Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, May 29, 2017

Memorial Day Special - An Open Email to Robin Young



Last Thursday, psychologist Kelly Posner Gerstenhaber was given 10 minutes of airtime on WBUR, a National Public Radio station based in Boston.

Gerstenhaber was interviewed by Here & Now's host Robin Young. I say "interviewed," but it was more like a free infomercial for antidepressants.

The 10 minute program which can be listened to here, was a classic example of a one-sided shtick regarding the safety of "antidepressants" such as Prozac, Paxil, Zoloft, etc. Gerstenhaber offered tidbits of information which she claimed to be true. In fact, nothing she said appeared to be true. Neither could she back up her ludicrous claims that prescription drugs cannot cause suicide.

To date, more than 36 comments have been left on the WBUR page and all have gone unanswered by Gerstenhaber and host Robin Young.

One such person who felt compelled to leave a comment was Kristina Gehrki. Kristina has been featured on this blog in the past here and here.

In honor of U.S. veterans and Memorial Day, today she emailed the host. Her open letter, published here in its entirety, includes some interesting analogies. It's powerful. Perhaps Robin Young will have the decency to reply?

Here's the email (Published with the permission of Kristina Gehrki)

--

Honoring US Vets, Active Duty Servicemembers & Families through Accurate, Unbias Reporting

Robin Young, Cohost of NPR/WBUR "Here and Now"
890 Commonwealth Avenue, Third Floor
Boston, MA  02215
email: info@wbur.org

Dear Ms. Young,

Today is Memorial Day. Given your father was a United States Marine, I'm sure you are reflecting on his service. As a Marine wife for many years, I share your connection to the Corps and appreciation for veterans, servicemembers, and military families. Here's an old photo of my daughter, Natalie, age three at the Bethesda Naval Hospital.


When reading your bio after last Thursday's NPR radio program I learned we have several other commonalities: We both have journalism backgrounds, been recognized for our efforts on behalf of children, and worked on White House related communications.

However, today I'm contacting you about something we don't have in common--something I hope we never do: I lost my daughter at age 19 to prescription-drug-induced death.

Natalie was suffering from akathisia and Serotonin Toxicity, severe adverse drug reaction (ADRs) caused by SSRIs (Prozac, Zoloft, Paxil, etc.) Dr. Roger Lane, a Pfizer scientist for the company that made the product (Zoloft) that caused my child's demise, has stated "the subjective components of akathisia are distinct and overwhelming." In another peer reviewed medical journal Lane went on to note "It may be less of a question of patients experiencing fluoxetine (Prozac)-induced suicidal ideation, than patients feeling that death is a welcome result."  (SSRI-Induced extrapyramidal side-effects and akathisia: implications for treatment - Roger M. Lane)

Further, Dr. Robert Temple, former director of the FDA's office of medical policy, has said "that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior." (Harris, New York Times, 9/14/04, p. A01)

Yet on your show last week it appears your guest, Kelly Posner Gerstenhaber, withheld this information.  Doctors who don't want to harm their patients would benefit from being better informed.

Natalie's doctor didn't recognize Natalie's symptoms as ADRs. She assumed Natalie was ill with various difficult-to-classify disorders. Natalie unwittingly documented her ADRs despite erroneously being told they were signs of unspecified illness and not ADRs. (You can learn about our avoidable tragedy here & here)). Informed of Natalie's violent death, her doctor screamed, "Oh my God! Oh my God! It doesn't make sense; she wasn't depressed." Natalie's doctor, who didn't communicate the risks related to the product she promoted, said she prescribed Zoloft because Natalie was "too focused on dieting and exercising."

Your program last week never mentioned "akathisia." It featured one guest, Gerstenhaber, with one agenda. Gerstenhaber didn't discuss the adverse side effects and withdrawal problems associated with the "antidepressant" drugs she promoted. Neither of you disclosed Gerstenhaber and her Columbia University project's financial and professional ties to these product manufacturers.

Perhaps this collective failure was simply an oversight? Whatever the reason, it is unethical. It is also poor journalism to cover this critical topic by excluding scientific research, medical experts and consumers whose views and lived experiences are far different from those expressed by a solitary guest. These troubling omissions can cause avoidable suffering and death of our nation's vets, servicemembers, and children.

Suicide is, literally, a life and death topic. More than 22 veterans die by suicide every day, many of whom were prescribed drugs that carry the FDA's Black Box warning stating these products can increase the risk of suicidal thoughts and actions. Like my family, many are never informed of the products' risks vs. benefits and never receive Informed Consent; Therefore, their basic human right to medical freedom of choice is effectively denied.

Your father and all our vets served to protect Americans' right to life, liberty and the pursuit of happiness. Tragically, for some unsuspecting consumers, SSRI drugs rob them of life, liberty and happiness.

Today as we honor our nation's vets, I also remember those who died from terrorist attacks. Some victims of the September 11th World Trade Center attack jumped to their deaths. No decent person would ever state these deaths were "suicides." Rather, these innocent victims jumped to escape a burning building. It is a similar situation when consumers die from self-sustained injury while suffering prescribed akathisia and psychosis. These iatrogenic deaths are not "suicides" in the traditional sense of the term; I use the word "suicide" only because the English language hasn't yet coined a definitive term to describe such death. Prescripticide is likely the most accurate term. And so it is: My teenaged daughter, Natalie, died from prescripticide, as do many veterans.

To hear your guest, Gerstenhaber, claim SSRI drugs have few risks and great benefits conjured up an analogy about peanuts.Years ago I left journalism to pursue a fulfilling profession in education. At the start of every school year, I received district letters alerting me of students with peanut allergies. These serious allergies could result in my students' deaths. When I hear Gerstenhaber dismiss the risk of SSRI drugs and tout all the supposed benefits, I think about peanuts and my students. What would I tell a parent whose allergic child died in my class because I cavalierly chose to bring students a special treat containing peanuts? How would the parent of the dead child react if I replied, "Peanuts are healthy for most children. They are high in protein, easy to swallow, cheap and widely available. Sorry your child died. But remember, for most of my students, these peanuts were a healthy snack."

I've worked with children and teens for decades and recently paid my respects to fallen servicemembers at the Vietnam Veterans Memorial. Many of these casualties were teenagers--the same age as my students--when they died. As I stood at the wall, I pondered how long a wall would be if a similar memorial honored victims of medical error and ADRs. Given that the broken U.S. medical system is the leading cause of death and injury, few visitors would have the stamina to walk such a great distance when paying respects to lost loved ones.

Today some vets who survive akathisia and other ADRs bravely share their experiences. Dave Cope, a Navy veteran, shares his avoidable suffering in an open Letter to Congress. Cope attended the Massachusetts Institute of Technology (MIT) near your WBUR office and, like fellow MIT grad, Dr. Kelly Brogan, would have been an appropriate source for last week's program. Another Boston-area resident and a finalist for the Pulitzer Prize for Public Service, Robert Whitaker, could have also been invited to share his research. Clearly, you need not have ventured far from your office to find reliable sources for more balanced programing.

Since Natalie's death in 2013, I've met many intelligent people whose loved ones also suffered ADRs and died iatrogenic deaths--people with no financial motives nor conflicts of interest. Their loved ones were pharmaceutical executives, lawyers, marketing professionals, doctors, teens, and children. In the interest of public health and responsible journalism, I respectfully request you host a follow-up program in which medical experts and families can share independent research, personal ADR experiences and fatal outcomes.

You can reach me at akathisiamatters@gmail.com should you wish to do so.

Semper Fidelis,
Kristina Kaiser Gehrki

--

"Netherworld," from the film 'Letters from Generation Rx' by Kevin P. Miller.

'Netherworld' is told from the voice of Natalie Gehrki and her mother Kristina.





Back story

Kelly Posner Gerstenhaber - Incredulous!






Sunday, May 28, 2017

Psychiatrists Launch Antidepressant Withdrawal Video




Want to know how to get off antidepressants?

Dismiss this 'educational' video, it appears as if it's been put together by people who really haven't a clue what they are talking about.

The video, as far as I can make out, is a result of an online survey carried out by The Royal College of Psychiatrists. I'm almost certain that I took part in the survey but can't actually remember? Six years of Seroxat (Paxil) use kind of kills memory cells.

Watch the video. My comments are beneath.



"Antidepressants help many people." - How many? How do they help them? Describe, in detail, how they act on the brain and, furthermore, how that action helps 'lift' depression, anxiety etc.

"After overcoming depression some find coming off antidepressants quite difficult." - Some? How many exactly, what are the figures? In any event, how does one know one has overcome 'depression' if the antidepressants are designed to make consumers feel like they aren't depressed?

(Paraphrasing) - "They might find their depression returns." - How do they know this, how do they know whether it's a return of the depression or whether it's a side effect of withdrawal?

"Deciding when to stop is really important, talk it over with your doctor first." - Herein lies a major problem. Dr's have been told by pharmaceutical companies and medicine regulators that these drugs are safe and effective. They have also been told that, despite there being warnings of antidepressant-induced suicide, these feelings only occur in a small number of people and, it's not the drug, it's the 'underlying illness'.

"If you've had one episode of depression it's best to stay on your antidepressants for six months to a year after you feel better." - Yes, they really do advise this but don't go into any detail as to why? So, in essence, they are telling us that despite feeling better carry on taking your antidepressant for a further 6 months to a year. So, if you have a clean bill of health, carry on taking something that will give you no benefit at all, right? To use an analogy, treat your headache with paracetamol and once the pain goes away continue taking paracetamol for 6 months to a year (despite you not having headaches anymore.)

"If you stop too soon, your depression is more likely to come back." - Ah, I see. So, by taking tablets to treat depression, even though your depression has cleared, it appears The Royal College of Psychiatrists are now claiming antidepressants 'prevent' further episodes of 'depression'? - Since when have antidepressants been used to help prevent the illness, I thought they were prescribed to help with depression and not prevent it? At this rate, The Royal College of Psychiatrists, would like to see us all on antidepressants, even though we have no depression.

"If your problems have been going on for sometime, your doctor might advise you to stay on antidepressants for longer." - So, if you have been taking antidepressants for a year or so and your problems still exist then the antidepressant is still working but it needs time to 'kick in', right? How many other drugs that have been licensed get such a carte blanche?

"Most people don't have troublesome side effects when coming off antidepressants, but some do." - Figures, what are the figures? Is this statement based on 8-12 week clinical trials or is it based on the post-marketing surveillance of these drugs?

"Most people said that their symptoms lasted up to six weeks." - This figure seems to be based on the online survey carried out by The Royal College of Psychiatrists. For transparency, it would be beneficial to see these figures produced by The Royal College of Psychiatrists.

"Talk to your doctor, they can help you make a plan, when to stop, how quickly to reduce the dose and who to contact if you have any problems." - So, doctors have had specific training in antidepressant withdrawal? How much training, who trained them? Who do doctors suggest you contact if you are having withdrawal problems?

"You may have some physical symptoms or your depression may return." This is really quite comical. On one hand you may have physical symptoms of withdrawal but it could be your depression returning. The doctor, who remember has had limited training regarding antidepressant withdrawal will, more than likely, tell you to restart. Once you do your withdrawal symptoms will magically disappear. Here's the rub, folks, your doctor will tell you that you was experiencing a return of the illness and not antidepressant withdrawal symptoms. Round and round you go.

"Ask your friends and family for support and maybe take some time off work." - Those same friends and family will not know anything about drug withdrawal - yes, they may spot signs of suicidality but won't make the connection that it could be the drug causing the suicidal feelings - they will assume, just as many doctors do, that it's the 'underlying illness'.

"Reduce your dose slowly, this helps to reduce symptoms." - Symptoms of what? How slowly. Where's the guidance here?

"Stay in touch with your doctor throughout the process." (of reducing) - I agree with this statement to an extent. However, this can be impractical for many people and they may send an email to their doctor or phone them. Doctor's then will have to make a decision to either continue the reduction process or, as in the case of Natalie Gehrki, increase the dosage. Natalie's story is here & here. Again, what training have doctors had to spot signs of worsening depression opposed to worsening symptoms of drug side-effects?

"Keep a diary of your symptoms and doses." - Have you ever tried writing when going through severe withdrawal? I could barely lift a pen, let alone write.

"Be prepared to stop the reduction or increase the dose as necessary." - Why? Is this due to the drug causing the symptoms or a return of the illness?

--

So, The Royal College of Psychiatrists have skipped over the most important issue surrounding antidepressants - suicidal thoughts, actions and completion. There is no reference to the condition of akathisia, a condition caused by prescription medications, in particular, antidepressants.

Here is a video, that is also animated, it was created by MISSD,  - it tells you all about akathisia.




So, after watching these two videos, who would you like to seek more advice from? The Royal College of Psychiatrists, who, it appears, are giving us more questions than answers, or MISSD, a non-profit organization dedicated to honoring victims of prescription drug induced akathisia by raising awareness and educating the public?


Bob Fiddaman




Saturday, May 27, 2017

Paxil in the News Again - Seven Deaths






PAXIL - Death one

It's a rare occasion when I can sit down on weekends and relax. Two news stories that I wish to share with you today can't really wait until Monday. A third, is a news story from 1998 that collectively ties in.

First off, GlaxoSmithKline, the company who had their arses kicked in Chicago back in April this year, have now decided to, once again, put Wendy Dolin and her family through the mill. Not content with the jury's decision, that ruled Paxil (also known as Seroxat) and GSK responsible for the death of Wendy's husband, Stewart, they have now filed a motion for a new trial citing, amongst many things, the trial "was not fair" and that Wendy "did not meet her burden at trial to prove her failure-to-warn claim and her allegation that generic paroxetine caused Stewart Dolin to take his own life."

Furthermore, GSK, just as they did at trial, are blaming Stewart's doctor for prescribing Paxil and also the FDA for apparently refusing to update the suicide warning on Paxil.

GSK are also, it appears, blaming the judge for not properly instructing the jury.

The motions states, "In contrast, the Court denied GSK a fair opportunity to cross-examine Plaintiff’s experts for bias and to present relevant evidence. In addition, Plaintiff had the final word at trial with expert testimony that went far beyond any proper “rebuttal.” These many errors resulted in extraordinary prejudice to GSK, jury confusion, and ultimately a verdict unsupported by the weight of the evidence. A new trial is required."

It was expected that GSK appeal the decision, let's face it, their highly paid law team of King & Spalding defend Paxil cases by the dozen and, even when settling or losing, they always claim that "Paxil has benefited millions of people worldwide", or words to that effect.

If GSK get the green light for a new trial it will mean further distress for Wendy Dolin and her family. More subpoenas, more questioning, more mud-slinging.

King & Spalding lost the case because a jury of men and women ruled against them. To save face, and to show GSK how they lost because it was an unfair trial, Messrs Bayman & Davis (King & Spalding) wish to bring their circus to town once more.

Stewart Dolin jumped to his death after Paxil induced akathisia, a condition that GSK, and other pharmaceutical companies, have played down for years.

I'll keep you updated on developments.


PAXIL - Death two & three

Back in 2011, 29-year-old Renske Hekman, from Baflo, Netherlands, was brutally murdered by her boyfriend, Alasam Samaria, who had picked up a fire extinguisher in the hall of her apartment and beaten Renske to death. He then shot a police officer dead.

Renske's father, Eddy Hekman and his daughter's killer, Alasam Samaria, have, in a remarkable twist of fate, now joined forces and wrote a book together. The book, Een coupé verder: over het drama van Baflo, wat eraan voorafging en wat erop volgde (The tragedy of Baflo, what preceded it and what followed), highlights Samaria's use of Paxil, particularly on the day he murdered, or was induced by Paxil to murder, Renske.

The book shows how on April 13, 2011, Samaria's psychiatrist tripled the dose of Paxil. At the scene of the crime police said of Samaria that he looked like "a zombie with empty eyes."

Just as in the Dolin Vs. GSK trial, evidence was shown how Stewart acted out of character. He had no previous history of wanting to kill himself. Paxil, like a lot of other SSRIs, can induce psychosis and consumers can, at times, feel not only suicidal but homicidal too.

PAXIL Death four, five, six and seven

In 1998, the town of Gillette, Wyoming, became infamous for all the wrong reasons.

Donald Schell (60) shot to death his family members, Rita Schell, Deborah Tobin, and Alyssa Tobin, before turning the gun on himself. Nobody knew, at the time, why such a loving man would carry out such a heinous crime.

Step forward surviving son-in-law, Tim Tobin, who brought a wrongful death lawsuit against Glaxo because Donald Schell was, basically, 'normal' before he started taking Glaxo's wonder drug, Paxil. The jury in the Tobin v SmithKline Beecham (SKB) trial concluded that Paxil could cause someone to carry out suicide or homicide and that the drug was in fact a proximate cause of the deaths in this case. Glaxo were fined around $6.4 million.


The Tobin verdict - Click to enlarge

At the time of the verdict, Charles F. Preuss, a lawyer for the manufacturer, GlaxoSmithKline, said the verdict was "a surprise." He added, ''This issue was raised in the early 90's, and since that time all the scientific articles have concluded that these antidepressants do not cause suicide or homicide or suicidal thoughts,'' 

Once again, GSK in denial, even after being held liable.

Seven deaths. One drug.

One would have thought the evidence, however, is clear...

Bob Fiddaman
Author of "The evidence, however, is clear, the Seroxat scandal."


Related

Dolin Verdict

The Guardian - Experience: I made peace with my daughter’s killer, by Eddy Hekman

New York Times - Tobin Verdict

Thursday, May 25, 2017

Kelly Posner Gerstenhaber - Incredulous!



 Kelly Posner Gerstenhaber

Dr. Kelly Posner Gerstenhaber is a visionary scientist, humanitarian, and philanthropist with a long-standing commitment to saving lives. Her focus on preventing death by suicide.

At least these are the claims of her bio found here.

For simplicity I will just refer to her as Posner.

Posner caused quite a stir earlier today when she was a guest on a radio show broadcast by WBUR.

She claimed that science shows prescription drugs 'Don't cause people to be suicidal.'

Posner, presumably from the area of Idontgiveadamn, which is situated on the planet Zog, obviously has some sort of delusions of grandeur, at least that's what her bio would suggest.

A humanitarian?

A long-standing commitment to saving lives?

What the program-makers, and, indeed, Posner, failed to mention was her ties to the industry. Back in 2009 Posner added her name to a study published in the Journal of the American Academy of Child and Adolescent Psychiatry. (JAACAP)

The JAACAP is infamous for the ghostwritten Paxil 329 study and despite many calls for it's retraction the journal are steadfast in not removing the fraudulant 329 study.

In 2009 Posner listed her following interests after adding her name to the Depressive Symptoms and Clinical Status During the Treatment of Adolescent Suicide Attempters (TASA) Study.

Here we get to see the reasoning behind her claims on WBUR.

"Dr. Posner has received research support from the following pharmaceutical companies, as part of an effort to help execute the FDA suicidality mandates/requests: Amgen, AstraZeneca Pharmaceuticals, Forest Laboratories, GlaxoSmithKline, i3 Research, Eli Lilly, Johnson & Johnson, H. Lundbeck A/S, Medtronic, Merck & Co., Next Wave Pharmaceuticals, Novo Nordisk A/S, Orexigen Therapeutics, Otsuka Pharmaceuticals, Pfizer, Roche, Sanofi-Aventis, Schering-Plough Corporation, Schwarz Biosciences/UCB, Sepracor, Takeda Pharmaceutical Company, Valeant Pharmaceuticals, Vivus, and Wyeth Research."

Furthermore, the Columbia Lighthouse Project at Columbia University, of which Posner is the founder and director, receives funding from pharmaceutical companies. Again, this was not mentioned by the program-makers at WBUR or, indeed, Posner herself.

The interview is unbelievable, nae incredulous.

Give this a listen, the usual 'underlying illnesses' is rolled out.

She also claims that suicides have risen since black box warnings in the US, Another fallacy that has been debunked many times.

On anecdotal reports of people dying by antidepressant induced suicide she said, "the greatest risk of suicide is a month before starting treatment, what is causing the risk is the medication not having  chance to work yet." Posner also claimed that she worked alongside the FDA and stated that there was not one suicide reported.

Hmm, she's either lying or the FDA didn't feel that she was important enough to give that information to.

Strange because I was present at the recent trial in Chicago where Paxil was implicated in the death of Stewart Dolin. The  jury heard about the following suicides during Paxil clinical trials. All the subjects were taking Paxil at the time of their death. (See Plaintiff's Exhibit 347)

Female, 56 - Suicide.
Unknown gender - 50 - Suicide by hanging.
Female, 42 - Suicide by overdose of doxepin.
Female, 18 -  Suicide.
Female, 58 - Suicide by hanging.
Male, 24 - Unknown if it was suicide - Patient was hit by a train and killed
Male, 34 - Suicide
Female, 48 - Suicide
Female, 46 - Suicide by hanging.
Male, 54 - Suicide, jumped under a train.
Female, 67 - Suicide - on the fourth day of the study she threw herself out of a window.
Female, 32 - Suffocation due to vomiting.
Female, 33 - Suicide, jumped from 4th floor balcony.
Male, 65 - Suicide by an unknown method.
Male, 23 - Suicide.
Female, 31 - Suicide.
Unknown gender , 86 - Suicide by hanging.
Male, 46 - Suicide/Homicide - on December 14, 1998, the patient went to the home he shared with his estranged wife and shot her, he then turned the gun on himself.
Male, 40 - Suicide.
Male, 35 - Suicide (Shot himself)
Male, 19 - Suicide (Shot himself)
Female, 58 - Suicide by hanging.

80% of these suicides were carried out by patients over the age of 30. (Back story)


Plaintiff's Exhibit 347


This is gut-wrenching to listen to as I know, and have met, many parents, husbands and wives who have lost loved ones to antidepressant-induced suicide.

WBUR need to either add Posner's conflict of interests or invite parents onto their show to rebut the outlandish claims you are about to listen to.




Feel free to leave a comment beneath this post or on the WBUR website here.


Bob Fiddaman




Wednesday, May 24, 2017

Under Cover Terrorists




There's so much hatred doing the rounds lately - I guess it takes an act of violence on children, innocent children, to get people riled.

And rightly so.

Terrorist Salman Abedi, who carried out the abhorrent act in Manchester two nights ago has been condemned by many. He walked into a foyer knowing what he was about to do, he did so because, it is believed, he had taken the written word from an ancient scripture literally. He probably believes that his actions will be rewarded by some fairy in the sky. "Here you go, Salman, here's some virgins for you, great job."

Many people, including friends and family, hang their hat on the mythical, Let's face it, there's no concrete evidence that God, any God, exists, yet we see throughout history how many atrocities have been carried out in the name of God.

Personally, I'm an atheist. As such, I avoid being manipulated by indoctrination of fairy tales. Not having a God in my life suits me just fine.

The world I move in has seen many child killers, but the public apathy suggests it's okay to kill children and, indeed, adults, if the perpetrators are multi-billion dollar industries.

During the past two days Facebook has seen people voice their shock and horror over the Manchester atrocity. Folks who normally post photos of what they are about to eat or weather updates have been so shocked and moved that they have voiced their opinions and condemned the actions. The Manchester atrocity was enough to get people enraged.

What if I told you that back in 2012, a white coach driver by the name of Geert Michiels carried out an act or terrorism? What if I told you he had no affiliation to any terrorist cell? Michiels deliberately drove his coach into a tunnel wall killing 28 passengers, 22 of whom were children. Would you still be inclined to vent your outrage on Facebook or any other social network?

Geert Michiels, 34, didn't have a weapon of destruction strapped around his body, but he was driving one.

But hey, he had no motive, no indoctrination, no manipulation of the mind... or so we are led to believe.

What if indoctrination came in the shape of a pill, what if that pill changed your outlook on life, on society as a whole? Wouldn't such a pill be snapped up by terrorist organizations such as those responsible for the events in Manchester? If one can manipulate the mind of a 22 year-old by preaching quotes from an ancient book then such a gift as one simple pill could speed up the process of manipulating someone who was once normal into a mass killer.

A full investigation into the coach crash was carried out by Swiss Chief Prosecutor Olivier Elsig, the results of which were inconclusive. He ruled out the involvement of a third party, shortcomings in the road surface or the tunnel infrastructure. Excessive speed, alcohol or technical problems with the vehicle were also ruled out. He, at no point, could determine whether or not Geert Michiels carried out an act of homicide/suicide with the vehicle.

From the investigation, and subsequent independent investigations, it was learned that Michiels was taking or withdrawing from Seroxat at the time of the crash. Seroxat is better known as Paxil in the US and Canada and Aropax in Australia.

It's become widely known that Seroxat can cause suicidal thinking in some people who take it, it has also been proven, in US Courts, that Seroxat was responsible for, not only suicide but homicide too.

Seroxat, by the manufacturers own admission, can cause a symptom called akathisia, in a nutshell, akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Seroxat was Geert Michiels 'bomb'. The drug caused adverse reactions that triggered a series of events in his brain. It was his indoctrination by proxy that eradicated his normal empathy and induced atypical thoughts of killing his passengers and himself. This became his mission in a split second. We know from the recent Dolin Vs. GSK trial that akathisia can be switched on and off in a second. We also know that for persons experiencing akathisia death can be a welcome result. This statement was made by Dr. Roger Lane who, in a 1998 article on akathisia, said, "It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation than patients feeling that 'death is a welcome result' when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders." - At the time, Roger Lane was working for pharmaceutical giant, Pfizer.

Pfizer make Zoloft, an akathisia-inducing drug.

Yet we see no world-wide condemnation of pharmaceutical companies or indeed those who are supposed to regulate the drugs you and I take.

22 people died in Manchester. - Salman Abedi's mind has been manipulated by indoctrination.
28 people died in Sierre. - Geert Michiels' mind had been manipulated by Seroxat.

I anticipate that Facebook posters won't be spreading the Sierre story far and wide.

Bob Fiddaman

Back stories

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

Did the Sierre Bus Driver Have a Pre-Disposition to Seroxat?

What is akathisia?

Advocates Against Prescribed Akathisia

Guest Post: Let's Bring Akathisia Out of the Darkness







Thursday, May 11, 2017

Guess Who's Being Sued Again?





Drug: Lamictal (lamotrigine)
Marketed and manufactured by GlaxoSmithKline.

According to the Daily Mail, the lawsuit, filed by Khaliah Shaw, 26, alleges that within a month of taking the drug, she had developed a rash on her face, while the skin on her lips had started to peel off. Although she visited her local ER, she was initially diagnosed with the flu.

Two days later, it is claimed, Miss Shaw woke up in excruciating pain, with the skin on her face, neck, back and chest falling off and her mouth covered in blisters.

The reaction left her skin permanently scarred, and she is slowly losing her sight.

Shaw, along with many others, are suing GlaxoSmithKline for promoting the product without warning of the risks, claiming more than $3.45 million in medical costs.

Shaw lost up to 90 percent of her skin.

More articles...

Woman's skin burned from inside out after dosage error, lawsuit claims

Wrong Treatment Melts Woman’s Skin Inside Out

Student, 26, who was almost blinded and lost 90% of her skin after taking common anti-seizure drug sues GlaxoSmithKline for more than $3 million


The GSK company mission statement is to, "help people do more, feel better, live longer."

Bob Fiddaman





Friday, May 05, 2017

Disdain Shown Toward Kids by Australian Medicines Regulator





dis·dain
noun

the feeling that someone or something is unworthy of one's consideration or respect; contempt.



So, Australia, a country I hold dear to my heart, apparently has a limp-wristed regulator in charge of it's drugs. Here's a news story from TodayTonight, a current affairs show broadcast in Adelaide, Australia, that may shock you. It was aired on Thursday May 4.

I can't find the words.

I know how Aropax (more commonly known as Paxil and Seroxat) can screw with your head. I know how it can make you feel like you want to kill yourself. I know the horrific withdrawal effects can make you feel like punching walls, and even people.

I know how GlaxoSmithKline wanted children to take it.

Also featured in this video is the story of a young girl who took Zoloft. Pfizer, it's manufacturer, don't seem to mind if kids take their drug either.

I honestly have never known an industry as sick as this one. It's difficult to put in to words because there seems to be such an incestuous relationship with pharmaceutical companies and global regulators. This relationship grows yearly and, it appears, not one medicine regulator seems to give a damn about children (as depicted in this video segment) being prescribed mind-altering drugs that aren't safe for adults, let alone 5 year-olds!




For more information on the SSRI problem in Australia join the Australian Antidepressants Class Action & Awareness Facebook group.


Bob Fiddaman

SSRI Deaths in Clinical Trials







Following on from MHRA Yell "Barracuda!", I have sent the following request (under the terms of the Freedom of Information Act) to the MHRA.

I can't see any reason why they can't answer, given they already confirmed to me, in writing, about the 22 deaths that occurred in Paxil clinical trials.

1. How many deaths occurred in the pediatric trials for Paxil/Seroxat. How many were by suicide and how many of those patients were taking Paxil/Seroxat at the time of their death?

2. How many deaths occurred in the pediatric trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

3. How many deaths occurred in the persons aged 24 or over in clinical trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

4. How many deaths occurred in the pediatric trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

5.  How many deaths occurred in the persons aged 24 or over in clinical trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

6. How many deaths occurred in the pediatric trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

7. How many deaths occurred in the persons aged 24 or over in clinical trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

8. How many deaths occurred in the pediatric trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

9. How many deaths occurred in the persons aged 24 or over in clinical trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

Bob Fiddaman








Thursday, May 04, 2017

Facebook Comments






I've managed to add a Facebook comments box at the end of each of my blog posts. I've been trying to figure out how to do this for a while. Much of my work gets shared or 'liked' on Facebook and now you can leave a comment by using the comment box below each post.

The comment feature on this old blog of mine has been problematic for many years. Hopefully, now, it will be easier for you all to leave a comment.

Bob Fiddaman.



Tuesday, May 02, 2017

MHRA Yell "Barracuda!"




I think I am familiar with the fact that you are going to ignore this particular problem until it swims up and bites you on the ass!Matt Hooper - Jaws


The above photo and caption are from the movie Jaws. Power and money-hungry Mayor Larry Vaughn, played by Murray Hamilton, refuses to acknowledge that the residents of Amity are at risk of a shark attack. If Vaughn doesn't close the beaches, the shark could harm and kill citizens. Matt Hooper, played by Richard Dreyfuss, is an oceanographer with a special interest in the study of sharks. He uses his knowledge to try and convince Vaughn to protect the town, but Vaughn ignores him. Given the popularity of Jaws (it won an Oscar), I assume we all know the outcome of Vaughn's callous ignorance, right?

I'm not Matt Hooper, but lately, I feel like him. For years I've been at loggerheads with the MHRA as I seek answers to improve public health. Today's blog spotlights my latest correspondence to/from the MHRA about the increased risk of adult suicide posed by Paxil.

The MHRA and FDA know SSRIs are not recommended for consumers under the age of 24 because these products increase the suicide risk. In the US there is a black box warning, and in Europe, the patient information leaflet highlights this increased risk of suicide for any consumers under age 24. It is actually printed in bold face font. (See Doublespeak)

What we don't know is how and why regulatory authorities chose to highlight the product's dangers in consumers under 24 and not communicate the increased suicide risk for consumers over 24.

Let's look at the facts regarding Paxil clinical trials. (Paxil is known as Seroxat in Europe.)

In GSK's Paxil pediatric trials, which included more than 1,000 patients treated with Paxil, there were zero completed suicides. We know this because GSK's vice president for regulatory affairs, Dr. David Wheadon, admitted this in a written statement. What we don't know is how many of the children who were given Paxil developed suicidal thoughts and actions. MHRA and the FDA apparently feel this information is not important for the public's viewing.

In GSK's Paxil adult trials, we know 22 deaths occurred, 80% of which were people over age 30. (See here.) What we now know, thanks to the evidence made public in the Dolin vs. GSK trial, 42 people taking Paxil developed suicidal thoughts and actions.(See here)

So, to sum up: No deaths occurred in Paxil pediatric trials, and 22 deaths occurred in Paxil adult trials. Twenty of these deaths were completed suicides, and 80% of these were people over age 30.

Surely, the MHRA never had this information?

Wrong.

Here's a series of emails between myself and the MHRA. Spelling and grammatical errors from the MHRA are as received.


From: Bob Fiddaman
Sent: 31 March 2017 14:54
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

On the current Seroxat Patient Information leaflet (Revised 11/01/2017) it states, under the subheading "Thoughts of suicide and worsening of your depression or anxiety disorder"...

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

· If you have previously had thoughts about killing or
harming yourself.
· If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an
antidepressant.

Q: Could you please explain why "young adult" is in boldface type font and who made the decision to include "young adult" in a boldface type font?

--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 5, 2017 10:44 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman

The SPC for Seroxat includes the following:

A meta‑analysis of placebo‑controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old (see also section 5.1).

As the above suggests that this particular age group are most at risk, the MAH will have suggested the emboldening of the text within the PIL. There are fors and againsts the use of emboldening, but in this particular case it has been considered appropriate.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 16 April 2017 15:52
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Chris,

Just so you know.

Plaintiff’s Exhibit 347: Each picture depicts a real person who completed suicide while taking Paxil in a GSK-clinical trial. The red “Vs” mean their specific suicides were violent in nature. There were multiple suicides using firearms, including a murder suicide by one patient. There were also two deaths from people jumping in front of trains.

When it comes to suicide attempts, GSK did not keep track of all the attempted suicides in their clinical trials because, according to their company witness, it would be too burdensome.

My question.

The MHRA knew about these adult completed suicides, correct?


Attachment added to email
--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 19, 2017 12:03 PM
Subject: RE: Drug labeling

Dear Mr Fiddaman

I can confirm that the MHRA is notified of all serious adverse events, as laid out in the Pharmacovigilance Clinical Trial legislation.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 19 April 2017 17:08
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Dear Chris,

For clarification. Were the MHRA notified of the 22 deaths that occurred in paroxetine (Seroxat) clinical trials carried out by GSK (SmithKline Beecham) and that 16 of those deaths (80%) were attributed to adults over the age of 30?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Friday, April 21, 2017 5:19 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman,

As stated in the previous email from Chris Penny the MHRA is informed of serious adverse reactions occurring in clinical trials in compliance with current legislation.


The deaths that you are referring to took place between approximately 1983 and 2003. This data would have been submitted to European Competent Authorities and the suicidality risk of paroxetine was formally addressed at a European level in 2003/2004. Class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the SSRIs based on data reviewed in 2004.


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

From: Bob Fiddaman
Sent: 21 April 2017 16:29
To: Clinical Trial Helpline
Cc: Pharmacovigilanceservice
Subject: Re: Drug labeling

Thanks Rosalind.

One final question.

The MHRA have no plans to update the Seroxat label regarding Seroxat-induced suicide in adults over the age of 24, correct?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Tuesday, April 25, 2017 2:05 PM
Subject: RE: Drug labeling


Dear Mr Fiddaman,

As stated before, class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the Selective Serotonine Reuptake inhibitors (SSRIs) based on data reviewed in 2004. Paroxetine is an SSRI. Suicidal ideation and behaviour is already addressed in the Paroxetine Summary of Product Characteristic (SmPC).


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

So, there you have it, folks. The MHRA decided to highlight the increased risk of suicide among consumers under age 24, and they decided not to highlight the increased risk of suicide among consumers over 24.

Why didn't the MHRA feel the need to highlight the 22 adult deaths that occurred in the Paxil trials? It appears the MHRA believes Paxil isn't safe for children, but is safe for adults?

Why, in 2017, is the MHRA still not updating the Paxil warning label for adults?

Why do the MHRA continue to highlight the risk of patients under the age of 24?

I think I know why. GSK already knew that their ideal target market for Paxil was not going to be children. GSK is not allowed to promote Paxil to children (but they still did and were fined for their criminal behavior.)

But GSK was not about to lose Paxil profits when it came to capturing the adult market. MHRA helped them out by emphasizing in the patient information leaflet that the risk is only for consumers under 24. By intentionally printing these specific words, "young adults," in bold face type, MHRA is essentially telling older consumers: "Pay no attention to this increased suicide warning if you are over 24. This product poses no increased risk of death."

Obviously, MHRA should warn older adults by highlighting the 22 deaths and including older adults in the warning. Perhaps MHRA's CEO, Ian Hudson, doesn't want to do this because, whilst under oath in 2000, he stated he had seen no evidence to suggest that Paxil "caused any person, worldwide, to commit an act of homicide or suicide."

I'll leave the final words to Ian Hudson, um, Mayor Vaughn who, despite knowing about the risks created by keeping the Amity beaches open, had this to say...

"You yell barracuda, everybody says, "Huh? What?" You yell shark, we've got a panic on our hands on the Fourth of July."


Bob Fiddaman

Related

Former Glaxo Safety Officer Becomes Head of MHRA

EXCLUSIVE: Dr Ian Hudson: In Defence of the Suicide Pill (Full Video Deposition)

Paxil Suicide - The Way GSK Hid the Link

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users





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