Zantac Lawsuit


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

Saturday, September 17, 2022

Zantac - The Heartburn Medication on Trial

 



There's been much talk about the popular heartburn medication, Zantac (ranitidine) causing cancer after independent laboratory testing found that one ranitidine 150 mg tablet produced 304,500 nanograms (ng) of a cancer-causing substance called N-Nitrosodimethylamine (NDMA), an amount that greatly exceeds the U.S. Food and Drug Administration’s (FDA) daily acceptable intake limit of 96 ng.

After learning this, the FDA, in April 2020, requested Zantac be removed from the market.

Zantac is manufactured by many pharmaceutical companies, several of whom have recalled it, citing "safety concerns."

The following types of cancers have developed in some people who took the Zantac:

Bladder cancer

Esophageal cancer

Gastric cancer / stomach cancer

Liver cancer

Pancreatic cancer

Prostate cancer

Breast cancer

Lung cancer

Colon cancer

On September 15, 2022 , Baum Hedlund Aristei & Goldman, attorneys headquartered in Los Angeles, California, filed Zantac lawsuits on behalf of thousands of people throughout the country who allege exposure to ranitidine causes cancer. The filing of 88 complaints on behalf of 7,291 claimants is one of the largest on behalf of Zantac cancer victims in 2022.

Allegations against the defendants, namely, GlaxoSmithKline (GSK), Pfizer Inc, Patheon Manufacturing Services LLC, Boehringer Ingelheim, and Sanofi, include:

Failure to Warn 

Manufacturing Defect 

Negligent Product Design

Negligent Manufacturing

Negligent Misrepresentation

Baum Hedlund's press release states, "...the defendants knew that Zantac (ranitidine) could degrade into a potent human carcinogen, NDMA, in the regular course of transport and storage, and within the human body, but failed to take any action to prevent consumers from being exposed." Furthermore, they add, "...lawsuits maintain that Zantac’s manufacturers made billions selling a product they knew posed an unreasonable risk to consumers. If the drug manufacturers had disclosed and disseminated the cancer risks associated with Zantac and OTC ranitidine products, the plaintiffs say they could have avoided the risk of developing cancer by instead using alternative medications that do not pose the same risk."

Baum Hedlund's Brent Wisner also said, he believes the defendants in the Zantac litigation “deliberately misled consumers because they knew that full disclosure of Zantac’s risks would limit the amount of money they could make selling the drugs.” Adding, "They
 knew that concealing the truth would protect profits. Their deception led to an epidemic of cancer in this country, and we intend to hold them accountable.”

History shows that, between them, the defendants, above, have made settlements for various violations over the years of more than 20 billion dollars. Pfizer top that list with fines/settlements of over 10 billion dollars whilst GSK run a close second with fines/settlements of over 8 billion dollars.

It remains to be seen if those figures will be increased during or after these Zantac lawsuits.


Bob Fiddaman








Tuesday, August 23, 2022

CHEMICAL IMBALANCE - PATIENT INFORMATION LEAFLETS FOIA TO MHRA

 



For the record, I emailed the MHRA earlier with the following request:

To whom it may concern,

According to UK legislation, [Regulation 267 of the Human Medicines Regulations 2012] it requires that marketing authorisation holders (MAH) of UK MAs and article 126a authorisations inform the competent authority of all changes to the labelling and patient information leaflets which are not connected with changes to the Summary of Product Characteristics (SmPC).

With this in mind, I hereby request the following information:

1. When did the marketing authorisation holders (MAH) of citalopram change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

2. When did the marketing authorisation holders (MAH) of escitalopram change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

3. When did the marketing authorisation holders (MAH) of fluoxetine change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

4. When did the marketing authorisation holders (MAH) of paroxetine change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

5. When did the marketing authorisation holders (MAH) of sertraline change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

Sincerely,

Bob Fiddaman


Wednesday, August 10, 2022

Do Antidepressants Save Lives?

 



I find the whole 'antidepressants saved my life' thing quite strange. I'm sure some think this to be true but what leads them to this conclusion? How do they know they wouldn't be alive right now if it wasn't for taking medication? To question this one is seen as a 'pill-shamer' or accused of stigmatizing.

Now, on the other side of the fence we have those who have been harmed by antidepressants. The 'lucky' ones are alive to tell their stories, many have died as a result of the antidepressant inducing suicide. This is plain to see and one doesn't need to assume if this or that may happen. It's already happened. 

There are physical signs of antidepressant harm too, Akathisia and other central nervous system injuries are just the tip of the iceberg when it comes to compiling a list of injuries that antidepressants can cause.

So, why does there seem to be a push back whenever anyone on social media chooses to describe their personal experiences of antidepressant harm?

Why are stories like this met with "they work fine for me", "they help millions of people world-wide", "they saved my life"?

Antidepressants can cause a lack of empathy, and what I see playing out here is people, who genuinely believe antidepressants help them, are refusing to acknowledge the harm antidepressants have caused others.

The 5 Empathy Skills:

To see the world as others see it, or perspective taking.

To be non judgemental.

To understand another person's feelings.

To communicate your understanding of that person's feelings.

Mindfulness (paying attention)

So, whenever I read anything on social media from someone harmed by antidepressants and this is followed with replies such as 'they saved my life' - I'm reminded of how antidepressants can remove the 5 empathy skills (above) - I know, because whilst taking Seroxat (Paxil) most, if not all of the 5 empathy skills, didn't exist in my world. It was only after withdrawing (19 month taper) empathy came flooding back.

Antidepressants are designed to blunt emotions and a lot of what we see on social media from those taking them shows that design is working. I see very little of the 5 empathy skills from those who oppose people posting about antidepressant harm. Shouting how they save lives doesn't help the person posting about the harms caused.

This whole area has been massively emphasized, of late, by COVID vaccine injuries. Many of those who opted to take the jabs will skip past the horrific injuries caused by the jab that are posted on social media on a daily basis. If they are not skipped, they are answered with the classic, "all drugs/vaccines carry a risk." Again, this does not help a mother or father wanting support because they now have a child suffering, for example, myocarditis, or a brother or sister distraught at losing a family member as a result of an adverse reaction to the vaccine.

I'm not aware that the COVID vaccine strips people of empathy but there's a very high percentage of people who have taken the jabs who show a complete lack of empathy.

Like antidepressants, or rather people that take them, we see the same scenario playing out with regard to the 'life-saving' comments.

"If it wasn't for the vaccine, I'd be a lot worse", or "the vaccine saved my mother from dying".

Again, people who claim this are speaking of possible future events, just as people who make the same claim with antidepressants.

This does nothing for those harmed or those grief-stricken.

I'm almost certain, in fact I'll bet my left nut on it, that this post will be picked up on Twitter by those firmly in the "antidepressants saved my life" camp and I'll be accused of either pill-shaming or stigmatizing ~ I can live with that, even though it's not true, because, as I mentioned above, I am well aware that antidepressants kill empathy.

As for the professionals who make the 'saves lives' claims, they have a possible ulterior motive. If you take away antidepressants then psychiatrists are only left with their communication tools and from what I've witnessed on social media platforms, particularly Twitter, communication skills are severely lacking in this field.

Finally, if you are taking an antidepressant and you believe it is keeping your head above water, that's great. I'm genuinely pleased for you. One, however, would need a time-travelling DeLorean to predict that without them you'd be dead.


Bob Fiddaman



Sunday, August 07, 2022

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

 


Last Thursday, the United States Judicial Panel on Multidistrict Litigation (JPML) issued an order consolidating Gardasil human papillomavirus (HPV) vaccine lawsuit claims. The order, according to a press release, allows the cases to move into coordinated discovery and pretrial proceedings.

When cases, like these Gardasil lawsuits, are complex, it is requested that they be moved to one district court. That one court can then handle all discovery and pretrial proceedings for the lawsuits. 

Multidistrict Litigation is handled by just one judge during the pretrial and discovery process where it is hoped parties will reach a settlement. If no settlement is reached then cases are sent back to their original courts.

Merck & Co will now have to submit written answers to some very tough questions regarding the number of claims made by plaintiffs.

On granting the consolidation of Gardasil human papillomavirus (HPV) vaccine lawsuit claims, the United States Judicial Panel on Multidistrict Litigation said, "These personal injury actions present common questions of fact arising from allegations that plaintiffs, or their minor children, developed postural orthostatic tachycardia syndrome (POTS) and various other injuries as the result of an autoimmune reaction to the Gardasil vaccine…"

Baum Hedlund Aristei & Goldman, are representing young men and women across the country who allege they suffered serious injuries as a result of Gardasi, injuries that include but are not limited to:

Autonomic Dysfunction (Dysautonomia)
Complex Regional Pain Syndrome (CRPS)
Premature Ovarian Failure (POF)
Fibromyalgia
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS)
Orthostatic Intolerance (OI)
Postural Orthostatic Tachycardia Syndrome (POTS)

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim


Bob Fiddaman






Saturday, July 30, 2022

Finally, the Chemical Imbalance Myth Has Been Put to Bed



There is no evidence that depression is caused by lower levels or reduced activity of serotonin in the brain, according to a recent analysis of 17 previous studies. 

The analysis, carried out by Joanna Moncrieff, MD, a professor of psychiatry at University College London, and her colleagues, tells us pretty much what we've known all along. The chemical imbalance marketing myth has been used as an indicator that people need antidepressants.

The response to this analysis, by many psychiatrists at least, has been eye-opening.

The Science Media Centre (SMC), whom I've wrote about before on this blog, were rolling out their 'experts'.

Dr Michael Bloomfield, Consultant Psychiatrist and UKRI Principal Clinical Research Fellow, Translational Psychiatry Research Group Head, UCL, said:

"The findings from this umbrella review are really unsurprising. Depression has lots of different symptoms and I don’t think I’ve met any serious scientists or psychiatrists who think that all causes of depression are caused by a simple chemical imbalance in serotonin."

Bloomfield really needs to brush up on his research skills. Just two years ago, Adrienne Nagy, Board President of the National Alliance on Mental Illness (NAMI), America's largest grassroots mental health organization, had this to say:

"We're continually trying to educate the public to know that mental illness is an illness like any other illness—it's a biochemical imbalance in the brain. It's no different than diabetes or heart failure."

Other examples of psychiatrists promoting the chemical imbalance theory can be viewed here.

Another SMC 'expert', Prof David Nutt, Edmond J Safra Chair and Head of the Centre for Neuropsychopharmacology, Imperial College London, seemed to be digging his heels in when reacting to the Moncrieff analysis with:

"It is only recently that we have developed the technology to measure serotonin release in the living human brain and in the first study of this type (currently under review) we did find decreased serotonin release capacity in people with depression. So, to dismiss the serotonin hypothesis of depression at this point is premature."

Nutt has, in the past, received grants and personal fees from Lundbeck and GSK and personal fees from Lilly, BMS, Otsuka, Servier, and Pfizer, the majority of whom market and manufacture SSRI's, the very same types of drugs promoted to correct a chemical imbalance. I think it's no coincidence that Nutt still wants to hold on to the serotonin hypothesis of depression.

The general consensus (from psychiatry) of this new analysis seems to be, 'So what, we've known all along that it was just a theory'. I think they're either missing the point or being deliberately obtuse.

Samei Huda, author and consultant psychiatrist, Pennine Care NHS Foundation Trust, went one further. 

Here's a screenshot of his tweet which implies Moncrieff and her colleagues have "right-wing associations."


Huda is well-known to members of the #PrescribedHarm community on Twitter, he is also well known for baiting Twitter psychologists and others with accusations of racism or right-wing associations, myself included.

I find his above tweet was specifically constructed to be inflammatory. Huda can be followed here. I blocked him a couple of years ago.

The point many psychiatrists, on Twitter at least, seem to be missing is patients have been sold a lie. Not one single psychiatrist has been able to answer the following, Is the patient, taking SSRIs, at risk or is increasing serotonin in the brain deemed safe?

These days, Twitter psychiatrists tend to block patient accounts who raise concerns, or even questions such as mine above.

The reaction has been eye-opening particularly when you contrast it with 'expert' reactions to the Cipriani 2018 study that claimed antidepressants work and are effective. Not only were 'experts' gushing over Cipriani's study, some were even calling for more antidepressants to be prescribed.

Professor Carmine Pariante, spokesperson for the Royal College of Psychiatrists, said of the Cipriani analysis "This finally puts to bed the controversy on antidepressants, clearly showing that these drugs do work in lifting mood and helping most people with depression."

A year later, Pariante was interviewed by BBC's Angela Rippon. According to Pariante, his team "chemically induce brain cells in test tubes to mirror the state of depression. Antidepressant medication  is then added". Furthermore, according to Pariante, "There is no evidence that we are over prescribing antidepressants, yes more antidepressants are prescribed today than 10 years ago but, in fact, most people who need antidepressants are not receiving an antidepressant."

Yes, he really did say this.

You can watch the full show, Truth or Scare, here.

The SMC's 'expert' reaction can be viewed here.

Bob Fiddaman





Friday, July 29, 2022

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

 


Victoria Trevisan

At the age of 13, Victoria Trevisan, a straight A student, received her first dose of the Gardasil vaccine, a vaccine said to prevent cervical, vulvar, and vaginal infections and precancers caused by all seven cancer-causing HPV types. She received the second and third doses of Gardasil in February of 2016 and July of 2016.

Immediately after receiving her third shot, Victoria fainted and hit her head on the window in the examination room at her doctor’s office. Just two days later, One month later, she became severely short of breath after five minutes of a soccer game and had to stop playing. Further, around a month later, Victoria went to a cardiologist to evaluate her myriad of symptoms which included, but were not limited to, a shortness of breath, chest pains, memory loss, and insomnia. Abdominal pain and nausea, anxiety, and brain fog were added to the mix during the following two months.

Victoria was forced to drop out of high school thus giving up any hope of a career working in the field of forensic science.

Now 20, Victoria now suffers with Chronic fatigue, amongst other serious post-Gardasil adverse events that include Fibromyalgia, Mast cell activation syndrome (MCAS), and Postural orthostatic tachycardia syndrome (POTS), all of which she alleges were caused by the Gardasil vaccine.

In a press release, Victoria said, “I just want people to know that this happened to me, and it can happen to anyone,” Victoria says. “It is important for me to share my story to help make sure others understand that there are risks. There hasn’t been a day that’s gone by since I received the Gardasil vaccine that it hasn’t affected me. I don’t want this pain for other kids.”

Baum Hedlund attorneys Bijan Esfandiary, Michael L. Baum, Stephanie B. Sherman, and Monique Alarcon, along with co-counsel Robert F. Kennedy, Jr, who filed the lawsuit on behalf of Victoria, say Merck’s conduct, including its false promotion of Gardasil and its failure to issue appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant harm to children and patients. Furthermore, Baum Hedlund attorney and shareholder Stephanie B. Sherman poses the question if Merck should be "trusted on Gardasil after causing one of the worst drug recalls in history with Vioxx, not to mention Fosamax and NuvaRing?" adding, "...evidence says no, they shouldn’t be trusted on Gardasil either,"

Up to 2019, the FDA's Adverse Event Reporting System (VAERS) have received than more 64,000 HPV vaccine adverse event reports.

You can read more about Victoria's lawsuit here.

Bob Fiddaman

Previous Gardasil Blog Posts

Thursday, August 20, 2020 - Baum Hedlund Take a Stand Against Vaccine Maker

Wednesday, June 15, 2022

Filing a Gardasil claim ~ What You Need to Know

 


There's much confusion from those injured by the HPV vaccine, Gardasil. Many questions, often not even known by medical professionals or government officials in the US.

Luckily, Californian based attorneys, Baum Hedlund Aristei & Goldman, PC, have uploaded a Gardasil Injury Compensation Guide to their website.

Baum Hedlund has filed over a dozen lawsuits thus far against Merck on behalf of young men and women who allege their injuries were caused by the Gardasil vaccine and they continue to evaluate new potential Gardasil cases and get them on the path for compensation.

I've covered some of the plaintiff stories on this blog (links at the bottom), many of which sees both women and men now unable to live normal lives due to severe adverse injuries caused by Merck's HPV vaccine. All of those reached out to the team at Baum Hedlund who, in turn, listened to their heart-breaking experiences before filing lawsuits on their behalf.

Baum Hedlund have been standing up for victims of pharmaceutical wares for many years now, more recently they were victorious against the giant corporation, Monsanto, who, knowingly, marketed and manufactured 'RoundUp', used by farmers, gardeners, maintenance workers, agricultural workers, and many others as an all-purpose weed killer.

To date, they have negotiated over $10.9 Billion Monsanto Roundup Settlements for victims who developed varying cancers after coming into contact with the toxic weed killer.

They've also recently filed a lawsuit against Gerber, Hain, Walmart, and other major baby food companies for knowingly selling infant and baby food products containing dangerous levels of arsenic, lead, cadmium, and mercury.

They are renowned globally for litigating high-stakes cases against major corporations, particularly in the commercial transportation, pharmaceutical drug, and consumer product industries.

With vaccine injuries poo-pooed by mainstream media, it's great to see a team of passionate advocates doing the right thing. They've always put clients first, I should know, I've followed their work since the early 2000s when they successfully negotiated a deal for plaintiffs who suffered debilitating withdrawal problems at the hands of GSKs Paxil.

I've even seen them in action when I went to Chicago for the Wendy Dolin v GSK Paxil Suicide trial.

They are friends for life.

The Gardasil Injury Compensation Guide answers many questions for those seeking help with their injuries and with Baum Hedlund there is no financial risk in pursuing a Gardasil injury claim.

It's a win/win for those seeking help.

Here is a link to the guide

And if you want to print off the guide to show to someone you may know injured by Gardasil, go here.

Bob Fiddaman

--

Gardasil Stories Covered On This Blog

Thursday, August 20, 2020 - Baum Hedlund Take a Stand Against Vaccine Maker

Thursday, September 17, 2020 - Californian Law Firm Lead the Way in Gardasil Litigation

Friday, January 22, 2021 - Fifth Gardasil Vaccine Lawsuit Filed

Thursday, February 04, 2021 - Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Friday, April 02, 2021 - Gardasil Lawsuits Continue

Monday, April 19, 2021 - Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

Thursday, July 22, 2021 - The Gardasil Vaccine Lawsuits Keep Piling Up




Thursday, May 26, 2022

Toxic Baby Food, the Subject of Lawsuit

 

7-year-old Noah Cantabrana

The Honourable Amy D. Hogue, a California state court judge issued a ruling on May 24 in favour of the parents who allege their seven-year-old son developed severe neurodevelopmental disorders after consuming baby foods that contain dangerous amounts of heavy metals. Moreover, it was ruled that Plaintiffs experts’ opinions that heavy metals are capable of being a substantial factor in causing ASD and ADHD are admissible.

Baum Hedlund Aristei & Goldman filed the first baby food lawsuit in California and possibly the nation against several baby food companies alleging they knowingly sell products tainted with arsenic, lead, cadmium, and mercury.

Lorenzo and Melissa Cantabrana's 7-year-old son, Noah suffers from neurodevelopmental disorders after consuming substantial quantities of baby foods from the following baby food manufacturers:


It's alleged that the above knowingly sold tainted baby food to unsuspecting parents.

Noah was diagnosed with autism spectrum disorder ASD when he was a 2-year-old. He also shows signs of ADHD. 

Noah has outbursts and meltdowns that can last for hours, has social interaction and communication issues, and often has trouble sleeping through the night.

“My son is facing lifelong challenges because he ate foods that we believed were safe,” says Melissa Cantabrana. “If the labels said anything about heavy metals, I never would have fed them to Noah. Parents have a right to know what is in the foods we put on the dinner table for our kids. These companies deprived us of that right. It’s shameful and they need to be held accountable.”


Baum Hedlund attorneys, Pedram Esfandiary and R. Brent Wisner, who represent the Cantabrana's

“It is clear to us that the baby food industry does not care about the health of young children,” says attorney R. Brent Wisner. “By continuing to sell their poisonous foods to unsuspecting parents, these companies are willing to put the most vulnerable segment of our population at risk for severe neurodevelopmental disorders.”

“The industry could make this heavy metals problem go away with relative ease if they sourced better ingredients and adequately screened their products before they reached store shelves,” adds attorney Pedram Esfandiary. “The reality is these companies will not change their behavior without decisive government and legal action. We can’t just sit around and wait around for that to happen, so this litigation will have to be the tip of the spear when it comes to protecting children’s health”

Key findings from a 2021 U.S. House of Representatives Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform Report showed that several major manufacturers knowingly sell baby foods containing as much as 180 parts per billion (ppb) inorganic arsenic, 6441 ppb lead, and 10 ppb mercury. They also manufacture their products using ingredients containing as much as 913.4 ppb arsenic, 886.9 ppb lead, and 344.55 ppb cadmium. 

Being interviewed on Spotlight on America, Melissa Cantabrana said,“I was just like blown away, It made me really angry…to think that these heavy metals are in baby food. And I immediately thought we don't have autism in our family. I instantly knew this is it. This is what I'm talking about.” Cantabrana told Spotlight on America that she sought legal help from Baum Hedlund’s Pedram Esfandiary and R. Brent Wisner, attorneys with first-hand knowledge of litigating cases against large corporate defendants like Monsanto Company (see Monsanto Roundup Lawsuit)

The Honourable Amy D. Hogue's ruling now means the case can move into the discovery phase, which allows for internal documents from the defendant companies to be released to the plaintiffs.

You can read more about this case and more potential lawsuits here.


Bob Fiddaman




Tuesday, April 19, 2022

Akathisia Awareness Rolls Out on The Tube



New adverts on the London Underground fuelled a Twitter storm about akathisia and related psych drug harms. The campaign is sponsored by MISSD, a non-profit that raises awareness of akathisia. MISSD was founded in 2011 by Wendy Dolin after the tragic death of her husband, Stewart, who died six days after taking Seroxat (called Paxil in the US). Akathisia isn't a garden variety "side effect." Akathisia can precipitate your death. 

The current campaign consists of more than 1,000 train posters informing passengers that antidepressants and antipsychotics can cause akathisia which can cause self-harm, violence, and suicide. It's fitting that these adverts are on the Tube, given that both akathisia and the London Underground System have been around for more than 100 years. Tube trains rolled out in 1863, and akathisia was first identified in 1902. Yet, judging by recent tweets, it seems that several psychiatrists have been asleep longer than Rip Van Winkle when it comes to akathisia awareness. (More on this below.)

More importantly, the Tube is an appropriate place for these posters because Tube stations close to psychiatric hospitals tend to have a higher incidence of suicide (Farmer et al., 1991; O'Donnell and Farmer, 1994). Suicide prevention charities, like the Samaritans, are probably aware of this since they also run Tube adverts. It's quite poignant then that these adverts, rigorously scrutinized by the advertising company's review team that works closely with Committees of Advertising Practice (CAP), are running on the Tube. 

Spot the Difference 

The original Tube advert MISSD submitted to the advertising review team/CAP is not the same as today's advert. You can spot the differences below. 

Original Poster

CAP Approved Poster 

MISSD has run mass transit adverts in the US without ever needing to change the copy for approval. But the UK's rules and regulators are different from those in the US. If MISSD didn't make the changes, these akathisia awareness posters would never run on the Tube. The changes include:

1. Target antidepressants and antipsychotics by explicitly naming them;

2. Add the word "rare," and;

3. Remove the phrase "Nobody is immune to akathisia." 

The specific mention of antidepressants doesn't bother me. SSRIs harm thousands of people, and SSRIs often induce akathisia. Withdrawal akathisia is also one of many components people can experience when suffering from Protracted Withdrawal Syndrome. 

But what does trouble me is baseless censorship by the powers that be. We'll never know who comprises the advertising review team/CAP. Are medical professionals reviewing the adverts? If so, what institutions are they from, and do they have financial or ethical conflicts of interest with the pharmaceutical industry?  

Many different drugs do cause akathisia. Psych drugs aren't the only culprits. Could the advertising review team/CAP explain to these moms why the akathisia risks posed by Roaccutane are less worthy of publicizing?

While they're at it, maybe the advertising reviewers can also explain what research they used to insist on the word, rare. Most logical people would not state that 50% and 80% are rare occurrences.

While MISSD prefers their standard advert that runs in the US, the non-profit decided it was better to run the current London campaign, which directs viewers to MISSD.co for more info, than no England awareness campaign. I agree. Medical organizations, suicide prevention charities, and many doctors have worked to keep akathisia risks in the dark. (Kind of like the recent sodium valproate story, a controversy that broke a few days ago yet has been known by British drug regulators for many years.)

Twitter Storm and Feigned Concern 

The majority of tweets sparked by the MISSD advert supported the awareness campaign. One advocate on Twitter who supports MISSD's mission did share her discomfort regarding the word "violence." But honest discussions about iatrogenic harms should include violence when it is a drug-induced effect. The parents of these 22 children who died in a school bus crash in Switzerland could share their thoughts on SSRI-induced violence. So, too, could the surviving relatives of these ten families. 

I suspect pharma has settled SSRI homicide cases out of court, but we'll never hear about those. However, one case that was made public was against GSK (then SmithKline Beecham). Donald Schell, 60, took two Paxil tablets before shooting his wife, their daughter, his granddaughter and himself to death on Feb. 13, 1998. A jury returned the following verdict:


Speaking of pharma brings me to this photo taken by Professor Anthony David, who saw MISSD's poster when he was riding on the Victoria line. David tweeted the adverts are "not helpful and should be removed." 

In 2018, David was appointed Director and Sackler Chair of the new UCL Institute of Mental Health. The Sackler Trust is the "charitable giving" arm created by the Sackler family--the same family responsible for Purdue Pharma's "uncharitable taking" of hundreds of thousands of lives lost due to the company's illegal opioid promotion.

Given the immense harm the Sackler family yielded for profit, it's inconceivable that UCL continues its financial relationship with the Sackler Trust. Moreover, I can't help but wonder if David is proud to carry the "Sackler Chair" title? Is he also proud of all the other money he's taken from other pharmaceutical companies who prescribe the types of drugs that can cause akathisia? They include Janssen, Eli Lilly, and Novartis.

Judging from his tweet, it's challenging to believe David cares about akathisia awareness and prescribed harm any more than the universities that continue taking Sackler's blood money and advertising their crime family partnerships. 

David's tweet invoked many responses from akathisia experts by experience and families whose relatives died avoidable akathisia-induced deaths. The tweet has had more than 230 responses, 99% of which criticise David's proclamation that the adverts should be removed.

One of David's colleagues at UCL, Prof Robert Howard, opined the poster was "Uninformative, confusing and frightening." Howard added the defamatory comment, "There's generally some kind of grift accompanying this kind of health disinformation. Calling it secondary gain would be too kind."

For those who don't know, 'Grift' is slang for "a group of methods for obtaining money falsely through the use of swindles, frauds, dishonest gambling." (UPDATE AT END OF POST)


Howard also tweeted that MISSD's website has "a lot of disinformation," but when asked to point out what was disinformation, he failed to respond. Further, neither Howard nor David have ever explained why they feel the poster is uninformative, unhelpful, and should be removed. They also haven't suggested ways their profession can increase awareness of this critical adverse drug effect. Howard's defamatory comments remain on Twitter today. 

Another Psychiatrist, Robertas Strumila, really scraped the bottom of the barrel when he responded to David's original tweet with this:


Strumila, based in Montpellier, France, later deleted his tweet after a backlash of comments from the prescribed harm community, many of whom have experienced debilitating side effects from antipsychotics. Strumila has never apologised, and Howard and David have never condemned his tweet.

Former Royal College of Psychiatrist President Wendy Burn, also tweeted about MISSD's adverts. Burn criticised them and tweeted, "Most people don't know what akathisia is." 


Um, FYI: Awareness-raising means making people conscious of a problem or issue. This fact, however, seems lost on Burn.

There are four types of akathisia, one of which is actually called Withdrawal Akathisia. MISSD covered this when presenting to RCPsych's International Congress in 2019, a conference session in which Burn herself introduced MISSD to the audience. Withdrawal akathisia has also been discussed in medical journal articles and research papers. The onset of akathisia can start when the dose of the drug is increased or decreased or the drug is stopped. That Burn didn't know you can suffer from akathisia after stopping these drugs is likely one of the reasons she states she hasn't seen it in her practice. Maybe her time needs to be "carefully balanced" between Twitter and taking the 1-hour MISSD Akathisia 101 course that can help her better recognize akathisia.

That assumes, of course, that Burn and other doctors want to recognize and warn patients about akathisia and other adverse drug effects. Lest we forget that in 2020, Burn made a startling revelation to Equally Well UK, an initiative that states it seeks to promote and support collaborative action to improve physical health among people with mental health challenges. 



According to the field of psychiatry, psychotic disorders are severe mental disorders that cause abnormal thinking and perceptions.

Answer me this, what can be more abnormal than one human failing to warn another human that a product may cause harm or, even death?

UPDATE: Prof Rob Howard decided to remove the defamatory post and has now issued a fauxpology on Twitter.

Bob Fiddaman

Poster Ad story in the media



Remember, akathisia can be caused by many different categories of drugs, not just antidepressants and antipsychotics, but also antibiotics, anti-hypertensives and many others.

If you are a doctor, pharmacist, coroner, journalist, or member of the public, and you wish to learn more about akathisia, take the FREE online accredited course here.





Friday, March 25, 2022

NEJM's Data Deceivers

 

NEJM states: "Our mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes."

Effective mission statements are supposed to be succinct, I presume NEJM chose to omit the other relevant sentence readers would want to understand, which is: "We don't care where the data comes from as long as it supports our chosen narratives."

de·ceiver

a person who causes someone to believe something that is not true, typically in order to gain some personal advantage.

New England Journal of Medicine (NEJM)

Eric Rubin, NEJM editor-in-chief

There have been nine editors-in-chief from 1921 to the present at the New England Journal of Medicine (NEJM). The current editor-in-chief is Eric Rubin, the former chair of Harvard T.H. Chan School of Public Health's Department of Immunology and Infectious Diseases. (Immunology is the study of the immune system.) Before Rubin, NEJM's editors-in-chief was Jeffrey M. Drazen, an asthma and lung disease expert. Aside from Rubin, no NEJM editor-in-chief has had a background in Immunology and Infectious Diseases. 

The Boston Tea Party (Outsiders rarely invited)

Rubin was selected after a NEJM "international" committee conducted a global search. The committee was chaired by Dr. Lynda Young, past president of the Massachusetts Medical Society. Dr. Beverly Woo, of the Department of Medicine at Brigham and Women's Hospital and a faculty member at Harvard Medical School, served as vice-chair. Other committee members were:

Dr. Alain Chaoui, FAAFP, President, Massachusetts Medical Society;

Dr. Karen Antman, Dean, Boston University School of Medicine;

Dr. Harris Berman, Dean, Tufts University School of Medicine;

Dr. Edward W. Campion, Executive Editor, the New England Journal of Medicine;

Dr. Lois Dehls Cornell, Executive Vice President, Massachusetts Medical Society;

Dr. George Q. Daley, Dean, Harvard Medical School;

Dr. Jack Evjy, Past-President, Massachusetts Medical Society;

Dr. Terence Flotte, Dean, School of Medicine, UMass Medical School;

Dr. Danny Jacobs, President, Oregon Health and Science University;

Dr. Thomas Lee, Chief Medical Officer, Press Ganey, and NEJM Catalyst Leadership Board Founder;

Dr. Joseph Loscalzo, Chairman of the Department of Medicine, and Physician-in-Chief, Brigham and Women's Hospital;

Dr. Graham McMahon, President and Chief Executive Officer, Accreditation Council for Continuing Medical Education;

Dr. Erika von Mutius, Professor of Pediatric Allergology, Dr. von Hauner Children's Hospital of the University of Munich, Institute for Asthma and Allergy Prevention, Germany;

Dr. John Noseworthy, Chief Executive Officer, Mayo Clinic;

Dr. Chana Sacks, Images Editor, the New England Journal of Medicine, Division of General Internal Medicine, Massachusetts General Hospital, and;

Dr. David Spriggs, Associate Editor, the New England Journal of Medicine, Director of the Gynecologic Oncology Program, Massachusetts General Hospital Cancer Center.

The vast majority of this "international" search committee works in the Boston area.

For historical reference, the first quarterly edition of the New England Journal of Medicine and Surgery and the Collateral Branches of Medical Science (Boston) was published in January 1812. It was a result of a collaboration between John Collins Warren, a Boston physician, and his colleague James Jackson. In 1921, their journal merged with the Boston Medical Intelligencer to become the Boston Medical and Surgical Journal; it also began weekly publication that year and was purchased by the Massachusetts Medical Society.

Rubin became NEJM's editor-in-chief in September 2019, approximately three months before the World Health Organization (WHO) was informed of cases of pneumonia in Wuhan City, China. On January 7, 2020, Chinese authorities identified coronavirus as the cause, and it was temporarily named "2019-nCoV." Rubin's September 2019 appointment as editor-in-chief at the NEJM was quite timely.

Not Long Before Controversy

Dressen is a preschool teacher from Saratoga Springs, Utah, who received the Astra Zeneca Covid vaccine during a clinical trial in November 2020. She has since experienced extensive adverse effects from the vaccine

On November 2, 2021, Bri Dressen participated in a US Senate meeting at which issues were raised about coronavirus vaccine harms and related mandates. Dressen was a clinical trial participant for the AstraZeneca COVID-19 vaccine. 

After having just one dose, Dressen experienced adverse effects. The effects were so severe and long-lasting that she had to quit her job as a preschool teacher and hire a nanny to care for her two young children. Here's her testimony.


Dressen followed up her testimony by writing to the NEJM. She felt compelled to do so after reading an article the journal published in September 2021, entitled 'Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine'

In her initial email, Dressen pointed out the article's inaccuracies. Surprisingly, her email was directly answered by NEJM editor-in-chief Eric Rubin. Rubin told Dressen the NEJM would not publish her letter. He claimed, "The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received."

Dressen contacted NEJM because they published inaccurate information that the journal should correct. She did not contact NEJM to request that her letter be published. However, the email exchange between Dressen and Rubin shows Rubin would not address these inaccuracies. Their email exchange can be read here.

Dr. Fernando Polack  is a Specialist in Pediatric Infectious Diseases. His work is funded by the Bill & Melinda Gates Foundation

Dr. Fernando Pedro Polack ~ Mira Vos! Argentina

Polack was the lead author in another NEJM article entitled, 'Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine', the conclusion of which was "A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines." BioNTech and Pfizer funded the trial.

As Covid hit Argentina, Polack became involved in a trial of immune plasma taken from patients who had recovered from Covid. This plasma was then given to patients who had recently contracted Covid. In May 2020, Polack speculated that this would make Covid like an ordinary cold.

The trial's conclusions boasted a positive outcome, and the results were published  in a February 2021 peer-reviewed article in--you've guessed it--the NEJM. NEJM reviewers concluded, "Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19."

BioNTech or Pfizer didn't fund this trial; The Bill and Melinda Gates Foundation funded it.

A subsequent systematic review and meta-analysis published in The Journal of the American Medical Association (JAMA) didn't agree with Polack and the NEJM reviewers. They cited, "Treatment with convalescent plasma compared with placebo or standard of care was not significantly associated with a decrease in all-cause mortality or any benefit for other clinical outcomes. The certainty of the evidence was low to moderate for all-cause mortality and low for other outcomes."

Who is Dr. Fernando Pedro Polack?

Take a step into the unknown and read Fishy Business in the Rio de la Plata, an article by Prof.David Healy, Psychopharmacologist, Scientist and Author.

Who are NEJM's Reviewers?

This is a list of people who served as NEJM's reviewers between January and June 2021. Readers of medical journals should be aware that these reviewers, like most--if not all--reviewers, are reviewing ghostwritten material and have never seen the raw data from clinical trials. Many reviewers are probably still unaware that the material they review is written by pharmaceutical companies or PR companies hired by pharmaceutical companies. Further, if some reviewers are aware, or made aware, of these data sources, it's likely they do not care.

Are these NEJM reviewers data deceivers who refuse to reveal the truth about the source of the "data" they review? Are they disinterested in reviewing raw data? Are they dispassionate about ensuring the validity of the data they promote? Regardless of the reasons, I contend NEJM reviewers are likely data deceivers because they've been seduced by the financial and professional benefits that come from serving as "prestigious" NEJM reviewers.

If you want to go down the rabbit hole of ghostwriting, I recommend the following introductions, 1, 2, 3

Bob Fiddaman





Monday, March 07, 2022

GUEST POST: P-450 Test and Multiple Chemical Sensitivity

 


I've heard many stories over the years regarding the troubles people have experienced whilst taking brain pellets marketed as 'antidepressants.' Kerri's guest post (below) is yet another example of how patients are pushed from pillar to post, often having to find their own way to resolve matters relating to brain pellet adverse events because of a severe lack of knowledge from prescribing physicians.

The three pellets featured in Kerri's story were, at a point in time, blockbuster products raking in billions of dollars for the drug companies who marketed and manufactured them, namely Lilly (Prozac) and GlaxoSmithKline (Paxil) and Pfizer (Zoloft). Three apparent drugs that are supposed to help but, as is my experience, cause more problems than the original 'illness' they are prescribed for. They all, allegedly, work in pretty much the same way. Drug company reps will tell you that A is better than B and C because, well, because that's what they are paid to do. They have no scientific evidence that one is more tolerable and causes less side-effects than the other.

I find it difficult to believe that neither Lilly, GlaxoSmithKline or Pfizer  knew nothing about the problems caused by the three products mentioned below, moreover, the journeys many millions face when taking them.

This is just a small part of Kerri's journey. She writes to warn others and to create an awareness that all is not lost if you, or someone you know, suffers the same fate as she.

Bob Fiddaman

--

I was taught to trust the doctors. I was taught to trust the prescriptions.  I was taught to trust the assessments I received from hospitals. And I did…but, this trust of these medical recommendations nearly killed me.

My name is Kerri Lynn and I was born in Long Beach CA, but was raised in the upper Midwest. I grew up in a dysfunctional home and early on, I gravitated towards addictive tendencies.  I strived to make good choices at this time, however, my best efforts to live life on life’s terms were mostly self-destructive.

"I was restless, irritable and discounted all the time being newly sober and I needed help facing life, or so I thought." 

At 13, I discovered drinking.  I partied all the time until my addiction stopped working for me.  I chased other self-destructive behaviors and relationships.  My out-of-control nature led to an ultimatum from loved ones: I had to find a solution how not to be self-destructive.

Pain and circumstances drove me to seek help from 12-Step Recovery.  This was really a challenge and about 60 days into this sober journey, I sought help from my family doctor.  I was restless, irritable and discounted all the time being newly sober and I needed help facing life, or so I thought.  My first prescription was for 20 mg of Prozac. 3 Days into this first prescription, I was unable to walk or talk.  I was severely anxious and my brain was racing and telling me to do delusional things like run outside naked.  I experienced Homicidal and Suicidal Ideation (I have come to understand that these are the symptoms of Serotonin Syndrome/Akathisia). I was panicking due to my reaction to this prescription, though I had no awareness that it was the prescription that was causing these symptoms.  I had to reach out to a former counselor to sorts things out.

I met with my former counselor the following Monday. I finally revealed I was taking Prozac, and he immediately called my prescribing physician to get me off this prescription.  This was the beginning of a 13-year nightmare with prescribed medications.

40mg of Paxil was my next prescription.  A year into taking this antidepressant, I woke up one morning and could not emotionally feel anything. I was terrified.  I called my doctor again and he tried yet another substitute of Zoloft.  At that point, all hell broke loose.  My doctor tried Paxil one more time and this sent me to the hospital.  Between 2000 and 2006, I was Hospitalized on 3 separate occasions due to drug toxicity or cold turkey drug withdrawal. 

"I exhausted every potential care and specialty option locally."

During these nightmare days, I was entertained with my expanded medical vocabulary.  I learned words like suicidal ideation, disassociation, delusion, hallucination, profuse night-sweats, rapid irregular heartbeats and agoraphobia.  We must not forget the bladder loss or rectal haemorrhaging, nor the black outs that would last more than 24 hours, when they would randomly introduce new medications.  And my favorite suffering were the overwhelming panic attacks.

Sadly, my entire investment in the “healing process” to this point only led to my condition becoming more and more dire.  The medical assessments only were dealing with a random set of symptoms that were mostly caused by the prescription and I could not break the cycle, no matter what I did or took.  Almost every diagnosis made things worse and added to my growing list of “untreatable symptoms.”  I exhausted every potential care and specialty option locally.  I even spent 2 weeks at the world renown Mayo Clinic only to achieve an inaccurate diagnosis once again of Visceral Extreme Hypersensitivity.  When I return to my home, I felt defeated and my local hospital would no longer allow me to make appointments, unless first reviewed by management over the phone.  These doctors thought I was crazy.

It is always darkest before the dawn.  I was under the care of many physicians.  Many were a significant part of the problem and few were graciously a part of what would be my life-changing solution.   I was blessed to be introduced to the Cytochrome P-450 test which analyses DNA and genetic strengths and deficiencies.  From this accurate genetic assessment, it was discovered that I have both fast and slow processes in my liver and kidneys.  This finally expressed a causality between reception and rejection of various medications.  It was also determined accurately that I am missing the GSTM-1/ Glutathione Gene.   It was finally determined that my true ailment was Multiple Chemical Sensitivity and all previous diagnoses actually placed me in grave risk by triggering my symptoms. The synthetic nature of the drugs being prescribed to me were actually poisoning me and triggered my multiple chemical sensitivity.  During the course of 13 years of prescriptions, my body has been damaged so that I will most likely be significantly chemically sensitive for the remainder of my days. 

"It is my hope that my story can guide people to new strategies so that nobody ever has to suffer like I did."

My hope is that by sharing my story that we can come to a new responsibility about how we seek and receive diagnoses.  The medical profession has a mission statement of seeking to do no harm.  This is not always the case.  From my experience, a measured suspicion is the best approach.  I now take the responsibility of doing my own medical research.  I trust my instincts and I am my own advocate.  Through my difficult journey my local provider actually became the first hospital in the country to study the P-450 genetic test.  I strongly recommend this assessment be the starting point.  Don’t utilize the P-450 as a last resort.

I am now 11-years medication free and stable.  I have to live the rest of my life being critically aware of my environment and surroundings due to my chemical sensitivity. However, today I have a strategy for living that works. It is my hope that my story can guide people to new strategies so that nobody ever has to suffer like I did.

~ Kerri Lynn

---

You can listen to Kerri's story in her own words here via the brilliant Akathisia Stories, a co-production of MISSD and Studio C.

You can read more about Cytochrome P450 (CYP450) tests here

Footnote:

Test limitations

Although they have potential, CYP450 tests have limitations:

Tests are available for only certain medications. Also, each test is specific to only one medication, so a change in medication may require another test.

Testing can't predict which medication will work best for you — it can only provide clues.

Not all insurance companies cover the costs of these tests.


Monday, January 31, 2022

MHRA's BAFFLING RESPONSE REGARDING VACCINE SAFETY

 



My on-going communication with the British drug regulator, the MHRA, has hit a bit of a roadblock. This isn't due to any lack of response, it's more to do with MHRA language that is meaningless and excessively abstruse. It's utter nonsense.

In early January, I requested information from the MHRA regarding their Yellow Card Reporting System, moreover, for reports filed for adverse reactions to the COVID-19 vaccines.

Their initial response needed clarification such was its ambiguity.

In a nutshell, the MHRA was telling me that a reporter, like you or I, could have a family member take a vaccine and some weeks later suffer heart problems and die. After talking with a GP or a heart specialist we can then decide if the vaccine played a part in the death of a loved one or not. We can make our own minds up whether we think the vaccine caused the death or whether the death appeared out of nowhere and isn't vaccine related.

The rub being, if we conclude it wasn't vaccine related, the MHRA will agree with us. However, if we believe the death to be vaccine related, the MHRA won't agree with us because, "In any individual case it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental." (See Yellow Card Reporting System Shown the Red Card)

The MHRA responding to FOIAs often throw up more questions than answers, none more so in this instance.

The MHRA told me they assess "Yellow Card reports using an internal follow up algorithm to determine whether any additional information such as test results, other drugs and/or medical history is required."

So, I asked what algorithm software they use. I was told, in a rather short email, the following:

"We can confirm that this is not a software algorithm."

To my knowledge, an algorithm is a process or set of rules to be followed in calculations or other problem-solving operations, especially by a computer. So, I pursued this further and asked the MHRA:

From: Bob Fiddaman

Sent: 24 January 2022 18:31

To: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

Subject: Re: GENQ-00150010 Follow up questions

Thank you.

Presumably then, it's a process or set of rules?

Could you please forward me this process and/or set of rules.

Thanks

--

Their reply, received this morning , has left me bamboozled.

from: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

to: Bob Fiddaman

date: Jan 31, 2022, 7:09 AM

Dear Mr Fiddaman,

The process around follow up is dependent on a number of factors, including the level of information within the original Yellow Card report and the specific issue reported. The follow up process doesn’t fall under a specific procedure and is assessment specific, therefore we are unable to provide you with the defined process or set of rule you have requested.

Kind regards,

Pharmacovigilance Service Team 

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

--

I have to say, this seems, to me at least, the MHRA are being deliberately obtuse.

To recap:

If you suspect the COVID-19 vaccine caused a death of a loved one, the MHRA will tell you it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental. But, if you change your mind and say you don't think the vaccine caused the death of a loved one, the MHRA will accept this.

Moreover, the MHRA use an internal follow up algorithm to determine whether any additional information such as test results, other drugs and/or medical history is required. However, this isn't software and it "doesn’t fall under a specific procedure and is assessment specific." They won't tell me how it works or, if indeed, it actually does. They cannot provide me with the defined process or set of rule(s).

The MHRA are in the habit of labelling question-askers 'vexatious', the definition of which is: causing or tending to cause annoyance or frustration.

Tell me, who is being vexatious here? Who is having their cake and eating it too?

Bob Fiddaman







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