Generic Paxil Suicide Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Wednesday, April 17, 2019

50 Years and Still Rockin'




Left-to-right: Mathy Downing, Bob Fiddaman, Kristina Gehrki, Kim Witczak

~~~

Love is all you need

~ Lennon–McCartney

~~~

Last weekend I celebrated some special champions of human rights at a star-studded Hollywood event. It was the 50th anniversary of the Citizens Commission on Human Rights (CCHR). I respect this organisation and support their goals which include investigating and exposing psychiatric violations of human rights and demanding medical doctors become competent. Today's post is about the well-attended California event.

The "S" Word

For some people out there, there's an elephant in the room whenever CCHR's public health and safety work is referenced. It's an elephant I noted in my book years ago and one that I'm never shy to address. That it has to do with labels is something I find ironic considering labels are often the first tool psychiatrists use to lead unsuspecting victims down the destructive path of wrongful drugging.

CCHR is a nonprofit mental health watchdog responsible for helping to enact more than 150 laws protecting individuals from abusive or coercive practices. CCHR has long fought to restore basic inalienable human rights to the field of mental health, including, but not limited to, full informed consent regarding the medical legitimacy of psychiatric diagnosis, the risks of psychiatric treatments, the right to all available medical alternatives and the right to refuse any treatment considered harmful.

CCHR was co-founded in 1969 by the Church of Scientology and Professor of Psychiatry Emeritus Dr. Thomas Szasz at a time when patients were being warehoused in institutions and stripped of all constitutional, civil and human rights. That the pharmaceutical companies and their PR machines often try to use one's spiritual beliefs to discredit those harmed and divert the public's attention away from real facts about the pharma and psych industry is nothing new. I've met countless victims and their families whose spiritual beliefs and the church they attend were the subject of depositions conducted by pharma. Pharma basically tried to link the SSRI-induced death of a 12-year-old girl to their family's Protestant religion and the church the family attended.

Here's the interesting thing. The surviving family members were questioned by the drug manufacturer's attorneys. They were trying to claim that the family were Scientologists because they supported the work of CCHR. For four hours the victim's sister was grilled. The drug manufacturer was trying to suggest that the family was unstable and that their sister/daughter died because of their beliefs and not because of Zoloft induced suicide.

That little girl, by the way, was just twelve-years-old and died by hanging shortly after her Zoloft dose was doubled. She weighed just 67 pounds.

Seriously, no kidding here. But what do you expect given pharma tried to blame another young child's death on possible "sex games" gone wrong. (The child was found hanging after consuming Zoloft and Pfizer claimed the boy may have died because he was possibly engaging in sex games. Matthew Miller was just 13 years old.)

So, back to the "S" word, Scientology. I was born into a Catholic family. While I no longer practice Catholicism, I also don't practice Scientology. Not that my religion should be anyone's business but my own, but apparently some people refuse to share helpful research, resources and stories of prescribed harm simply because of other people's religious beliefs or affiliations. This alarms me because as I noted, labelling and censorship is exactly what the psych and pharma industry promote to keep information about prescribed harm out of the public's eye. I'd hate to see people killed or harmed because they didn't have an opportunity to access factual information and/or read the avoidable tragedies of prescribed harm suffered by their neighbours.

I have many friends with various spiritual beliefs. They include Catholics, Scientologists, Protestants, Muslims, Hindus and atheists. While I'm always interested in learning more about my friends' personal beliefs, my friends don't pressure me to believe as they do and none have ever tried to convert me. Most people would agree it is wrong to be ridiculed and slandered based upon one's religious principles.

In my 13 years as a public health and safety advocate, I've seen one church constantly targeted and maligned by the psych and pharma industry--the Church of Scientology. It doesn't take a genius to figure out why pharma attacks Scientologists. One need only to look at the reliable and extensive research and resources freely offered by CCHR to understand why CCHR is a target of these industries. In addition, I suspect if any of these other religions advocated as CCHR does, they, too, would be targeted by psychiatry and pharma.

These well-funded, systemically-organized attacks are merely manipulation tactics. An appropriate word for this behaviour is one I've just invented and rather like: hoodwinkery. So don't be hoodwinked by hoodwinkery.

Now back to last weekend's CCHR 50th anniversary events.

Library Meets Rock Gig

A CCHR event is a cross between a library and a rock gig. This may sound like a contradiction, but here's why I describe it as such. Attend any CCHR event and you will find yourself in a room full of knowledgeable people. Everyone there knows what's going on in the dark world of brain pellets. Audience members and hosts represent the knowledge, and the rock gig vibe is represented by, well, by accomplished musicians.

This Los Angeles event was the third one I've attended. (I also previously attended a CCHR award event in the UK years ago.) This year's human rights award recipients were film-maker Kevin P. Miller and attorney Andy Vickery. I have previously corresponded with both and was glad to meet Kevin Miller last weekend. Unfortunately, I never had a chance to meet Andy Vickery because honorees are swamped by the masses at after-show parties where everybody wants to talk with them. (I know because years ago I was one of several people recognized by CCHR for advocacy work.)


I was glad to meet award-winning documentary filmmaker, Kevin P. Miller. For those who don't know, Kevin wrote and directed both Generation RX and Letters from Generation RX. Like me, Miller has met many families destroyed by products marketed as "antidepressants." I prefer to simply call these pills brain pellets. It's a dark world we both move in yet it is also rewarding when we can improve public health by publicizing the personal experiences of those who have been prescribed harm. Kevin's humanitarian efforts shine in his documentaries. He is committed to human rights and long after his films are finished, he still speaks with the families of the victims, many of whom have become personal friends. He never forgets those whose stories he compassionately shares. I was glad to see Kevin, a kind-hearted man whose previous films have covered other human rights issues such as veterans and the homeless, recognized by CCHR for his contributions to a better society. I salute you, Kevin.


Another CCHR human rights award recipient was trial lawyer, Andy Vickery. Vickery was moved to tears when delivering his acceptance speech.

If you click on the New York Times link above about young Matt Miller who died while taking Zoloft, you'll see it was Andy Vickery who represented the family against Pfizer. Vickery was one of the first attorneys to represent families harmed by SSRIs and shined a public spotlight on the link between Paxil and violence when he represented the family of Donald Schell.

In 1998 the town of Gillette, Wyoming was shaken to its core, not by invading aliens arriving in motherships playing the five tones. Gillette was shaken by the Paxil-induced homicide and suicide of Donald Schell. Schell, age 60, shot to death his wife, daughter and baby granddaughter before turning the gun on himself. At that time nobody knew why such a loving man would carry out such heinous crimes. Thanks to Andy Vickery, the public soon learned about the link between Paxil and violence.

Schell's surviving son-in-law, Tim Tobin, brought a wrongful death lawsuit against GlaxoSmithKline, Paxil makers. 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. (1)

In 2004, some two years after the Tobin verdict, the FDA mandated black box warnings about the risk of antidepressant-induced suicidality, which SmithKline had denied, but which the Tobin case proved existed. The Black Box Warnings were a positive step in the right direction when it comes to protecting the public. However, the FDA does not require that the warning be clearly communicated by prescribers.

Vickery's award is well deserved.


(1)

For Those About to Rock... Da Sisterhood (You know who you are!)

The event itself was classy. It's glitz with a message and that message comes across loud and clear in a fantastic awards' show with top-notch talent. Award-winning Broadway star, James Barbour and Mark Isham, a Grammy-award winning, Oscar-nominated recording artist ended the program with an amazing rendition of the song "From Now On."

The spectacular finale had me wanting to jump on the table in the style of Thor whilst pulling a sword from my side. I was pumped up and proud of CCHR's accomplishments. Man, these folks know how to put on a show.

I met with past winners. I met with old friends and made new ones. I had a special time celebrating 50 years of CCHR and honouring Kevin and Andy. There really aren't enough superlatives for this ass-kickin' organisation that, in the face of extreme adversity, continue to fight to safeguard human rights for all.

It was especially rewarding for me to spend time with CCHR UK's Brian Daniels. I've known Brian for years. He's a top advocate and a dear friend (Oooh friend**). You kind of know how deep a friendship is when you, for whatever reason, don't see a lot of one another, but when you do meet again it's as comfortable as slipping into an old favourite coat. Brian is not only a friend, but he's also a fellow warrior and we share the same goals in life. (Oooh sharing friend**)

Another long-time friend, Gary Brown, was recognized for his support of CCHR. It was great to see Gary on stage. He is another favourite coat of mine.

I fully anticipate today's blog will be met by some with silence and continued censorship. While I don't give a toss if some people choose to judge or label me, I do care about protecting the innocent. If I saw my neighbour's kid playing with matches in his backyard, I wouldn't first ponder if my neighbour was a Catholic or a Muslim or a whatever before I rushed over to inform the parents and save their child from the fire.

CCHR has your back, folks, whatever your beliefs. I, unequivocally, have theirs too.






Bob Fiddaman


**In-joke

Wednesday, April 10, 2019

13 - Who Would Have 'Thunk' It?





This week the Fiddaman Blog turned thirteen. It is now officially a teen which, ironically, is often the subject of this blog.

Inception

I vividly remember it's birth. It was a simple cut and paste job regarding Richard Brook who resigned from the Government's watchdog on antidepressants after it tried to cover up its own ten-year failure to identify serious side-effects of the controversial drug Seroxat.

Thirteen years on and that government watchdog, namely; The MHRA, are still sat thumb-twiddling and protecting drug companies.

A lot has happened since the inception of this old blog of mine. Stalkers, accusations, threats of lawsuits, a book, two human rights awards, radio shows, securing a settlement for a parent, talks, mainstream media attention, etc.

Who would have 'thunk' it?

I started this blog because I was concerned that the UK Medicines Regulator, the MHRA, was stonewalling questions posed to them regarding the notorious brain pellet, Seroxat. Thirteen years on and I tend not to bother with the MHRA anymore. I've met with them several times but no progress ever seems to come from such meetings. They are, as I suspected, limp-wristed beings from the planet Buffoonery.

It's fair to say I've taken my foot off the gas this year regarding this blog. There's only so much one person can endure when writing about children, husbands, wives, etc. whose demise started from taking brain pellets without full knowledge of the adverse risks vs. minimal, if any, benefit. I've shed many a tear for those who are no longer with us, and I carry their memory in my heart.

While blogs play an important role in advocacy, today's advocacy often happens in an instantaneous way via social media, especially on Twitter. You can follow my Twitter account here to see some of those interactions.

I find fellow advocates on Twitter, some of whom also started blogs long ago. One of whom, Truthman, deserves a hearty shout out for dedicated research and having the courage to tell it like it is.

We've stood together throughout the years, loudly banging the drum that sometimes it feels like we are joined at the hip. Brothers in arms, perhaps?

Truthman's work attracting and corresponding with drug company whistleblowers is greatly admired for I know how much time and effort is involved when whistleblowers reach out.

I salute you, Truthman!

There are others to thank, most of whom are dead, due to brain pellet induced suicides. It's those children, husbands, wives etc whom I am indebted to. I would never have met their surviving loved ones if it wasn't for their passing. There's far too many to mention, which, in itself, is a very sad state of affairs.

Who would have thought thirteen years ago this blog would still be going? Today almost 2.5 million views and still new people land on my blog, searching for info about drug withdrawal, birth defects, akathisia, drug-induced suicidality and suicide...I wish it weren't the case. I hope for the day when nobody has a need to search for such info.

I do feel the tide has turned during the past thirteen years. Many of the newer advocates offer new ways to reach out to the public. Many professionals have spoken out about the dangers of brain pellets. This was pretty much unheard of when I first started blogging. We had one or two forums, no Facebook, no Twitter and only a handful of professionals speaking out. Social media has, indeed, made a huge difference. I salute all who try to make a difference.

13 years, huh? Thanks for the readership. I'll be celebrating today with my partner, a cheeky smile, and maybe a glass of red wine as I (hopefully) watch my football team, Aston Villa, win again tonight.

Bob Fiddaman







Monday, March 18, 2019

BBC Fail on Antidepressant Mythology





Every time there's a chance to air the truth about brain pellets we fail, and we fail miserably.

Take a radio interview on the BBC2 radio show hosted by Jeremy Vine as a classic example.

Guests included Sarah Vine, Daily Mail columnist and wife of Conservative Member of Parliament, Michael Gove and also TV and social media health spokesperson, Dr Sarah Jarvis.

Sarah Vine has been quite vocal of late about her struggles with depression, moreover, with her prescription brain pellet, Cymbalta, prescribed to combat her depression.

Yes, it's great when a high profile name discusses the difficulties of withdrawing from a particular brain pellet, but it's not so great when that person doesn't really have a clue about the history of the said brain pellet. Quite who made Sarah Vine a spokesperson for the prescribed harm community remains a mystery. No doubt having a husband who is a high-profile politician helps.

Sarah Vine is not the right person to be talking about brain pellets, let's just make that abundantly clear. Her performance on Jeremy Vine's (no relation) radio show proved this.

I feel for her. Her withdrawal sounds bad, particularly with a brain pellet that comes in capsule form with beads of a toxic substance. Quite how she tried to withdraw is unknown as Cymbalta is particularly difficult to taper from as it has no liquid version nor can you cut it in half due to the capsule being full of beads reminiscent to the hundreds and thousands one places on top of an ice-cream.

Sarah Vine experienced brain zaps, tinnitus, joint pains and irritability when trying to stop Cymbalta - her tapering regime is, however, unknown as she never went into detail about this. She did, however, claim that Cymbalta helped with her depression. Speaking with Jeremy Vine and Sarah Jarvis, she told them, "I understand depression is chemical as well as circumstantial and I think that they (brain pellets) do redress the chemical imbalance."

I can only assume that Sarah Vine lives in a posh part of London with her MP husband and not in some hut on the planet Zog. I would assume that she has done her research on these brain pellets by trawling through drug company or psychiatry-based websites.

Hey Sarah, guess what? You're so wide of the mark?

Sarah Vine went on to say that, "For the majority of people the benefits outweigh the risks". Again, this is the mantra of drug companies and psychiatry.

Be nice to know if this journalist/columnist has evidence of this?

The resident doctor, Sarah Jarvis, played down the claim regarding a recent study that highlighted how the majority who take brain pellets have withdrawal effects by stating, "That was a study which was ONLY (her emphasis) identifying patients through a questionnaire.

The host, Jeremy Vine, never once asked the resident doctor if she had ever seen the full safety data for brain pellets.

Memo to Jeremy Vine - talk to people who can, at the very least, put the professionals in an uncomfortable position.

Journalism - a fucking dying art.

The interview can be heard approx halfway through the Jeremy Vine show.


Bob Fiddaman







Wednesday, March 06, 2019

Life-Saving Evidence





Last month the Q & A between myself and Carmine Pariante broke down. For those who don't know, Pariante is a professor of biological psychiatry at the Institute of Psychiatry at King's College, London, and consultant perinatal psychiatrist at the South London and Maudsley NHS Trust. He apparently has no sway in whatever the Royal College of Psychiatrists (RCP) say or do yet always seems to speak on their behalf.

Pariante was interviewed on BBC Radio 4 today after the subject of brain pellet withdrawal once again made the news in the New York Times. He was introduced as someone "from the Royal College" and proceeded to carefully and selectively bang the drum regarding the safety of brain pellets, so much so that even RCP were tweeting his quotes from the show (Fig1). Quite why Pariante is the College spokesperson is anyone's guess.



Check out the use of the word 'most'.

What irks me more than anything with the above tweet is that features a certain unproven claim in that brain pellets save lives. There will be many who claim that they do, I for one, find this ludicrous given that nobody can prove this. Sure, we get those people who claim, I would have killed myself if it wasn't for Prozac, Paxil etc but they cannot be 100% certain that they would have gone on to complete suicide, even if previously they had experienced suicidal thoughts.

This "life-saving" claim really has no substance and shouldn't be allowed, or at the very least should be preceded by, "they can induce suicide in people." One thing I've noticed about high profile shrinks such as Pariante is that they never ever talk about brain pellets inducing suicide, at least not on radio or TV shows, and certainly not in the mainstream media.

During my Q&A with Pariante last month he had this to say to me about brain pellet-induced deaths:

"I accept that it is possible that some patients might have died as a consequence of taking antidepressants, and my heart goes to them and to their families. But these, as tragic and sad as they are, are very rare events."

No mention of this in today's BBC show though.

Pariante was invited to speak today after the show had previously aired Daily Mail columnist, Sarah Vine, who spoke about her own troubles trying to withdraw from brain pellets. Adding their voices were Prof John Read and Patient safety advocate James Moore. Everything they said was pretty much undone with Pariante's 'life-saving claim'.

I'm getting sick to the back teeth of this outlandish claim and it beggars belief why nobody ever presses these key opinion leaders for evidence.

If, as both Pariante and Vine suggested, brain pellets save lives don't you think this would be a huge marketing advantage for the drug companies? I've read through every single leaflet in brain pellet boxes (SSRIs) not once do the drug companies claim that their product can save your life, so why does Pariante et al claim otherwise? If drug companies had evidence that their product was, in fact, a miracle pill, don't you think they would have used this as a major selling point?

What does Pariante know that we don't?

The radio show was, for me at least, disappointing. Why is nobody asking these shrinks how they can prescribe brain pellets when they have never seen the full safety data of the said brain pellets? Has journalism become so poor that the newer breed of writers have not grasped how to ask for supporting evidence when someone makes outlandish claims, or have they not grasped how to get to the root of a problem with decent questions?

If prescribers, such as Pariante do not have the full safety data then they know very little about withdrawal. They have no withdrawal data from drug companies either unless they care to trawl through countless pages of files released in drug company litigation. The evidence is there, they're just too lazy or pig-shit ignorant to read it.

Brain pellets do not save lives, to suggest that they do is a real kick in the teeth for those who have lost loved ones to brain pellet-induced suicide. It's a carefully crafted piece of PR spin, it's a trump card that they hold because (they claim) they have seen many patients saved by SSRIs.

Quite strange then, that these same shrinks have, for nearly 40 years not witnessed 'anyone in their clinical practice' suffering from severe brain pellet withdrawal. They see what they want to see, or what they are paid to see.

That not so nice acronym, N.I.C.E, was mentioned in the BBC show. They claim they are working on developing new guidelines for prescribers - they, just like every man and his dog, have never seen the full safety data that the drug companies hold, they, just like every man and his dog, are assuming that the evidence supports brain pellet use because they have published papers to prove this. What they don't tell you is the published papers are ghostwritten by the drug companies who pay key opinion leaders to add their names to these shoddy publications.

Here's a thought to ponder on. Why do you think drug companies don't say "THESE DRUGS WILL SAVE YOUR LIFE" on the insert in the box that accompanies brain pellets? Would it be something to do with making fraudulent claims?

Have you ever heard of anyone suing drug companies because the brain pellets didn't save their loved one's life? Of course not, because drug companies don't make this absurd claim.

Meantime, these brain pellets are responsible for endless misery, be it through the mourning of a loss of a loved one or watching a loved one's personality change as he/she tries to cope with the horrendous withdrawal effects these toxic chemicals cause.

I'm reminded of a quote from the late, great, Christopher Hitchens:

"What can be asserted without evidence can also be dismissed without evidence."

Pariante has, in the past, received funding from brain pellet manufacturers, Johnson & Johnson, GlaxoSmithKline, Lundbeck and Pfizer (source)

Bob Fiddaman


Monday, February 18, 2019

Q&A with Carmine Pariante






Carmine Pariante FRCPsych is a professor of biological psychiatry at the Institute of Psychiatry at King's College, London, and consultant perinatal psychiatrist at the South London and Maudsley NHS Trust. He received his PhD from the University of London and his MD from Gemelli University, Rome (Source Wikipedia)

Toward the end of last year, I became increasingly concerned about the behaviour of some of the psychiatrists on Twitter, many of whom were (and still are) belittling patients harmed by brain pellets.

I was hoping to discuss this in person with Carmine Pariante but due to logistics and time restraints, this never happened. Instead, we both agreed on a Q&A.

Sadly, for me at least, communication between us (via email) came to an abrupt end.

My reasons for ceasing communication can be seen in the thread of emails below. I will leave it to readers of this blog to decide whether or not I made the correct decision in ending the conversation.

Carmine wanted the last word but because he opened the questioning and was given ample opportunity to express himself, I have denied this request. I did inform him, however, that he can leave a comment on here if he wishes or publish this Q&A with his additional comment on his own website.

As a side note, when I eventually retire from this often dark and depressing arena, I hope some of the newer advocates, of which there are plenty, take up the issue of clinical trial data that is withheld and ghostwritten literature. It's the single most important issue regarding brain pellets, any other debate is irrelevant until this issue has been tackled and resolved. We need to speak about this because it has been sidestepped for far too long.

Bob Fiddaman

--

Q&A with Carmine Pariante

** Some grammatical errors have been rectified

Pariante
All medications have profound side effects: antibiotics, painkillers, or drugs for cardiovascular disorders. People suffer severe and life-threatening, unpredictable adverse effects taking many common medications. Do you think that antidepressants are simply like any other drugs: helpful and safe for a lot of people; ineffective, unsafe and intolerable in an important minority of patients; and tragically able to cause severe, unpredictable, life-threatening adverse effects in a small minority of patients? If not, how are they different from other medications?

Fiddaman
First off, I'm happy you raised this issue as it seems to be the defence of many psychiatrists when the efficacy and dangerous issues of antidepressants are raised.

Yes, all medicines carry risks of adverse events but, in the main, those other medicines target specific areas or diseases. I wouldn't really class suicidality as an "adverse event", to do so plays it down and it becomes lumped together with headaches, nausea, dizziness etc, as do the issues of withdrawal, birth defects, sexual dysfunction.

Antidepressants can induce suicidal thinking and, in some cases, completion of suicide, I hope we can agree on that?

To take a gun and pull a trigger, to tie a noose and wrap it around your neck, to take a knife and stab yourself through the heart, to jump from a bridge to your death, all carry horrifying images but this is the stark reality of it for some people. These should never be classed merely as 'adverse events' - these are people, both young and old, who, because of antidepressants, killed themselves because of an inner restlessness (akathisia) caused by these drugs. Nobody in authority, except for a small handful, seems to want to address this issue, opting instead to deflect by wishing to talk about the adverse events of 'other drugs.' I have never seen any discussion by yourself or RCP that tackles this issue. It's almost as if its a taboo subject for you or something you, and your peers, are ignorant of?

Do I think antidepressants are safe and effective for a lot of people and not safe for a minority? - No. I think both prescriber and patient believe they are safe and effective when in actual fact this may just be the placebo effect at work. If, as you suggest, they do help people then I'd like to know how? Aspirin, for example, helps by targeting the pain and swelling - What do antidepressants target, why do people seem to do well on them (group A) when others don't (Group B)? What is it that group A has that group B doesn't? Also, one should not use the term 'safe and effective' when one knows that they cannot clearly state this because of the suicide link. Isn't it more important to say, these drugs could induce suicide but are safe and effective for others? What's more important to you given that you, or anyone else for that matter, have never seen the raw data that drug companies seem reluctant to release?

I think depression is over-diagnosed and, as a result, antidepressants are over-prescribed. If you see today's figures as a modern-day clinical trial then the results will, of course, favour their safety and efficacy - the more taking them actually masks the problems people face whilst on them, be it suicidal thoughts or withdrawal problems. If, for example, two in ten people suffer at the hands of antidepressants then prescribing more would eventually bring this figure down. In any event, the apparent safety and efficacy of these group of drugs are based on 8 to 12-week clinical trials. In the real world, people are taking them for much longer. In the real world, people aren't 'severely' depressed, as they are in clinical trials, they may just be going through a bad stage of their life because they may need help due to circumstances in their environment. A pill cannot magically pay bills, fix broken marriages, or help a child pass exams but, for some prescribers, this seems to be the reason why they prescribe them.

I feel the question you asked here is irrelevant when the focus should not be 'other meds cause problems' - the focus should be, 'we acknowledge that these drugs can make people self-harm, have suicidal thoughts or, at worst, kill themselves and/or others.' This is what needs to be addressed, along with a whole other multitude of dangerous adverse events associated with these drugs. Talking about it and referencing 'other drugs have adverse events' is shying away and playing down the risks.

If an airline company had a fleet of ten 737's and one of those planes was unsafe to fly in, I doubt very much if the airline CEO would say 'one of our planes, we don't know which one, is unsafe to fly in but the other 9 are safe'.

In the case of antidepressants, prescribers are, in essence, playing Russian Roulette when they prescribe them. It's an unfair advantage prescribers have as they never take turns in pulling the trigger.

Pariante
I should probably start by stating one thing on which I am sure you and I both agree. I am, like you (and many others) very concerned that antidepressants (especially the selective serotonin reuptake inhibitors) may have more frequent negative effects than originally thought, in terms of reactions to both taking the antidepressants and to stopping them. The reasons behind this slow building of awareness within the medical and psychiatry communities are multiple.

Certainly, there has been a lack of transparency on such data from clinical trials conducted by pharmaceutical companies in the 90’s and early 2000’s , before current guideline and practice changed.

But there is also an objective difficulty, at times, to distinguish between these described negative effects of antidepressants (for example, the increased anxiety, physical agitation and suicidal ideation, which has been typically described in young patients) and the increased anxiety, physical agitation and suicidal ideation that are common symptoms during a depressive illness.

Withdrawal symptoms at the time of stopping these drugs (especially if stopped abruptly) have been well described and are recognizable, but distinguishing symptoms that develop weeks or months after stopping antidepressants from the relapse of the depressive illness  (which, in most patients, has a continuous, peak-and-trough natural course), is very difficult.

Of course, we do need to develop better clinical and research understanding of these negative effects.

There is one thing on which we obviously disagree: you believe that antidepressants are not helpful at all, to any patients, and thus, for you, any negative effect is an unjustified burden. I do not agree with you on this.

Most of the medical and psychiatric communities, and hundreds of studies conducted so far, clearly show that antidepressants do work in improving the core symptoms of depression – especially, the pervasive sadness and lack of hope and motivation that so many patients describe as unbearable, in their account of this serious condition.

We shall not forget that most people who commit suicide suffer from depression and that antidepressants, when you study a large population of patients taking antidepressants, do reduce suicides rates in adults and older people (although in young people, as I have said before, it might be different).

You say that antidepressants do not work, that they have only a “placebo effect” and thus that they are like “dummy” pills. But this is simply not correct: hundreds of studies have been conducted comparing antidepressants to a placebo (“dummy pills”), showing that antidepressants are better than placebo in improving the aforementioned core symptoms of depression – the pervasive sadness and lack of hope and motivation.

Moreover, there have been many studies who have examined other drugs that affect the brain (for example, opioids and benzodiazepines), which in theory should have a very strong placebo effect, yet they lack this specific antidepressant effect of improving the pervasive sadness and lack of hope and motivation.

Of course, you are right that antidepressants are not safe and effective for everybody, for 100% of patients who take them. In fact, only 50% of patients respond very well to an antidepressant, and probably only around 75% are somehow helped. And yes, some people suffer from severe negative effects, sometimes life-threatening.

I accept that it is possible that some patients might have died as a consequence of taking antidepressants, and my heart goes to them and to their families. But these, as tragic and sad as they are, are very rare events.

Many more patients do not die, do not take their own life, because they are on antidepressants.  Not only the scientific and clinical studies demonstrate this, but also the testimony of many such patients who have gone public with their positive, life-saving experience with antidepressants.

In response to one of your comments, I would like to stress that this is the same exact situation that afflicts all branches of medicine. People suffer from negative effects of medications, or even die, because they take drugs for pain, hypertension, infection, cardiac problems: all drugs have the potential to induce negative (and sometimes life-threatening) effects. Your example of the airline company applies to all of medicine.

Yet we take medications because we know that in general, we are more likely to benefit than to suffer from them; that many more people benefit from them than suffer from their negative consequences.

It is the same for antidepressants – although I acknowledge that, if you think that there is no benefit from taking antidepressants, you may only see the burden. But clinical and research evidence (and patients’ accounts) tell us that these drugs do help patients.

Of course, you are right that there is a risk that antidepressants may be prescribed too much, to people who do not need them – and, for these people, the negative effects would outweigh the benefits.

However, all the clinical guidelines are strongly preventing this from happening. Clinicians and psychiatrists are reminded over and over again that antidepressants should only be prescribed to people with ‘clinically-significant depression’, and not to people with a ‘bad stage in their life’, to use your words.

‘Clinically-significant depression’ means being so sad and hopeless and tired that we cannot go to work, or socialize with friends, for weeks and months; that our work and family life suffer; that we feel that life is no longer worth living; that we think about taking our own life, or that we plan to do so. These are the people that should be prescribed antidepressants.

Yes, more antidepressants are prescribed today than 10 years ago, but this may also mean that more people are seeking help because the stigma against depression has reduced. It does not need to be a bad thing if these drugs are taken only by the people who really need them.

Where do we go from here?

Personally, I am grateful to the ‘harmed’ patients community who, through social media and advocacy, has raised awareness of the fact that antidepressants may have more serious negative effects than we originally thought.

The question now is: how do we help these patients, and help the patients who may be suffering from such negative effects in the future, while also at the same time protecting the patients who are benefiting from taking antidepressants, and will continue to do so in the future?

How do we bring my community and your community together, since we both want the same things: help people who suffer from depression?

Fiddaman
You and I will have to agree to disagree on the points you raise, Carmine, otherwise, we will get bogged down in missing the glaringly obvious. Before I answer your question, regarding the prescribing community and the prescribed harm community moving forward, I'd like for you to answer the following...

Do you think withholding clinical trial data is appropriate?

Do you think ghostwriting is acceptable?

Pariante
**Note**
Carmine added a personal note to this email suggesting that I was being discourteous. I have not added the personal note but it can be provided should the need arise


Let me first clarify that I can only express an opinion as a scientist. I have never been involved in conducting or participating to, a commercial clinical trial, or a trial for regulatory purposes, nor I have ever worked work for a regulatory agency; so I am not familiar in details with the process required by the FDA or equivalent regulatory bodies.

Having said that, as a scientist, let me say again that I believe that, in general, it is not appropriate to withhold any type of clinical data, and, in fact, any type of data.

As I have mentioned before, pre-registration of clinical trials and of analyses has changed the culture both for scientists and for pharmaceutical companies. Analyses of both efficacy (whether a drug work or not) and safety (what are the side effects)  should now be routinely pre-registered as part of the process, and the data presented when the study has been completed.

Again, as I have said before, for releasing individual-patients data there are additional issues such as confidentiality of patients, but there are procedures in place to do this, when ethically possible, and there are different types of processes based on whether the data are released to a public database or to an independent group of scientists for re-analyses.

I repeat again that clinical trial data – and in fact, any data – should never be withdrawn just because the researchers do not like the results!

Regarding ghostwriting, again as a scientist, to me being an author of a scientific paper requires full knowledge of the data. For a clinical trial, these include efficacy, safety, and other clinical, biological or psychological measures that are relevant to the paper.  In addition to the knowledge of the data, an author would need to be fully aware of the analyses and their implications. If you define as ‘ghostwriting’ the practice of appearing as an author on a scientific paper without such full knowledge, then let me say again that I am always against it.

Fiddaman
Having re-read your note to me, I'm surprised at your hurt tone. I and lots of others have been damaged by treatment. This is not something to handle lightly by saying something along the lines of, "Now, don't be angry." I am angry with the system. I'm also now concerned. I had no idea whether you do clinical research or not. The issue is your practice as a clinician and that of your colleagues. I fail to see how any of you can safely treat me or those I love if you have no access to the data and if the entire literature on meds is ghostwritten.

The extreme example of this at present is the ever-increasing use of antidepressants for teens where up to 100,000 children are on them. Yet there is not one positive trial of these drugs for children who are depressed, not one. Even the Prozac trials, that got Prozac licensed, are negative. Ditto for the paroxetine trials for children when the FDA issued an approvable letter for it.

Some doctors won't be too concerned by the sufferings of their patients (out of sight, out of mind). But even for you, the worry must be that patients in general, or the managements who employ doctors, are eventually going to wonder if you're worth having. Unless someone like you gets to grips with these issues, which you're better placed to do than I, you are at risk if/when things go horribly wrong. If there is no place in the system for recognising that treatment can kill or maim, you, the prescriber, are likely to end up in the firing line. Despite what you may think about my stance on antidepressants, I don't want this to happen to you or your colleagues.

How can any prescriber at the moment relay informed consent to any of their patients? From my point of view, I'd love some sense that you were bothered by this issue, Carmine, because then I'd think we might make some progress.

As I stated, I'm surprised at your hurt tone. Yet I do find it refreshing to see a doctor who feels and shares emotion. I say this given that many doctors cannot recognize, or refuse to acknowledge, the "hurt" they cause others when blindly prescribing. Blind prescribing is common given that doctors give people antidepressants without knowing the risks because doctors, yourself included, haven't seen the data.

Pariante
Why do you say I am not bothered by the data not being available - I keep saying that I am! I am also saying that the situation is improving with new rules and regulation

I have not said “don’t be angry” at the situation or the system - I said don’t be angry at me, Carmine, who is talking to you

Doctors in all specialities prescribe based on guideline; guidelines are written based on independent review of the evidence by experts, and the evidence includes safety and efficacy data. It is simply not true that all the l literature on meds is ghostwritten - and in any case, I condemn ghostwriting and I am confident that data transparency is much more advanced now.

So I am really not sure I understand where you and I disagree.

Fiddaman
This is a very important subject we are talking about please try and stop taking things personally. I am just asking questions that I feel many may like to see your answers.

Close to all the literature on on-patent drugs is ghostwritten. Nice Guidelines, where they refer to drugs, are based on ghostwritten literature and they have no access to the data. Being independent is meaningless if the conclusions are predetermined by the ghostwriting.

Where is the evidence to show anything is better?

Pariante
I disagree that the situation is, today, as grim as you depict it, although I agree that this has been an important problem in the past.

First of all, all the drugs that you and the community of harmed patients are concerned about (such as SSRIs) have been off patent for many years, often decades. The data have been released in the last few years and in fact, this is the reason why we do know so much more now about their adverse effects, as the many scientific papers on antidepressant-induced suicidal ideation or severe withdrawal symptoms testify.

Second, for the (very few) newer drugs still on patent or in development, there are clear rules and regulations for all trials to be registered before the results are known, and for all data (efficacy, safety, factors influencing response) to be published when the study has been completed.

Ghostwriting is unequivocally criticized or banned, and rightly so, by scientific journals and medical organisations.

The NICE or other experts panels have access to published scientific data which today is presented with excellent ethical and professional standard – because of the new rules and regulations, and also because of a change in culture about data transparency across scientists, pharmaceutical companies and regulatory bodies.

Has this been a problem in past? Yes, of course. But I think that the present is better and the future will be even better.

Fiddaman
You casually claim, “the present is better and the future will be even better.” yet provide no evidence to support your claim. You don't know whether the drugs you prescribe are safe because you've never seen the clinical trial data. NICE doesn't know either as they have never seen the drug company data. It is deeply disturbing that none of these facts appears to bother you and fellow prescribers.

Patient safety cannot be a chief concern and the Hippocratic Oath cannot be honoured when ghostwriting and cherry-picked data is an accepted, routine practice. Despite your claims, things have actually gotten worse, not better. Consider:

The recent approval of esketamine, a new mind-altering drug marketed to treat depression, is based on some of the shoddiest trials ever conducted.
Current antidepressant trials in children are now being conducted in Colombia, the Russian Federation, Ukraine, American foster homes and correctional facilities (Lundbeck's vortioxetine trials). Everyone knows the reasons why and none are for the benefit of product consumers.

You should be more concerned about the data you don't see, rather than what you do see. I asked a critical question about clinical trial data and ghostwriting because this is the foundation upon which fraudulent and harmful psychiatric prescribing is built. Whether it be delusion or deceit, most psychiatrists cannot or will not acknowledge that they are unsure about drug safety. To do so would expose psychiatry's cracked foundation and bring the walls tumbling down.

I have been a drug safety advocate for more than a decade. My readers are intelligent and I respect their time. Your limp-wristed response is offensive. I must conclude that continuing our Q&A is unfortunately of little or no benefit to readers.

Thank you for your time. I will post our brief Q&A on my blog as previously promised. You are free to do the same.


--

Tuesday, January 08, 2019

Supreme Court Analyzes Merck's Ambiguous Wording




I'll admit it: I'm a legalese geek. But unlike certain companies peddling certain products, if I was too self-conscious to admit such, my failure to do so wouldn't hurt anyone.

Lately, I've been keeping a close eye on the court proceedings regarding Merck's Fosamax. Fosamax is a drug used in the treatment and prevention of postmenopausal osteoporosis. Ironically, Fosamax has been causing bone fractures in some consumers just as SSRIs can and do cause "depression," anxiety and akathisia in some consumers. But many Fosamax lawsuits haven't been heard by juries because Merck claims the company informed the FDA regarding bone fractures and the FDA failed to act by changing, or agreeing to change, the labeling.

The Merck case which was heard yesterday by the Supreme Court bears striking similarities to the GSK vs Dolin case. GSK also argued that it informed the FDA about the suicide links related to its Paxil product. (Paxil is an SSRI "brain pellet" that wreaks havoc among users while reaping billions in GSK profits. GSK claims it did everything to warn the public and doctors about Paxil-induced suicide risks. However, just as in the Fosamax case, GSK claims the FDA failed to agree to update the label.

Reading yesterday's Supreme Court transcript is fascinating and I highly recommend you download the 50-page transcript which is linked at the foot of this post. It provides an up-close look at how drug companies use the FDA's impotence to their advantage. Not only does the FDA fail to protect consumers, it proactively protects drug makers by serving as a revolving-door employment agency between pharma, the FDA and back again. Drug companies and the FDA create ambiguity and seem to enjoy a mutual understanding that this ambiguity will later be used to avoid lawsuits, protect shareholders and keep consumers in the dark regarding adverse drug effects.

Déjà vu: Dolin vs GSK

Wendy Dolin filed suit after her husband, Stewart, died when he jumped in front of a Chicago train. Stewart was taking a generic version of Paxil made by Mylan Pharmaceuticals, but GSK, the original manufacturers of Paxil, was responsible for the labeling and any subsequent label updates.

GSK tried to weasel its way out of a trial by citing the circumstances that Merck is now using as a defense in the Fosamax trials. GSK failed and the Dolin trial was heard by a jury who found for Dolin. Not only did the jury find that GSK was responsible for failing to warn consumers of the increased suicide risks created by Paxil, the jury also recognized that Paxil caused Stewart to suffer from akathisia, an adverse drug effect, prior to his death. Dolin was awarded compensation for both Stewart's Paxil-induced death and for Stewart's Paxil-induced suffering prior to his prescribed demise.

The Dolin trial, which lasted six weeks, ended with the jury awarding Wendy Dolin $3 million. But GSK appealed and the jury's decision was later overturned by the Seventh Circuit Court of Appeals. The overturned ruling didn't relate to the jury's finding that Paxil caused Stewart's death. Rather, it related to whether the label and failure to update the label, was the responsibility of GSK or the FDA. Dolin appealed but the Seventh Circuit refused to reconsider its decision to overturn the verdict. Dolin has taken her case to the Supreme Court where attorneys representing victims of Fosamax were yesterday.

A bit confusing, perhaps, but in short: Dolin won and GSK appealed. GSK won and the Dolin case is now in the hands of the Supreme Court.

Dolin's attorneys, Baum Hedlund, likely kept tabs on yesterday's proceedings given Merck's defense is similar to GSK's. The pharmafia conveniently blames its buddies at the FDA because partners in crime don't squeal on each other. Their silent pact sometimes helps both legally avoid responsibility for harming and killing unsuspecting consumers.

Like GSK, Merck is attempting to blame the FDA. Both companies try to adeptly muddy the legal waters so much so that jurors-even those who find the product causes adverse effects-become confused about who, exactly, should be accountable for faulty labeling and related tragic outcomes.

In cases such as Dolin vs GSK, it seems the amount awarded to plaintiffs is sometimes reduced not because the jury doesn't believe the product causes harms, but because the jury is effectively confused by pharma's legal strategy to "blame" its FDA pals. At the end of the day, pharma execs and FDA regulators likely slap each other on the back over dinner and drinks and cryptic "atta boy" correspondence. The end result is that consumers harmed by pharmaceutical products are further harmed by these cozy corporate/FDA ties.

Stress Fractures vs Emotional Lability

Merck is claiming that the FDA denied Fosamax label updates after it was learned a large number of atypical femoral fractures occurred among Fosamax users. Merck claims it proposed a change to the label but the FDA told them the wording in Merck's new proposal was inadequate. The FDA's complete response letter, in essence, said it didn't believe Merck had done a decent job with their proposal to change the label. Therefore, the FDA covers itself by responding to pharmaceutical companies and pharmaceutical companies understand they are essentially off the hook given the FDA won't follow up regarding proposed label updates and pharma won't either.

Merck did indeed inform the FDA about Fosamax related fractures but Merck labeled them stress fractures and not atypical femoral fractures. Thus, when the FDA read Merck's proposal for a label change they may have assumed these stress fractures were a relatively minor adverse drug effect. The FDA tends not to include extensive risk info in patient information leaflets because doing so might prevent consumers from seeking drugs as "treatment."

GSK used the same Merck tactic with its Paxil product after it was forced to acknowledge the number of suicides related to Paxil that occurred during Paxil clinical trials. GSK didn't tell the FDA that Paxil can cause adults to end their lives when suffering from a terrifying Paxil-induced condition called akathisia. Instead, GSK labeled suicidality as "emotional lability" just as Merck labeled atypical femoral fractures as simply "stress fractures."

Tossing the Egg

Imagine the CEO of an egg factory learns that many eggs contain bacteria that can cause serious harm and/or death to consumers. The CEO contacts a government regulator and says they have a problem. The government regulator doesn't think it's a severe problem and simply tells the egg factory to monitor the situation. But the egg CEO only told the regulator part of the story, stating that many eggs were cracked. The CEO didn't mention the bacteria inside the eggs that had grown as a result of said cracks.

It's a win-win for the egg factory. They can continue to sell eggs that are cracked, further, if a wrongful death lawsuit is brought against them, they can deny liability by stating, "We warned the government regulator but they decided not to do anything about the problem."

Both GSK and Merck had secrets hidden in their cracked eggs. The eggs were never fully opened by either company and the FDA only took a sneak peek through the cracks. GSK and Merck don't believe a jury should decide whether the FDA would have approved a label update had either company submitted an updated label change after receiving a first response from the FDA. Both companies claim the FDA wouldn't have sanctioned a second proposed label change. These companies are making assumptions, assumptions they aren't entitled to make despite that the CEO's likely have learned what to expect from their FDA friends.

Why nobody has thought to subpoena the current FDA Commissioner, Dr. Scott Gottlieb, is beyond me. Put Gottlieb on the stand, make him take an oath and ask him the very same questions the judges and legal teams are fighting over. Then again, Gottlieb would probably side with the drug companies given the FDA's incestuous relationship with pharma.

GSK, Merck and the FDA enjoy having their cake and eating it, too. But I doubt they use cracked eggs when together they cook up their half-baked legal excuses.

Bob Fiddaman



Merck Supreme Court Transcript

Wendy Dolin Petition to Supreme Court


Tuesday, December 18, 2018

Brain Pellets On Tap in America




Tim Alexander is a film-maker. He is in the post-production phase of his groundbreaking, Legal Death - In Drugs We Trust,  a series of 12 one hour episodes that explore every aspect of why so many people are dying, killing and having their lives, families, and relationships ruined after they begin taking prescription medications, particularly Opioid Painkillers, Antidepressants, Psychotropic Drugs, Benzodiazepines, Fluoroquinolone Antibiotics, and Statins as prescribed by a psychiatrist and primary care doctors.

More on this in the future.

Tim's Facebook group, the Legal Death - In Drugs We Trust Group, is a page I've been following with interest, particularly as Tim uploaded a few clips of his mini-series.

Today, my jaw dropped.

Here's why, in Tim's own words.

THIS IS A IMPORTANT WARNING ABOUT DOCTOR VISITS!

I was just at the doctor's moments ago because my lovely wife Karen makes me go. I am 100% healthy never once with any drugs or other medical issues. The video posted below tells the story of what happened, watch it.

The most important question they had for me was how was my brain. First, the nurse asked them, and then the doctor walked in and asked them again. I asked the doctor why that was the first question, he said he was not sure but he thinks the Pharmaceutical Companies or the Government mandates that they ask, as it is on a federal level for Mental Health Evaluation.

I never sought that. I asked him if he went to school for Mental Health and was qualified in it, he smiled and said "No", but said he did have a little training. I asked him what would have happened if I had said yes to the questions, he said it would have automatically triggered more questions. I asked what would happen if I answered in a way that was yes, I was depressed, was he qualified to prescribe me a medication? He said "Yes". I said how if you were not trained in the brain? He said my answers would allow him to look them up and diagnose me and give me one of the few FDA approved medications for the symptoms I said I had, and that is the way the screening works. I asked him what kind of medications and what did they do? He told me they were FDA approved antidepressants and they worked on certain specific regions of the brain that he didn't understand, but that they effectively relieved the symptoms of depression, and said it with a smile.

He was maybe 32 at best, he didn't know snot. I saw it first hand with my own eyes and experience, I was just a few wrong words away from a major Pysch Drug being given to me from a man who was not trained in the brain, diagnosing me from a simple questionnaire, and who had no idea what they do or how they worked. This was the second time this happened to me, it happened last year with a different doctor the exact same way.

They are nationally PUSHING THESE DRUGS ON A FEDERAL LEVEL, these Mental Health diagnoses are promoted, not selectively given because of an apparent need at the doctor's judgement. If I had a bad job with stress or trouble in my relationship I could have been thrown down the drug rabbit hole for it by a doctor with no clue just by saying I have been down, or a bit depressed. That is what I am making this movie, to WARN PEOPLE WHO DON'T KNOW THIS YET, not to talk to the people who do know it. You must protect you, and that starts with being on guard and being careful how you answer any doctor's questions, it is almost as bad as talking to an arresting officer, your words can be used against you, but in this case TO DRUG YOU. 'Legal Death - In DRUGS WE TRUST' is a WARNING to protect your life from a few simple questions that could destroy it forever!

Tim Alexander

Top 20 Popular Posts From Fiddaman Blog 2018







Top 20 popular posts from 2018. '

Saturday, January 06, 2018
GSK Call In the Fireman

Monday, January 08, 2018
Who's Hiding the Clinical Trial Benefits of Antidepressants?

Friday, February 09, 2018
Masterfully Harming Kids for Profit

Friday, February 23, 2018
Media Frenzy - Antidepressants Are Safe!

Tuesday, February 27, 2018
RCP Remove Damning Antidepressant Document From Website

Wednesday, February 28, 2018
Guest Post: I’m Depressed about Antidepressants

Thursday, March 01, 2018
Royal College of Psychiatrists - 63%

Friday, March 09, 2018
Scooby and Those Pesky Tweeters Rumble Psychiatry

Tuesday, March 27, 2018
India: GSK Whistleblower Names and Shames - Part I

Sunday, April 08, 2018
The NYT Addresses Antidepressant Withdrawal Issues

Thursday, April 12, 2018
The Truth About SSRI Withdrawal/Dependence

Thursday, April 19, 2018
Stop It!

Thursday, May 10, 2018
We Speak For The Dead To Protect The Industry

Sunday, June 17, 2018
Dutch Court Rules for Plaintiff - Seroxat (Paxil) Psychological Damage

Tuesday, August 14, 2018
Guest Post: Irresponsible Reporting Harms Parents & Children

Friday, August 17, 2018
Psychiatry: A Faith-Based System?

Tuesday, September 04, 2018
GSK Study ID - 29060/356 - The Missing Suicide Attempts

Sunday, September 16, 2018
No Action to be Taken Against GSK for Hiding Suicide Data

Monday, October 01, 2018
Breaking... Antidepressants cause Majority Withdrawal Symptoms

Monday, October 22, 2018
GSK Study 356 - The Truth is Out - 25 years Too Late!


Merry Christmas to all the truth tellers out there!

Bob Fiddaman




Saturday, December 15, 2018

Hetlioz: The Body Clock Brain Pellet





It's been a while since I last blogged. GSK has, seemingly, been good boys and girls for a while and Twitter seems to be where all the action is these days regarding the defence of brain pellets and some shocking behaviour from the field of psychiatry. More on that if you follow me on Twitter.

Today, I'm going to revisit a 2014 blog post of mine that was recently brought to my attention by a reader. The post, Blind Date With Vanda's Hetlioz, can be viewed here.

Hetlioz (tasimelteon) is an FDA approved medication for the treatment of Non 24 Sleep-Wake Disorder in the totally blind and is marketed and manufactured by Vanda Pharmaceuticals.

What is Non 24 Sleep-Wake Disorder?

According to Vanda Pharmaceuticals Hetlioz webpage, it's a "serious, chronic disorder that disrupts a person's circadian rhythms. Non-24 affects up to 70% of people who are totally blind, whether you were born blind or became so later in life."

All seems to be above board until you peel back some of the layers.

The clinical trials for Hetlioz are surrounded in controversy:

 - The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

 - The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

 - Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

 - Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.

The marketing of Hetlioz has also come under close scrutiny too. Back in 2015, Stat News ran an article regarding the airtime that Vanda Pharmaceuticals had bought to advertise its sleep/wake disorder drug, $29 million worth of airtime to be exact.

Stat News posed a pertinent point, they pointed out that the target audience for Vanda Pharmaceuticals were blind members of the public, so why the heavy promotional push on TV?

Here's one of the ads they ran across America.



Stat News also claimed that the adverts helped Vanda Pharmaceuticals net a tidy profit of $73 million in revenue.

Hetlioz Indications

The product labelling for the drug does not specifically state that it is to be used by blind people only. This leaves the door open for Vanda Pharmaceuticals to target other patients (non-blind).

Public Citizen, a nonprofit consumer advocacy organization, has filed a petition asking the FDA to correct the labeling to indicate the drug is only for patients with the disorder and who are totally blind, a population numbering approximately 100,000. Public Citizen is concerned the existing labeling may encourage off-label use in people who are not blind and have some other type of sleep disorder.

A Concerned Citizen

A concerned citizen recently wrote to me and told me he, and others, were digging into recent activities of the promotion of Hetlioz. He told me, "We are extremely confused by what we are finding. First off, it appears they are targeting Medicaid patients for Hetlioz with an estimated 80% of revenue coming from Medicare part D. Second, how can they be seeing 2x-3x demand from sighted patients vs blind if non-24 affects mostly blind people and is rare in sighted patients? Third, Cafepharma and glassdoor posts seem to indicate that there is rampant off-label promotion of Hetlioz going on via the company's psychiatric initiative.  This is just a sampling of what we are finding."

Vanda Drug Reps

The same citizen sent me two videos in which we can see Vanda Pharmaceuticals drug reps target patients and not doctors, as is the norm for drug company reps. The first video sees two reps for Vanda speak with what appears to be a mixed audience of visually impaired and blind subjects at Lighthouse, an organisation that promotes the independence, equality and self-reliance of people who are blind or have low vision. What is striking is the Vanda rep at the beginning of the first video asks the audience to fill out the paperwork if they feel they have any symptoms and give it to her and she will contact their physician. I'm unsure of the legality of this. The second rep throws out the question, "How many of you have difficulty sleeping at night?" When 6 or 7 raise their hands he tells them that it could be because they have 'Non 24 sleep/wake disorder'. He then goes on to tell the audience how everyone has a "master body clock in their brains."

I have to point out that neither of the reps mentioned the drug Hetlioz.

One of the audience members tells the rep she has Non 24 and takes Seroquel for it. Hmm.

If anything, this video gives an insight into how drug company reps play their audience. I found it fascinating, I hope you do too.

PS - He's not very good.

**Raw copies of both videos have been downloaded.



So, just as brain pellets were promoted because people had a 'chemical imbalance', along comes another mystery brain anomaly, this time it involves some sort of ticking clock. If you watched the video above you'll note how many times the rep drums home the 'body clock' claim.

The second video is much shorter than the first and shows pamphlets left behind by the Vanda reps. The leaflets, although visible are also written in braille and direct readers to http://www.non-24.com/ - where there's more talk about the 'body clock.' Again, there doesn't seem to be any direct-to-consumer advertising of Hetlioz on the webpage but there's plenty of talk about patients going to see their doctor to explain they may have symptoms of Non-24.




I can only speculate that Vanda reps have already visited their doctors and planted the 'Non-24' seed and what new drug can treat it.

As I mentioned above, I'm not sure if drug company reps targeting patients is entirely ethical so I wrote to a former drug company rep turned whistleblower for her opinion. I asked her if this was legal. She replied:


"No, this is not legal in the U.S. but I cannot provide any documentation to this effect. We were just instructed by the companies that I worked for that it was illegal to interact with patients regarding care/drug regimens. Unless something has changed...I left the industry in the year 2000."

In my 2014 blog post I mentioned the link between Vanda Pharmaceuticals and The National Sleep Foundation (NSF). 

New information I've learned is that Charles A. Czeisler, an American physician and sleep researcher, was President of NSF and is/was on Vanda's scientific advisory board. Also, Dr. Stephen Lockley, the Harvard sleep expert overseeing the Hetlioz clinical trials, received grant support from Vanda Pharmaceuticals.

Blogger, 'Frugal Nurse', has also been investigating Non-24 and Hetlioz. She writes:

On January 31, the Food and Drug Administration announced its approval of tasimelteon for treatment of Non-24.
Approval was based on results of 2 trials: . . . a 26-week study that included 84 patients, . . . and a 19-week trial that included 20 patients . . .
Really? Market approval based on 104 patients over 6 months?
And what were they testing for exactly? Patients experiencing a better night’s sleep, or less daytime drowsiness? No, something called “entrainment” or re-setting of circadian rhythm, measured by melatonin byproducts in the urine.
Frugal nurse also has an opinion on the Non-24 website. She writes:

The informational website for Non-24 is classic pharmaceutical advertising.
It’s not about selling a drug—at least not directly. It’s about helping you understand what Non-24 is and why you might suffer from it. The site helpfully (and slyly) provides a sidebar of symptoms to aid self diagnosis:
Not being able to sleep when you want
Excessive sleepiness during the day
Daytime napping or dozing off during the day
Periods of poor sleep quality at night
Sleeping through the night, but not waking up feeling alert and refreshed
Problems with focus and concentration; trouble with memory
Difficulty with daily tasks
Feeling irritable
Oh my God, I’ve got Non-24!!
If you are “experiencing any of these symptoms,” you are invited to fill out your name and address and “give permission” for Vanda to send you “information about Non-24 and about medicines that treat Non-24.”
As an added incentive, when you sign up, Vanda will make a $24 donation to the “blindness community.”
We can see from her research that Vanda's marketing is widening the net. They don't just want blind or partially sighted people to ask for this drug, they want, it appears, people with insomnia too, a condition that Hetlioz is not indicated for.

Jet Lag

In March this year, Vanda Pharmaceuticals announced that Hetlioz demonstrated significant and clinically meaningful benefits in nighttime and daytime symptoms of jet lag disorder. The press announcement stated:
Vanda intends to seek marketing approval for the use of Hetlioz in the treatment of jet lag disorder.  Vanda believes that if Hetlioz is approved by regulatory authorities for the treatment of jet lag disorder it will potentially offer a therapeutic solution to many travellers and will likely represent an important commercial opportunity for the company. 

You're not kidding! According to drugs.com the cost for Hetlioz oral capsule 20 mg is a staggering $15,186 for a supply of 30 capsules, depending on the pharmacy you visit.

It's no surprise that Vanda are trying to tap into the market of jet lag. It is reported that more than 30 million US residents make trips abroad each year to overseas destinations. Of these, 60% (approximately 20 million) travel to destinations in Europe, Middle East and Asia. That's an awful lot of potential customers for Vanda.

Another market they will no doubt be persuading doctors to prescribe to is the insomnia market. Around 1 in 3 people have at least mild insomnia. Many poor sleepers have developed poor sleep habits.

So, the body clock drug that was initially aimed at blind people now has a much larger potential. Jet lag and insomnia will become the new 'Non 24 Sleep/Wake Disorder'. Sufferers will be spun the story about 'body clocks' and the importance of setting the timing of that clock back to normal.

What next?

Will we see Hetlioz pushed on kids who can't sleep because they have normal teenage worries, or perhaps the man or woman who are facing employment stresses and can't sleep? Remember, the FDA left the door wide open when they agreed that this drug could come to market. Hetlioz has not been studied in children and it is not recommended for use in children but history shows that drug companies always try to widen the net when selling to the public. One only has to look at the group of SSRIs that are currently prescribed off-label to children.

How Does Hetlioz Work?

Hetlioz works to enhance the effects of the receptors for melatonin. In particular, it binds and augments the MT1 and MT2 receptors within the brain. This induces sleep.

So, is Hetlioz merely another brain pellet then, one being sold on the back of a spinning story that involves body clocks in the brain, just as SSRIs were heavily promoted on the spinning story of a chemical imbalance in the brain?

Finally, last month the FDA issued a warning letter to Vanda Pharmaceuticals. The warning letter chastized Vanda for failing to warn Hetlioz users of its most common adverse reactions, namely; headaches, increased alanine aminotransferase, which is the term used for elevated liver enzymes, nightmares or unusual dreams, and upper respiratory or urinary tract infection. These are common adverse reactions, folks!

Nightmares or unusual dreams? Nothing like taking a drug to help you with sleep, huh.


Bob Fiddaman

Back Story




Saturday, December 08, 2018

NATALIE JULIA GEHRKI



Natalie would have been celebrating her 25th birthday today but for the intervention of prescribed brain pellets.

To honour her please take, and pass on, the accredited Akathisia101 course which was designed and created by Natalie's mother, Kristina.

I have a lot of anger toward those responsible for Natalie's death. The prescribers who kept adding brain pellets, despite obvious signs that the brain pellets were slowly killing this beautiful young girl. The drug companies, for not being truthful about those brain pellets. The mental health system, for basing its entire diagnostic model on guesswork. The regulators, for its limp-wristedness and incestuous relationship with the drug industry.

Today, Natalie's family should be celebrating, instead, they are going through the motions of what might have been. Only if you have buried a child will you know the pain and suffering this family are going through today, a pain that never goes away but is magnified on birthdays, anniversaries, Christmas, Easter, Thanksgiving etc.

Natalie's story can be read in two parts here and here, it's harrowing reading, nonetheless its compelling evidence that prescribers, drug companies, regulators and the mental health system all had a part to play in taking this young woman away from her family.

I never got to meet Natalie, I never got to meet any of the kids I have written about over the past 12 years - all share one thing in common - their lives were taken by a sick and twisted monopoly of greed, fraud and psychopathy. They all will sleep well tonight, they all will blame one another for the mistakes they have made over the years but none will take the gauntlet and say enough is enough. Instead, they continue to push these brain pellets, making excuses for those who died whilst on them, blaming the victims, blaming the illness, blaming everyone and everything but themselves.

Shame on all of the above who each played a part in creating the feeling of loss that Natalie's family are suffering today. Shame on them all for continuing to ignore the mess they created.

My thoughts are with Kristina today and also Natalie's family.

Bob Fiddaman





Friday, November 16, 2018

Truth or Fiction: What are Parents to Believe?



This post is the second in a series, from Kristina Kaiser Gehrki, that started with “When a Stranger Calls.” It explores the active role pharma-funded “patient advocacy” organizations play in creating and delivering school-based mental health education targeting children.

“The truth.” Dumbledore sighed. “It is a beautiful and terrible thing and should, therefore, be treated with great caution.” – Harry Potter and the Sorcerer’s Stone

Parents in Fairfax County, Virginia tend to be affluent and well educated. The 2016 US Census found the median household annual income is more than $114K, and 60% of adults age 25 and older hold a bachelor’s degree or higher.

Well-paying jobs and well-rated schools help attract families to the region. Every high school in the Fairfax County Public Schools (FCPS) district has been “designated among the most demanding public schools in the country” and the county’s magnate program, Thomas Jefferson High School for Science & Technology, ranks in the top ten of all US high schools. Fairfax parents often spend money for private services (music lessons, tutoring, counseling, etc.) in anticipation they might improve their children’s academic and emotional wellbeing. Therefore, I was unsurprised to see a large turnout at the 5th annual FCPS Mental Health and Wellness Conference.

My work with FCPS spanned more than a decade. The district first hired me as an independent communication consultant. Shortly after, I was hired “in-house” as a central office communication specialist. Later I became a marketing teacher coordinator because I missed working directly with children. I am very familiar with the inner workings of FCPS from district headquarters to individual schools. However, I had never previously attended this annual conference.

Before I discuss the instructional content taught at the conference, it is important to convey some background info that helped spark its creation. For decades, the school district had draconian disciplinary policies ranging from silly to tragic. FCPS made the national news in 2009 when a high school at which I taught suspended and sought the permanent expulsion of a teenage girl who took her birth control pill at lunchtime. The FCPS disciplinary actions made the national comedy show, the Colbert ReportAnother student was denied school attendance for nearly two months because she had her acne medication in her locker.

These FCPS disciplinary procedures received attention from the American Civil Liberties Union given that students who were suspected of wrongdoing were routinely interrogated by school administrators and police officers assigned to each school. When principals suspected students of possible wrongdoing, it was common practice to call students into the principal’s office, hold them for hours, deny them a phone call to their parents, and fail to explain any possible Miranda-type Rights. School administrators sometimes told students if they wrote and signed confessions of wrongdoing, the school district would “go easy on them.” Often the adults’ promises of leniency in exchange for students’ cooperation were never honored and many students who signed incriminating personal statements received the maximum district punishment allowable.

The consequences and related downward spiral for two other FCPS students punished for wrongdoing were tragic. The high school boys were suspended and expelled from their neighborhood schools and, understandably, struggled with the resulting shame caused by being ostracized and alienated from their friends. The Fairfax school district stated the boys could face possible arrest if they should ever step foot on their former school’s property at any time to include weekends. This meant the students, both football players and one who was described as a “model student,” could never again attend a sporting event, high school dance or any other social activity at their former school at which their friends would be. Both boys became depressed after their involuntary transfers and both later ended their lives. One of the sessions offered at the FCPS conference I attended was presented by the Josh Anderson Foundation, created in memory of one of these two FCPS students who died.

ADHD: A Sharp Increase in Diagnosis

Given FCPS' long history of severe punishments that failed to use restorative justice principles to help children learn and grow from mistakes, I really wanted to attend the session titled, "Resilience and Thriving: The Secret Power of Stress." But I just couldn't do it considering the ironic title in relationship to the district's not-so-distant past. Instead, I attended two other sessions both of which featured the National Alliance on Mental Illness (NAMI) and Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD). The first was titled, “Community Resources for Families and Youth.” Instructors included the Executive Director of the National Alliance of Mental Illness (NAMI) northern Virginia office, a representative from CHADD’s northern Virginia chapter and another representative from an organization for foster and adopted children.

Some information parents and teachers learned in this session included:
  •  ADHD is a serious disorder that has a neurobiological and neurochemistry basis.
  • If financial means is a deterrent to have children assessed for ADHD and other DSM disorders, parents can ask the school system for screening/services and some external services are free or provided at discounted rates depending upon family income.
  • ADHD diagnosis should not be based on children’s self-reporting of symptoms because “evidence” shows children’s perceptions don’t always correspond with the cognitive and functional disabilities professionals can best identify during objective assessment.
  • If teachers share with school personnel their concerns about students possibly having a disorder like, say, ADHD, the Individuals with Disabilities Education Act includes “Child Find” which federally mandates that schools locate, identify and evaluate all children with disabilities from birth to age 21.
  • CHADD publicizes ADHD as a life-span disorder. The presenter at this FCPS session repeatedly stressed ADHD is also an adult disorder. CHADD has a poster illustrating this life-span disorder approach. 
  • CHADD, which bills itself as the National Resource on ADHD, offers a Teacher-to-Teacher program purported to have “expert educators” to help teachers understand ADHD.

Some information parents and teachers did not learn from this session:
  • CHADD’s 2013/14 report states it is “increasing service related programs such as Parent to Parent and Teacher to Teacher. These strategies are focused on increasing revenues…” 
  • The number of US children and teens receiving a diagnosis of ADHD increased by 43% from 2003 to 2011. 
  • The chances of a child being diagnosed with ADHD and prescribed ADHD drugs are related to the state in which the child resides. For example, children living in Kentucky are three times more likely to be labeled with ADHD than are children living in Nevada.
  • Boys are three times more likely to be labeled with ADHD than are girls.
  • 25% of children in preschool who have been diagnosed with ADHD are being given drugs and receiving no talk therapy or other behavioral interventions. 
  • The United Nations International Narcotics Control Board (INCB) expressed concerns about CHADD’s active lobbying for the use of Ritalin for children labeled with ADHD while being heavily funded by the makers of Ritalin. INCB said this promotion of sales of an internationally controlled substance could be identified as covert advertising and charged CHADD with being a vehicle for marketing a controlled substance directly to the public in violation of the Controlled Substances Act of 1971. 
  • Ritalin maker, Ciba-Geigy (now Novartis) admitted CHADD was their conduit to the public. CHADD and National Institutes of Mental Health personnel were regular visitors at the Department of Education office of Special Education authoring ADHD materials.
  • American taxpayers are also funding CHADD given that two federal agencies, The Center for Disease Control (CDC) and the National Center on Birth Defects and Developmental Disabilities (NCBDDD) each donated $500,000 or more to CHADD this year.
Before this session ended, I asked the instructor how CHADD was able to offer so many parent and teacher programs, some of which include free dinner. She said CHADD operated through donations and grants. Pharmaceutical companies were never mentioned.

The reality is CHADD’s top corporate donors are pharmaceutical companies. Shire Pharmaceuticals, makers of several ADHD drugs, contributed a minimum of $100,000 to $299,999 in 2018. In 2014 the US Justice Department announced Shire pharmaceuticals paid $56.5 million to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs to include Adderall XR and Vyvanse, both marketed for ADHD. 

Next in line is Supernus Pharmaceuticals donating $25,000 to $99,999 to CHADD in 2018. Supernus began as a US subsidiary of Shire and is currently “developing multiple candidates in psychiatry to address significant unmet medical needs in the treatment of Impulsive Aggression (IA) and for the treatment of ADHD.” CHADD’s total pharmaceutical-related funding for 2018 is much more given that in 2009, CHADD took more than $1.5 million from pharmaceutical companies alone, roughly 36% of its total 2009 revenues. This includes pharma funds for advertising.

The third top CHADD corporate donor in 2018 is Akili Interactive, a company that develops video games marketed to help treat children diagnosed with ADHD. I’m including Akili’s $25,000 to $99,999 donation to CHADD as a pharmaceutical-related donor, however, because Shire is directly invested in Akili. In addition to the monetary investment, Shire worked closely with Akili to structure and launch the first clinical study of the Project: EVO™ billed as a cognitive measurement product in pediatric ADHD. This week in typical FDA and industry revolving-door fashion, Akili announced it has hired former FDA and Pfizer employee, Dr. Anil Jina, as head of medical affairs preparing to “launch its first digital medicine and drive the aggressive expansion of its pipeline.”

Educate Before You Medicate

Reading the description of the second session gave me some hope. Titled, “Educate Before You Medicate," the session description stated: “Prescription medication are being more widely used among children. However, medications alone will not improve the health of children. Learn about the proper use of common medications and lifestyle changes to help keep children healthy.” The instructor held a doctorate in pharmacy and his bio stated he is a healthcare consultant, entrepreneur and patient advocate.

We viewed the instructor’s PowerPoint which shared data about how to safely store medications, a brief overview of nutrition, and common prescription drugs that are sometimes abused by teens. I waited for some information about adverse drug effects, particularly data that pertained to children and teens, but this info wasn’t part of the presentation.

Some information parents and teachers learned in this session included:
  • “Most medications used to treat mental illnesses such as depression, bipolar and others take an average time of 4 to 6 weeks before these drugs are the most effective.”
  • Many mental illnesses have a biochemical basis.
  • People need to stick with their medication plan and should not stop taking their medication.
Near the end of class, the instructor asked attendees for questions or comments. A parent started asking questions about psychiatric drugs and side effects, specifically inquiring about Zoloft. Out of respect for privacy, I won’t share the gender of this parent or their child’s. The worried parent shared frustrations about the teen’s deterioration. The parent’s frankness surprised me a little given that publicly discussing mental health topics is sometimes seen as a cultural taboo in the parent's country.

The instructor-pharmacist responded to the parent’s questions with something to the effect of “it’s important to discuss these issues and possible side effects with your doctor.” I understood the reasons for his response. Unfortunately, I also understand far too well that doctors are often unable or unwilling to recognize their pharmaceutical interventions have destroyed those they professed to help.

I raised my hand and mentioned akathisia, serotonin toxicity and the FDA Black Box suicide warnings on all SSRIs. I shared the RxISK.org website where adverse effects are reported by actual users. The instructor went over to his laptop and accessed the RxISK website. He then returned to the lectern and shared with the class the Walgreens pharmacy website. He said parents can learn more about individual drugs on this website, adding it was “more reliable” presumably because it was from Walgreens. I replied that I had nothing against Walgreens. (My daughter was a college freshman and worked in the Walgreens beauty department at the time of her death). I pointed out that the Walgreens website likely only contains the drug info provided by drug makers and not by actual drug consumers. If parents look for information about Zoloft on the Walgreens website the instructor provided, they will not learn about akathisia. Further, the FDA Black Box warning is not readily apparent on the Walgreens Zoloft homepage and users must click an additional link to find this warning. Parents and teachers will also not find akathisia info on the CHADD and NAMI websites the FCPS conference instructors praised as valuable resources.

During his presentation, the instructor promoted NAMI. When class ended, he encouraged us to take a NAMI handout before we left.

Some information parents and teachers did not learn from this session:
  • US FDA Black Box warning info, suicidality as an adverse drug effect and Informed Consent was not part of the prepared instruction
  • A significant percentage of NAMI’s funding is from pharmaceutical companies. Exact funding amounts are obfuscated given NAMI’s broad donation categories of “$5,000 or more.” However, a US Senate investigation into NAMI’s conflicts of interest determined NAMI took $23 million from pharma between 2006 and 2008. It is reasonable to assume this year NAMI collected more of the same. 
  • NAMI’s 2017 annual report has a long list of pharmaceutical “corporate and foundation supporters.” They include Eli Lilly, AstroZeneca, Otsuka America Pharmaceuticals, Takeda Pharmaceuticals North America, Lundbeck, Bristol-Myers Squibb, Allergan and PhRMA (a trade group for the pharmaceutical industry). 
  • Pfizer heavily funded NAMI in 2009 when the company was busy illegally promoting the drug, Geodon, for non-approved use in children. Pfizer paid more than $2 billion in criminal and civil fines for pushing their antipsychotic drug onto pediatric, adolescent and geriatric patients for off-label uses. 
One Parent’s Search for Answers

After we left the session, the parent who bravely sought information about drug side effects started telling me about the child’s deterioration. I politely stopped the conversation and asked if it was okay if I tried to "guess" the sequence of events. I asked because I strongly suspected what was happening to this parent’s teenager is similar to what happened to mine. I thought if I could accurately tell this parent the “story” of their child’s demise before being told, it might better encourage the parent to seek out independent and accurate info that could save the teen’s life. I then recounted the adverse effects that ended with my daughter, Natalie’s, prescription-drug-induced death. The parent nodded in agreement as I was speaking.

The parent then shared their family’s lived experience. The teenager was prescribed Zoloft. After starting this SSRI, the teen changed dramatically and started self-harming. New drugs were added and the SSRI dose was increased. The teen subsequently attempted suicide. At the present time, it is unlikely this teen will be able to leave home for college. These symptoms were not part of the teen's original presenting challenges.

I recommended a list of books and online resources for the parent. I spelled out the word akathisia on a piece of paper so that the parent could seek critical mental health and wellness information upon returning home.

"The ancient study of alchemy is concerned with making the Sorcerer's Stone, a legendary substance with astonishing powers. The stone will transform any metal into pure gold. It also produces the Elixir of Life, which will make the drinker immortal.

You know, the Stone was really not such a wonderful thing. As much money and life as you could want! The two things most human beings would choose above all – the trouble is, humans do have a knack of choosing precisely those things that are worst for them." Dumbledore – Harry Potter and the Sorcerer’s Stone

The third post in this series highlights actions parents, teachers and schools can take to improve and safeguard children’s well-being.


Kristina Kaiser Gehrki is a public health and safety advocate who believes our most important knowledge stems from personal experience. She holds degrees in strategic communication, journalism and education. Her teenage daughter, Natalie, died a prescription-drug-induced death after suffering SSRI adverse drug effects that were undiagnosed by her doctor and improperly treated with SSRI dose increases.








Please contact me if you would like a guest post considered for publication on my blog.