Zantac Lawsuit

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

Wednesday, June 28, 2017

The Anecdotes

If the benefits of SSRIs are loosely based around anecdotes then why are the MHRA ignoring the 'anecdotal' risks?

In December 1996, Stevie unexpectedly received a diagnosis of clinical depression and a prescription for Seroxat, an SSRI antidepressant.

Now, listen.

Stevie's story is one of many featured on 'Let's Talk Withdrawal'. An innovative series of podcasts from James Moore.

Bob Fiddaman


Sunday, June 25, 2017

What if We're Wrong About Antidepressants?

Sometimes it's good to step outside the bubble of one's opinion and venture into the bubble of another's. If more people and cultures would do this, the world would possibly be a much safer place.

So, what if we, as public health advocates, have been wrong about the lack of efficacy and safety of psychiatric drugs? Let's say for the sake of healthy argument, that we are wrong and antidepressants:

1. Are not addictive
2. Are easy to withdraw from
3. Are safe for children to take
4. Are used to rectify a chemical imbalance

What we are left with is the opposite of the 4 points above. By conceding them we are ignoring a hell of a lot of scientific evidence. (but hey, some people still think the earth is flat despite overwhelming evidence showing it's not.)

1. We've been told by pharmaceutical companies and drug regulators that antidepressants are not addictive, they acknowledge that "some people" may find discontinuing from them "problematic" but, they claim, "Addiction is characterized by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect, and a number of other features." However, the English dictionary describes it somewhat different. it states: a compulsive need for and use of a habit-forming substance characterized by tolerance and by well-defined physiological symptoms upon withdrawal.

2. If drug companies and drug regulators play semantics over point one then point two can be backed up by their claims in point one. It has to because point two raises the issue of withdrawal within the meaning of the true definition of addiction. The medical definition of withdrawal is: A psychological and/or physical syndrome caused by the abrupt cessation of the use of a drug in an habituated person. The therapeutic process of discontinuing a drug to avoid the symptoms of withdrawal. There are many forums on the Internet where users of antidepressant drugs have sought help because they have had, or are having, extreme difficulty withdrawing. With pharmaceutical companies and drug regulators making claims that these are easy to withdraw (ahem, 'discontinue') from, these people, seemingly, have nobody else to turn to except fellow-users of these medications. Furthermore, drug companies and regulators  don't use the term, “withdrawal symptoms,” preferring instead to use, “discontinuation symptoms.”

3. Health care professionals still prescribe SSRI's to children, they do so 'off-label'. By doing this they are telling us that SSRIs are safe for children. I mean, who would give a child a dangerous drug if they thought it was dangerous for them, right? However, what's perverse about this is those same health care professionals have access to the product labelling which states, amongst other things, that there are warnings "about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24."

4. When SSRIs first hit the market the manufacturers needed a selling point. They didn't just want those who were extremely depressed taking their drugs, they wanted to cast the net wider. This practice has continued throughout the years with new 'brain disorders' springing up, almost on a yearly basis. ADHD, OCD, and Bipolar spring to mind here. So, where did they spring from? Well, in a nutshell, they came from man, or rather a group of men. The Diagnostic and Statistical Manual of Mental Disorders (DSM) is the handbook used by health care professionals in the United States and much of the world as the authoritative guide to the diagnosis of mental disorders. Created in 1952, it listed 106 disorders. It's third edition listed 265 disorders and it's fourth edition listed 297 disorders. The current DSM, after coming under heavy fire regarding the labelling of normality, hasn't increased the number of disorders per se, instead they have added subtypes to the previous disorders. For instance, caffeine intoxication and “caffeine withdrawal” are now listed as a disorder in the latest edition of the DSM. So, too much coffee or Red Bull, in essence, means you have a mental disorder.

The 'chemical imbalance' was a marketing campaign by pharmaceutical companies, the first being Eli Lilly who sold and marketed Prozac. Over time, this theory has gained momentum and has become an almost accepted fact. Even today, despite the chemical imbalance theory being debunked as a marketing strategy, we see the product label making claims that "It is thought that depression is caused by a chemical imbalance, or depression may be caused by a chemical imbalance. Remarkably, there is not one shred of scientific evidence that supports this claim. It's called indoctrination. It happens all the time, yet we, take it on faith because we can't be bothered to do our own research or we put our faith in those who make these lavish claims. Here's a few instances of indoctrination.

1. Three Wise Men
We see them depicted on Christmas cards, we see our children play them in Nativity plays, we see endless books telling us about these three guys. Truth of the matter is, nowhere in the Bible does it specify there were three.

2. The Great Wall of China
Because of it's enormous structure you can see the Great Wall of China from space. I actually thought this one was true. Surprisingly, it's not visible from space, no single structure is visible from orbit. The visible wall theory was debunked after China's own astronaut, Yang Liwei, said he couldn’t see the historic structure. There was even talk about rewriting textbooks that support this theory. To date, that's not happened.

3. Bananas Grow On Trees
Another one that had me stumped, until I researched it. Bananas actually grow on herbs, a perennial herb; in fact, it is the largest of all herbaceous flowering plants.

4. Bats Are Blind
Another myth. Bats can actually see almost as well as humans. However, at night, their ears are more important than their eyes.

These are just four examples of how we, without researching, believe in facts that aren't facts at all.

Now, I'm betting that these four examples of untruths will be used in the pub or in quizzes. I'd bet all the money in my bank account that no such pub quiz would ever include the chemical imbalance myth though. Because many still believe it to be true despite having no evidence to prove it.

With the first four points covered, is it worth researching points 5 to 8?

5. Antidepressants do not cause psychosis
6. Antidepressants do not induce akathisia
7. Antidepressants do not cause people to self-harm
8. Antidepressants do not induce suicidal thinking and, almost definitely, do not induce completed suicide.

You can find Google here.

Bob Fiddaman

Friday, June 23, 2017

Prozac: Three Blind Mice

Three blind mice, three blind mice,
See how they run, see how they run,
They all ran after the farmer's wife,
Who cut off their tails with a carving knife,
Did you ever see such a thing in your life,
As three blind mice?

Most believe the author of Three Blind Mice was a teenager named Thomas Ravenscroft. The origin of the words, according to many historians, stem from Queen Mary I and her staunch Catholic beliefs. due to her violent persecution of Protestants, she was known as 'Bloody Mary'. The reference to 'farmer's wife' in Three Blind Mice refers to the huge estates she possessed. The 'three blind mice' were three Protestants convicted of plotting against Queen Mary I.  She did not have them dismembered and blinded as inferred in Three Blind Mice, she had them burnt at the stake! 

Ah, don't you just love the morals and ethics of religion! Even today we still see people being killed in the name of something that cannot be seen or heard. History shows that religious books have been responsible for many deaths, or rather the way religious scriptures are been interpreted. The Three Blind Mice rhyme has similarities to a recent study in Japan.

The study, sponsored in part by Takeda Pharmaceutical Co. Ltd., involved mice pups bred to mimic the distinctive behaviors and brain abnormalities seen in autism. After inducing autistic traits, the mice were fed Prozac. The authors claim Prozac caused dramatic improvements in the animal's social interactions and communication patterns. The Prozac, which was administered through the mother’s milk for 19 days. Furthermore, according to the study, "newborn mice got a daily injection of Prozac in their first six days of life, the treatment appeared to restore normal vocalization patterns and reduce anxiety-like behaviors well into adulthood."

The study is littered with assumptions and seems to promote a chemical imbalance theory that both humans and mice allegedly have. The study doesn't seem to explain what was done to impair the animal's brain function. What it does claim is that Prozac improved the brain damage the researchers caused. 

It claims to show that Prozac cleared whatever was induced in the mice so, in essence, this could just possibly be one drug counteracting another drug.

The spin in this study is obvious. The authors have induced a series of brain abnormalities in mice pups then made claims that these abnormalities are almost identical to the abnormalities found in people with autism.

Here's the irony: Toxic exposures during pregnancy, such as the use of antidepressants, can disrupt brain processes before birth and shortly afterward. So, if antidepressants can disrupt the brain process before and after birth, why not treat that with, um, another antidepressant!

It must have been a slow news day at the Los Angeles Times whose health corespondent, Melissa Healy, ran with the study. Her article is littered with assumptions. She claims Prozac, "is thought to elevate mood and quell anxiety by increasing the availability of the neurotransmitter serotonin in the spaces between certain types of brain cells." I suspect her article is mainly a reprinted press release.

The key word here is "thought." Anything that follows it can, and should, be taken with a pinch of salt. It's clever marketing because our eyes are drawn to the science when, in actual fact, there is no science, it's just supposition.

Furthermore, the jounalist states, "Research on humans suggests that, during early brain development, those who will go on to develop autism have unusually low levels of serotonin in critical areas of the brain."

Now, here's a game for you all. What is the keyword in the above sentence?

Answers in the comments section or on my Facebook page please.

Science is an intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment. This Japanese study has done none of that.

Don't you just love the morals and ethics of clinical trials and unscientific journalsm reporting!

Full study here.

LA Times article here.

Bob Fiddaman

Wednesday, June 21, 2017

Mother Reveals Shocking Truth Behind Daughter's Death!

Take a good look at the beautiful young woman pictured above. Heather Blower was just 18 when she was found hanging in her bedroom by her sister, Heidi.

Earlier today I was alerted to a post that featured Heather and Heidi's mother, Paula.

I was halfway through the post when I had to stop. Tears were welling and I had to dry my eyes. Anger was also rearing its ugly head because the incompetence highlighted in Paula's guest post is all too familiar.

One would have thought that after 11 years of researching and blogging about this I'd be almost immune to the pain and suffering felt by those left behind when they lose children under such tragic circumstances. The tragedy here is heightened because of the ignorance of apparent health care professionals and a spineless regulator who have been alerted to stories like this time and time again and done absolutely nothing!

Heather was dragged through the system, her mind, body and soul tortured by raving lunatics who chose to ignore obvious signs of antidepressant adverse reactions.

Once dead and with her lifeless body barely put to rest, those same health care professionals thought it their duty to target Heather's surviving sister, Heidi. They offered her antidepressants, this was refused. They then, with their infinite knowledge of  "we know better than you", recommended that Heidi be moved into an apartment because, they told her mom, “you’re stopping her having antidepressants and getting well.”

The guest post is difficult to read, it will make you sad and, hopefully, make you angry enough to share it far and wide. If you have health care professionals in your family or if you have them as friends then you have a moral and ethical duty to tell them (not ask them) to sit down and actually let this sink in.

Paula has shown courage for speaking out, a courage that comes in the face of adversity. It's time for us all to show courage. It's time for us to say enough is enough.

Losing Heather is featured on the brilliant AntiDepAware website here.

Bob Fiddaman

Monday, June 19, 2017

UK Figures See Rise in Antidepressant Use in Under 18's

Data obtained from The Guardian newspaper has revealed that over 166,000 consumers under the age of 18 were given antidepressant medication between April 2015 and June 2016, including 537 aged six or under.

These figures really shouldn't shock and are, more than likely, underestimated. Quite why the Guardian is only revealing statistics for those 18 and under is a mystery. The current recommendations is for antidepressants not to be used in treating anyone 24 and under - so we have a absence of data here.

To offer balance, albeit in the form of professionals with links to the pharmaceutical industry, the Guardian quoted David Taylor, who is a spokesperson for the Royal Pharmaceutical Society. He claimed, “Antidepressants are only used in children in circumstances where there is clear support from robust clinical trials. Adolescents with anxiety, obsessive compulsive disorder and post-traumatic stress disorder may be prescribed antidepressants, and fluoxetine is used in depression.”

Robust clinical trials?

Where are those 'robust' clinical trials he refers to?

Offering balance, Dr Antonis Kousoulis, a clinician and assistant director at the Mental Health Foundation, said the figures show “we are failing to provide a choice of age-appropriate psychological treatments at the point of the need”. He continued, “GPs over prescribe antidepressants often because of the long waiting lists for specialist services,” adding. “But the evidence that these medicines are effective in children is not as comprehensive as is it for‎ drugs for other conditions.”

Surely we can't use long-waiting lists for psychological treatments as an excuse to put children and adolescents in danger?

The National Institute for Health and Care Excellence (NICE) also weighed in with, "antidepressants should be given only to teenagers and children with moderate or severe depression."

This goes against the recommendations of both the manufacturers of these drugs and the limp-wristed regulatory agency who claim to protect the public from harm from unsafe drugs.

NICE also claimed, "Fluoxetine (Prozac), which is sold under the trade name Prozac, is the only drug recommended for younger people, but other medication can be used as second-line treatment if fluoxetine does not work."

Really, other medication can be used?

I've long had a beef about the word 'recommendation'. In a blog post of mine from 2014, "Not Recommended", I highlighted how this term is, in essence, nothing more than a legal requirement. It protects the pharmaceutical industry and the regulator because they can always claim, after an antidepressant-induced death that, they have both warned about antidepressant use in this age group. It covers them legally and the only ones left to blame are the prescribing doctors who, in their defence, will claim there's a long waiting list for psychological treatments so "I had to prescribe something."

What they are prescribing are a series of mind-altering drugs known to cause suicidal feelings and, in many instances, suicidal completion. With comments and advice from the likes of NICE, the Mental Health Foundation, and the Royal Pharmaceutical Society doctors in the UK must be as confused as I.

It's crystal clear, to me at least, that the warning needs to change. "Not recommended" needs to be dropped and replaced with “must not be used” in children and adolescents.

Of course, it would be too much to ask the British drug regulator (MHRA) to come out and oppose the prescribing of these drugs to kids. Recent communications between the MHRA and myself shows MHRA wants citizens to pay them for information regarding suicides in SSRI clinical trials - see MHRA Seek Payment For Info on Deadly Drugs.

If a regulator is reluctant to release the full information about these drugs then what hope do doctors have when deciding whether or not they are safe? Oh, I know, the "not recommended" cop out!

What is startling about these recent figures is that 537 consumers, aged six or younger, were prescribed these mind altering drugs. But don't expect any response other than, "We have warned practitioners that these groups of meds are not recommended for this age group."

The Guardian article can be read here.

Bob Fiddaman

Wednesday, June 07, 2017

Trump Nominates King & Spalding Attorney

Who is Christopher A. Wray?

Well, he's a litigation partner in King & Spalding's Washington DC and Atlanta office.

And who, I hear you ask, are King & Spalding?

Well, they're the law firm who just got spanked in Chicago. They defended GlaxoSmithKline, arguing that their antidepressant, Paxil, did not cause the suicide of Stewart Dolin.

The jury saw through the weak defence and found Glaxo liable.

Prior to joining the firm, Wray served from 2003 to 2005 as the Assistant Attorney General in charge of the U.S. Department of Justice’s (DOJ) Criminal Division, the same department who, in 2012, slammed down a $3 billion fine after GlaxoSmithKline pleaded guilty to a whole host of federal crimes.

So, what duties does one who becomes director at the FBI have to carry out?

Well, he's basically responsible for its day-to-day operations.

The FBI has jurisdiction over violations of more than 200 categories of federal crimes.

So nice to know that one of King & Spalding's biggest and wealthiest clients, GlaxoSmithKline, may now have someone to oversee any future criminal behaviour of theirs.

This shit just writes itself.

Nice move, Don.

Bob Fiddaman

Monday, June 05, 2017

MHRA Seek Payment For Info on Deadly Drugs

Well, true to their word it took the MHRA 20 working days to answer my Freedom of Information request.

As you will see from my response I'm going to need the help of you, the public, on this issue.

My response:

I received your claim that releasing the information requested would be too costly for your office. Given that human lives are at stake (a value far greater than your work hours), I request the following:

1) Please estimate the amount of money you require in exchange for obtaining this information.

2) Please separately estimate the number of hours of work you might have to complete to "research" and answer each of my Freedom of Information questions.

I will set the wheels in motion for public crowd-funding so the answers to these questions can be in the public domain. The same public that have a right to fully informed consent can then decide whether or not they think antidepressants are safe and effective based on the information you seem reluctant to release.

I look forward to working with the public to raise your requested funds.

Bob Fiddaman

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