised by David Graham and others, leading critics to point out that several of the panellists had financial ties to Eli Lilly. (Source)


Adverse event reports regarding psychiatric drugs don't scare me. Suppressing them does.

Here's what the FDA sent investigative reporter, Andrew Thibault.


AERS Case Number 5749577

This case concerns a 10 year-old boy - The FDA, who were sent the information by Eli Lilly, have redacted all of the information. Ask yourself why they would do this? (Click on images to enlarge)

http://www.murdermeds.com/index.php/2016/01/26/aers-case-number-5749577/

--

AERS Case Number 5781644

This case concerns a 16 year-old boy - The FDA, who were sent the information by Eli Lilly, have redacted all of the information. Death was the adverse event being reported, although we don't know if it was a homicide or suicide. The 16 year-old boy was on 60mg of Prozac per day.

http://www.murdermeds.com/index.php/2016/01/26/aers-case-number-5781644/

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AERS Case Number 6328428

18 year-old male, prescribed 10mg Prozac daily. 

http://www.murdermeds.com/index.php/2016/01/26/aers-case-number-6328428/

--

AERS Case Number 6526177

15 year-old boy. Homicide, Physical assault and withdrawal "syndrome"

http://www.murdermeds.com/index.php/2015/12/05/aers-case-number-6526177/

--

AERS Case Number 7979016

16 year-old boy, prescribed Prozac "off label" - he went on to carry out a homicide. He first attempted suicide, this failed - he later went on to stab to death an unknown male/female. Interestingly, his psychiatrist assessed the homicide, self injurious behaviour and manic symptoms as being related to Prozac use. The report mentions that Health Canada were involved in putting the information together which would suggest that the 16 year-old boy was living in Canada.

http://www.murdermeds.com/index.php/2016/01/24/aers-case-number-7979016/

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AERS Case Number 8255398

27 year-old male. Killed his wife then himself. 

http://www.murdermeds.com/index.php/2016/02/04/aers-case-number-8255398/

--

So, there you have it. Prozac, it seems, is the one antidepressant that the FDA seem to be tight lipped about. Not surprising given that in 1991 several of the FDA panellists had financial ties to Eli Lilly. They concluded that Prozac was safe.

Bob Fiddaman

Source - Murder Meds Database.

Previously in the Homicide Files series.

The Homicide Files: Paxil/Seroxat

The Homicide Files: Celexa & Lexapro

The Homicide Files: Cymbalta

The Homicide Files: Effexor

**Prescripticide is defined as a death that is caused by an adverse reaction to a prescription drug.