Duchesnay Correct Violation: No Apology

Canadian pharmaceutical company, Duchesnay, who market and manufacture the controversial morning sickness pill Diclegis, have corrected a violation, earlier flagged by the American drug administration (FDA).

In a bizarre twist, to the uneducated eye, it looks as if socialite, Kim Kardashian, is making the changes. Let's compare the two posts by Kardashian (none of which mention that she has been paid by Duchesnay to endorse it's morning sickness pill.)

Kardashian's original advert for Diclegis

The FDA, after reviewing the one-sided ad, told Kardashian to remove it and also wrote a warning letter to Duchesnay. The FDA letter warned Duchesnay that they were violating certain rules as they didn't include the risks surrounding Diclegis.

Here's how the ad looks today...

The 2nd (corrective ad) features more text than the original. I think only a person from the planet Zog would believe that it was written by Kardashian.

Duchesnay have confirmed, more or less, that they have corrected their original mistake by proxy, via their Twitter account.

They have also issued a press release via their website here.


To date, no apology has been made by either Kardashian or Duchesnay for violating FDA rules and for potentially duping millions of future consumers of Diclegis.

Back stories regarding Diclegis and the whole Kardashian debacle are below.


Bob Fiddaman




Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

The Duchesnay and FDA Runaround

MHRA: Double Standards

I first became aware of the British drug regulator, the MHRA, adding a copyright notice to Freedom of Information request responses some time ago.

They first did this to me in 2007. I had sent them a series of questions regarding the suicide link in GlaxoSmithKline's antidepressant Seroxat (known as Paxil in the US)

The copyright notice reads...

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder. 

I, as you would expect, took umbrage to this and let my feelings known via this blog (here)

Again, this time in 2014, the MHRA, once again saw fit to include a copyright notice to another response to a Freedom of Information request I had sent them. This was in response to an FOI request I had sent them regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury) Back story here.

Earlier this week I was contacted by Cheryl Buchanan who has, in the past, wrote a guest post for this blog. (here) Cheryl had requested an answer from the MHRA (under the terms of the FOIA) regarding SSRi use in pregnancy. It's important to note that Cheryl has been at loggerheads with the MHRA and citalopram manufacturers, Lundbeck, for some considerable time now.

The MHRA sent Cheryl a response and included a copyright notice. Cheryl wrote back the following to them.

Dear MHRA,

Thank you for responding to my request, I have some further questions which I will sent to you shortly but at the moment I am perplexed as to why you have put a copyright on the response you sent me?  I feel it is within pubic interest to have the data within the response available to anyone who would like to see it. Is every paragraph copyrighted or am I allowed to share any of the information which relates to myself and my own report?

The response from the MHRA was...

Copyright information is included in responses from the agency where data is presented to the requestor. Data given in these types responses has the potential to be taken out of context, and the agency would wish anyone who has requested information from us to include the context when sharing information.

The agency is happy for you to share information released under the Freedom Of Information Act, indeed from the agencies perspective the response is already deemed as being “in the public domain”. The copyright notice is included as the information should be able to be traced back to the MHRA as the source, and as mentioned previously, the context can be included.

So now I'm confused?

You see, when a pharmaceutical company apply for a licence for one of their drugs they are supposed to submit supporting evidence. They do this by cherry-picking the best results from clinical trials. The poor results (ie; those showing that efficacy has not been proven) are never sent to the MHRA.

Here's my take on the MHRA copyright notice.

Would it be fair to say that when pharmaceutical companies submit clinical trial results to the MHRA in support of drug licensing that they include the failed clinical trials...so the actual benefit of a drug isn't "taken out of context"?

Just a thought.

What's good for the goose is good for the gander, right?


Bob Fiddaman.

Study 329: The Final Chapter

"Truth will come to light; murder cannot be hid long." 

William Shakespeare - Merchant of Venice (1596)

Let's make no bones about it. Study 329 is, and always has been, a ghostwritten publication based on deception and intended to result in financial gain.

The putrid stench of deception has been obliterated, redesigned and is now a sweet smelling single rose, a small token gesture of truth for all those harmed by GlaxoSmithKline's fraudulent 329 study, of which there are many (children and adolescents)

Study 329 is, without doubt, the most infamous of all antidepressant studies. It reeks of deceit, of greed, of dishonesty, of financial kickbacks and has left a slimy trail of death and destruction in its wake.

I have, for my part, written and published many articles on this blog regarding 329. Three of which, Sally K. Laden, The Paxil Ghostwriter Part I, and Sally K. Laden, The Paxil Ghostwriter Part II - Emotional Lability, ending the trilogy in this series with, Sally K. Laden, The Paxil Ghostwriter Part III - Summation. being amongst the most popular.

329 highlights how one company saw a niche in the child depression market and, without due care and consideration, made unfavourable clinical trial results into favourable results.

329 is the spin of all spins, the retraction of which from The Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), has been called for many times.

Now, a group of tenacious researchers have shone a very bright light on what 329 should have revealed. Their findings will be published in the British Medical Journal (BMJ) next month.

Meantime, the Study 329 website has been launched and offers some interesting facts about the fraud behind GlaxoSmithKline's darkest hour.

The Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trial, should shock all who care about integrity in drug safety.


Bob Fiddaman.

The Paxil Kid From Pictou County

I thought I'd heard the last of the Paxil horror stories. I thought doctors and psychiatrists would have got the message by now that Paxil is not safe, is not suitable for children and adolescents but...

A story hit me hard today, a realization that this abhorrent antidepressant is still destroying lives.

Shawna (not her real name but being used to protect the identity of her and her son) is a mother who has took it upon herself to fight for her 20 year-old son.

The story bears all the hallmarks of psychiatric abuse but, hey, how can you prove that when so many people believe that psychiatrists actually know what they are doing? In truth, they don't, in truth they use people as guinea pigs to see if they can tolerate drug a, b,c or d.

Shawna’s son was extremely shy and had just come out of a relationship. Shortly after he, according to a Canadian news website, "spiralled into a deep, dark depression that saw him in his unlit room, unable to sleep, eat or perform even day-to-day tasks."

His mother did what she thought best and took him to a hospital where he was prescribed Paxil... yup, just like that.

This from the article...

He was prescribed the anti-depressant Paxil which she was told would help alleviate his depression, but instead it made things worse.

Shawna said the side effects of the drug were probably more devastating than his symptoms of depression. He started to threaten to kill him himself, sending her “goodbye texts” and wandering off without any contact for hours and hours.

“It was just crazy thinking,” she said. “You couldn’t get him to do anything. She said the final straw was when he spent 32 hours straight on the rocks at a local beach, contemplating whether he wanted to take his own life.

Shawna's son was then admitted to hospital where, she says, he received no care and was just left sitting in a room  for three days with no visit from any psychiatrist. On the fifth day, however, he was seen by a psychiatrist.

**Insert drum roll here**

The psychiatrist told both Shawna and her son that he needed to be kept on the drug Paxil because it takes 30 days to work properly, despite the side effects.

Where does it say that on the Paxil labeling? Why didn't the psychiatrist associate Shawna's sons actions as an adverse reaction to the Paxil he was taking? If a patient is threatening to kill himself shortly after being put on Paxil why on earth didn't the treating psychiatrist acknowledge that this may have been down to the treatment?

So, Shawna's son continued to take the Paxil.

Here's the article again...

For the next month, she said, things were going from bad to worse.  He was in and out of Aberdeen’s mental health unit as well as Kentville and Antigonish’s units for short three-day stays. After being released from the units each time, she would have to call the police to help search for him because the suicidal thoughts kept coming and the wandering continued.

Mental Health and the Police

Here's where the story takes a rather absurd twist.

Shawna was told by a police officer that the only way her son could receive proper treatment would be if he was arrested. She was told by the officer that her son, once arrested, would then be "in the system" and "sent to Dartmouth for a 30-day mental health assessment."

A few months later her son was arrested for assault. Just as the police officer had told her, Shawna's son was given the treatment he needed - care. He is now on house arrest, under her care, and without the help of any psychiatric counseling.


The family doctor is slowing weaning him off the Paxil.


Afterthought

It's glaringly obvious to anyone reading this account that a 20 year-old kid was given a drug that gave him an adverse event, a dangerous adverse event. His treating psychiatrist should have intervened and guided his patient off the drug - instead, he chose to ignore the obvious signs of Paxil induced mania and told the kid to continue taking the medication. That's abuse by anyone's standards.

As for the mental health system in Nova Scotia, well, what can you say?

It takes an officer of the law to tell a patient's mother to, basically, get her son arrested, so he can receive appropriate treatment.

Talk about a comedy of errors!



Bob Fiddaman.



Source: Mom desperate to get help for son

Fortitude Law Take on Seroxat Cases in UK

The Seroxat group action has been running for almost 10 years now. GSK have, for whatever reason, refused to make any kind of settlement to the 107 claimants who have alleged that they suffered severe withdrawal at the hands of Seroxat and, more importantly, were not warned about this dependency problem.

In 2010 the group action came to a grinding halt. A legal battle, behind the scenes, was unfolding and claimants, of which I am one, had their public funding withdrawn. This is quite common in UK action against pharmaceutical companies.

Sufficed to say, the group action was put on hold (stayed) whilst the legal wrangles were ironed out.

Good news is, we now have new representation.

Fortitude Law, a law firm based in London, are now representing the UK claimants and are set to return to the High Court to confront GlaxoSmithKline and show them evidence that Seroxat caused these withdrawal reactions to the claimants. I assume it will be the same evidence that US courts were shown back in 2002 when 3,000 or so claimants alleged that Seroxat caused them dependency. Glaxo resolved that case yet refuse to do the same in the UK.

The Fortitude Law website has now gone live and they have a contact form on there for people wishing to ask questions about the current group action.

Fortitude Law can be found here.



Bob Fiddaman.

The Duchesnay and FDA Runaround

As some of you may know, I became intrigued by the whole Kim Kardashian promotion of Diclegis on her Instagram account a number of weeks ago. My interest peaked when Diclegis manufacturer, Duchesnay employee, Danny Martel, wrote me on Twitter, basically telling me to "educate myself." (Back story)

If you're up to speed on the whole Kardashian promotion you'll know that recently the FDA became involved. They told Kardashian to remove the advertisement and wrote to Duchesnay to inform them that they had violated certain rules in as much that they cannot advertise the benefits of a product without listing the risks of the said drug. The letter, addressed to Eric Gervais, Executive Vice President Duchesnay, Inc. can be viewed here.

Bravo to the FDA for monitoring social networks.

Here's where is gets a tad worrying.

The FDA gave Duchesnay until August 21 to respond to the warning letter, they wrote...

OPDP requests that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce. Please submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. 

Well, we are three days over the deadline and still I see nothing on either the FDA or Duchesnay websites that suggest that a response has been made - so, I wrote to the FDA, who told me that they  "are  not able to comment on an ongoing compliance action, as this information may be privileged confidential information. I’d recommend asking the company if they would be open to sharing information with you."

So, I wrote to Duchesnay and asked them the following...

I am writing to ask if Duchesnay are prepared to share their letter of response they wrote to the FDA regarding the Diclegis promotion (Kim Kardashian) warning letter.
I have wrote directly to the FDA who, in turn, suggested I write directly to you.
Sincerely,

Duchesnay's response is bizarre, to say the least...

Bob,
We will share information once it is publicly available. We do not have that information at this time. 

Share the information when it's publicly available?

Um, I'm not nitpicking but shouldn't it be Duchesnay making this information public? I mean, what, or who are they waiting for?

The last paragraph of the warning letter sent to Duchesnay reads...

Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice. 

I think it's fair to say that this is a matter of public interest. Something which I pointed out to the FDA who then went on to tell me...

You could submit a Freedom of Information Act request. FDA Office of Media Affairs does not process FOIA requests. 

Seems a kinda half-arsed way to get an answer to a pretty simple question.


Bob Fiddaman.

Back Stories

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

US Attorney General Eric Holder and the Revolving Door

Covington - DOJ - Covington

I'm not really into American politics, not really into British politics either, I'd sooner read knitting patterns as politics, in general, bores me rigid.

That's not to say that every now and again something pops up that is of interest. None more so than the recent news surrounding US Attorney General, Eric Holder.

Holder was part of the legal team for the Department of Justice (DOJ) - the same team that fined GlaxoSmithKline a staggering $3 billion for promoting its best-selling antidepressants (Paxil and Wellbutrin) for unapproved uses and failing to report safety data about its top diabetes drug, Avandia.

Bizarrely, Holder had previously worked for the law firm, Covington, who specialize in representing (defending) pharmaceutical companies in litigation.

It was quite a turnaround. One minute Holder is defending pharmaceutical companies, the next, he's prosecuting them.

Strange then that, after just 6 years with the DOJ, he should return to Covington as a partner.

So, what input, if any at all, did Holder have regarding the negotiations of the $3 billion settlement figure, and, more importantly, could the original figure, said to be a lot more than $3 billion, have been whittled down by Holder? Furthermore, who was exactly behind the Wellbutrin promotion, was it, as some sources suggest, the current CEO of Glaxo, Andrew Witty, who, at the time of the illegal promotion, was Vice President General Manager of Marketing for Glaxo?

I'm just throwing the question out there because this revolving door between Covington and the DOJ seems, to me at least, to be bordering on being incestuous.

News of Holder's double u-turn came via Melayna Lokosky who has wrote a quite brilliant blog post where she raises many questions regarding Holder's latest "unethical move."

Her blog can be read, in full, here.

Lokosky also tweets about it via her Twitter account, here.


One to keep an eye on.


Bob Fiddaman.

MHRA Missing Key Seroxat/Paxil Withdrawal Information

You may remember that back in July I wrote about the Yugoslavia paroxetine (Seroxat UK, Paxil US) trial (here and here)

In 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how Paxil (known as Seroxat in the UK) could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping Paxil) could have been suffering withdrawal symptoms.

With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.

Seeing as Glaxo are a British pharmaceutical company I decided to write to the British drug regulator (MHRA) to request, under the freedom of information act, information relating to Glaxo's trials in Yugoslavia.

My email to them read...



Dear Sir/Madam, 

Pursuant to the federal Freedom of Information Act, I request access to and copies of a a clinical trial in Yugoslavia that commenced in 1988.

The trial was, as far as I am aware, sponsored by SmithKline Beecham (SKB) and was known as the "Yugoslavia trial" or "relapse trial."

I am specifically requesting the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal.

I look forward to your reply within 20 business days, as the statute requires.

Thank you for your assistance.

Sincerely,

-- 
Bob Fiddaman




The MHRA have now answered this request.

Are you holding your breath folks?

The current Chief Executive of the MHRA is Dr. Ian Hudson. Before joining the MHRA, Hudson was the World Safety Officer for GlaxoSmithKline (then SKB)

Later this year GlaxoSmithKline will be defending allegations in the UK regarding Seroxat withdrawal. One of Glaxo's experts to be called will be Dr. Rashmi Shah. Shah was employed by the MHRA between 1987 and 2004. Positions held were Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

You can draw your own conclusions.

Bob Fiddaman.

MHRA Blind to the Facts Over Lariam

Earlier today the BBC reported on the concerns surrounding an anti-malaria drug.

Lariam (mefloquine) is said to be causing concern regarding its side-effects, of which suicidal thinking and completed suicide are listed.

Worryingly, Lariam is handed out to soldiers who train or are in combat in countries where malaria is rife.

Surely, a pill taken to prevent malaria can't be that bad?

Think again.

I accessed the MHRA's Drug Analysis Prints (DAP's) earlier today - the results for Lariam were startling. Question is, why have the British drug regulator overlooked the glaringly obvious?

In all, there have been 19 reported fatalities regarding Lariam. Okay, not a great deal but when you look into the DAP's you will find that 9 of these 19 deaths have been death by suicide.

One thing the MHRA have always played down with antidepressant related suicide is that it could be the "illness" that caused the suicide and not the product. Fair enough, I guess but in the case of Lariam, the patients subjected to this particular drug do so because they wish to prevent something and not suppress or cure something.

Let's dig a little deeper.

Lariam was created by the military in the 1970's and manufactured by pharmaceutical company, Hoffman-La Roche.

Lariam Tablets contain the active ingredient mefloquine. They are used to treat malaria and to help prevent you from catching malaria.

Drug Analysis Print for Lariam (MHRA)

• Total number of reactions 6713 
• Total number of ADR reports: 2282 
• Total number of fatal ADR reports: 19

Let's focus on the adverse reactions associated with 'psychiatric disorders.'

There here have been...

• 18 reports of Abnormal behaviour.
• 24 reports of Affect lability (rapid shifts in outward emotional expressions; often associated with organic brain syndromes such as intoxication.)
• 61 reports of Agitation
• 304 reports of Anxiety
• 38 reports of Aggression
• 82 reports of Paranoia
• 11 reports of Personality change 
• 67 reports of Confusional state 
• 61 reports of Disorientation
• 19 reports of Delusion
• 341 reports of Depression
• 10 reports of Depersonalisation
• 14 reports of Dissociation
• 28 reports of Irritability
• 59 reports of Mood swings 
• 15 reports of  Mental disorder
• 11 reports of Mania
• 162 reports of Panic attack
• 119 reports of Abnormal dreams
• 146 reports of Nightmares
• 113 reports of Hallucinations
• 19 reports of Acute psychosis* 
• 76 reports of Psychotic disorder
• 9 reports of Completed suicide
• 33 reports of Suicidal ideation 
• 12 reports of Thinking abnormal 

* Bizarrely, there has been one reported death of "acute psychosis" - This seems to have been omitted from the "completed suicide" catagory - unless, of course, the person died naturally?

So, a whole heap of psychiatric disorders are being reported to the British drug regulator. They, as usual, log these reports and make them public to geeks like me.

What is worrying here is that Lariam is the standard drug used for British soldiers training or fighting wars in countries that has a presence of malaria.

So, just to spell it out for the limpless drug regulator.

A drug causing or apparently causing all of the above is given to men and women who, as part of their training and/or duty of combat, are given guns and live ammunition.

All of the above reports were spontaneous reports sent through the Yellow Card System, a system that the MHRA are proud of. How many, if any at all, have the MHRA investigated?

A question I put to them under the Freedom of Information Act.

Dear Sirs,

According to the MHRA's DAP for the drug MEFLOQUINE there have been 19 reported fatalities associated.

Whilst I understand that this does not mean the drug caused the fatalities I would, however like to draw your attention to the number of people that have died by suicide whilst taking MEFLOQUINE

Your own figures suggest that, out of the 19 reported fatalities, 9 have been by completed suicide. This is significantly high for a drug used to treat malaria.

Under the terms of the freedom of information act, I would like to know how many of these 9 reports the MHRA have investigated and what were the outcomes of these investigations.

Furthermore, there have been 33 reports of suicide ideation, and 4 suicide attempts. The Psychiatric disorders reported for this particular drug are quite staggering. Again, Under the terms of the freedom of information act, I would like to know how many reports of Psychiatric disorders have been followed up by the MHRA.

Sincerely,

Bob Fiddaman

--

I am quite flabbergasted at these figures.

This, ladies and gentlemen, is the MHRA at work. They collect adverse reports (Yellow Cards) and file them. Aren't they supposed to protect the public from unsafe drugs?

How is a system that reports adverse reactions protecting the public? What are the MHRA doing regarding investigating the 9 suicides (possibly 10)?

It seems absurd that a drug given to healthy patients (soldiers) is still on the market when reports of it are possibly the cause of all of the above psychiatric disorders.

The MHRA have 20 working days to reply to my FOI request.

I will, of course, publish any reply they give to me. It's a matter of public interest.


DAP'S

Bob Fiddaman.

Glaxo Collaboration With CISNC - A Cause For Concern?

I'm often sent tips by followers and friends of my blog. This one was of particular interest to me, sent to me by a fellow Facebooker, who shall be known as "Susan."

It seems GlaxoSmithKline have teamed up with Communities In Schools of North Carolina (CISNC)

The reason? Well, it's kinda difficult to read between the lines because, as usual, any funding aimed in the direction of children's well-being is vague where pharmaceutical companies are concerned.

A press release from Education North Carolina (EDNC) shows us that GlaxoSmithKline and CISNC have "joined together to announce tools and training to ensure that students in the state’s lowest performing schools have access to high quality wraparound services to propel success in school and beyond."

Tools and training?

The press release goes on to say that...

Yesterday at CISNC’s “2015 Impact Training: Mission Possible” event in Cary, GSK announced a $360,000 grant to enable Communities In Schools of North Carolina to put high quality, research-based interventions in schools to increase attendance, improve behavior, enhance coursework, and engage more parents and families.

Should we be concerned about this or should we be applauding Glaxo?

Exactly what are research-based interventions that will improve behavior? Sadly, the press release doesn't elaborate.

I did some digging.

Glaxo, who have a HQ in Research Triangle Park, N.C, seem to be caring a lot about their community in North Carolina. On the surface, this looks good for GSK.

In 2013, GlaxoSmithKline and Community Care of North Carolina (CCNC) announced the initiation of a new approach to analyzing health information that allowed healthcare providers and payers, with the touch of a button, to analyze patients' medication challenges in real time to determine "effective ways to overcome barriers to delivering quality care."

In a 2013 press release, Glaxo announced...

The service utilizes "prescriptive analytics" to analyze the data and determine suggested interventions that are most likely to facilitate better patient engagement and ultimately, improved patient outcomes.

They added...

... the goal of the project is to assist these healthcare professionals in determining – and responding to medication-related problems that often lead patients to use their medicine incorrectly, or to not adhere to the treatment regimen prescribed by their doctor. 

Hmm.

So, I'll ask again, exactly what are research-based interventions that will improve behavior?

A quick glance of CISNC's page shows that Lisa Benna of GlaxoSmithKline is a board member. Benna is Human resources vice president at Glaxo.Previously she worked for Wyeth in a range of roles in both organization development and HR roles in R&D, Manufacturing and Commercial.

Eric Hall (Pictured above), who is the president and CEO of the Communities In Schools of North Carolina, was previously National Director of Educational Services where, according to his LinkedIn page, he managed and supported a network of over 50 non-traditional schools for students at-risk of dropout across nine states. In his role, he worked to establish value-added models of teacher evaluation, implement common core standards, develop teacher and school leader professional development pathways, and also worked closely with state and local policy-makers to ensure effective practices for serving at-risk students.

I understand that there are problem students, what I can't quite grasp here is why CISNC would team up with a pharmaceutical company who has a pretty poor record when it comes to the safety of children. Is it just purely about the $360,000 grant GSK have given them?

Will they be influenced by GSK's kind offering, will those children with behavoral problems, who, after being offered one-to-one adult supervision, be then sent down the mental health road and prescribed GlaxoSmithKline drugs such as Wellbutrin, Paxil, Lamictal, all medicines used to treat mood disorders?

Maybe I'm clutching at straws here. Maybe GlaxoSmithKline have turned a corner and are trying to make amends for their previous abhorrent treatment of children with Paxil. Maybe it's just a huge PR exercise or maybe Glaxo have ulterior motives?

Whatever way you slice it, GlaxoSmithKline have pleaded guilty for promoting medicines to kids, medicines that were unsafe for kids. Why would any organisation connected with children wish to have GSK on board?

It's a head scratcher for me.

I Tweeted the following to CISNC - they never replied.

So, I fired off an email to Jill Cox, who is the Communities In Schools of North Carolina contact. I basically want to know what these research-based interventions are and whether or not they involve the use of psychiatric medication.

Dear Jill, 

I read with great interest that CISNC have recently joined forces with GlaxoSmithKline and announced tools and training to ensure that students in lowest performing schools have access to high quality wraparound services to propel success in school and beyond.

The press release, I read, also states that "Yesterday at CISNC’s “2015 Impact Training: Mission Possible” event in Cary, GSK announced a $360,000 grant to enable Communities In Schools of North Carolina to put high quality, research-based interventions in schools to increase attendance, improve behavior, enhance coursework, and engage more parents and families."

Exactly what are research-based interventions that will improve behavior?

I'd be grateful if you could let me know the answer to this at your earliest convenience.

Sincerely,

--
Bob Fiddaman

I will, as usual, keep you updated if Jill responds.

Now, here's something that I bet you all thought you'd never read, from me at least.

I think it's safe to say that I am probably one of Glaxo's biggest online critics but I have to take my hat off to them and, probably for the first time ever, give them praise, particularly for looking after the residents of North Carolina. Credit where credit is due, I guess.

The North Carolina GlaxoSmithKline Foundation offers grants to various organisations and charities across the state of NC. Since 1986 they have awarded $65 million in grants to North Carolina nonprofit organizations. I do applaud them for that. However, this should not, nae should never, detract from the fact that GlaxoSmithKline have caused a lot of harm to a lot of people with their antidepressant Paxil - there are other prescription medications manufactured by Glaxo that have also caused death and heartache, Avandia for one.

When we balance up the good that they have, it appears, done for these nonprofit organizations in North Carolina against the bad they have done with drugs such as Paxil and Avandia we still see a company that is almost Jekyll and Hyde-like. It's almost as if grants such as the above are handed out to ease the conscience of their abhorrent history. It would be far better, in my opinion, if GlaxoSmithKline were seen to hand out cash awards to those they have harmed and not make them, or their families, have to jump through legal hoops in Paxil suicide litigation, Paxil withdrawal litigation and Paxil birth defect litigation. Glaxo will only ever settle when they know they cannot win trials. It seems absurd, therefore, that they seem to paint themselves whiter than white when handing out cash awards to nonprofit organizations across North Carolina. For families affected by Paxil, be they families who have suffered a loss of a child or adult due to Paxil induced suicide or mothers who have given birth to children with heart defects due to Paxil ingestion during pregnancy or for those affected by the horrendous withdrawal problems Paxil has caused them, seeing Glaxo hand out $65 million to organizations must be a kick in the teeth.

On one hand they giveth, on the other hand their drug, Paxil, taketh away.

And that just doesn't sit right with me. It never will.





Bob Fiddaman.

The Dirty Duchesnay Diclegis Promotion...Rumbled

Well, it appears the FDA do have teeth after all, well much bigger fangs than their British and Canadian counterparts the MHRA and Health Canada.

The American medicine regulator has fired off a warning letter to Duchesnay, the Canadian based pharmaceutical company, who recently hired the services of  socialite, and model. Kim Kardashian. It's unknown how much Kardashian was paid by Duchesnay to promote their morning sickness pill, Diclegis to her 47 million social media followers.

The FDA, in a letter to Duchesnay's Executive Vice President, Eric Gervais, have come down hard and highlighted a number of violations.

• The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts. 
• The social media post misbrands DICLEGIS within the meaning o the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. 
• These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated. 

The warning letter goes on to say that The Office of Prescription Drug Promotion (OPDP) expressed concerns regarding violative promotional activities for DICLEGIS as recently as November 2013.

On November 12, 2013, OPDP sent Duchesnay an Untitled Letter regarding a letter announcing the approval of DICLEGIS. The letter cited in the Untitled Letter was false or misleading because, among other concerns, it omitted all risk information and omitted material facts regarding DICLEGIS’ important limitation of use. OPDP is concerned that Duchesnay is continuing to promote DICLEGIS in a violative manner. 

The OPDP have now requested, according to the warning letter, that Duchesnay " immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce." They have also requested that Duchesnay, " submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. "

It only seems like yesterday that Duchesnay's Market Analyst, Danny Martel. wrote me on Twitter and told me to "educate myself" regarding Duchesnay's Diclegis. This coming after my first post about the Kardashian controversy (links below)

Good to see the FDA showing their teeth and it will be interesting to see the grovelling letter of apology Duchesnay now make to the FDA.

The FDA Warning letter to Duchesnay can be downloaded here.


Bob Fiddaman

Back Stories.

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

Lilly's Cymbalta Expert

Late last week a jury ruled that Eli Lilly and Co. isn’t liable for withdrawal symptoms including brain zaps experienced by a woman, Claudia Herrera, after she quit the antidepressant Cymbalta.

The crux of the argument, it seems, was that Lilly faced claims of not disclosing, on the warning label for Cymbalta, that 44% of users, in its own studies, suffered discontinuation side effects. Instead, plaintiff lawyers argued, Cymbalta’s label initially disclosed that 2% or more experienced certain side effects.

Lilly's legal team hit back suggesting that  the 44% figure wasn’t relevant to prescribers because, in the same studies, 22% of subjects discontinuing a placebo also reported side effects. The label discloses the Cymbalta withdrawal side effects that occurred significantly more frequently than those of people who took a sugar pill.

Obviously, both sides would need more evidence to provide to a jury. Lilly's expert. it appears, may have tipped the balance.

Douglas Jacobs, a psychiatrist, told jurors there’s no evidence in the medical literature of withdrawal symptoms lasting for months. Herrera’s symptoms might have been a manifestation of her underlying depression and anxiety disorders,

It's classic pharma defence, blame the "illness" and not the drug. So exactly who is Lilly's expert, Douglas Jacobs? Well, he and Eli Lilly go way back.

In 1991, Jacobs' brainchild, "National Depression Screening Day" was launched throughout America/ Two years later, in 1993, it was learned that "National Depression Screening Day" were funded by a number of organisations. The year 1993 saw them receive around $300,000 to $400,000." About half of that came from Eli Lilly Co (1)

Human rights organisation, the CCHR, wrote extensively about Jacobs ties with Lilly here. The article, entitled, "SIGNS OF SUICIDE – A MENTAL HEALTH QUIZ THAT FAILS", highlights how The Signs of Suicide® Prevention Program was produced and sold to schools by a non-profit organization called Screening for Mental Health. (SMH)

Founder and Director of SMH was... you've guessed it, Dr. Douglas Jacobs.

Here he is (below) receiving a cheque on behalf of SMH. The cheque of $500,000 was presented to Jacobs by Bob Pitsal of... you've guessed it, Eli Lilly.

In fact, from 1996 to 2008, Eli Lilly handed over a staggering  $3,920,425.00 to SMH. (2)

Further reading about Lilly's connections with National Depression Screening Day can be found here.


More recently, Jacobs has been in the news for controversial statements made in regard to Daniel Marsh.

Marsh was just 15 when he broke into the home of an elderly couple and brutally stabbed them to death.

Three years previously Daniel Marsh, who at that time was just 12, was honored by a local American Red Cross chapter for saving his father’s life when the elder Marsh suffered a heart attack behind the wheel of the family’s car.

So, what could change a seemingly thoughtful caring 12 year-old into a sadistic killer just three years later?

On day 7 of the trial of Daniel Marsh it emerged that he was on a number of psychiatric medications. This, from Charmayne Schmitz (3)

Wellbutrin was added to Daniel’s existing medications with the first visit to Dr. He on January 30, 2013, and was started at 50 mg. On the second visit, February 12, 2013, it was increased to 100 mg. This was after Daniel’s mother told the doctor that Daniel was attending school daily, eating properly and had no problems with the additional medication. It was noted in the file that the medication may be increased later to 150 mg. On February 27, the mother called and asked that the medication be increased to 150 mg.

Daniel was seen by Dr. He again on March 14, 2013. Daniel’s mood and anxiety were noted as improved, but he was still depressed, and somehow anxious about his friends. As on the initial visit, he answered, “No,” to Dr. He’s questions about having homicidal/suicidal feelings or tendencies. The doctor’s summary was that he “tolerates” the medication.

On April 16, 2013, the next office visit, Daniel appeared more depressed and anxious. Daniel told the doctor that he had become angry and kicked the family dog. His mother said he had stopped taking the Seroquel that had been prescribed since December of 2012 because he didn’t like how it made him feel. It was noted that he was in the severe clinical range. The Zoloft, also being prescribed since December, was increased to 150 mg at that time.

By telephone on May 1, 2013, Daniel’s mother reported that Daniel was in crisis. He refused to restart the Seroquel and she requested different medications to calm him down. Abilify was prescribed. Lab tests were ordered because Dr. He wanted to know what triggered the crisis. The tests came back positive for marijuana.

The next office visit was on May 30. Daniel showed signs of severe depression, anxiety, muscle tension and anger. The Wellbutrin was increased to 300 mg. Daniel had been recently suspended for bringing a pocket knife to school. Daniel’s mother reported that he would only take the Abilify as needed, when he had extreme anxiety, not as prescribed on a daily basis. This was the last time Dr. He saw Daniel.

Jacobs, who was an expert for the prosecution in the Marsh trial,  was adamant that drugs and doctors could not be blamed for Daniel’s violent acts, in fact Jacobs, who was paid $15,000 to review the medical records of Daniel Marsh and testify about his findings, was later cross-examined by Deputy Public Defender Ron Johnson.

Once again, Charmayne Schmitz covered the story (4)

Dr. Jacobs was disciplined once for failure to diagnose in a suicide case. He charged half his fee despite the discipline. Johnson read the finding: “Dr. Jacob’s opinion was naïve and not with common sense,” from the State Board of Maryland. Dr. Jacobs claimed that he never read their finding.

Johnson then raised the issue that Dr. Jacobs was paid by a drug company, Roche, about $30,000 to $40,000 in 1998. He also testified at a Congressional Hearing in 2000 for Roche, about a relationship between the drug Accutane and suicidal tendencies. Afterwards, the FDA issued a black box warning for Accutane. Dr. Jacobs also worked on two other cases of wrongful death for Roche.

Eli Lilly and Company was one of the contributors to his non-profit. Lilly makes Prozac. Up to 200,000 people were screened by the program. 60% of those would have possibly seen a physician, so Lilly stood to gain 120,000 patients.

Zoloft is not approved for pediatric patients, except for OCD (obsessive-compulsive disorder). This is stated in the black box warning. Jacobs said in clinical trials children have a high placebo response. So, there is no stated evidence that Zoloft works for pediatric patients. When questioned, Jacobs said the clinical experience has shown it to be beneficial.

Dr. Jacobs said there isn’t a lower dosage of Wellbutrin for a 15-year-old. It would be the same as for an adult.

Johnson raised the issue of the medical guide again. It mentions anger, violence and aggression. The doctor treating Daniel “made a clinical judgment.” Daniel was asked about these symptoms and said he had none. Daniel did tell the therapist, but he wasn’t explicit.

Trials of drugs are usually 16 weeks. There are no trials for combinations of drugs. The only evidence is from case reports. The case reports are not evidence of causation unless the FDA gets a large number of them. The doctor then dismissed a case study mentioned by Johnson from a medical journal, stating that “young kids have violent thoughts” on Prozac. The doctor said there weren’t a lot of them reported.

Daniel Marsh was sentenced to 52 years to life.


Hardly surprising then that months later Jacobs is once again in court giving evidence regarding another antidepressant, this time Eli Lilly's Cymbalta, where he told the jury that "there is no evidence of withdrawal symptoms lasting for months." Adding that, "Herrera’s symptoms might have been a manifestation of her underlying depression and anxiety disorders."

It leaves me wondering if the Jury in the Cymbalta lawsuit were made aware of Lilly's expert witness.

Google "eli lilly douglas jacobs" and see what it throws up.

A similar case to that of Herrera's is set for trial in California later today.



Bob Fiddaman.



(1) 1,300 Sites Nationwide To Test For Depression - October 05, 1993
(2) Signs of Suicide – A Mental Health Quiz That Fails - Citizens Commission on Human Rights
(3) Testimony by Marsh Psychiatrist – Part Two - Charmayne Schmitz 
(4) Harvard Psychiatrist Puts Blame on Patient and Family - Charmayne Schmitz 

Glaxo and Former Whistleblower Suspect Reunite

Straight out of a Mills & Boon romance novel comes news that Vivian Shi and GlaxoSmithKline have joined forces again.

The whole Chinagate scandal is one that keeps resurfacing.

For those who haven't been following, I'll try and break it down with bullet points.

• GSK executives were sent a series of emails that alleged that bribery was rife amongst their operations in China and the main man behind the bribery network was GSK's Mark Reilly.
• GSK then hired the services of ChinaWhys, a company run by Peter Humphrey and his wife.
• Humphrey targeted Vivian Shi, GSK's former head of government affairs. 
• According to Jim Edwards over at Business Insider, "Inside GSK, management suspected that Vivian Shi, the company's head of government affairs, sent the emails. There was no evidence, but GSK investigated her travel expenses and eventually she left the company sometime after October 2012 along with her boss, John Lepore, who joined media group Reed Elsevier as head global government affairs.
• Vivian Shi had, some years previously, been fired. GSK said it was on the grounds of alleged irregularities in travel expenses.
• Investigating partners Peter Humphrey and his wife, Yu Yingzeng, were  released from a Chinese prison early last month after each serving close to two years, a sentence that was based on charges of "illegally obtaining private information."
• Mark Reilly, who originally told Humphrey that the whistleblower allegations were false, later went on to plead guilty. He was given a suspended prison sentence and deported.
• Glaxo were fined £300 million and issued a public apology for their corrupt behaviour.

Now, it appears, Glaxo and Shi have kissed and made up. Reuters are reporting that Glaxo have rehired Shi, although it is unclear in what capacity they have rehired her for.

This is almost as bizarre as Bobby Ewing and the famous shower scene.

More news coming if and when updated.

Bob Fiddaman.

C-Day for Eli Lilly

I do love it when pharmaceutical companies enter into trials (litigation) in the small hope that they can persuade judges to toss cases on points of law.

Litigation fascinates me and it's something that has been very much part of my reading materiel over the past few years or so. I should have studied law, I guess it's never too late - sadly I have the memory of a sieve and don't think I could soak and retain any information given to me... and then sit a bar exam. So, it's just a hobby of mine to read through court transcripts and depositions.

There are many stages of litigation before it actually gets into court. In the main, both sides try and strike a deal that will suit both parties, those making the claim and those defending the claim. Pharmaceutical attorneys are in the business of saving their clients money so they will do pretty much everything in their power to make it difficult for plaintiffs. America is different to the UK in the respect that Pharmaceutical companies, when facing group actions (class-action lawsuits) try to consolidate them all so they are heard in a specific state, a state that may have a different set of rules (laws) than any other state, a state that normally gives them a better chance of success (due to favourable laws)

Pharmaceutical attorneys also apply for "Summary Judgement". In a nutshell this means that they apply to a judge and ask him to strike the cases against them because, "they will argue that no factual issues remain to be tried and therefore a cause of action or all causes of action in a complaint can be decided upon certain facts without trial."


One recent motion for "Summary Judgement" came in the cases Herrera v. Eli Lilly and Company (case no. 2:13-cv-2702-SVW-MAN) and Hexum v. Eli Lilly and Company (case no. 2:13-cv-2701-SVW-MAN)

Eli Lilly and Company are defending cases brought against them regarding their antidepressant, Cymbalta. The crux of the claim is that Lilly failed to adequately warn the plaintiffs and their physicians of Cymbalta’s true withdrawal risks. Lilly filed a motion for "Summary Judgement" and the judge (Judge Stephen V. Wilson, U.S. District Court for the Central District of California, Los Angeles) denied them this motion. Now, Lilly go to trial to face the allegations and, more than likely, they will use points of law throughout the trial, or rather they will exhaust every single avenue to try and get the cases dismissed. If this doesn't show the average person how guilty they are then I don't know what will.

The beauty of this trial is that Lilly are up against a formidable team in Baum, Hedlund, Aristei & Goldman. The Los Angeles based law firm have quite a history when going up against pharmaceutical companies. They, along with three other law firms are representing over 2,000 plaintiffs who allege they have suffered injury, and in some cases, death, due to symptoms suffered while attempting to discontinue Cymbalta.

Cymbalta has been prescribed widely and there have been many reports of severe withdrawal reactions to it. Lilly, just like other antidepressant manufacturers, chose to either ignore these reports or, as the case may be, play down the reactions, ie; blame the illness rather than the product. It's a classic stance of the pharmaceutical industry and, it has to be said, a classic stance of those who regulate prescription medications (FDA). You can judge for yourselves if you think it's difficult to taper from Cymbalta, here.

These cases are ones that I shall be keeping tabs on. The first starts Tuesday Aug. 4 in Los Angeles.

Oh to be living in California right now. I'd pretty much drop everything to be present at trial, I'd pretty much like to see Baum, Hedlund, Aristei & Goldman in action and Lilly attorneys too.

I like a flutter now and again - I'm betting that Lilly will, at some point during these series of group actions, cave in and settle. First though, they must try to find legal loopholes to avoid paying out millions of dollars, those dollars being the profit they have made on Cymbalta. Profit that came about due to their failure to warn against the horrific withdrawal reactions many have had to endure.

Let's get these items of disclosure out into the public domain, let's see how Lilly played down the risk.

Yup, I do love it when Pharmaceutical companies refuse to offer settlement. It makes blogging such a pleasure and enlightens and educates me.

Sad, I know but, hey-ho, some folks like to knit, some like to go to the gym.

I like to read and disseminate information regarding the dangers of these drugs and the way that pharmaceutical companies, such as Lilly, hold back information from the public purely to keep their pockets bulging and to keep their shareholders happy.

More coming soon.


Bob Fiddaman.