"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Friday, March 09, 2018
Scooby and Those Pesky Tweeters Rumble Psychiatry
I've stood back in amazement whilst watching psychgate unfold. It's been fun to watch the Royal College of Psychiatrists (RCP) crumble over the past few weeks. Back in February, they were rejoicing about the release of a "new" study proclaiming antidepressants work better than placebo and that they now have evidence to prove it. Wow!
Remarkable, 30 years after the launch of Prozac and we are being told we now have evidence that it, and other SSRIs, are actually better than placebo!
Reading between the lines of the study and the flurry of tabloid headlines and you'll see the results have been known for many years - RCP just put a different spin on it, along with the Science Media Centre, of course. Drugs marketed as "antidepressants" appear to possibly be better than placebo ONLY for sufferers of Major Depressive Disorder (MDD). And this result was limited only to a drug trial lasting 8 weeks. It's not known if "antidepressants" are better than placebo after 8 weeks and these drugs were never meant for long-term consumption despite that many psychiatrists lucratively prescribe them permanently to uninformed patients.
Anyway, I've pointed out the flaws in past blogs.
Moving on to more recent events
As I reported previously, Wendy Burn and David Baldwin, both of the RCP, landed themselves in hot water when they co-authored a letter to The Times newspaper. They claimed, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment."
One has to dissect the above comment to understand its meaning. Not only did they claim a majority of patients, they claimed a "vast majority." By saying "vast majority" they are implying it's at the high end of the spectrum. So, not just a majority, but a 'vast' one.
In actuality, both Burn and Baldwin were hideously wrong, their figures, or rather their estimation, was plucked out of thin air, in much the same way that is a diagnosis. When asked for evidence of their hideous claim, both Burn and Baldwin have failed to show any. The comment remains and no effort of a retraction has been made, nor an apology for getting it catastrophically wrong.
It was James Moore who set the ball in motion when he confronted Wendy Burn on Twitter. The correspondence (tweets) can be seen here. I shall now refer to James as Scooby as he's the brains behind the exposing of Burns and Baldwin. (Ugh, what a horrible thought, Burns, and Baldwin exposing themselves.)
I jest, and I shouldn't really, because this is a very serious subject. Proclaiming withdrawal symptoms are resolved within 2 weeks is dangerous and throws further stigma onto those experiencing withdrawal problems. In essence, Burns and Baldwin are saying anyone who experiences severe withdrawal after 2 weeks is either a liar or is merely imagining the horrific, debilitating withdrawal effects. Nice, huh?
It appears Burns and Baldwin have messed with the wrong people. They may feel they have the weight of the profession behind them but you should never mess with patient safety advocates such as Moore (ahem, Scooby).
Today a formal complaint of misleading the public on a matter of public safety has been lodged with RCP against Burn and Baldwin. The complaint, signed by Professor John Read of the University of East London, on behalf of many psychiatrists and victims of antidepressant withdrawal can be read here.
Scooby Scoop
Scooby wouldn't be Scooby without a perfect ending. So, what does Scooby do? Well, he interviews the complainer, John Reed.
Reed comes across as someone who knows his onions. His utter dismay of recent events shines through in this short interview. He also has actual evidence that Burn and Baldwin are wrong as he conducted his own study into withdrawal effects from antidepressant drugs. Listen and share. It will have you whooping and shouting screams of approval, or disapproval, depending on which side of the fence you sit, the side with evidence, or the side without.
Credit to James Moore for starting the snowball and for continuing to roll it.
Zoinks!
Bob Fiddaman
Thursday, March 01, 2018
Royal College of Psychiatrists - 63%
As many of you already know, Professor Wendy Burn, President – Royal College of Psychiatrists, and Professor David Baldwin, Chair, Psychopharmacology Committee – Royal College of
Psychiatrists have been sent a letter regarding recent remarks in an opinion piece published by The Times newspaper. The letter, sent to Burn and Baldwin, is calling for the pair to publicly retract, explain and apologise for the statement.
The opinion piece to The Times was signed off by both Burn and Baldwin and it caused quite a stir amongst users, and former users of antidepressants. Burn and Baldwin wrote, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment."
Many outraged present and former patients took to Twitter to confront Wendy Burn where she was told that her opinion did not tally with a 2014 study posted on the Royal College of Psychiatrists website. It was a study that was due to be revised in Oct 2017, however, it appears, that it never was.
The study showed that 63% of people suffered from antidepressant withdrawal. The most common side effect listed by the Royal College of Psychiatrists, was Anxiety (70%). Electric shocks, better known as 'head-zaps' was seen in 48% of those who participated in the study. Imagine that, a drug gave 70% of patients symptoms of anxiety during withdrawal!
Burn, who often prescribes antidepressants claims that she never witnesses withdrawal in the majority of her patients. Let's assume 70% of her patients suffer anxiety during withdrawal - it's probably safe to say that Burn diagnoses them with such and re-introduces the antidepressant - and round and round the patient goes. It beggars belief - if an antidepressant can induce anxiety then (ahem) treat that anxiety with an antidepressant!
When the survey was pointed out to Burn on Twitter, she claimed she never knew of it. 24 hours later the survey was taken down and now many feel it was removed because it didn't tally with the comments made by Burn and Baldwin in The Times.
Carmine Pariante, who is often a spokesperson for The Royal College of Psychiatrists, claimed on Twitter that he had been told: "The leaflet expired in 2016 and should have been revised then. @rcpsyc will produce a revised leaflet with an updated evidence-base and with input from patients and GPs."
However, a video which seems to accompany the survey was uploaded in 2015 to youtube. Remarkably, there is no mention of the 63% who suffered withdrawal effects, nor is there any mention that a quarter of those surveyed experienced withdrawal effects for 12 weeks or longer (as was stipulated in the original survey (here)
The video, which claims that "Most people don't have troublesome side effects when coming off antidepressants," once again, goes against their own study findings. More bizarrely, the video contradicts the above claim with, "Most people said that their symptoms lasted up to six weeks."
If that doesn't confuse you then I don't know what will!
To add more confusion to the pot they claim that the side effects may just be your depression returning ("You may have some physical symptoms or your depression may return.")
Moreover, the video still remains in the public domain - for whatever reason, it has not been taken down by the Royal College of Psychiatrists. One can only presume that the findings in the video haven't 'expired' and the Royal College of Psychiatrists have no plans for an updated 'evidence-base and with input from patients and GPs.'
It seems to me that the Royal College of Psychiatrists are having their cake and eating it here.
Anyway, here's the video that was published on YouTube on Jun 26, 2015. A backup copy has been made just in case the Royal College of Psychiatrists decide to move this video too.
Backup
Bob Fiddaman
Wednesday, February 28, 2018
Guest Post: I’m Depressed about Antidepressants
The following is a guest post from James Moore, creator of the popular Facebook forum, "Let's Talk Withdrawal" and host of Mad In America's successful podcast series.
James, like many, has been perplexed by recent news. James, like many, has many questions and thoughts.
Here are some of those thoughts.
I’m Depressed about Antidepressants
In the early hours of the morning of Thursday 22nd February, I did what we should never do and idly checked my phone. My heart sank as I read the headlines. The media were falling over themselves to report the results of a study published in the Lancet comparing the efficacy and tolerability of 21 antidepressant drugs. On that day, the word ‘antidepressants’ had its highest ever number of Google web searches in the UK.
The hashtag #MedsWorkedForMe started trending, followed a little while later by #MedsDidntWorkForMe as claims of stigma were hurled back and forth. It descended from a discussion of the results of a scientific paper that, at best, had very modest conclusions, to a polemic rant. Unfortunately, much of what was reported was #FakeScience.
There has been a lack of critical analysis of the headlines and of the study itself. I implore you to read the study, it is not a long piece, if nothing else, read the discussion where you will see for yourself that the authors write: "It should also be noted that some of the adverse effects of antidepressants occur over a prolonged period, meaning that positive results need to be taken with great caution, because the trials in this network meta-analysis were of short duration."
The headlines have increased stigma for all, whether you take and benefit from a drug or whether, as in my case, you have been harmed by them. Divisions have been deepened and we have encouraged so many people to accept the drugs without really considering if they are right for them.
I am not anti-psychotropic drugs, what I am against is the lack of informed consent and the perpetuation of the chemical imbalance as a justification for medicating so many. I don’t want to try and convince you, I just beg you to read the science. If there are any practicing psychiatrists, doctors, therapists or counselors out there who are still promoting this mistruth, for the good of your patients please contact the Royal College of Psychiatrists, who will themselves confirm they do not support the idea of a chemical imbalance. (Fig 1) Better still, if the Royal College could issue a position statement and publicise it as widely as the Lancet study, that would help us all.
Fig 1
The truth is, we just don't know if there is a purely biological explanation for depression and why some cope and some don’t, but we seem afraid to admit that to each other.
Admitting that the chemical imbalance is a myth does not denigrate the beneficial effects of chemical substances, alcohol temporarily lifts many moods on a Saturday night, but not because people are suffering from alcohol deficiency syndrome.
I do not and would not criticise anyone who needed some distance from traumatic or stressful experiences, and if tablets work for that, bravo. However, we are treating anxiety and depression as chronic illnesses, to be viewed as diabetes is. If broke my leg, I would want a cast while my fractured bones healed, but once healed, if I continued to rely on my cast and crutch for the rest of my life, I would be unable to function without them.
On Thursday, February 22nd, I felt depressed but it was not because my chemicals were imbalanced, it is because we so readily accepted spin as truth. For those advising that I should be taking an antidepressant to deal with this period of low mood, I am and it hasn’t helped one bit. If you feel yours is helping, I am genuinely happy for you.
James Moore
Tuesday, February 27, 2018
RCP Remove Damning Antidepressant Document From Website
"Figures Don't Lie, but Liars Figure" ~ Mark Twain
As soon as Wendy Burn and David Baldwin pass their remedial maths exam, they have some serious explaining to do.
In a recent letters to the editor publication in the British media (pic below), Burns, president of the Royal College of Psychiatry (RCP) and Baldwin, RCP psychopharmacology chair, claimed: "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment." Yet, their own survey shows at least 63% of respondents reported difficulties withdrawing from the SSRI drugs Wendy and David frequently defend.
Click on image to enlarge
I'm unsure what type of maths training one needs to become a doctor, but it appears Burns and Baldwin skipped the maths requirement as both believe 63% is not a "majority."
Their claim prompted many questions from people on Twitter who 1) know how to count and 2) have struggled to withdraw from drugs marketed as "antidepressants."
Burn went wild on Twitter with her frequent tweets claiming antidepressants work and people using them shouldn't be 'shamed'. (Fig 1) Though it makes for a well-orchestrated PR tactic to try and muster the troops by claiming unknown others are trying to attack and "shame" them for drug consumption, I've yet to see anyone publicly shaming others for following doctors' orders.
Fig 1
Burn went on to claim "most people can stop them without problems." She backed up her claim by adding a link to a 2003 paper entitled, "Relapse prevention with antidepressant drug treatment in depressive disorders: a systematic review."
Enter James Moore, creator of the popular Facebook forum, "Let's Talk Withdrawal" and host of Mad In America's successful podcast series. Moore pointed out that Burn's claim did not jive with RCP's own "Coming Off Antidepressants" leaflet featured on RCP's website. Despite being president of RCP, Burn is apparently clueless regarding her organization's public information. (Fig 2)
Enter James Moore, creator of the popular Facebook forum, "Let's Talk Withdrawal" and host of Mad In America's successful podcast series. Moore pointed out that Burn's claim did not jive with RCP's own "Coming Off Antidepressants" leaflet featured on RCP's website. Despite being president of RCP, Burn is apparently clueless regarding her organization's public information. (Fig 2)
Fig 2
After regurgitating a 2003 study in desperate attempt to back her claims, Burn later backtracked stating...
Burn then quickly vanished from the conversation.
Less than 24 hour hours later, RCP had removed its "Coming Off Antidepressants" leaflet from its own website despite RCP's claim "We hope that you find the information given in this leaflet useful"
Thanks to Moore's quick thinking, he had already downloaded RCPs damning leaflet that contradicts the claims made by RCP's president and psychopharmacology committee chair.
Less than 24 hour hours later, RCP had removed its "Coming Off Antidepressants" leaflet from its own website despite RCP's claim "We hope that you find the information given in this leaflet useful"
Thanks to Moore's quick thinking, he had already downloaded RCPs damning leaflet that contradicts the claims made by RCP's president and psychopharmacology committee chair.
Last week we frequently heard Burns and other RCP spokespersons, such as Carmine Pariante, shouting from the rooftops "Extra, extra, read all about it: 'groundbreaking' study shows antidepressants work better than placebo." Pariante further claimed that the findings 'put to bed' the controversy surrounding antidepressants. For most, the controversy has never been whether or not they figured better than placebo in clinical trials. The controversy is whether or not they can cause severe withdrawal problems, psychosis, and both suicidal thinking and completed suicide.
Back to RCP's own antidepressant withdrawal survey and today's abrupt removal of their website leaflet.
The survey, carried out by RCP in 2014 and last reviewed in 2017, showed a staggering 63% of respondents experienced withdrawal when stopping drugs marketed as "antidepressants."
Of their findings, RCP wrote:
In all, 866 people participated in the survey, a quarter of which equates to 216. Contrast this figure to the article penned by RCP's president and psychopharmacology committee chair who state, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment."Of their findings, RCP wrote:
"People in our survey reported that the symptoms generally lasted for up to 6 weeks. A small percentage of symptoms lasted longer than this. A quarter of our group reported anxiety lasting more than 12 weeks."
Some questions we need to ask RCP include:
1. Why does a study published by the RCP in 2014 and reviewed in 2017 bear no significance when RCPs President and psychopharmacology chair address the media?
2. Do Wendy Burn and David Baldwin suffer from amnesia or do they merely fail to understand basic mathematics? i.e.; 63% is more than half.
3. Why did RCP recently remove this survey and accompanying leaflet from its website days after announcing the "controversy surrounding antidepressants has now been put to bed" and 24 hours after James Moore showed Burn that her claims did not tally with her own organization's findings?
4. Most importantly, RCP's leaflet regarding SSRI withdrawal stated: "We hope that you find the information given in this leaflet useful." Given that only yesterday RCP believed its info for those suffering from SSRI withdrawal was important, why did RCP remove its useful info today? Is there a new study published in the last 24 hours that shows zero percent of the population suffers from SSRI withdrawal? I don't think so.
Doctors take a Hippocratic Oath to First Do No Harm. Although 63% of people who suffer from SSRI withdrawal is clearly a majority, the point is that even if this figure were only 1%, does RCP not feel an ethical obligation to help all its members help all their patients? The Hippocratic Oath is not based on majority percentages; rather, it is based on individual doctor/patient relationships.
Here's the 4-page leaflet...
For a bit of fun, I've put together five songs I feel Messrs Baldwin and Burn may like to listen to.
Don't Try To Hide It - J. Geils Band
Thick As A Brick - Jethro Tull
Here Today, Gone Tomorrow - The Ramones
Add It Up - The Kinks
Clearly Quite Absurd - Deep Purple
Bob Fiddaman
Special thanks to James Moore
**UPDATE**
Back stories
Friday, February 23, 2018
Media Frenzy - Antidepressants Are Safe!
Lead author, Andrea Cipriani
Like hungry sharks, today the "mainstream" media feasted on lies and half-truths as it dutifully regurgitated a new study analysis by Andrea Cipriani et al. The so-called "study," heavily promoted by "mental health" organizations, claims to determine drugs marketed as "antidepressants" are safe and effective.
Twitter pill-pushers, the Royal College of Psychiatrists and other "mental health" campaigners backslapped each other throughout the day. I even received a few emails from family and friends inquiring if this is the definitive study.
No, it is not. And I don't state this because of the large boxes of substantial evidence I've compiled as a drug safety blogger for 12 years. Instead, the timing of this self-proclaimed "study" and the critical info it intentionally omits is basically the smoking gun that points to fraud.
The study, which was merely a "research" team reviewing 522 trials of "antidepressants," claims to show "antidepressants" work better than placebo. What the Twitter pill-pushers failed to declare is that out of the 522 trials examined by "researchers," 78% of the studies were funded by drug companies. The 522 trials lasted only eight weeks. This pooled "study" doesn't determine that long-term use of "antidepressants" is safe or effective. But this question was intentionally left out as drug company studies--and researchers who profit from drug companies--typically never ask questions to which they already know the answers. Also, nowhere in the study does it discuss the dangers of SSRIs nor note that these drugs were never intended for long-term use.
Taking to Twitter, the Royal College of Psychiatrists (RCP) gleefully seemed to wet its pants as it tweeted false claims. One taunting RCP tweet to BBC investigative journalist, Shelley Jofre, read...
@ShelleyJofre, thought you'd be interested in this story today: Anti-depressants: Major study finds they work https://t.co/TEr3gG11v4— RC of Psychiatrists (@rcpsych) February 22, 2018
The RCP looks foolish for such immature tweets, and I'd state this even if this "study" were accurate.
Nevertheless, Jofre previously investigated "antidepressants" and showed that many consumers suffered severe withdrawal and suicidality caused by ADRs. She has also highlighted that these drugs can and do cause violence and deadly harm to self and others.
RCP's Professor Pariante further claimed, "This meta-analysis finally puts to bed the controversy on antidepressants." I doubt Pariante's pie-in-the-sky wishes will come true, but his apparent delusions include the belief that if he makes loud and frequent proclamations, the public will eventually accept them as truth.
I'm unsure if Pariante's proclamation refers to his delusion that "antidepressants" work better than sugar pills taken for 8 weeks. Or is Pariante claiming "antidepressants" don't cause suicidal thoughts, actions and suicide itself? Is Pariante stating akathisia, a condition that can and does lead to suicide, is of no concern? Does he believe horrendous withdrawal effects people suffer when trying to come off them are merely consumers' delusions? Or perhaps Pariante may have been talking about the birth defects and infant deaths SSRIs cause?
Pariante pranced around on various TV and radio shows throughout the day making his outlandish claims based on a study that used data funded by drug companies. To diminish this fact, Pariante, like many other pill pushers, claimed drug-funded studies are unbias. Today on Science Media Centre's website, he proclaimed "...the paper analyses unpublished data held by pharmaceutical companies, and shows that the funding of studies by these companies does not influence the result, thus confirming that the clinical usefulness of these drugs is not affected by pharma-sponsored spin."
Really? Such a claim is outlandish whether one is talking about dangerous drugs or a study funded by CocaCola claiming Coke tastes better than Pepsi.
Dr. David Healy, a professor of psychiatry at Bangor University, had this to say:
Bizarrely, Helen Stokes-Lampard, who is Chair of the Royal College of General Practitioners, tweeted about the new analysis:The Cipriani paper discussed today is junk. It is based on ghostwritten papers with no access to the data. No one - not MHRA or FDA have had access - none of the notional authors of these papers have had access - none can let an independent expert see what the data shows— David Healy (@DrDavidHealy) February 22, 2018
Begs the question why Cipriani et al decided to pull data from studies that lasted just 8 weeks if these types of drugs are supposed to be taken for 'at least six months.'These are drugs designed to be taken for at least six months and not a short amount of time - @HelenRCGP— RCGP (@rcgp) February 22, 2018
For Americans reading this, a general practitioner is your average doctor. It's general practitioners who prescribe more SSRIs than psychiatrists. Now, it seems, they have something to hang their hats on to.
Pattern of Deceit
So, anyway, back to my theory about the timing of today's "news."
I've been blogging about drug safety for more than a decade and have seen patterns emerge when public opinion begins to sway regarding "antidepressants" safety and effectiveness. In the past year, several authors have released books regarding the dangers of antidepressants. While this isn't new news as many authors have exposed dangerous drugs and pharma/psychiatric industry fraud, today social media more quickly disseminates info directly to the public when promoting new books. One example is that Johann Hari, who recently gained media attention when extracts from his new book, 'Lost Connections: Uncovering the Real Causes of Depression – and the Unexpected Solutions', were published in The Observer. Hari was also given a platform on various radio and TV shows. Hari, was shut down by the RCP and the various lickspittles hired by the Science Media Centre. (More on them later)
It seems large bureaucratic "mental health" organizations & their spin doctors aren't agile enough to keep up their lame rebuttals; hence, today they joined the media circus to make a loud splash with their new carefully planned spin.
The public has also recently seen increased attention regarding the link between prescription drugs and violence as more info unfolds regarding two high-profile cases of mass shootings. A recent autopsy report on Las Vegas shooter Stephen Paddock noted he had "anti-anxiety" drugs in his system at the time of death. (1) Meanwhile, Henderson Behavioral Health, an independent organization, has released information noting that Florida shooter, Nicolas Cruz, was "receiving mental health treatment services and that he was taking medication." (2)
After both of these mass shootings, the public began asking whether or not the shooters were taking prescription drugs. They asked because it is increasingly becoming more difficult for prescribers to deny the link between prescription drugs and violence given that the majority of these massacres have been carried out by someone under the influence of prescription drugs.
This threatens the financial livelihood of members of the Royal College of Psychiatrists and other "mental health" organizations. When more people question the safety of "antidepressants" psychiatrists whose jobs increasingly rely on lucrative prescribing, will lose their livelihood or be forced to provide meaningful therapy.
The timing of this new "study" was carefully crafted by those who financially benefit from promoting "antidepressant" consumption. This includes the pharmaceutical companies who paid for a large portion of the studies pooled by Cipriani. The lead author was, today, busily answering prepared tweets today from industry admirers who are thrilled to see Cipriani prancing around. Pay no mind to the fact that Cipriani is really an emperor with no clothes.
Science Media Centre: Heavy on the Media, Soft on Science
So, how does a canned "study"on such an old subject attract heavy media attention? The Science Media Centre (SMC) to the rescue. SMC is a self-proclaimed think tank of spin doctors disguised as scientists. You can read more about them here. When I first started blogging, it was primarily the job of pharmaceutical reps and opinion leaders to promote drug use. Now, it seems, SMC and social media PR staff are doing the job for them. Despite large PR budgets and staff, I anticipate more people will question the safety of these drugs as more school children are violently killed by former classmates. RCP knows this, too.
But back to today's sharks and their bloody feeding frenzy: Do you know that Bull sharks eat other sharks including juvenile members of their own species? Present-day psychiatry knows it's a dying field and with the promotion of today's new analysis by all those at the RCP, it would suggest that they will always be the silent bystanders as many people struggle at the hands of these drugs.
Finally, I want to leave the last word to the study authors. One has to bear in mind here, that suicide figures are rising as prescriptions for "antidepressants" increase. Here's the death warrant they promoted today in the British media:
"More people should be offered medication when suffering from mental health problems."
Bob Fiddaman
(1) Las Vegas shooter had anti-anxiety medicine in system, autopsy says
(2) Parkland Shooting Suspect Was Receiving Treatment, Medication When Probe Closed
Friday, February 09, 2018
Masterfully Harming Kids for Profit
eu·phe·mism (noun)
1. the substitution of a mild, indirect, or vague expression for one thought to be offensive, harsh, or blunt.
"Part of my job is to create ‘masterful’ euphemisms to protect Medical and Marketing." -- Guess Who?
If you think the above quote is from a sleazy character in the hit TV series Mad Men, you'd be partly right. It is indeed uttered by a sleazy character, but in this case, it's a real person, a mad woman named Amy Rubin. When you learn what Rubin did, you'll understand why this woman can't accurately be called a lady.
As a Regulatory Affairs Manager for Forest Pharmaceuticals, Rubin proudly used her marketing skills to help pull the wool over the FDA's eyes regarding Forest's dangerous, ineffective drug, Celexa, which carries the generic name of citalopram. Rubin made her self-aggrandizing declaration in a memo sent to Dr. Charles Flicker, Senior Medical Director of Forest Laboratories as the two concocted ways to stretch the truth so that more doctors would prescribe Celexa for children and adolescents.
Spin Doctors At Work
Forest Pharmaceuticals conducted the MD-18 study involving Celexa, an SSRI now owned by Allergen. MD-18 was supposed to be a double-blind, placebo-controlled clinical trial of pediatrics. According to unsealed documents and testimony, MD-18 was only able to achieve a positive result by including nine patients in the study that were, as Forest’s medical director stated, “automatically unblinded” due to a supposed dispensing error. (Blinded means that a study's investigators are not supposed to know who consumed the product and who consumed the placebo.) The MD-18 investigators did know who was consuming Celexa and who was consuming placebo. And Forest Pharmaceutical execs knew this, too. The MD-18 study was flawed and biased.
The company then whitewashed the data in a draft letter to the FDA stating that incorrectly dispensed pills could have “potentially unblinded the study,” - After the draft was passed around Forest Labs they decided to rephrase the term and acknowledged that the wrongly dispensed pills could have the “potential to cause bias.” By omitting the word 'unblinded' Forest was deliberately trying to hoodwink the FDA and create the false impression of positive results.
Forest then actively promoted the MD-18 study to encourage doctors to prescribe Celexa for children. The company later used the flawed MD-18 study to gain FDA approval for its other SSRI, Lexapro (escitalopram) and promoted it for adolescents. The result: Forest made money peddling snake oil to doctors knowing that unsuspecting parents would likely later make funeral plans for their children.
Last month Los Angles law firm, Baum, Hedlund, Aristei & Goldman, wrote a letter to Greg Shapiro, Chief of the Affirmative Civil Enforcement Unit, regarding a series of agreements that Forest made in 2010 with the United States Attorney’s Office for the District of Massachusetts. (USAO). Baum Hedlund points out that the 2010 settlement agreement missed some crucial evidence.
Baum Hedlund states:
"Over the past several years, our litigation has revealed that the scope and extent of Forest’s fraud was not honestly disclosed to the USAO (or, to the Food and Drug Administration) and that Forest misrepresented material facts underlying the USAO’s prosecution. Documents and testimony obtained in our litigation have been unsealed, over Forest’s objection, and we have prepared a detailed memorandum outlining Forest’s misconduct and fraud with the hope the USAO will consider reopening its investigation."
The unsealed correspondence between Rubin and Flicker shows how pharmaceutical companies intentionally and routinely put the public--including children and teens--at great risk of harm and death from their products.
Wreckless Endangerment of Children
I tried to find a photo of Amy Rubin to show you what an evil spin doctor looks like, but it seems Rubin is camera shy. For her role in creating a medical holocaust that harms and/or kills thousands of innocent children, I've chosen a makhsheyfe or Baba Yaga photo to represent Rubin. If today Rubin is a mother, I imagine the reckless endangerment she helped unleash in neighborhoods across the globe isn't something she'd want to do to her children or grandchildren. But harming children is merely business as usual for Amy Rubin and her pharma colleagues.
So, as Forest's Rubin once wrote that it was part of her job to "create ‘masterful’ euphemisms to protect Medical and Marketing", it's part of my job to protect children and adolescents.
I hope Amy Joyce Rubin, age 64, has no contact with the innocent children in her Paterson, New Jersey neighborhood.
There are many appropriate adjectives we could use to describe Rubin, most of which are four-letter words. I'll leave it to you to fill in the blanks.
Bob Fiddaman
Baum Hedlund's letter to the Chief of the Affirmative Civil Enforcement Unit can be read here.
Tuesday, February 06, 2018
BBC Newsround: Antidepressants
BBC flagship programme, 'Newsround', a children's news show, are looking to hear from families in the UK whose children (17 or under) have had good or bad experiences on antidepressants.
I'm promoting this as I feel education regarding these drugs really should start at a grassroots level, namely, our children.
Here's what lead researcher Oliver Newlan wrote me.
BBC Newsround are interested in speaking to any families of children currently aged 17 or under who have had good or bad experiences of being prescribed antidepressants.
If there are any experiences you feel you would like to share please could you email oliver.newlan@bbc.co.uk by Thursday 8th February 5pm.
We will deal with your experiences sensitively and will not make anything public without your explicit consent.
Bob Fiddaman
Sunday, January 28, 2018
Generic Paxil Lawsuits Filed
Canadian pharmaceutical company, Apotex, have been delivered a hammer-blow regarding the manufacturing and labeling of generic Paxil, an antidepressant known by its generic name of paroxetine.
Paxil is the brand name of paroxetine and has various different brand names all over the world, in the UK, for example, it's known as Seroxat.
The hammer-blow comes on the back of Baum Hedlund & Rapoport Law Offices glorious victory over Paxil manufacturers, GlaxoSmithKline (GSK) last year. GSK, who denied that it was their responsibility to advise generic makers that Paxil increased the risk of suicide to adults beyond the age of 24, lost in a landmark case in Chicago...and have been crying about it ever since. More on GSK throwing their toys out of the pram further on down this post.
Because of the victory against GSK, Baum Hedlund have now wrote a letter to Apotex, the content of which is pleasing to the eye for a drug safety advocate such as myself.
Baum Hedlund’s letter to Apotex:
Dr. Jeremy Desai
Mr. Bernard Sherman
Mr. Jack M. Kay
Apotex, Inc. 150 Signet Dr., North York,
ON M9L 1T9, Canada
Re: Paxil and Suicide
Dear Messrs. Desai, Sherman, and Kay:
I am writing to Apotex as the exclusive holder of the New Drug Application for Paxil. As of January 2014, Apotex became exclusively responsible for the content and accuracy of the Paxil and paroxetine label, charged with ensuring the label remains up-to-date and adequate at all times.
This letter officially places you on notice that the label for Paxil does not adequately warn about the risks of adult suicidal behavior and that it needs to be corrected. It is my hope that Apotex will take swift action to protect the health and safety of patients taking Paxil/paroxetine.
On April 20, 2017, a federal jury entered a verdict against GlaxoSmithKline, Inc. (“GSK”), and in favor of a widow of a Chicago man who killed himself six days after starting a generic version of Paxil. As part of that verdict, the jury concluded that the Paxil label, as it has existed since 2007, is inadequate because it fails to properly warn about the risks of adult suicidal behavior causally related to ingestion of Paxil/paroxetine. Specifically, the paroxetine label did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults with Major Depressive Disorder (“MDD”) of all ages and the FDA’s 2006 analysis of a statistically significant 2.7 times greater risk in adult patients across all indications. Indeed, since 2007, the Paxil label has not only failed to warn about this increased risk, it has stated the opposite—that the suicidality risk did not extend beyond the age of 24. This verdict was rendered after more than five weeks of testimony and evidence that focused on the extensive clinical, scientific and medical evidence pertaining to paroxetine.
The Dolin trial transcripts can be viewed here: https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/gsk-paxil-trial-transcripts/
The Dolin trial exhibits can be viewed here: https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/paxil-trial-exhibits/
Please review these transcripts and documents. They reveal a serious problem, one that Apotex is in a unique position to remedy.
This is your opportunity to do the right thing and remedy the deficiencies in the Paxil label. Failure to take action would mean your company is deliberately refusing to correct a known and quantifiable risk. Any suicides or attempted suicides that could have been prevented by a label change are now on you. We urge Apotex to take swift action to protect the public health.
Best,
BAUM HEDLUND ARISTEI & GOLDMAN, P.C.
Brent Wisner
Michael L. Baum
Pedram Esfandiary
Further to the letter sent to Apotex, Baum Hedlund are now looking for consumers who have attempted suicide whilst taking Apotex generic Paxil. Moreover, consumers relatives whose loved ones completed suicide whilst taking the Apotex version of Paxil.
If you would like to speak with a Paxil lawyer about filing a claim, please contact Baum Hedlund by filling out the form here, or calling them toll free at 1-800-827-0087.
As mentioned (above) GSK have been crying like big babies since the verdict against them was returned last year. They, via their poor performing attorneys, King & Spalding, have since asked for a retrial and been denied, they then, remarkably, rejected the decision of the Judge not to grant them a new trial (boo hoo)
Now, it appears, GSK who have blamed everyone but themselves for the untimely Paxil-induced suicide of Stewart Dolin, are now preparing to take their greivances to the United States Court of Appeals for the Seventh Circuit.
This, to me at least, smacks of obstinance on GSK's part and, it has to be said, on the part of their defence team of King & Spalding, whose lead attorney, Andrew Bayman, recently cited his firm's failure in Dolin Vs GSK as an "accomplishment."
King & Spalding's mediocre performance in Chicago last year was an eye-opener for me, this, of course, should not distract the brilliant teamwork of Baum Hedlund & Rapoport Law Offices who revealed several telling documents during trial, one of which showed that an internal analysis, carried out by GSK in 2006, showed that patients taking Paxil were nearly seven times more likely to attempt suicide than those on placebo.
The Dolin v. GSK Paxil Trial Exhibits can be viewed here.
The Dolin Vs GSK Paxil Trial Court Transcripts can be viewed here.
Bob Fiddaman
Monday, January 08, 2018
Who's Hiding the Clinical Trial Benefits of Antidepressants?
First off, ponder this.
If an opponent in a pool game told you that if you use the 8 ball as the cue ball you will not foul, would you believe them? What about if they kept on insisting this claim to be true? Or would you ask questions to someone else to ascertain if the claims of your opponent were true?
Read on.
Over the past month or so I've been blocked on Twitter by three well-known psychiatrists.
Wendy Burn, a consultant psychiatrist at Leeds and York Partnership NHS Foundation Trust and president-elect of the Royal College of Psychiatrists.
Allen Frances, who was the chair of the DSM-IV Task Force and of the department of psychiatry at Duke University School of Medicine, Durham, NC. He is currently a professor emeritus at Duke.
Peter Kramer, Clinical Professor Emeritus of Psychiatry and Human Behavior. Kramer is also the author of numerous books, many of which he likes to promote on Twitter.
So, why have these three well-known, and some would say, intelligent orators, blocked me?
Well, it would appear that rather than answer a simple question I put to them, they decided to put their fingers in their ears and bury their heads in the sand. It's a question that should be answered and one that, to date, has not been adequately answered by anyone from the medical profession, the pharmaceutical industry or any global regulatory agency. It's a question the media never seem to ask either. It's a question I've put to the Royal College of Psychiatrists on many occasions too, they have just chosen to ignore me.
Wendy Burn, who regularly accepts adoration on Twitter yet fails to answer bereaved parents, was first.
My current view of her online profile looks like this.
Next up was Allen Frances, a man who changes his opinion like the wind, depending on whom he wishes to appease.
My current view of his online profile looks like this.
Finally, after attempting to answer my question with some quite unbelievable and unprofessional answers, was Peter Kramer.
My current view of his online profile looks like this.
So, three psychiatrists, all with one thing in common: An inability to answer a question that forms the crux of their beliefs. I urge anyone reading this to ask their healthcare professionals the same question and to contact me if given an answer. If three eminent psychiatrists or pharmaceutical companies, or even medicine regulators cannot answer, then I doubt very much if your average prescriber will either.
The question should be answered because it forms the basic safety and efficacy point of why antidepressants are on the market.
So, what was the question?
"Please list the benefits of antidepressants."
I asked this question because it was once put to me by an old advocate/friend of mine, Matthew Holford. It's a great question and turns the focus off the risks and onto the benefits. Remember, after the clinical trials of these drugs, which lasted between 8 & 12 weeks, a licence was granted because the "benefits outweighed the risks." We all know what the risks are because today most of them are clearly on the antidepressant labels.
Out of the three psychiatrists, Peter Kramer, who has authored such books as 'Listening to Prozac', came up with, or thought he did, an answer. The benefits are "having a good time with your kids", he told me, adding, "progress in your career."
Interesting. My response, which resulted in Kramer throwing his toys out of the pram (blocking me) was, "So, in the 8-week clinical trials for antidepressants the benefits of "having a good time with your kids" was seen. Benefits also seen in the 8-week trial was "progress in your career", is that your position, Peter?"
Ladies & gentlemen, boys & girls, we have all been duped for years and the claim that antidepressants outweigh the risks is, I believe, a fraudulent claim just as the 'depression is caused by a chemical imbalance' claim was.
It's incumbent of us all to seek an answer to this question because without an answer, without the actual truth, pharmaceutical companies and medicine regulators will continue to tell doctors that the benefits outweigh the risks - they, in turn, will continue to tell patients, who, in turn, tell friends and family members. The piss-sodden snowball will grow until we all stop it gathering more momentum.
So, next time you hear the term, "The benefits of antidepressants outweigh the risks", ask the person who is making this claim for a list of the benefits reported during the trials. Don't accept the anecdotal comments, such as, "they saved my life" or "they helped me." These are irrelevant anecdotes. What you are seeking is the list of benefits that persuaded the medicine regulators to grant these drugs a license. Ergo before all the hype came about them apparently saving lives.
Remember, suicidal ideation, self-harm and a whole host of other risks have been reported in clinical trials and we have all been told, 'Hey, there's no need to worry because there were more benefits.' Thing is, ladies & gentlemen, boys & girls, they have failed to show us a list of these benefits. They, if there are any at all, have been hidden from us in much the same way the number of suicidal subjects in clinical trials was hidden. Through various litigation we have unearthed a lot of the hidden risks but, to my knowledge, no drug company has ever been sued because antidepressants work too well.
We need a list of the benefits and we need them now!
We have all just taken their word on trust.
And we should all, rightly, be very angry!
Bob Fiddaman
Saturday, January 06, 2018
GSK Call In the Fireman
I've recently finished reading, for the second time, John Grisham's excellent, 'The King of Torts', a novel that highlights underhand tactics used by the pharmaceutical industry.
In 'Torts' we are introduced to a character who goes by many names. To keep this simple I'll just be referring to him as 'Max Pace.' Pace is hired by pharmaceutical companies to douse the flames when it arises that a drug that has been on the market has serious and life-threatening side effects. The information is purposely leaked by the pharmaceutical companies via Max Pace whose job it is to target prosecuting attorneys in the hopes of a quick and cheap settlement. Pace describes himself as a fireman, someone whose job it is to 'put out the fire.'
The character reminded me a great deal of Peter Humphrey, the outsider who was brought in by GSK China to douse the flames of a whistleblower who, at the time, was threatening to spill the beans on GSK China's illegal activities which included, but weren't limited to:
- Bribing Mark Reily, GSK's head of China Operations, in the form of 'sexual relations' in return for maximizing business for China Comfort Travel (“CCT”). - CCT was an important part of the GSK bribery and promotion scheme because it facilitated a money laundering operation in connection with the bribing of hospitals and doctors who prescribe GSK drugs to patients.
- Funneling 3 billion yuan (US$482 million) through this network to recipients. Receipts were forged for purchases and transactions that never took place, including fake conferences.
- Bribing doctors and other medical staff were to sell GSK products, the cost of those bribes was added to the price of the products that consumers paid for.
Enter the fray Peter Humphrey and his wife Yu Yingzeng who were hired by GSK China to investigate a whistleblower whom they believed was behind a series of emails sent to the company big-wigs, including the then CEO of GSK UK, Andrew Witty. Humphrey and Yu operated ChinaWhys, an International Business Risk Advisory Firm.
Humphrey and Yu were told by GSK China that they believed Vivian Shi, then the company’s government relations head in China, was the whistleblower but they needed proof. The allegations made by the anonymous whistleblower did not concern them.
In a nutshell, it was the job of Humphrey and Yu to create a report on Shi to frame her as a vindictive former employee.
The Sex Tape
Whilst in talks with GSK China, Humphrey, and his wife learned of a sex tape that the anonymous whistleblower had sent in via an email attachment. The sex tape showed Mark Reily and an unnamed woman and was sent to GSK executives along with the corruption allegations. A further 23 emails were sent to Chinese governmental entities throughout China.
GSK told Humphrey and his wife that the allegations had previously been investigated and were false.
According to a court document, during an April 15, 2013, meeting, Humphrey asked GSK officials for copies of the anonymous whistleblower allegations, but GSK refused to provide them. Instead, the document claims, GSK officials stressed that GSK had improved its compliance mechanisms following earlier corruption and other illegal activities that led a DOJ settlement in 2012 ($3 Billion to resolve fraud allegations and failure to report safety data)
The court document. PETER HUMPHREY; YU YINGZENG; CHINAWHYS COMPANY LTD Vs GLAXOSMITHKLINE PLC; GLAXOSMITHKLINE LLC, was filed in United States Court of Appeals for the Third Circuit on 1st January 2018.
More on this 'appeal' later.
In essence, GSK was playing down the allegations, even though they knew them to be true, and using Humphrey and Yu into advancing GSK’s efforts to conceal its bribery activities.
The court document, which I have a copy of, also states:
On June 26, 2013, a GSK employee finally sent two of the whistleblower emails to Humphrey while he was in the United States.
Over the next two days, police raided multiple GSK China offices. Following those raids, GSK senior legal counsel Jennifer Huang asked ChinaWhys to investigate the Public Security Bureau (PSB) and to “prepare an Organic analysis ASAP on the Chinese political regime, particularly on Chinese Communist Party Regime, PSB, and state council with official’s name identified.”
Humphrey and Huang had a phone call that same day, while Humphrey and Yu were in the United States. Huang said she wanted to investigate the PSB “to find out who’s who in the investigation.” At that point, Humphrey became concerned that GSK was seeking now to obstruct the investigation by Chinese authorities and replied that he could not do anything that could be deemed as violating state secrets and thus could only use public information for his research.
On July 1, while Humphrey and Yu were still in the United States, GSK China’s head of business development, Leslie Chang, asked Humphrey to investigate various government organs. Humphrey refused. Then, after returning to China, Humphrey met again with Mark Reilly (the head of GSK China) in a hotel room as Reilly was preparing to flee the country. At that time, Humphrey advised Reilly that ChinaWhys could no longer provide service to GSK.On July 10, 2013, ChinaWhys was raided by the police who told Humphrey, “This was ordered from above. This is related to GSK.”
Around the same time, four senior GSK China executives were also arrested. In response to those arrests, GSK’s global CEO, Sir Andrew Witty, claimed that GSK’s head office in London lacked knowledge of the whistleblower’s allegations and “had no sense of this issue.” This, according to the court document, was untrue.
Humphrey and Yu were arrested for illegally buying and selling private information and detained for almost a year before their trial. During this year of detention and whilst awaiting trial, GSK stated that its China business “hired ChinaWhys in April 2013 to conduct an investigation following a serious breach of privacy and security” (the Reilly sex tape) but that ChinaWhys was “not hired to investigate the substance of the allegations of misconduct made by the whistleblower.” This, according to the 2018 court document, was a misleading statement by GSK and prolonged Humphrey and Yu’s incarceration because British diplomats attempting to intervene on Humphrey and Yu’s behalf did not have accurate information about what had led to their arrest.
One British official involved in those efforts to intervene on behalf of Yu and Humphrey claimed,“GSK were really cagey. They just kept saying it was routine work and kept the information deliberately vague. When we went to the Chinese we were arguing with one hand tied behind our backs.”
On September 19, 2014, GSK PLC issued a Statement of Apology to the People of China in which it announced that “GSK China Investment Co. Ltd (GSKCI) has been identified according to Chinese law to have offered money or property to non-government personnel in order to obtain improper commercial gains, and has been found guilty of bribing non-government personnel.” GSK was fined $492 million for its bribery activities in China in the biggest such penalty ever imposed by a Chinese
court. The then GSK CEO, Andrew Witty, stated that “Reaching a conclusion in the investigation of our Chinese business is important, but this has been a deeply disappointing matter for GSK.” In addition, Mark Reilly, the head of GSK China, was convicted for his part in the bribery scheme. He was sentenced to three years prison with a four-year reprieve and ordered deported, meaning he will never serve his sentence.
Humphrey and Yu. however, were treated less favorably. In August 2013 they were both convicted and imprisoned in China under harsh conditions for almost two years in squalid conditions and crowded jail cells. They were both denied urgent medical attention and were separated from each other Humphrey developed prostate cancer, for which he did not receive proper treatment and as a result, the cancer became life-threatening.
In June 2015, the couple was released from prison.
Humphrey watched the TV coverage of the GSK trial from his Shanghai prison cell. He was shocked by the contrast between his punishment and theirs.
"Suspended jail sentences for three or four of the main culprits when I and my wife had been sentenced to years in prison," he says, adding, "Someone asked me recently why someone like Mark Reilly (GSK China's boss) could be set free and we were in jail. I think it's very simple, we don't have half a billion dollars. That story was about money from the beginning. Money got them into trouble and money got him out."
In November 2016, Humphrey and his wife filed suit against GSK where they sort to seek damages from GSK relating to the loss of their business (ChinaWhys), compensation for the emotional and physical harm and damage to their reputation.
Almost one year later, U.S. District Judge Nitza Quinones Alejandro, threw out the case claiming that a U.S. Supreme Court ruling barred lawsuits filed under the federal Racketeer Influenced and Corrupt Organizations Act (RICO) over injuries that occur entirely outside the United States such as this one involving incidents in China.
“For this reason", he said, "Plaintiffs lack standing to assert civil RICO claims, and these claims are dismissed."
Undeterred, Humphrey and Yu have now appealed this decision, hence the Jan 1, 2018, filing. They are requesting that the United States Court of Appeals reverses the order of the District Court dismissing the Complaint for failure to plead a “domestic injury”.
I covered the Chinagate scandal in great depth when news broke back in 2013. A chronological list of the blogs can be seen below. To date, it's some of the most rewarding research and reporting I've ever done on this old blog of mine.
Remarkably, GSK re-hired the services of Vivian Shi, whom they thought was the whistleblower. Reily, according to MalayMail Online, became part of GSK's senior executive team in London
Bob Fiddaman
BACK STORIES:
Glaxo - The Sex Tape Scandal
GSK's Mark Reilly Accused of Running a "massive bribery network"
I'm Just a Blogger - Here's GSK Served on Prawn Crackers
GSK Hiked Product Prices to Fund Bribery Scam
GSK's Sales Reps Want Their Money Back
GSK's Private Investigator [The Video]
Peter Humphrey's 2012 Presentation - Pharma Bribery
GSK's Chinese Whispers and David Cameron
“GSK were really cagey", Claims Whitehall Official.
Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.
GSK CHINA - Bribery was Rife 13 Years Ago
Witty Plays Down China Scandal
Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly
Book Your Holidays With GSK Travel
Andrew Witty... I know narrrrrrrrthing
Glaxo - The Sex Tape Scandal
GSK's Private Investigator [The Video]
Peter Humphrey's 2012 Presentation - Pharma Bribery
GSK's Chinese Whispers and David Cameron
"GSK were really cagey", Claims Whitehall Official
Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations
GSK CHINA - Bribery was Rife 13 Years Ago
GSK's Hired Detectives - Day One, As It Happened
So, What Do You Think, Mr Harvey Humphrey?
GSK Plead Guilty For Being "Very Decent"
Glaxo's PI Released From Prison
The Penny Drops for GSK's Private Investigator
GSK's Mark Reilly and the Word, 'Opaque'
Glaxo and Former Whistleblower Suspect Reunite
GSK China Bought Patient’s Silence for $9,000
Lawsuit Alleges GSK's Witty Lied to the Media - Part I
ChinaWhys Vs GSK - The Claims - Part 2
More Woes for GSK as Peter Humphrey Files Suit
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