Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Diazepam. Show all posts
Showing posts with label Diazepam. Show all posts

Tuesday, July 25, 2017

EXCLUSIVE: MHRA Asked Sky News to Remove Antidepressant Reference





The controversy and confusion created last week by MHRA and their Sky News article continues. In the interview, MHRA enforcement officer, Danny Lee-Frost, stated, “...sleeping pills and antidepressants are a lot more dangerous. People have committed suicide as the ultimate resort to try to get off them. They are fiercely addictive.”

The original article aired on the Sky News website at 10:14 am on Thursday, July 20.

I wrote to Lee-Frost approximately an hour later asking:
Is it now the position of the MHRA that antidepressants are addictive and that "people have committed suicide as the ultimate resort to try and get off them?"
Can you clarify that this is a personal belief or one of the MHRA?
Lee-Frost promptly responded:
Dear Mr Fiddaman
Thank you for your enquiry regarding the article commissioned by Sky News on the dangers of buying medicines online.
I work in the Enforcement group and my role is concerned with investigating illegal activity involving medicines. I am not medically qualified and therefore matters of clinical diagnosis are not in my area of expertise.
The focus of this piece was the online sale and supply of medicines and the increased use of Facebook as a medium of sale.
Part of the interview concerned sleeping tablets and I referred to Zopiclone and Diazepam specifically.
We have seen an increase in the number of websites offering both of these medicines for sale. Sky presented evidence that both were available on Facebook and I asked for details of the sites they had found in order to make further enquiries.
We also discussed the dangers of purchasing large quantities of these medicines from websites without medical supervision and the increasing amounts that we are seizing as part of our enforcement activities.
My reference to suicides was in relation to a case that the MHRA is aware of involving addiction to Zopliclone.
Sky did not include the interview in its entirety in their piece.
Regards
Danny Lee-Frost MSc
Head of Operations
Enforcement Group 
What's striking here is the timeline of events.

At 3.15 pm Sky News edited its original version and omitted part of Lee-Frost's original statement. The statement had been changed to, "The sleeping pills and antidepressants are a lot more dangerous. Sleeping pills particularly, they can be addictive. People have committed suicide as the ultimate resort to try and get off them. These are fiercely addictive."

However, the video of Lee-Frost's original statement remained on the Sky News website.
Screenshots, with Sky News provided subtitles, are found below:


The original video can be viewed here, with Lee-Frost's 18-second segment here.

Puzzled as to why Sky News would change Lee-Frost's direct quotes and make edits after publication, I inquired:

Stephanie Jones, Sky News PR Manager, states:
"The changes were made after MHRA got in touch to clarify Frost's comments. They made the point that antidepressants shouldn't be included with sleeping pills."
Hmm...MHRA and Lee-Frost's original statements couldn't possibly be referring to ads such as this, now could they?



All ads still remain on Facebook today.

Lee-Frost's Email Response

Let's look at the email Lee-Frost sent me, in particular, his statement:

"My reference to suicides was in relation to a case that the MHRA is aware of involving addiction to Zopiclone."

This new info is troubling as nowhere on the product labeling does it suggest Zopiclone can be addictive. Moreover, the SPC label does not mention suicide being a result of withdrawing from Zopiclone.

The  SPC-DOC_PL 41684-0003.PDF is hosted on the MHRA website and was last updated on 02/06/2017

If Zopiclone is or can be addictive as soon as you start taking it, as Lee-Frost suggests (see video) then why does MHRA omit this info on its website? Moreover, if Zopiclone is a drug where "people have committed suicide as the ultimate resort to try to get off them," why is this relevant information not included by MHRA in the SPC?

The SPC for the other drug mentioned  in Lee-Frost's  reply, Diazepam, does not support Lee-Frost's two claims that:

1) withdrawal can lead to suicide and
2) is "fiercely addictive once you start taking them"

On the subject of dependency (addiction), the Patient Information Leaflet for Diazepam states:
Dependence: When taking this medicine there is a risk of dependence (a need to keep taking the medicine). The risk increases with the dose and length of treatment period.

As you see, the Patient Information Leaflet clearly states the risk of addiction increases with the length of the treatment period. It does not state it "can be addictive as soon as you start taking it." Therefore, it's safe to assume MHRA believes neither Zopiclone or Diazepam can cause addiction as soon one starts taking them, nor can they cause people to carry out "suicide as the ultimate resort to try to get off them" as Lee-Frost claimed.

According to MHRA's public documents, Lee-Frost's claims are false. So why would Lee-Frost believe differently than his employer, the MHRA? (Remember, Lee-Frost is the head Enforcement Officer of the MHRA!)

Why would he make repeated statements that antidepressants can be addictive and cause suicide upon withdrawal if he did not know this to be true?

Why would he later claim he was speaking about Zopiclone and Diazepam instead of antidepressants as he said in his original article?

Why would MHRA contact Sky News and direct them to change their Enforcement Officer's own statement?

I think I know why and my readers likely know why, too. I believe in his Sky News interview, Lee-Frost was speaking about antidepressants as a whole. He subconsciously told the truth, something MHRA didn't appreciate. I believe MHRA knows that drugs labeled "antidepressants" are addicting. It appears MHRA also knows "antidepressant" withdrawal is such torture that some people would rather die than suffer these drug side effects. Hence, sufferers end their lives. I don't prefer to call these drug-induced deaths "suicides" as they are iatrogenic.

Stay tuned: Next week the saga continues with the MHRA and Lee-Frost responses.

Lee-Frost now claims the suicide related to Zopiclone withdrawal he referred to in his first email to me, was simply "anecdotal."

an·ec·do·tal
[ˌanəkˈdōdl]

ADJECTIVE
(of an account) not necessarily true or reliable, because based on personal accounts rather than facts or research

Bob Fiddaman







Monday, March 30, 2015

Almost a Quarter of 'Suicide' Pilots on Psych Drugs





Well, wouldn't you know it.

CNBC are running with the headline, 'Germanwings crash prompts overhaul, calls for more mental health checks.' - only thing is, the article does not state who is actually 'calling.' Is it the airlines, is it worried passengers or is it those that work in the field of mental health?

On Thursday The Boston Globe ran a very thought-provoking article regarding the 24 US Aircraft-assisted suicides between 1993-2012.

The data collected showed toxicology reports for 21 of the 24 pilots. They were unable to obtain toxicology reports for 3 of the 24 pilots.

So, we have 21 pilots to work from.

Out of those 21 pilots, 5 were on psychiatric medication, or at least had psychiatric medication in their bloodstream at the time of the Aircraft-assisted suicide.

Case #8 - Pilot (41) - Diazepam, Nordiazepam (anti-anxiety)

Case  #9 - Pilot (40) - Alcohol, Cocaine, Diazepam & Nordiazepam (anti-anxiety), Temazepam (insomnia), Oxazepam (anti-anxiety/depression)

Case #14 - Pilot (54) - Venlafaxine, Desmethylvenalfaxine (depression)

Case #18 - Pilot (44) - Fluoxetine & Citalopram (depression), Diphenhydramine (allergic reactions/motion sickness), Alcohol

Case #22 - Pilot (25) - Alcohol, Citalopram (depression), Clonazepam (anti-anxiety)


It would be churlish of me to suggest that the drugs made them do it so, just like the Boston Globe data, I will show you the other mitigating circumstances.


Case  #8 - Marriage proposal declined

Case  #9 - Criminal history; suspect of arson

Case #14 - Under therapy for severe depression

Case #18 - History of depression w/ hospitalizations; shortly before the event, he was in hospital for attempted suicide

Case #22 - Distraught over breakup with girlfriend; alcohol and medication consumption prior to accident


Cases 14 and 18, it appears, show that the two pilots were diagnosed with depression and treated with medication. The other three cases don't seem so cut and dry.

Case 8 had a marriage proposal decline yet was found to have Diazepam and Nordiazepam (anti-anxiety) in his system. Was he being treated or did he just manage to get his hands on these tablets? If he was being treated then I cannot see anything in the Diagnostic Statistical Manual of Mental Disorders (DSM) that states that dealing with a marriage proposal decline is a mental illness.

Case 9 had a criminal history and was suspected of arson, yet in his blood system we find Diazepam & Nordiazepam (anti-anxiety), Temazepam (insomnia), Oxazepam (anti-anxiety/depression). Again, nothing in the DSM about using medication on someone with a criminal history.

Case 22 was distraught over breakup with girlfriend. In his system they found Citalopram (depression), Clonazepam (anti-anxiety). Since when does splitting up with a partner deem someone as being mentally ill?

So, a staggering 23.8% of pilots who took part in Aircraft-assisted suicides between 1993-2012 were on psychiatric medication/or had taken psychiatric medication prior to the suicide.

Now, we have more "calls" for mental health checks which will no doubt mean more pilots on psychiatric medication.



Now, let's take a look at the three pilots that they wasn't able to pull toxicology results from.

Case #11 - Restraining order; escorted away from home

Case #16 - Ongoing treatment for depression

Case #24 - Difficulties in personal life; joked about suicide


I think we can be, at the least, 90% certain that case 16 was on some form of antidepressant medication. If this was the case then it pushes the total figure of Aircraft-assisted suicides that were medicated up to 27.2% (6 out of 22 pilots)

If case 24 had difficulties in his personal life and was being treated, just as case numbers 8, 9 and 22 were, then the figure rises again to 30.4%

However, we cannot speculate.

The fact still remains. 23.8% of pilots who took part in Aircraft-assisted suicides between 1993-2012 were on psychiatric medication/or had taken psychiatric medication prior to the suicide.

Now let's breakdown the list of drugs.

Diazepam (2)
Nordiazepam (2)
Temazepam
Oxazepam
Venlafaxine
Desmethylvenalfaxine
Fluoxetine
Citalopram (2)
Clonazepam



Diazepam 

Side Effect Reports – By Outcome

Completed suicide (1,885 reported)

--

Nordiazepam 

Nordiazepam is the primary metabolite of diazepam

Completed suicide (1,885 reported) (diazepam)

--

Temazepam

Completed suicide (543 reported)

--

Oxazepam

Completed suicide (87 reported)

--

Venlafaxine

Completed suicide (1,818 reported)

--

Desmethylvenalfaxine

Completed suicide (147 reported)

--

Fluoxetine

Completed suicide (1,560 reported)

--

Citalopram 

Completed suicide (2,191 reported)

--

Clonazepam 

Completed suicide (1,924 reported)



I don't know about you but I'd much rather know if a pilot was on antidepressant-type medication given the above results, wouldn't you?

Now, here's the rub folks.

On April 5, 2010, the FAA announced that pilots who take one of four SSRi antidepressant medications – Fluoxetine (Prozac), Sertraline (Zoloft), Citalopram (Celexa), or Escitalopram (Lexapro) – will be allowed to fly if they have been satisfactorily treated on the medication for at least 12 months.

Two from that list, namely Fluoxetine and Citalopram, were found in the toxicology reports of pilots #18 and #22.

It begs the question, why did the FAA, in 2010, announce that pilots would be allowed to fly on 4 SSRi type medications, two of which have since been found in pilots who have used an aircraft as a choice of suicide?

Will be interesting if German authorities release details of the prescription medications they found in the apartment of Andreas Lubitz, although I suspect the media will focus on his state of mind rather that what prescription medication may have contributed to his state of mind.

It ain't rocket science folks but the mainstream media are still missing the bigger picture, as are the FAA and other aviation authorities.



Bob Fiddaman.



**Completed suicide figures obtained from RxISK drug database.



BACK STORIES

Co-pilot, Andreas Lubitz Germanwings

Andreas Lubitz - The Drugs Don't Work.

SSRIs Render Unfriendly Skies.

Documents obtained from the FAA under the Freedom of Information Act.












Thursday, July 07, 2011

Samantha Parnell - Caught in the Mental Health Trap

Samantha Parnell -  8 different psychiatric drugs

When Samantha Parnell was just 15 she, like many teenage children, experimented with recreational drugs, her choice being skunk, a selection of selectively bred cannabis strains.

Her parents, Sharon and Steve, became aware when she started behaving out of character, in fact her mother thought that her daughter had a brain tumour such was the drastic change she had seen in her. Alarmed by this Sharon took her daughter to a local hospital whereupon Samantha finally admitted that she was smoking cannabis.

Confused and showing signs of agitation a doctor injected Samantha and told her that it would help calm her, the hospital then prescribed her Risperdal, an antipsychotic used to treat schizophrenia. The hospital told her parents that Risperdal was a standard drug they used to treat teenagers who had taken street drugs. Samantha's parents were also informed that the "medicine" was well tolerated.

As weeks turned into months Samantha found it difficult to tolerate the Risperdal, in fact, recalls her mother, "the Risperdal made things worse." When Samantha told the health care professionals about her intolerance they simply upped the dose. She was told by medical staff that they needed to keep adjusting the dose until "they got it right" as everyone needed "different amounts."

In 2007, seeing no marked improvement, Samantha was prescribed Zyprexa. Concerned, her mother told the prescribing doctor that she was not happy that her daughter was being prescribed drugs and asked if there were any alternatives.The doctor told her there were no alternatives and that this was the standard treatment.

Things went downhill for Samantha and her behaviour became worse, so bad was her behaviour that she was sent into an acute young persons unit where she was given more psychiatric drugs.Her parents noticed that Samantha became lethargic and showed little or no emotion and also learned that she was self-harming, she also lost track of time and didn't know what day it was, recalls her mother.

In a phone conversation with Sharon, she told me:

It was just a downward spiral, by this time she was a shadow of her former self. She asked Steve and me several times please help me too die. Can you imagine that, she even said I’ll write you a letter so you and daddy don’t get into trouble.

Samantha was becoming more violent and her mother noticed that it became worse just a couple of weeks prior too her menstrual cycle. Sharon relayed this to Samantha's doctor as she felt it may be of importance. Her doctor, apparently, never investigated this finding.

During 2007 Samantha was in and out of hospital units and was also sectioned under the mental health act where she was prescribed Clozaril, an atypical antipsychotic, her parents had to sign a consent form and were told that their daughter's blood would be checked regularly as it could interfere with her white blood cells.

Sharon:

I didn’t like the sound of it at all but it was said this was the last she could try as this is the drug they use for treatment resistant people. 


At this point Samantha was taking three drugs, Zyprexa, Abilify and Lamictal, a fourth, Clozaril, was added to the mix and each time medical staff tried to 'up' the dose Samantha's heart reacted which ultimately saw Samantha admitted to a cardiac unit where she was told the Clozaril had to be stopped with immediate effect. Her mom recalls:

Whilst introducing Clozaril they reduced her from Zyprexa. Each time they tried to raise Clozaril her heart reacted so the cardiac doctor said it must be stopped immediately. They then proceeded to put her back on Zyprexa and also adding Abilify and lamotrogine.


Samantha's Clozaril was substituted with Diazepam, a benzodiazepine used for the short-term relief of symptoms related to 'anxiety disorders'.

Sharon:

Hindsight is a wonderful thing, if we knew then, what we know now, I would have said no. Sam’s life at this moment in time is a mess; I never want to hear of another child being abused by so called doctors again with these so called medicines. Sam has been so violent and she has hurt people and damaged lots of things too but their drugs have done that to her.


On 20th May 2011 Sharon took Samantha to a private hospital too see a consultant obstetrician and gynaecologist. She explained all of her daughter's mood swings and violent outbursts. After discussion, he prescribed Oestrogen patches for Samantha to wear two weeks on and two weeks off and said, "if you get a 10% difference after the two cycles then I will put her on the lowest dose to start just too see and then maybe go up to the next dose if it works for her."

The patches seemed to calm Samantha down somewhat, although she was still experiencing rage. The patches,recalls her mother, "stopped her more violent outbursts, she stopped attacking people and smashing up the place."

Unfortunately, Samantha, had previously attacked a bus driver who had refused her on a bus, Samantha had tried to board the bus with a train travel card and lashed out when she was refused to board.

Yesterday, Samantha, now 19, was sent to a medium secure unit. Her mother wrote a letter to the court explaining what she believes to be the reasons why her daughter acts the way she does. It bore no weight with the magistrate.

The final words goes to Sharon:

I know from the research that I have done on these so called medicines that two of the drugs Sam was on, clearly says can interfere with women’s hormones and they never told us that in the beginning. The same as they only chose too tell of what they call minor side effects. Anyone who has been on these drugs and anyone who has looked after anyone on these drugs know they are actual side effects.

Sharon Parnell has been creating awareness about the use of psychiatric drugs in children and wishes for parents across the UK to research any psychiatric drug prescribed to their children. Her website, Revelations UK has been running since 2010.

To date Samantha Parnell has been prescribed the following psychiatric drugs;

Diazepam
Phenergan
Olanzapine
Lamotrigine
Risperidone
Clonazepam
Aripiprazole
Clozaril

She is currently spending time at a secure unit, a young woman trapped in the mental health system, hooked on psychiatric medication that has escalated her problems and eradicated nothing.

Her mother sought the help of professionals, that help resulted in misery starting in 2006 and, it appears, continuing throughout 2011. Samantha Parnell has been punished enough, it's time for those responsible to remove their heads from the sand, it's time to stop the chemical cosh whipping of this young woman.

She is one of many thousands of children, teenagers, adults and elderly caught in the mental health trap.

Bob Fiddaman.




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