Generic Paxil Suicide Lawsuit


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

Sunday, September 16, 2018

No Action to be Taken Against GSK for Hiding Suicide Data





Earlier this month I posted previously unseen documents that clearly showed how GlaxoSmithKline (GSK) hid 9 suicide attempts from the results of a 1993 clinical trial posted on their website. See - GSK Study ID - 29060/356 - The Missing Suicide Attempts

The documents were sent to me by 'Kathy', who is the moderator of the Facebook page,  Australian Antidepressants Class Action & Awareness and an administrator for the Australians For Safe Medicines Facebook page.

After publishing my findings, Kathy wrote to the Therapeutic Goods Administration (TGA) and asked if they would be taking action against GSK for failing to report the 9 suicide attempts in the Aropax clinical trials, known as GSK Study #356.

The TGA's response is staggering, to say the least.

Dear Kathy

Thank you for emailing the Therapeutic Goods Administration (TGA). I acknowledge your concerns about the GSK clinical trial (A double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability) that was conducted in 1993-1994.  However, the TGA is unable to comment about the clinical trial as it was completed twenty four years ago.

As has been explained to you previously, the TGA’s safety monitoring is based on rigorous pre-market assessment and then the post-market signal investigation area of the TGA monitors the safety of medicines, to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials.

Thank you for your interest in medicine safety.

Regards

Bernadette Barton
Assistant Director
Adverse Event and Medicine Defect
Pharmacovigilance and Special Access Branch

--

On the 'About TGA' section of their website, they state: "TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products.

Just to be clear, the results of GSK Study #356 failed to mention 9 suicide attempts, moreover, they failed to say which group these 9 suicide attempts pertained to. Study #356 had two active drugs, namely paroxetine and fluoxetine, both of which are selective serotonin reuptake inhibitors (SSRIs). There was no placebo group in the study.

As a regulator who claims to "manage any risks associated with individual products" I am utterly gobsmacked by their response above.

Surely a regulator should be asking GSK why they failed to include these 9 suicide attempts. Surely they should be telling GSK to publish the correct statistics and not a watered down version of what actually occurred during the study.

In essence, the TGA is saying, we don't care if the public doesn't know how many suicide attempts occurred in either the paroxetine or fluoxetine group. We don't care that GSK failed to report that the percentage of suicide attempts was a staggering 11.11%. We don't wish to manage these risks, even though we claim on our website that we do. We don't care the public isn't armed with this information when visiting their doctor or psychiatrist. We don't think 9 suicide attempts in a clinical trial is important.

I find the last line of the email kind of ironic: "Thank you for your interest in medicine safety."

Are they taking the piss?

Bob Fiddaman





Tuesday, September 04, 2018

GSK Study ID - 29060/356 - The Missing Suicide Attempts




Fluoxetine - AKA Prozac
Paroxetine - AKA Aropax, Seroxat, Paxil

Study ID - 29060/356
A double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability.


Snapshot was taken 3rd September 2018

Study ID - 29060/356/_1
Extension phase for a double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability.

Both studies appear on the GSK Study Register website, the second study is a continuation (extension) of the first.

As you can see, both studies were double-blind, which means neither the patient or investigator knew what drug they were taking/prescribing. After the trials have been completed, GSK can break the code and find out on which drug the adverse events occurred. In this case, one suicide in the paroxetine group and one in the fluoxetine group; no suicide attempts in the paroxetine group, and; two in the fluoxetine group, one of which was a completed suicide. In both groups, there was one suicide each, both were women.

According to recently obtained documents from the Therapeutic Goods Administration (TGA), the #356 trial reported 7 suicide attempts* (2 of which were completed suicides). However, there is no mention of the 5 attempted suicides on the GSK Study Register website, at least not for paroxetine. They do, however, cite two suicide attempts for patients taking fluoxetine during the trial, one of which was a completed suicide.

*Further, more documents show that there were in fact 9 suicide attempts in Study #356, however, there is no mention of this on the GSK Study Register website.

Masking the suicide attempts
GSK report that there were 6 subjects with non-fatal serious adverse events (SAEs) in the paroxetine group and 10 in the fluoxetine group. A total of five (2 paroxetine, 3 fluoxetine) are in the Drug Abuse (Overdose) category.

Drug overdoses
Could these be deemed as attempted suicides or were the overdoses unintentional? If, indeed, they were attempts at ending one's own life, then why is it not reported as such? Well, according to recently obtained documents, no suicide attempts were made by overdose.

Therapeutic Goods Administration (TGA)
Who are the TGA?

The TGA  is Australia's regulatory authority for therapeutic goods. They carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. They are the American equivalent of the FDA and British equivalent of the MHRA.

The Previously Unseen Documents for Study ID - 29060/356
These were obtained under the Freedom of Information Act and forwarded to me by 'Kathy' who runs the Australian Antidepressants Class Action & Awareness Facebook page. Kathy copied me in on a lot of the correspondence between herself and the TGA. The process of obtaining the following documents took a considerable amount of time; I'd estimate the best part of a year. Kathy's tenacity and doggedness paid off.

After initially requesting payment for the documents, the TGA apparently had a change of heart and released many documents pertaining to Study #356, most of which make for very interesting reading. Before I publish them, it's important you understand the reasons why there are many redactions (black-outs) in the documents. According to the Australian Freedom of Information Act 1982, there are a number of exemptions where certain information may be redacted. They include: protecting patient privacy; irrelevant material; documents disclosing trade secrets or commercially valuable information and; documents subject to legal professional privilege.

Human Research Ethics Committees (Australia)
It may be unethical for a researcher to continue a trial if:

(a) there are or have been substantial deviations from the trial
protocol;
(b) side effects of unexpected type, severity, or frequency are
encountered

National Statement on Ethical Conduct in Research Involving Humans

You'll hear more about the Human Research Ethics Committees (HREC) in the documents below.

First off, the two suicides...

32-year-old female 
Causality: "Possible"
Outcome: Death, maybe drug



46-year-old female
Causality: "Possible"
Outcome: Death, maybe drug




Attempted Suicides

According to the study posted on the GSK website, there were only two suicide attempts, both of which occurred in the fluoxetine group. One of these was fatal. However, the documents obtained from the TGA say something quite different. There is a contradiction as to exactly how many suicides attempts occurred. Firstly, according to a Paroxetine Clinical Study Meeting, Dr Sykes claimed there were 9 reported suicide attempts, two of which were completed suicides.

The study meeting, according to the document, was held on Friday the 26th of November, 1993



However, 4 months prior to Dr Sykes' claims, GSK, then SmithKline Beecham, sent a letter to all investigators involved in the trial. They stated, "...we have now received reports of 7 suicide attempts (including two deaths) for the 356 study comparing paroxetine to fluoxetine."

The letter, below, goes on to state how confident they are that, "the number of suicide attempts in this study is within that expected as a consequence of the depressive illness per se."

In other words, it wasn't the drug, it was the illness.



In between these two letters, we have a document from a Professor (dated September 1993). The letter was sent to the Research Ethics Committee.

GSK had made contact and told him about the suicides and suicide attempts. Here it gets interesting because it gives us the number of those enrolled (63). The Professor states, "...there have been seven suicide attempts including two deaths in the first 63 patients included in this Australian multicentre study." (11.11%)

The letter,, signed off by an Associate Professor at the School of Psychiatry, goes on to say how he had researched data and had found no evidence that either paroxetine or fluoxetine increase suicide rate or ideation in depressed patients. Remember, this was 1993 - no lawsuits had yet revealed the extent of those who had died or attempted suicide on paroxetine, or indeed Prozac.


In November 1993, the Research Ethics Committee ceased enrollments for the study because of the "reported cases of suicidal gestures'.  A review of the attempted suicides was needed before #356 could proceed.





#356 was halted and, it seems, an independent review of the study took place one year later. The independent review clarifies that there were actually nine suicide attempts, two of which were successful. In all, according to the review, there were 100 patients enrolled. The review, however, found no reason why the study shouldn't continue. (Attempted suicides = 9%)

Of the 91 patients who did not attempt suicide, the review states, "26 either withdrew or were withdrawn prematurely from the trial."  No reason is given for this.

According to the review, no suicide attempts were made by means of a drug overdose.

Here is the 25-page Independent Report.

Comment

Where are these missing suicide attempts? Why are they not reported on the GSK Study Register website?

There were 7 suicide attempts when 63 patients were enrolled (11.11%) . Surely this figure should have raised a red flag?

There were 9 suicide attempts when 100 patients were enrolled (9%) . Even this figure is astronomically high.

Investigators and review panels didn't really have much to go on back in 1993/94, apart from, of course, GSK's own information and published literature that was mainly ghostwritten by PR companies hired by GSK.

From the early onset of this study, GSK made it abundantly clear to investigators (prescribers) that there was no supporting evidence that suggested paroxetine could induce suicidal ideation. The study was double-blind so the patients and investigators didn't know what drug was being used.

Today, on the GSK Study Register website we see that since the study completion, GSK broke the code (so they could see what patient took what drug). They admit to having one suicide in the paroxetine group and one in the fluoxetine group. What they don't do, and they've had 25 years to rectify, is show us what drug caused the suicide attempts. According to the findings, we see no attempts in the paroxetine group and 2 (one completion) in the fluoxetine group. This would suggest that they also broke the code for the suicide attempts but only showed 2 (both in the fluoxetine group) when the documents obtained from the TGA show that there were 7 attempts when 63 patients were enrolled and 9 attempts when the enrollment reached 100.

The 356 Study that sits on the GSK website today doesn't really raise any red flags in its current format. With documents I've published today should we have a need to be concerned?

It is unknown in what group the non-fatal suicide attempts occurred. For all we know they could have all occurred in the fluoxetine group. I'm unsure why GSK have omitted such important data but I can speculate.

It leaves me wondering that if such a trial was carried out today, would the review board still claim there is no link between either paroxetine or fluoxetine and suicidal ideation?

Since the year of this #356 study (1993) GSK has paid $390 million for suicides or attempted suicides said to be linked to paroxetine. This has included an average of $300,000 to resolve 300 attempted suicide cases and an average of $2 million for 150 suicide cases. (Source)

The most recent paroxetine suicide case involves former corporate lawyer Stewart Dolin, whose life ended when he jumped in front of a Chicago Transit Authority train on July 15, 2010, while taking a generic version of Paxil. On April 20, 2017, an Illinois federal jury found GSK liable for Stewart Dolin’s death and ordered the pharmaceutical company to pay $3 million to Wendy Dolin. However, on August 22, 2018, the Seventh Circuit Court of Appeals overturned the verdict claiming, "GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case. Therefore, they said, the lawsuit should have been dismissed." Further, they added, "Court judges erred when they allowed to go to trial a lawsuit brought by Stewart Dolin's widow (Wendy Dolin)"

By 2000, Eli Lilly had reportedly paid more than $50 million to settle more than 30 Prozac (fluoxetine) lawsuits related to murders or suicides. There were also undisclosed settlements. While Prozac suicide lawsuits spiked in the 1990s, Lilly faced less litigation after the drug lost patent in 2001 and generics flooded the market. An FDA-required black box warning for suicide ended all “failure to warn” lawsuits. (Source)


Bob Fiddaman

Special thanks to 'Kathy' of the Australian Antidepressants Class Action & Awareness Facebook Group

Kathy is also an administrator for the Australians For Safe Medicines Facebook page.

She is now in the process of requesting suicide information from Venlafaxine trials in Australia.




Thursday, August 23, 2018

Judge Hamilton & Co Toss $3M Dolin Verdict


Yesterday's decision from the Seventh Circuit declared "the drugmaker (GSK) can’t be sued under Illinois law for insufficiently warning of suicide risk on a drug’s label, when that label’s language was set by federal regulators."

Read on...

pre·con·ceived
adjective
(of an idea or opinion) formed before having the evidence for its truth or usefulness.




Mayor Larry Vaughn (left)

Jaws Synopsis

During a beach party at dusk on Amity Island, New England, a young woman, Chrissie Watkins, goes skinny dipping in the ocean. While treading water, she is violently pulled under. The next day, her partial remains are found on shore. The medical examiner's ruling that the death was due to a shark attack leads police chief Martin Brody to close the beaches. Mayor Larry Vaughn overrules him, fearing that the town's summer economy will be harmed. The medical examiner now concurs with the mayor's theory that Watkins was killed in a boating accident.




Seventh Circuit Judge David Hamilton


On May 30, 2018, the Seventh Circuit Court of Appeals heard a plea from GSK with regard to reasons why they don't feel they shouldn't pay a $3million fine handed down to them last year. During the oral arguments, Seventh Circuit Judge David Hamilton (Pictured above) repeatedly voiced doubts over the issue of so-called “innovator liability,” or the theory that the original makers of a drug – the “innovator” – should be held liable for the effects caused by others’ imitation product. Hamilton stated that it could significantly harm the pharmaceutical industry, and consumers and patients who rely on the medications invented and manufactured by the industry.

Ironically, the actor who played Mayor Larry Vaughn in the movie Jaws, Murray Hamilton, shares the same surname as Seventh Circuit Judge David Hamilton. To my knowledge, they are not related.

I've been a fan of Jaws, particularly the screenplay, for many years. It bears so many striking similarities to the pharmaceutical industry (the shark) and the advocates that try to highlight wrong-doings, Quint, Brody, and Hooper. 

Yesterday's decision from the Seventh Circuit declared "the drugmaker can’t be sued under Illinois law for insufficiently warning of suicide risk on a drug’s label, when that label’s language was set by federal regulators."

Seventh Circuit Judge David Hamilton. Circuit Chief Judge Diane P. Wood and Circuit Judge Diane Sykessaid, said, "GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case. Therefore, they said, the lawsuit should have been dismissed." Further, they added, "Court judges erred when they allowed to go to trial a lawsuit brought by Stewart Dolin's widow (Wendy Dolin)"



Former Glaxo CEO, JP Garnier

"There is a legal right for us to go directly to the public"

Nowhere in the Seventh Circuit's panel conclusion does it state that paroxetine wasn't responsible for Stewart Dolin's induced suicide, in fact, it suggests that it did, but claims GSK did enough to warn Stewart, even though the FDA didn't heed that warning. The ruling failed to mention the deposition, shown at the 2017 Dolin trial, by former Glaxo CEO, JP Garnier, in which, when asked, "You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?", he answered, "Yes...it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."

In response to the ruling, Michael Baum, senior partner at Baum, Hedlund, Aristei & Goldman, stated “We are surprised and disappointed with the court’s ruling and respectfully disagree. We will be exploring Ms Dolin’s options.”

"You go in the cage, cage goes in the water, you go in the water. Shark's in the water, our shark."

The FDA has remained silent throughout. They are, it appears, answerable to nobody. With an admission by GSK's former CEO that there is a legal right for GSK to go to the public, ergo, they can bypass the FDA, the question still remains, why didn't they?

GSK, and other pharmaceutical companies are, as we know, in bed with each other. It's a sick, incestuous relationship that puts everyone who ingests a pharmaceutical product or who uses a medical device, at harm - the same harm that Seventh Circuit Judge David Hamilton used in his defence of the pharmaceutical industry. It would appear that they can be protected from harm but the same rules do not apply to consumers, we simply go in the cage, cage goes in the water, we then go in the water. Remember that next time you pick up your next prescription, folks!

The pharmaceutical and regulatory pools are infested with sharks!

Afterword:

A Japanese submarine slammed two torpedoes into our side, Chief. We was comin' back from the island of Tinian to Leyte, just delivered the bomb. The Hiroshima bomb. Eleven hundred men went into the water. Vessel went down in twelve minutes. Didn't see the first shark for about a half an hour. Tiger. Thirteen-footer. You know how you know that when you're in the water, Chief? You tell by lookin' from the dorsal to the tail. What we didn't know... was our bomb mission had been so secret, no distress signal had been sent. Heh.

They didn't even list us overdue for a week. Very first light, Chief, sharks come cruisin'. So we formed ourselves into tight groups. Y'know, it's... kinda like ol' squares in a battle like, uh, you see in a calendar, like the Battle of Waterloo, and the idea was, shark comes to the nearest man and that man, he'd start poundin' and hollerin' and screamin', and sometimes the shark'd go away... sometimes he wouldn't go away. Sometimes that shark, he looks right into ya. Right into your eyes. Y'know the thing about a shark, he's got... lifeless eyes, black eyes, like a doll's eyes. When he comes at ya, doesn't seem to be livin'... until he bites ya. And those black eyes roll over white, and then... oh, then you hear that terrible high-pitch screamin', the ocean turns red, and spite of all the poundin' and the hollerin', they all come in and they... rip you to pieces.

Y'know, by the end of that first dawn... lost a hundred men. I dunno how many sharks. Maybe a thousand. I dunno how many men, they averaged six an hour. On Thursday mornin', Chief, I bumped into a friend of mine, Herbie Robinson from Cleveland- baseball player, boatswain's mate. I thought he was asleep, reached over to wake him up... bobbed up and down in the water just like a kinda top. Upended. Well... he'd been bitten in half below the waist. Noon the fifth day, Mr. Hooper, a Lockheed Ventura saw us, he swung in low and he saw us. The young pilot, a lot younger than Mr. Hooper. Anyway, he saw us and come in low and three hours later, a big fat PBY comes down and start to pick us up. Y'know, that was the time I was most frightened, waitin' for my turn. I'll never put on a life jacket again. So, eleven hundred men went into the water, three hundred sixteen men come out, and the sharks took the rest, June the 29th, 1945.

Bartholomew Marion Quint ~ Amity Island, MA

--

Bob Fiddaman


Backstories in chronological order:







Friday, August 17, 2018

Psychiatry: A Faith-Based System?





Prof Wendy Burn, president of the Royal College of Psychiatrists (Image: publicity picture)

Wendy Burn, President of the Royal College of Psychiatrists has recently engaged with fellow sufferers of antidepressants via Twitter. Burn, 58, had blocked a number of followers but in a recent u-turn has now unblocked many of those who criticized her stance on antidepressant withdrawal.

Burn fuelled the fire earlier this year when she, along with RCP colleague, David Baldwin, wrote a letter to the Times newspaper claiming, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment." (back story)

Burn's presence and engagement on Twitter is refreshing, and sometimes very frustrating. For the advocates who criticise psychiatry and the wanton use of antidepressants, it's been eye-opening and, at times, jaw-dropping. None more so than the following snapshot of tweets she and I had.

Here's the order in which they were asked and answered.



Surprisingly, Burn didn't respond to my last two tweets. I'm not chastising her for failing to respond, as I know she is also answering many other queries from disgruntled service-users.

It would appear Burn bases her diagnosing and prescribing system based on faith rather than actual science. Here's why:

First off, by Burn's own admission, she works, in the main, with elderly patients, 65 and older.

Burn asserts that elderly people metabolise more slowly so drugs stay in their system longer, which, assumes Burn, minimises withdrawal.

Drug metabolism is the process by which the body breaks down and converts medication into active chemical substances. The primary site of drug metabolism is the liver, the organ that plays a major role in metabolism, digestion, detoxification, and elimination of substances from the body.

Research has found that people fall into one of four general metabolizer types. (1)

The Four Metabolizer Types

- Poor metabolizer: Patients who are poor metabolizers experience a very slow breakdown of medications, making side effects more pronounced. That means standard doses of certain medications may not work as intended.

- Intermediate metabolizer: A slowed metabolism may impact breakdown of medications, causing effects similar to poor metabolizers, but not as pronounced.

- Extensive metabolizer: Considered a “normal” rate of metabolism. Patients are likely to metabolize medication normally and medication is likely to work as intended.

- Ultrarapid metabolizer: Patients in this group metabolize medications too quickly to experience relief from symptoms of depression or other disorders.

Are elderly people more prone to a poor metabolizing system?

According to statistics (2), 40% of the elderly regularly take five or more concomitant prescription medications, add to this the fact that many medications have more than one metabolic pathway, and you can see how prescribing, or adding medication into the mix, can be extremely dangerous for anyone 65 and older.. Furthermore, if, as Burn assumes, 'most (elderly) are slow metabolizers', then without any test in place prior to prescribing she, along with other treating physicians are basically taking it on faith that the person in front of them is a poor, intermediate, extensive or ultrarapid metabolizer.

I asked Burn if she carried out any Pharmacogenomic testing prior to prescribing to her elderly patients. She never responded.

If you, like me, struggle to grasp how the metabolizing system works then a layperson's explanation may help.

Let's say I am a poor metabolizer and my best friend is an extensive metabolizer. Both of us are depressed and both have been prescribed an antidepressant of the SSRI family.

After taking the drug at exactly the same time, my friend excretes it far quicker from his body so when it's time for our next dose I am at a slight disadvantage because my second dose will be topping up my first dose, whereas my friend will have most of his original dose excreted from his system or a higher percentage of it than I.

Now, let's say we are both on these drugs for 6 weeks. The build-up of the drug in my body will be far greater than that of my friend. He may be able to withdraw without any problems, whereas I may find it extremely difficult to withdraw. I may also have toxicity in my system.

If Burn assumes that the elderly are slow metabolizers then when prescribing to them she is doing so by using a belief rather than any scientific testing such as pharmacogenomic testing. If, by her own admittance, she knows they are slow metabolizers then they will more than likely endure what I did in the example above.

One should also take into account a person's genetic factors when prescribing. Genetic factors account for 20 to 95% of patient variability in response to individual drugs. (3) - It seems perfectly logical then that a prescriber would choose to ensure the safety of their patient when prescribing a drug. By claiming that they 'monitor' patients is clearly not good enough, particularly when they have a tool at their disposal that can predict if their patient will struggle on the drug they prescribe, moreover, if the drug will stay in their system longer making the withdrawal process more difficult.

Quite why this isn't mandatory will, more than likely, be blamed on the expense and how 'time-consuming' the whole process can take. I really don't buy into the 'monitoring' angle, I mean, how can a prescriber monitor a patient 24/7?

Burn is on a hiding-to-nothing when she is posed questions by many drug safety advocates on Twitter. I give her kudos for attempting to tackle the hundreds of tweets she receives daily now that she has unblocked many of those who previously opposed her views.

Science can only be the winner here and not assumptions. One prescriber may have different approaches than another - one may be more thorough when deciding to prescribe. Assuming a patient may or may not be a slow metabolizer is tricky ground though. If we can't predict (without pharmacogenomic testing) then should psychiatrists and doctors really be prescribing toxic drugs to patients at all? It's Russian Roulette, but we are told, and always have been, that the benefits outweigh the risks.

Serotonin toxicity, often incorrectly called a "syndrome", is best managed by reducing and/or discontinuing the offending drug(s). If left untreated it can lead to akathisia, an emotional state that can sometimes include the emergence of strange and unusual impulses, often of an aggressive nature. It can also lead to violence and suicide. (4)

Burn, in defence of her statement to criticisms of her Times letter, has claimed that in her clinical experience she has never seen a patient suffering from severe withdrawal from antidepressants. We have to take this at face-value as there is no way of knowing if, a; Burn knows the difference between antidepressant withdrawal and "depressive symptoms" and, b; whether or not she is being truthful.

Many elderly patients trust prescribing physicians, my own mother did when she was alive. Many don't like to 'rock the boat'. We often hear the elderly make claims such as, "The good old doctor went through years of med school, so they know exactly what they are doing", and, "they wouldn't give me a drug that could harm me."

Reminds me of the statement King & Spalding's lead attorney made in his closing statements to the jury in the Dolin v GSK Paxil-induced suicide trial:

“Don’t you think if these medicines caused suicide someone would have spoken up?” ~ Andy Bayman - King & Spalding.

The jury did.

I long for the day when Wendy Burn and her peers acknowledge that the drugs they prescribe to children, adults and the elderly may be the cause of depressive symptoms and feelings of hostility. Judging by her current stance, however, I think we may be in for a long wait.

Bob Fiddaman


(1) Fast, Slow or In-Between: How Your Genes Affect Medication Success
(2) Pharmacogenomic Treatment Support, Today’s Geriatric Medicine, Vol. 7 No. 4 P. 20
(3) Hypothesis: comparisons of inter- and intra-individual variations can substitute for twin studies in drug research.Pharmacogenetics. 1998 Aug;8(4):283-9.
(4) What is akathisia?

The Unscrupulous Activities of Monsanto (Video)




A fascinating insight into the unscrupulous activities of Monsanto is doing the rounds on YouTube.

The show, The HighWire, hosted by Del Bigtree, invited Baum Hedlund's Lead and co-counsel, Brent Wisner and Robert F. Kennedy Jr into the studio to discuss the recent $289 million verdict against Monsanto.

The success for the plaintiff, Dewayne Johnson, will be short-lived as the former groundskeeper has terminal cancer and is, sadly, expected to die soon. The victory could set a massive precedent for thousands of other cases against Monsanto. I hope they name a law after Johnson, his courage to step up to the plate and take on the unethical and immoral Goliath needs to be remembered...forever.

Monsanto, as expected, has appealed the verdict.

The interview starts at 38.40 and features, amongst other revelations, jaw-dropping internal emails from Monsanto employees who wanted to keep the cancer link 'in-house' rather than tell an unsuspecting public.


Bob Fiddaman


If you have been diagnosed with non-Hodgkin lymphoma after being exposed to Roundup weed killer and would like more information about whether you might have a potential Roundup lawsuit, please contact a personal injury attorney at Baum, Hedlund, Aristei & Goldman



Tuesday, August 14, 2018

Guest Post: Irresponsible Reporting Harms Parents & Children



Kristina Kaiser Gehrki

Irresponsible Reporting Harms Parents & Children 
By Kristina Kaiser Gehrki

In 1987 I was an optimistic college student earning my first degree in journalism from a top 10 university program that was then, and remains today, highly ranked by the Associated Press.

I vividly remember class discussions about the Washington Post—a newspaper that had diligent reporters such as Bob Woodward and Carl Bernstein who exposed wide-scale corruption to include President Nixon’s Watergate scandal. Back then, venerable Washington Post reporting was often seen as a public service for the greater good. It was good journalism about which Academy Award-winning movies like “All the President’s Men” were made. 

Flash forward to the present decade and it appears journalism ethics and responsible reporting has gone the way of the dinosaurs. Yesterday’s article in the Washington Post titled, “Your Child is Nervous About the New School Year, Which May be Normal—or Not,” is just one of a long string of examples.

In an effort to sell and publish articles, journalists often write stories called “evergreens.” Such articles have a long shelf life and keep their leaves when autumn arrives. I suspect the “Your Child is Nervous” article by Jill U. Adams was likely written as an evergreen, and the back-to-school marketing headline was later crafted to catch the attention of concerned parents who want to ensure their kids are happy and healthy.

As a parent, trained journalist and former teacher, Adams’ article caught my attention because of what she claims and what she chooses to omit.


Jill Adams -  freelance science journalist

Former Pharma Employee-Cum-Reporter Promotes Risky Drugs for Kids

Adams states kids with anxiety can benefit from cognitive therapy—and certain drugs. She specifically asserts: “Medications can help, too, particularly the class of antidepressant drugs known as selective serotonin reuptake inhibitors, or SSRIs.” 

Really? Given that Adams is also a trained pharmacologist, one presumes she is aware of research that finds SSRIs are neither safe nor effective for children. Adams neglects to mention such nor does she inform her Washington Post readers that she studied psychoactive drugs for Johnson & Johnson. 

I can’t help but wonder, was Adams working for Johnson & Johnson when the company criminally marketed Risperdal for unapproved use by children? More than 30 children died and more than 1,000 reported serious complications. The US Dept. of Justice effectively forced Johnson & Johnson to pay more than $2.2 billion to resolve these criminal and civil charges. 

Parents Denied US FDA Black Box Warning Info


US FDA Black Box Warning

While promoting SSRIs to reduce childhood anxiety, Adams also fails to mention that SSRIs carry the US FDA’s most serious Black Box warning. (Above image). She doesn’t note SSRIs cause akathisia which often causes psychosis and unwanted deaths. Reporters are not legally required to communicate FDA Black Box warnings with the readers who trust them. Doctors are not legally required to share FDA Black Box warnings with the parents who trust them. But that doesn’t mean it is ethical for either to withhold such life-saving information.

Failure to Share Conflicts of Interest

Adams also neglected to inform readers that her quoted source, psychiatrist John Walkup, has several potential conflicts of interest to include taking free drugs and money from many pharmaceutical companies.

Adams’ Health and Science section article is simply the latest of many accountability and ethics problems found in mainstream newspapers. Years ago after my teenaged daughter died a prescription-drug-induced death, I contacted the Washington Post about similar omissions and reporting errors. My valid concerns backed up by published data were met with a virtual pat on the head and false promises to contact me should they ever again cover this topic.

A Constant Pattern of Zero Accountability

Systemic errors of omission don’t just occur in newspaper articles; they also rear their ugly heads in the Letters to the Editor and Op-Ed pages.

The Washington Post Letters to the Editor section requires writers to “disclose any personal or financial interest in the subject matter of their letters.” However, in 2014, the newspaper published a letter that appeared to be written by your average Joe, a man named David from Vermont. David’s letter was in response to a Washington Post article about SSRIs, depression and children. His letter expressed concern for children who are depressed and supported the use of pharmaceutical products as effective treatment.

I noticed the letter writer’s last name was “Fassler” and realized this seemingly average Joe from Vermont was Dr. David Fassler, a child psychiatrist and frequent testifier to the FDA in support of the pharmaceutical industry. Fassler describes himself on his LinkedIn page as a specialist in “child and adolescent psychiatry” and “forensic psychiatry” and notes he’s worked with the Executive Director of NAMI-Vermont. NAMI, is the National Alliance for the Mentally Ill and has been the subject of Congressional investigations into its deep financial ties to the pharmaceutical industry. 

Fassler testified at the 2004 FDA SSRI hearings in support of prescribing SSRIs to children. Specifically, “David Fassler of the American Psychiatric Association cautioned that the FDA should not scare patients away from treatment.” Ironically, this was a quote from the Washington Post.

The FDA also heard testimony from many family members who carried photos of their dead loved ones while recounting the torturous SSRI Adverse Drug Reactions they suffered before dying. After the hearings, the FDA responded, albeit far too late, by placing the Black Box suicide warnings on SSRIs.



Fassler’s more recent FDA testimony supported prescribing atypical antipsychotics to children.

Who “Works” for Whom?

But back to 2014. I contacted Fassler to inquire why his Washington Post letter to the editor didn’t disclose his medical credentials nor any personal and financial interests in the subject matter. Our correspondence is below:

On 7/11/14 12:32 PM, Kristina G. wrote:
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Hi David,

I read with interest your letter to the Washington Post. I was wondering why you didn't share your expertise as a child psychiatrist, experience testifying, and work with pharmaceutical companies? If you write the Post again, perhaps you should include your background so readers can better respect and understand your viewpoints. 

Regards,
Kristina Gehrki

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On 07/11/14 5:36 AM, David F. wrote:
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Hi Kristina

I did tell the Post I was a child psychiatrist, but they chose not to include any identification. 

I don't do any work w/ pharmaceutical companies.

David

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It’s important to note Fassler stated: “I don’t do any work w/pharmaceutical companies.” Perhaps he also has no personal or financial interests in the subject matter he wrote about? What is not debatable is that Fassler is an active member of The American Academy of Child and Adolescent Psychiatry (AACAP) and ran for their national position as AACAP Treasurer in their 2013 election. It must be an important position considering AACAP states that in 2012 their “60th Annual Meeting Sponsorships” included “Pharmaceutical sponsorships” that “totalled $175,000.”

I can’t help but wonder if Fassler sat next to Dr. John Walkup at this annual conference when Walkup was a featured speaker at AACAP’s 2013 Psychopharmacology Update Institute. I also wonder if Fassler read AACAP’s 2013 Report to the Council that stated:

“August 14, 2012 Informed on August 4 that Wayne Batzer, M.D. resigned as a member of AACAP stating, “The Academy is clearly reliant on continued pharmaceutical industry funding and I am no longer able to accept this.” 

Looking back on it, I’ve come to accept Fassler’s statement “I don’t do any work w/pharmaceutical companies” at face value. To me, its relevancy depends upon how one first personally defines the word “work.”

Experience is the Best Teacher

Today I’m no longer an optimistic college student. While I’ve earned more advanced degrees and certificates, the most important knowledge I’ve gained since my daughter, Natalie's, prescribed demise comes from experience and research. Independent research and unbiased “journalism” uncovers unimaginable fraud, collusion, corruption and ethical violations in nearly every nook and cranny—from university medical schools to medical associations, from pharmaceutical headquarters to neighbourhood pharmacies, from national papers to your hometown rag, and right on down to your local doctors.

As a former high school marketing teacher, I understand parents want their children to start the school year off right. Parents want to believe things that will provide comfort. Seeking comfort is a basic human trait. But I implore parents who might read yesterday’s Washington Post dribble or another newspaper’s misleading article tomorrow: Remember, just because something sounds comforting doesn’t mean it is true.

When Natalie was 10, I took her to a therapist because of concern about mild school anxiety. I wanted the best for my child. Unfortunately, what we anticipated would be talk therapy soon turned into drug “therapy” prior to the FDA’s SSRI Black Box warning. It’s tragic that misinformed parents who read such articles might unwittingly go down the same dangerous drug path from which there may be no return. I speak up simply because I don’t want to see other trusting parents caused permanent discomfort when later they find themselves visiting their children’s graves.

Natalie’s prescribed demise is featured here & here. Like Anne Frank, Natalie's diary documented her torture and it is hoped society can learn from these systemic atrocities.


Kristina Kaiser Gehrki is a public health and safety advocate and educator. She holds degrees in crisis and strategic communication, journalism and education but feels her most relevant knowledge stems from personal experience. Her teenage daughter, Natalie, died a prescription-drug induced death after suffering SSRI Adverse Drug Reactions and SSRI withdrawal that was undiagnosed by her doctor and improperly treated with SSRI dose increases.





Thursday, July 19, 2018

Royal College of Psychiatry: "Unprofessional Conduct"





The Royal College of Psychiatry (RCP) continues traveling down its road of willful ignorance regarding a formal complaint submitted to them by more than 30 mental health experts last February.

Digging through the timeline of events, you'll find that RCP orchestrated a media frenzy surrounding a study of drugs marketed as "antidepressants."  The analysis by Andrea Cipriani et al that was unveiled in February again over-hyped the supposed benefits of  "antidepressants." Two members of the RCP, Wendy Burn and David Baldwin, went further by claiming, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment."

If this was a throw-away comment on Twitter one could be more forgiving, however, Burn and Baldwin's comment was published in the Guardian newspaper. RCPs claim was met by health professionals and patient safety advocates who adeptly pointed out that RCPs down-playing the horrific withdrawal effects of antidepressants contradicted RCPs own previously published content, "Coming Off Antidepressants." 

RCP previously noted that a staggering 63% of respondents in its own survey reported difficulties withdrawing from SSRI drugs ("antidepressants.")

When the RCP-published study was brought to the attention of Wendy Burn via Twitter, it was swiftly removed. RCP later claimed it was "out of date" and needed "updating."

Understandably outraged at RCP's seemingly intentional public health misinformation, many mental health experts submitted a formal complaint to RCP demanding that Burn and Baldwin be asked to provide evidence that backed up their claims that, "in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment."

The formal Complaint was dismissed by RCP without a full investigation and without a right of appeal.

Undeterred, the 30 mental health experts continue to push for evidence from Burn and Baldwin, and indeed the RCP. However, RCP refuses to provide any such evidence. RCP will not retract its claim provided to the Guardian newspaper and refuses to publicly apologize for its disinformation and/or "error."

Two days ago, the 30 mental health experts wrote to The Rt. Hon. Matt Hancock MP, the newly appointed Secretary of State for Health and Social Care, to inform him that “the Royal College of Psychiatrists is currently operating outside the ethical, professional and scientific standards expected of a body representing medical professionals.”

The full letter, along with a timeline of events can be read here.

The recent arrogance shown by RCP, Burn, and Baldwin is typical of a system that protects prescribers and further harms those who have suffered at the hands of prescribers. Burn, who is the current President of the RCP, should know that any comment she makes in the media represents the views of the college, which is probably why her colleagues are not asking Burn to back up her claims.

RCP knows it takes longer than two weeks to withdraw from antidepressants, they know this from their own study carried out several years ago. When the statistics from their own study didn't tally with their president's comments, RCP pulled the study from its own website within 24 hours and then concocted a story that it was 'out-of-date.' No effort has been made to reinstate the original study with amendments.

The stance of RCP highlights the dangerous smoke-and-mirrors world of psychiatry. It's a world where arrogant 'professionals' can pretty much claim whatever they want without having to show any evidence. Burn and Baldwin had a golden opportunity to ethically inform the public that there is a growing problem of psychiatric drug withdrawal. But instead of improving public health and safety, they chose to protect their own image and economic livelihood.

Burn, Baldwin, and indeed the whole college are walking a tightrope but they have a wide safety net beneath them should they fall. The consumers of the products the college promotes and prescribes have no such safety net, many have died while others have fallen and will continue to fall as long as the likes of Burn and Baldwin continue to publicly deny reality.

Shame on Burn. Shame on Baldwin. Shame on the Royal College of Psychiatry. Their PR game is a crying shame that will cause more avoidable harms to the unsuspecting public.


Bob Fiddaman





Saturday, July 14, 2018

GSK Management in a Tizz Over Fiddaman Blog





Following on from Parts I & II (Links below)

It always amazes me how corporate entities spring into action when news of alleged violations go public. None more so than GlaxoSmithKline who, it appears, have been keeping tabs of the Indian whistleblower allegations published on my blog.

Here's an email they sent to Navneet Kumar after he raised issues about the working violations of senior officials at GSK India.

After reading the email (below) you'll see a link to a British newspaper article from the Evening Standard that also highlights Navneet's allegations.

Navneet approached me shortly after Truthman published a series of emails on his blog, GSK Licence To Kill. Shortly after publishing the emails, Truthman took a sabbatical and took down his blog.

 Here's an email GSK to Kumar shortly after I published Part II:

"I am GSK’s Vice President for Compliance for Emerging Markets.  I understand that you have recently been in touch with Bob Fiddaman, author of a weblog that has recently posted several allegations against GSK that he attributed to you.  Please note that GSK takes all allegations of misconduct seriously, including those raised in Mr. Fiddaman’s weblog.  Pursuant to GSK’s Code of Conduct and Speak Up culture and procedures, we encourage everyone to raise concerns about potential unethical or illicit conduct.  During your employment, including in connection with the disciplinary proceedings that preceded your dismissal from the company last year, GSK’s policies and culture require the company to have provided you with opportunities to raise concerns relating to GSK’s business practices, including concerns with the conduct of any employees.  If you have documents, electronic data, or other evidence that you believe would be relevant in order for the company to conduct a thorough review of the allegations made in Mr. Fiddaman’s weblog or any other concerns that you may have, GSK would appreciate you providing such evidence to us.

"If you would like to speak with someone in the company about this or any other concerns that you believe have not been addressed, we would be happy to make a member of the company’s Corporate Investigations or Compliance Team available to speak to you."


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COMING SOON

Kumar met with a GSK official after the above email was sent to him. I'll be publishing the outcome of that meeting soon.

Bob Fiddaman

Back Stories

India: GSK Whistleblower Names and Shames - Part I

India: GSK Whistleblower Names and Shames - Part II

London Evening Standard - Glaxo faces lawsuit as salesman claims he was bullied for whistleblowing



Wednesday, July 11, 2018

Sex, Lies, & Duct Tape






I see the thought police are at it again.

Not content with associating playing computer games as a mental disorder we now see more widening of the net, this time coming from the World Health Organisation (WHO).

An article from CNN runs with the headline, WHO classifies compulsive sexual behavior as mental health condition. Reading through it you'll find that the conclusion, from WHO, is based on...um, nothing. No science, no studies, just nothing.

Sexual Behaviour Disorder, WHO claim, is defined as "persistent pattern of failure to control intense, repetitive sexual impulses or urges resulting in repetitive sexual behavior." The article adds:

"The disorder may interfere with someone's ability to go to work or finish school. It can hurt relationships. And although someone with this disorder may want to resist their constant need for sex, they've been unsuccessful. They may not even get pleasure from the repeated sexual activity."

Finish school?

Are they talking about teachers here or kids?

Wait, there's more:

"A person with this disorder has had to be dealing with it over an extended period of time, according to the definition, which gives an example of six months or more."

Puberty

In boys, puberty usually begins between the ages of 10 and 16. Once it begins, it lasts about 2 to 5 years. But every child is different. And there is a wide range of what is “normal.” During puberty, you'll probably start having more sexual thoughts and urges. You may feel attracted to males, females, or both.

Dang it! Look at all those 10 to 16 year-olds with "Sexual Behaviour Disorder." Quick, take their minds off such lurid thoughts, distract them with, um, I dunno, a computer game or something. Oh no, we can't, that's a mental disorder too!

Thinking, whatever it may be about, is, it seems, tantamount to having a disease of the brain.

Average

According to shape.com, researchers learned that, on average, men think about sex 19 times a day. The average women thinks about sex 10 times a day. Gadzooks! we're all perverts!

Lack of Sex Drive

Okay, so what if none of the above applies to us, what if we aren't perverted because we have lustful thoughts and desires? Well, according to the psychiatry bible, the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), we have yet another mental disorder, this time, Hypoactive sexual desire disorder, a "brain disease" defined as "a sexual dysfunction and is characterized as a lack or absence of sexual fantasies and desire for sexual activity." This doesn't, however. just apply to males, in fact, the DSM splits it into two categories, namely: "male hypoactive sexual desire disorder" and "female sexual interest/arousal disorder."

So, we either think about sex too much or we don't think about it enough.

The Middleman/Woman

Psychiatry here have a scale, it's a scale that they have created entirely themselves, on one end are the perverts, on the other end are the frigid. In between, supposedly, is the "normal", but only by psychiatric standards.

As we grow older we think about sex less often, in fact, I haven't thought about it during the whole time I've been writing this... huge melons - Ah, I failed at the last hurdle...huge, wobbly, dangly ones - there I go again - I must fall into the first group of abnormal people!

WHO and the DSM authors will be taking their comedy show on the road soon - look out for Psychiatric seminars in your local press.

Meantime, whatever your sexual preference, beware that stopping in hotel rooms may cause rise for concern for your psychiatrist, as Alan Partridge (Steve Coogan) painfully shows here.



Bob Fiddaman

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