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Friday, February 12, 2016

The Great British Institution that is GSK








In the space of just one week the British pharmaceutical giant, GlaxoSmithKline, have found themselves under the world spotlight for four different stories, all of which have shown that they are, once again, up to no good...allegedly.

Feb 5, 2016

Nigeria has filed criminal charges against Glaxosmithkline Nigeria Plc, and their officials, over alleged fake lottery promo.

The ten count criminal charge number FHC/L/478C/15 was filed before a Federal high court in Lagos by the Police Legal Officer from Force Criminal Investigation Department, Force Headquarters.

(Link)

--

Feb 9, 2016

UK Seroxat Litigation to Press Ahead

Defendants, GlaxoSmithKline, sought an order that would have had the effect of bringing these proceedings to a permanent halt.

In arriving at his conclusion to not grant GlaxoSmithKline their order, Mr. Justice Foskett said...

(Link)

--

Feb 11, 2016

Glaxo Declined FDA Invitation to Discuss Paxil Adult Suicide Warning

Two further motions denied in the Dolin Paxil Suicide lawsuit.

(Link)

--

Feb 12, 2016

GSK fined £45m for paying to delay cheap versions of anti-depressant Seroxat

GSK has been fined for paying money to generic drug companies to prevent the potential entry of generic alternatives to its own "blockbuster" anti-depressant.

(Link)


The GSK mission statement is that they want to help people do more, feel better and live longer.


Hmm

Coming soon

A special investigation into GSK Nigeria PLC and, in particular, their legal counsel.


Bob Fiddaman






Thursday, February 11, 2016

Glaxo Declined FDA Invitation to Discuss Paxil Adult Suicide Warning






I love the rain 
Well, I love the rain 
Here she comes again 
I love the rain 

Ian Astbury
Billy Duffy


In appealing a judgement made by Judge James B. Zagel in the WENDY B. DOLIN, Plaintiff v. SMITHKLINE BEECHAM CORPORATION, Defendant, case Glaxo have found themselves in hot water after a recent court document was made public.

The document is yet another ruling by Judge James B. Zagel who, it appears, is the current thorn in the side of GlaxoSmithKline who have been pulling all the strings to try and halt, be it temporary or permanent, this case going to trial.

Back stories of Glaxo's shenanigans at the foot of this post.

The latest attempt by Glaxo to undermine the previous judgments in this Paxil suicide case comes as no surprise, to me at least.

Basically they, via their highly paid legal team of King & Spalding, have just had two further motions denied by Judge James B. Zagel. In giving his opinion Zagel offers his reasoning, and it just doesn't look good for Glaxo, particularly where their defence of Paxil causing suicide in adults is concerned.

Zagel's Memorandum and Opinion Order shows that...

"On June 22, 2007, the FDA extended an invitation to GSK to discuss the option of keeping the 2006 Paxil-specific adult language in its current label by requesting a formal meeting. Specifically, the FDA told GSK: “If you would like to discuss this matter further [keeping the 2006 Paxil-specific adult warning in the Paxil label], please submit a formal meeting request.” GSK, however, never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data. Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of the 2006 Paxil-specific adult warnings."

Zagel denied Glaxo's  “implied conflict preemption” motion,

The second motion (summary judgment) filed by GSK centres around their claim that the prescribing doctor  knew that Paxil increased the risk of adult suicidal behavior prior to prescribing the drug to Wndy Dolin's husband, Stewart. GSK also argued that the Paxil warning label is "adequate" as a matter of law. Glaxo also went over old ground that Judge Zagel has previously ruled on, that being that  they (GSK) cannot be held liable because Mr. Dolin ingested the generic form of Paxil and not the name-brand drug itself.

On denying Glaxo's four-part summary judgement motion, Zagel said that according to testimony the doctor in question did not know that Paxil increased the risk of suicidal behavior in adults over 24 prior to prescribing Paxil to Mr. Dolin in 2010. Furthermore, he  relied upon the 2010 Paxil label before prescribing Paxil to Mr. Dolin and that the 2010 Paxil label does not adequately warn about the risk of suicidal behavior beyond age 24.

Zagel added, "This is enough to defeat GSK’s motion for summary judgment."

It's raining pretty hard for Glaxo at the moment. In the UK, on Feb 4th 2016, Glaxo had similar requests turned down - once again the drug involved is Paxil, although it is sold and marketed as Seroxat in the UK. (See UK Seroxat Litigation to Press Ahead)


Dolin is represented by Michael L. Baum, Bijan Esfandiari, Frances M. Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC and David Rapoport, Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.

GlaxoSmithKline is represented by Alan S. Gilbert of Dentons, Andrew T. Bayman, Todd P. Davis and Heather M. Howard of King & Spalding LLP and Robert E. Glanville, Tamar P. Halpern and Eva Canaan of Phillips Lytle LLP.

Source: Public Access to Court Documents (Pacer) 


Bob Fiddaman

Back Stories

DOLIN V GSK












Tuesday, February 09, 2016

Exclusive: UK Seroxat Litigation to Press Ahead





FOR IMMEDIATE RELEASE

Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. (1)

Defendants, GlaxoSmithKline, sought an order that would have had the effect of bringing these proceedings to a permanent halt.

In arriving at his conclusion to not grant GlaxoSmithKline their order, Mr. Justice Foskett said...


"The Defendant is anxious (it might be said, over-anxious) to stop this litigation in its tracks. The motivation may simply be a total conviction that there is, in effect, no case to answer and that it is wrong to be harassed with unmeritorious claims. Alternatively, it may derive simply from a desire not to have to face in this jurisdiction the kind of claims brought in the USA and elsewhere. It may, of course, be a combination of both."

Mr. Justice Foskett had previously asked both parties to supply him with a summary of other litigation throughout the world concerning Paroxetine. In his Judgement Mr. Justice Foskett said...


"Although the list of actions provided to me on behalf of the Claimants is longer than that provided by the Defendant, a cursory comparison suggests that they largely cover the same material. Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a "putative class action" consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged "discontinuation symptoms." In January 2012 a class-wide settlement with no admission of liability was achieved. Again, the claims would have gone to a jury trial in the absence of settlement."


It's good to see this on-going litigation finally get the thumbs-up to move forward to trial, and in my view the Honorable Mr Justice Foskett has to be applauded here for meticulously combing through arguments from both parties.

Mr Justice Foskett's Judgment seems to have paved the way for both parties to, at the very least, now plan where they are going with this.


The case between: SANDRA BAILEY AND OTHERS (Claimants) and  GLAXOSMITHKLINE (UK) LIMITED (Defendant) will now proceed to trial.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)

Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.



Declaration of Interests: I am one of the claimants.

(1) Bailey & Ors v Glaxosmithkline (UK) Ltd [2016] EWHC 178 (QB) (04 February 2016) 














Friday, February 05, 2016

Birth Defect Ethics, Are They as Simple as Black & White?






Quite often questions come to me, usually at night whilst in bed alone, save for the background music of Hans Zimmer that helps me drift off to sleep.

One such question, invoked another, they both kept me awake for most of the night as I mulled over possible answers, the most obvious answer, of course, would be jail time.

Here's what I was mulling over.

SCENARIO:

A husband and wife have a disagreement over treatment. Mrs Smith has recently been told that she is pregnant, she has also been diagnosed with depression and has been told by her physician that if left untreated it could harm her fetus. Mrs Smith believes the risk of taking antidepressants during pregnancy is too high, she has read stories that they can cause birth defects.

Her husband, Mr Smith, does not believe the risks are that high, he's read many published papers from academics that suggest antidepressant treatment will save the baby from becoming distressed inside the womb and depressed when born.

So, here's the dilemma. It's his child just as much as it is his wife's. They are at loggerheads over the decision to medicate - does the expectant mother have the final say?

This isn't the question that kept me awake.

Mr Smith, decides to treat his wife with antidepressants (without her knowledge... ergo, without her consent)

Every day he crushes two antidepressants into her dinner - he does so because he wants to protect his child from being distressed in the womb or being born depressed. Hey, he's read the literature and believes it to be true.

24 weeks later

Sadly, Mr and Mrs Smith are informed that the fetus has developed defects. Mrs Smith's OBGYN has informed them both that the fetus has developed a number of birth defects, namely; cardiac defects (heart), pulmonary defects (lung), neural-tube defects (brain and spinal cord). Chances of survival, at birth, he informs them, are very slim.

Mrs Smith, along with her husband, decide to abort the fetus, it's a heart-wrenching decision.

Aftermath

Shorty after the termination of his wife's pregnancy, Mr Smith comes clean and tells his wife that he had secretly been administering antidepressants into her food and now believes that the medication may have contributed to the birth defects in their child.

So, here's the two questions...

1. What legal action, if any, could Mrs Smith take against her husband?

2. What defence, if any, could Mr Smith use in a court of Law?

Be interesting to hear/read your comments on this one either via the comments section (below) or via my Twitter account (here) or Facebook Blog account (here)


Bob Fiddaman.


Related:

Prozac: Uncharted Down Syndrome Territory













Thursday, February 04, 2016

Prozac: Uncharted Down Syndrome Territory








The University of Texas Southwestern Medical Center have announced new research and planning to see if Prozac (fluoxetine) can improve brain development, intellectual functioning, and behavior of children with Down Syndrome (DS) when given prenatally and postnatally during the first 2 years of life.

According to a breakdown of the study, found here, pregnant women and their unborn child will be assigned randomly to receive either fluoxetine or placebo in the study. Participants will have a 2 in 3 chance of receiving fluoxetine or placebo.


The study suggests...

During the prenatal study period, participants will take their assigned medication orally. After her child is born, the mother will stop taking the oral tablet of her assigned medication and her child will start a liquid solution of the medication to be taken orally. After birth, the fluoxetine dose will be adjusted as needed.

This, as far as I am aware, is a first as the ingestion of antidepressants by pregnant mothers has never been studied in a clinical trial before because, to date, it has always been deemed unethical. It throws up debate, much of it centered around antidepressants and the birth defect link, although this study's aim is not to prove whether or not antidepressant use in pregnancy can harm the fetus.

Very little has been mentioned in the press about this study save for a spattering here and there citing a study in mice whereby it was shown that mice with the extra copy of Down syndrome genes (like humans with DS), apparently improved the disturbed processes of brain development/function when treated with Prozac.

It's a tricky area as the target subject in this new study are both pregnant mothers and fetuses that have already been deemed to be carrying DS genes. Any help DS children can get in life should be applauded but is it right to put them at risk?

Half of the funds for the study have been raised by father, Paul Watson, who heard about the success of the studies in mice. Paul's son was born with Down syndrome.

Here's NBC reporting on the study... (If video does not load then it can be viewed here)




For years Prozac has been cited as one of the more safer SSRis on the market, in the UK, for example, it can still be prescribed to minors legally, the only SSRi that, apparently, does not show evidence of inducing suicidal thoughts in children and teenagers taking it. Surprisingly, the American drug regulator, the FDA, feel that Prozac should, just like the other SSRis on the market, carry a black box warning listing the dangers of its use in children and adolescents. As with all SSRis Prozac has never been deemed safe to give to pregnant mothers, that decision is left to both treating physician and the mother.

This study bothers me somewhat. Who has made this decision whereby it is now deemed ethical to study an antidepressant in a living fetus, end of the day a fetus with the down syndrome gene has just as much right to life as a "normal, healthy" human fetus.

Why has this study been given the green light, moreover, isn't this merely a guinea pig trial using a drug that can potentially cause more harm to the fetus on someone (the fetus) who has no say in the matter?

The study's lead author, Dr. Carol Tamminga, said, "the medical community has been giving Prozac to children with Down syndrome for years, but the effects of giving it to children in utero haven’t been tested." She added, "and this will really be the first controlled trial where we will get to test does this really work or not."

Tamminga's biography page shows that she has served as a Member and Chair of the Psychopharmacological Drugs Advisory Committee of the FDA. However, there is no mention of the payments made to her by Prozac manufacturers, Eli Lilly.

Jan. to Dec. 2011 - $1,574 for Business travel and other value.

Jan. to Dec. 2013 - $466 for Business travel and other value.

Jan. to Dec. 2013 - $267 for  Business Meals.

Tamminga has also received research support from Sunovion and travel funds from Autiphony Therapeutics and has served as a consultant for Astellas, Kaye Scholer LLC for Pfizer, and Lundbeck.

According to Drugwatch it is estimated that thousands of people have filed Prozac lawsuits citing a variety of adverse events including mental, emotional and physical suffering. Early cases have claimed that Prozac has caused an increased risk of suicidal thoughts and violent behaviour. Drugwatch also claims that by the year 2000 Prozac manufacturer, Eli Lilly had reportedly paid out more than $50 million to settle more than 30 Prozac lawsuits related to murders or suicides.

Drugwatch also claims that Prozac has been linked with birth defects, including anencephaly, a fatal defect in the neural tube. Newborns also can experience septal defects, damaged hearts or cleft lip or palate.

Yet here we are in 2016 putting this powerful SSRi into the bodies of pregnant mothers who are carrying a fetus with DS genes. Furthermore, here we are in 2016 giving a newborn baby from the age of 0-2 years the liquid formulation of Prozac.

Background of the study can be read here. Results are expected to be available within 12 to 18 months.

I do hope all the participants are given all the information about Prozac, including the information about the $50 million paid out in Prozac lawsuits related to murders or suicides and also Prozac's link to birth defects.

I honestly don't know what to say anymore.

Bob Fiddaman.


Related

Prozac Took My Child (Guest Post)

Open Verdict Returned in Prozac Related Death














Tuesday, February 02, 2016

Pharmaceutical Rape - Do We Need Video Evidence?







A series of guest posts on David Healy's blog (links at the foot of this post) have coined a new phrase, "Pharmaceutical Rape."

The posts, eloquently written by Laurie Oakley, a first-time author (Crazy And It Was - Surviving the Corporate Pharmaceutical Corruption of Western Medicine) and, in her own words, a simplicity junkie who delights in the rhythms of the so-called ordinary, have caused quite a stir and are a series of extracts taken from Laurie's second book, 'Rape Is Not A Metaphor - A Framework For Understanding Everyday Pharmaceutical Harms', due for publication later this year.

When one reads the headline, 'Pharmaceutical Rape' one can take it as the writings of a conspiracy theorist who is merely out to grab headlines, to shock, or one can also see it, as I do, as the quintessential analogy of the harms pharmaceutical companies (and their wares) can cause those who are not fully informed of potential risks when taking prescription medications. (That means all of us).

In fact, it's not even an analogy as it stands very much alone in its own right, yet we find ourselves explaining or clarifying it. Nor should it be deemed a metaphor, to do so would distract the reader from the harsh reality of it all. It is exactly what it is, it exists yet it's taken mother of two, Laurie Oakley, to tap into our psyche to show us what is already in front of us, such is the stranglehold and culture of the pharmaceutical industry.


In her latest post, Pharmaceutical Rape: The Good Patient, Laurie defines pharmaceutical rape culture. Take a long hard look at this paragraph, it's pure poetry...

A pharmaceutical rape culture is a culture in which iatrogenic harms are pervasive and normalized due to societal attitudes about medicine and health care. It is a complex set of beliefs that tolerates the commercialization of healthcare and supports everyday harms in medical and mental health care settings. It is a society where harm is only acknowledged as rare, yet is accepted as necessary, and inevitable. In a pharmaceutical rape culture, doctors and patients unknowingly trust what are oftentimes pseudo-scientific facts put forth by drug makers about drug safety. Both doctors and patients end up disbelieving the reality of the adverse events they see, and instead believe alternate explanations for such events. A pharmaceutical rape culture condones widespread medical harms that are rooted in reckless practices within the industry-government-medical trade alliance because multiple societal systems are involved in producing, reproducing, and disseminating “information” about pharmaceutical products. This “information” sat-urates the public and reinforces that alliance.

Coining the term, 'Pharmaceutical Rape', Laurie writes...

Pharmaceutical rape stems from the collective decisions of powerful individuals within an industry-government-medical trade alliance. It is an offense that results in an invasive violation of bodily autonomy for the victim. A pharmaceutical product is introduced into one’s body that causes harm — something one did not consent to — something that one had a legal right to more information about so that a different choice could have been made. Most often, it involves trusting and having that trust violated.

Which leads me to a video that has recently gone viral on the internet. It's not for the faint-hearted. Before you click the play button imagine, if you will, that the officers featured in the video, are, to family and friends, law abiding citizens who never cross the line between right and wrong. On the face of things they are decent human beings who have sworn an allegiance to protect the public.

Take a good look at their version of events compared to the version that was captured on CCTV. Also, listen to the county sheriff at the end of the video.





It's pretty shocking huh?

The video above depicts what is wrong with power. Imagine if the only angle of this footage that ever became available was the angle filmed by officers on the day, the victim, in this case Derrick Price, would no longer be the victim and, more than likely, the officers would have been praised for keeping crime off the streets.

The video is, more or less, an insight into how the public can be vocal when they see an abuse of power. Sadly, in the world of the pharmaceutical industry, the public rarely get an insight into what really goes on behind closed doors - many cases of harms caused by pharmaceutical drugs are settled and evidences are sealed and locked away from the public. We have no leaked videos of pharmaceutical bosses preparing their reps to promote drugs for use in children...when those drugs have never been deemed safe in children, nor do we have video footage of reps bribing doctors with monetary payments or lavish "gifts". More importantly, for me at least, is that not one single CEO of any pharmaceutical company, to my knowledge, has lambasted and taken action against those managers or key opinion leaders who knowingly violated the bodily autonomy of the countless victims who have suffered at the hands of pharmaceutical drugs, many of whom have been children.

Let's not forget the bystanders, namely the medicine drug regulators who have, for years, sat back and watched this pharmaceutical rape and said nothing - an accessory to pharmaceutical rape, perhaps? Remember, this isn't just pharmaceutical rape, it's pharmaceutical rape of minors.

Is the video above anymore shocking than the points raised by Laurie Oakley?

Judge for yourself by reading the first three parts in a series of five.







Bob Fiddaman


Further Reading:

















Wednesday, January 27, 2016

The Mental Health "Stigma"











Two news items of interest were sent to me over the past few days, both, it would seem, are aligned with one another.

First off, let's take a look out the worn out phrase that lots of mental health specialists and even celebrities seem to trawl out every 5 minutes or so.

The mental health stigma

This from the Mental Health Commission in Australia, I plucked the first one that appeared in a Google search, all mental health foundations say pretty much the same.

Three out of four people with a mental illness report that they have experienced stigma. Stigma is a mark of disgrace that sets a person apart. When a person is labelled by their illness they are seen as part of a stereotyped group. Negative attitudes create prejudice which leads to negative actions and discrimination.

There's not a day goes by when we hear the calls of organizations or celebrities calling for an end to mental health stigma. Canadian writer and actress, Mary Walsh, is one such celebrity.

Walsh is a spokesperson for Bell Let's Talk, an organization that has, according to their website, "Committed over $100 million to support a wide range of mental health organizations, large and small, from coast to coast to coast."

Bell Media is Canada’s premier multimedia company with leading assets in television, radio, out-of-home advertising, and digital media. Bell Media owns 30 local television stations led by CTV, Canada’s number 1 television network.

Today, Today, Bell will donate 5¢ more to mental health initiatives for every:


  • Text message sent
  • Mobile & long distance call made
  • Tweet using #BellLetsTalk
  • Share of the Facebook image

That's a very generous offer given that the figure could run into the millions of dollars.

I'm in agreement with them to a certain extent. Yes, we should talk about mental health but the subject matter shouldn't be what more can they do to help depressed people, it should be what harm are they doing to depressed people.

BellLetsTalk, however, seem to back up their stigma claims with some "facts", of which there are many. Here's a few...


In Canada, only 1 out of 5 children who need mental health services receives them. - CMHA

Mood and anxiety disorders impact an estimated 22% of the Canadian population. - CMHA

Suicide accounts for 24% of all deaths among 15-24 year-olds and 16% among 25-44 year-olds. - CMHA

CMHA stands for the Canadian Mental Health Association, their homepage shows one of their principle sponsors to be Lundbeck, manufacturers and marketers of such drugs as Celexa (citalopram) and Lexapro (escitalopram) - which leads me nicely to the second news item that was sent to me this week.

Yesterday the New York Times (NYT) ran a feature regarding an apparent influential government-appointed health panel who have called for women be screened for depression during pregnancy and after giving birth.

Their claims, according to the NYT, "comes in the wake of new evidence that maternal mental illness is more common than previously thought; that many cases of what has been called postpartum depression actually start during pregnancy; and that left untreated, these mood disorders can be detrimental to the well-being of children."

The panel gave its recommendation, which was published in the journal JAMA, a “B” rating, which means depression screening must be covered under the Affordable Care Act.

In the NYT feature a woman/mother is quoted, seemingly to support the call for "maternal mental illness."

Melissa Mead, 30, of The Dalles, Ore, tells the NYT that shortly after her son Brady’s birth, she experienced postpartum depression, anxiety and O.C.D. In her own words she "cried continually, barely slept, rarely left home and was scared to death that my baby was going to suffocate."

Hello!

Isn't this a normal response to giving birth, isn't this just a motherly instinct?

The NYT goes on to say that...

After a year, she saw a psychiatrist for talk therapy. When her second son, Emmett, was born, and she had more symptoms, including fearing that she would stab herself with a kitchen knife, Ms. Mead tried several medications until one worked. She now volunteers for Postpartum Support International.

Several medications until one worked? Are we led to believe that some of them didn't work? Shock, horror, you mean some antidepressants don't work?

Mead is now a volunteer for Postpartum Support International (PSI), an organization whose purpose it is to increase awareness among public and professional communities about the emotional changes that women experience during pregnancy and postpartum.

In 2015 the PSI and Tree of Hope Foundation held their Annual Conference. The conference theme was "Planting seeds of hope: overcoming stigma, increasing options and embracing innovative treatments."

Ah, there's that word - "treatments."

Because the NYT featured a woman's story to support the calls for more screening for women with "maternal mental illness", I thought I'd throw in a story about the kind of treatments used to treat mothers during pregnancy.

Lundbeck's Celexa (citalopram) is one such treatment.

Back in 2013 Scottish mom, Cheryl Buchanan, wrote a guest post for this blog. It was with regard to the birth defects caused to her unborn child. Cheryl aborted her child at 23 weeks after being told that the fetus had severe abnormalities which meant she was incompatible with life.

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl.

Scans had detected a series of anomalies in her unborn child, namely...

  • Diaphragmatic hernia or eventration
  • Long bone immobility
  • Cystic hygroma 
  • Unilateral cleft hand
  • Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

  • (Foetal death in utero) - drug related - possible
  • (Pulmonary hypoplasia) - drug related - possible
  • (Diaphragmatic hernia) - drug related - possible
  • (Hand deformity) - drug related - possible
  • (Skin laxity) - drug related - possible
  • (Skin swelling) - drug related - possible
  • (Drug exposure in utero) - drug related - possible


The actual documents can be viewed here.

Now, I'm sure many people get the cold shoulder treatment when diagnosed (labelled) with a mental illness - but is there really a stigma attached to it?

I'll go out on a limb here and suggest that there is more of a stigma attached to people like Cheryl Buchanan speaking out against the use of antidepressants during pregnancy - people like Cheryl are deemed irresponsible for taking the stance that she has - normally by healthcare professionals and those who wish to believe that antidepressants are safe during pregnancy.

You want facts?

During the citalopram animal reproduction studies it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Meantime, more calls for screening women for mental health illnesses is being touted in the widely read New York Times. If you think the pharmaceutical companies, including Lundbeck, aren't behind this latest push then think again.

Both stories call for more help with the stigma associated with mental illness, of course they do - Big Pharma have something to sell and they want you in their corner helping them push their drugs on unsuspecting mothers.


Bob Fiddaman



















Thursday, January 21, 2016

Two Former Glaxo Scientists Charged With Trying to Steal Data






It never rains but it pours for poor old Andrew Witty. Last week it was learned that he had been implicated for ignoring the claims of an employee that dishonest study data was used to promote the effectiveness of a smoking-cessation product, NiQuitin. And now the company that he is CEO of are (yet again) in the news.

It appears that the dust hasn't yet settled in China and two former scientists at a GlaxoSmithKline research facility in Pennsylvania have been indicted for allegedly scheming to steal data on an in-development cancer drug from the research facility and sell them in China.

Yu Xue and Lucy Xi were scientists working at GSK's research facility in Upper Merion, Pennsylvania and had allegedly engaged in a scheme to steal GSK research data, procedures and manufacturing processes for biopharmaceutical products.

Xue, it is alleged, emailed confidential information from her GSK email account to her personal email account so she could then forward it to Li and Mei, two of three others named in the complaint, with whom she, in 2012, founded Chinese companies Renopharma Inc., Nanjing Renopharma Ltd. and Shainghai Renopharma Ltd.

Although this doesn't show GSK in a bad light it does beg the question about the security at GSK.

The indictment charges all five people with conspiring to fraudulently obtain property from GlaxoSmithKline, theft and wire fraud, according to Business Insider.

It's a pity we don't get Glaxo employees trying to steal GSK's procedures for researching, developing and manufacturing other products, Paxil and Wellbutrin for example. Or maybe more of their reps coming forward and blowing the whistle on the illegal promotion of these two particular antidepressants.

So, already in 2016 we have two news stories featuring British pharmaceutical giant, Glaxo. One showing that dishonest study data was used to promote the effectiveness of NiQuitin, the other for showing how two of their own employees breached security and tried to pass off trade secrets.

Ah well, they're getting better - at least no kids have died as a result of their latest shenanigans.

Bob Fiddaman.






Wednesday, January 20, 2016

Goldilocks, the Untold Paxil Story





I wrote this back in 2011 and think it's worthy of a re-post.

It's a modern day version of a tale we are all familiar with - it's also something we should all pay heed to - when reading you can substitute 'Paxil' for any other antidepressant currently on the market.

**WARNING** Contains profanity.


Goldilocks and the Three Bears...A 21st Century Perspective


Once upon a time there was a little girl called Goldilocks.

Goldilocks was 10 years old and had been diagnosed with a mental disorder, her inability to stay awake in the classroom and consequent poor marks meant she had been deemed as having GAD, Generalized Anxiety Disorder. The school psychiatrist said that Goldilocks was "stressing" about things at night and not getting enough sleep, this would often result in her falling asleep during school lessons. He prescribed her Paxil, a selective serotonin reuptake inhibitor [SSRi] but it didn't agree with her, in fact she became suicidal whilst on it. Later, her psychiatrist switched medications, opting instead for Cymbalta. She was to take her dose just before she went to bed at night.

On the morning of May 20, 2011, Goldilocks had decided to "bunk off" school. Her morning had started badly, her parents had been arguing again about money, her father was pissed off at her mother because there was no food in the cupboards, this meant Goldilocks had to go without breakfast. She left her parents house hungry and sought solace in the forest adjacent to the family home.

It was around about midday that Goldilocks felt severe hunger pangs, these were increased by a sweet smell in the distance, she knew immediately that the aroma drifting through the forest was that of Porridge and she was certain she caught a whiff of maple syrup too. "Yummy", she thought as her little legs carried her toward the sugary delight.


The Bear family were rushing around that morning. Mummy Bear was panic-stricken as she had run out of her medication, ironically that medication was Paxil. Baby Bear looked on in horror as he saw his mummy anxious, agitated, shaking violently and yelling at the top of her voice, "WHERE'S MY PAXIL?"



**Actual document from SmithKline Beecham**




Daddy Bear was busying himself making Porridge. Baby Bear liked it when daddy made the Porridge as he always added maple syrup.

"Have you taken your Ritalin Baby Bear?" Daddy Bear asked.

"Yes daddy, with my milk as I always do each morning", replied the 9 year old Baby Bear.

"OH, IT'S ALRIGHT FOR YOU ISN'T IT. AS LONG AS YOU'VE TAKEN YOUR MEDS THEN EVERYTHING IS OKAY. WHAT ABOUT ME...WHERE'S MY PAXIL?", Mummy Bear howled.

"Calm down dear," Daddy Bear interjected.

"CALM DOWN...CALM FUCKING DOWN? DO YOU KNOW WHAT IT'S LIKE WHEN I MISS MY DOSE OF PAXIL? HAVE YOU EVER FUCKING EXPERIENCED THE BRAIN ZAPS AND NAUSEA, YOU INCONSIDERATE PRICK"

Mummy Bear was having one of those bad days thought Baby Bear.

"Okay, let's head on down to the pharmacy, the Porridge can wait, it's too hot to eat at the moment anyhow. We can take a drive down to the village and let it cool down, it will be just perfect by the time we get back", announced Daddy Bear.

Daddy Bear wasn't looking forward to driving the car, he had a fear of driving, a deep rooted problem from his childhood, his psychiatrist had told him. Daddy Bear had been prescribed Xanax, a benzodiazepine.


Goldilocks had saw the Bear family climb into the family saloon, the mother seemed like a right bitch, swearing and shouting at her husband and child.

Once the saloon had turned the corner, Goldilocks made her way toward an open window she had spied upon her approach. The sweet smell of maple syrup was overpowering. She climbed through the aperture and made her way to the kitchen where she saw three bowls of Porridge on the table.

She tested each bowl before gulping down the contents of the small child bowl, the others were just too hot.

Goldilocks was feeling comfortable in her surroundings and she lost all sense of time and fear. She sat on a chair in the lounge and flicked on the radio that was close by.

"...and we are going over to to our reporter on the scene right now. Ed, what can you tell us about the shooting?"

"Well, it appears that a woman walked into the Mahoney Drug Store about 15 minutes ago and calmly walked up to a shop assistant and shot her in the head. I've been privy to see the CCTV footage and it appears the woman had been somewhat agitated upon entering the store. It also appears that she was refused medication by one of the staff members, the video shows her trashing the store before leaving through the door. 5 minutes later she returned, walked calmly up to the shop assistant and pulled out a firearm and shot the assistant in the head. Police have secured the area and it seems another two people have been found shot in a family saloon, early indications report that it is a man and small child but we cannot confirm that just yet..."

Goldilocks knew Mahoney's Drug Store, it was just a five minute journey from her school. Oh well, she thought, probably someone with mental health problems.

She turned off the radio and headed up the stairs where she found a bed, the overpowering urge to sleep had come on like a speeding train. She lay on the bed and reached for the half empty glass of milk on the bedside cabinet, next to the glass was a box of Ritalin, she had heard of this drug before, sixteen of her classmates were taking it. She carefully opened the blister pack and, one by one, swallowed the 14 tablets.

It was to be the final sleep she would ever have.


Bob Fiddaman










Tuesday, January 19, 2016

Is Contraceptive Pill, Rigevidon, Safe?





Is the contraceptive pill, Rigevidon, safe? Well, the MHRA seem to think so, unless, of course, they have been misquoted by the press.

I don't normally write about drugs outside of the psychiatric medication circle but this one grabbed my attention as it's from Birmingham and we can see clearly how the MHRA operate. To be honest, I'm flabbergasted at their shrug of the shoulders. I'll explain why later. First, here's the story...

Teaching assistant Fallan Kurek, 21, Tamworth, died after taking the contraceptive pill, Rigevidon and an inquest into her death has opened this morning.

According to the Birmingham Mail, "A scan revealed that Fallan had a large clot on her lung, causing the right side of her heart to become inflamed." Furthermore, her parents claim that doctors told them that she may have died as a result of taking the contraceptive pill, Rigevidon.

The shoulder shruggers, the Medicines and Healthcare products Regulatory Agency (MHRA), were contacted by the Birmingham Mail and  "insists the pill is safe and that women should continue to take it."

Wait a minute here...

Here we have parents of a dead girl who claim that doctors told them that their daughter may have died as a result of taking a drug - and the MHRA are disputing this because they claim the pill is safe?

So, let's just get this straight.

If a doctor, or doctors, file an adverse reaction report to the MHRA implicating a drug in the death of someone then the MHRA (because they are already convinced of a drug's safety) dismiss the adverse reaction? Furthermore, they go public with their opinion?

I'm somewhat baffled. Isn't the premise of the regulator to investigate adverse reaction reports impartially?

How are they being impartial in this instance with such a broad statement?

Let's take a look at the patient information leaflet (PIL) for Rigevidon, ironically hosted on the MHRA website.


The pill and thrombosis

Your chances of having a blood clot are only increased slightly by taking the Pill.

• Of 100,000 women who are not on the Pill and not pregnant, about 5 will have a blood clot in a year.
• Of 100,000 women taking a Pill such as Rigevidon, about 15 will have a blood clot in a year

So, 10 more women are more likely to develop a blood clot when taking Rigevidon, yet the MHRA claim it's "safe and that women should continue to take it."

The leaflet goes on to tell us...

Venous thrombosis

The use of any combined pill, including Rigevidon, increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any contraceptive pill.

Yet the MHRA claim it's "safe and that women should continue to take it."

The leaflet goes on to tell us possible side effects...

Like all medicines, Rigevidon can cause side effects, although not everybody gets them.

These side effects have been reported in women using the pill, which can occur in the first few months after starting Rigevidon, but they usually stop once your body has adjusted to the pill.

The following serious adverse events have been reported in women using combined oral contraceptives...


  • Venous thromboembolism (a blood clot in vessels)
  • Arterial thromboembolic disorders (the blocking of an artery)


Yet the MHRA claim it's "safe and that women should continue to take it."

Maybe the Birmingham Mail misquoted the MHRA or maybe the MHRA have now decided to ignore warnings on patient information leaflets?

I'm perplexed as to why the MHRA can claim a drug is safe and that women should continue taking it when the patient information leaflet suggests otherwise.

Rigevidon is marketed and manufactured by Hungarian pharmaceutical company, Gedeon Richter.


Bob Fiddaman.


**UPDATE**

Coroner returns narrative verdict.

http://www.birminghammail.co.uk/news/midlands-news/fallan-kurek-inquest-contraceptive-pill-10755513



Wednesday, January 13, 2016

Paxil Suicide Case Set For Trial






For those who have been following this particular case you'll know some of the methods GlaxoSmithKline's lawyers, King & Spalding, have been using to try and get the case dismissed before it goes to trial.


Background

In June 2010 Stewart Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression".

Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.

Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine (Paxil)

Stewart's wife, Wendy Dolin, filed suit against GSK claiming Paxil had induced the suicide of her husband. ((Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)


Legal Background

First off, GSK argued that Dolin was taking the generic version of Paxil marketed and manufactured by Mylan, ergo they were not responsible for the drug inducing suicide. However, a  U.S. District Judge told Mylan that they would not have to face any trial but said Glaxo was responsible for the generic drug’s design and warning label and would have to face negligence claims.

Since filing, Dolin has been sent more than 30 subpoenas from GSK, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself.

GSK then turned their attention to four expert witnesses. One of those witnesses, Dr. David Healy, came under heavy fire from Glaxo’s gunslingers, King & Spalding. They had accused Healy of being a radical activist who held an extreme bias against GSK. Furthermore, GSK had probed into Healy’s private life and had, during a 10 hour deposition, talked more about his finances than the actual science behind Paxil and induced suicide.

GSK filed motions to exclude all four expert testimonies from the trial, they were denied these motions by Judge James B. Zagel who, in summary, said...

“I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable.”

Moving Forward

Yesterday (Tuesday Jan 12) Judge James B. Zagel ruled that the suit filed by Dolin should now move straight to trial. Glaxo, via their attorneys, weren't happy and, according to Law360, spent nearly an hour arguing that David Healy, an expert for Dolin, should reveal documents tied to a patient of his who committed suicide. However, privacy laws suggest that Healy could be fired if he were to reveal patient information. One would have thought that Glaxo know all about privacy laws, it was they who told Healy that he could not reveal any information he gleaned by looking at GSK's own internal documents in a previous case against them, a case incidentally that implicated Paxil and suicide. GSK lost that case - Judgement below.



Dolin is represented by Michael L. Baum, Bijan Esfandiari, Frances M. Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC and David Rapoport, Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.

GlaxoSmithKline is represented by Alan S. Gilbert of Dentons, Andrew T. Bayman, Todd P. Davis and Heather M. Howard of King & Spalding LLP and Robert E. Glanville, Tamar P. Halpern and Eva Canaan of Phillips Lytle LLP.




Here's Wendy speaking openly about her husband's induced suicide. She speaks with grace, courage and dignity, quite the opposite to how GlaxoSmithKline and their highly paid attorneys have treated her.




Bob Fiddaman.













GlaxoSmithKline: No Smoke Without Fire - Witty Implicated






I love stumbling on court documents, especially when those documents are complaints against British pharmaceutical giant, GlaxoSmithKline.

GlaxoSmithKline made claims that they were going to be more transparent after the Department of Justice handed down a record breaking $3 billion fine to them back in 2012.

Cynics, such as me, didn't believe them. Looks like this old cynic has been proven right.

Former GlaxoSmithKline biostatistics manager, Alexandre Selmani, has filed a whistleblower lawsuit in a New Jersey state court. The complaint alleges that GSK fired Selmani for alleging dishonest study data was used to promote the effectiveness of a smoking-cessation product, NiQuitin.

The complaint alleges that GSK engaged in an “illegal, deceptive marketing program” to promote the product “without justification” as a “significant advance” in nicotine treatment.

More importantly, than previous whistleblower lawsuits, this complaint implicates Glaxo's CEO, Andrew Witty.

This, from the complaint, verbatim.

In 2012, Seimani discovered that there were numerous mistakes made in the "Smokers Health Project" being conducted by Defendant Kotler, Selmani's direct supervisor and a Director of Biostatistics, at Defendant GSK , specifically the mistakes involved with the Phantom Patch study 53820642 and the Nicotine Film study RH01589, which affected the projects quality. 
As early as the spring of 2012 Selmani brought the mistakes to the attention of Defendant Kotler and demonstrated to Defendant Kotler that his mistakes rendered the results of the project to be unreliable.
In mid-December of 2012, having had no success with Defendant Kotler, Selmani advised the company's then vice president Howard Marsh (hereinafter "Marsh',) via e-mail, that mistakes were being made in the "Smokers Health Project", specifically Selmani showed Marsh that the study on the Phantom Patch 53820642 had numerous mistakes in the statistical methodology which affected the quality of the results. These studies had been conducted by Defendant Kotler.
Within fifteen minutes of Selmani sending the e-mail to Marsh, Marsh responded to Selmani via e-mail which stated: "Whilst it is important to create a culture of technical debate and challenge, it is vital that we do this in a professional manner. I appreciate that sometimes on email the tone of your intent may be misconstrued". Still nothing was done to correct the mistakes. 
On February 18, 2013, Selmani again brought the mistakes in the studies 53820642 and RH01589, to the attention of Defendant Witty, the CEO of the company, specifically, by sending an email advising him of the mistakes in some of the CH clinical studies which had the capacity to cause negative consequences and potential health and safety issues for the general public. In the e-mail, Selmani reported that his current manager, Defendant Kotler, refused to make corrections to the errors in the clinical studies as set forth supra. The errors related to the studies were outlined in the a-mail. They were ignored and the studies were made public on April 8, 2014 in the Journal of Psychopharmacology. 
Selmani sent out various other emails voicing his concerns over the discrepancies, one in July 2013 to James Ford VP Counsel as well as Kenneth James, Head of Research and Development. Furthermore, On June 2, 2014, Selmani sent an e-mail to Defendant Emma Walmsley the company's CEO GSK CH (London, UK). Following this email Selmani was told by Human Resources that he should no longer report to Kotler, however, he was not given another manager to report to.

After 9 months, it appears GSK had a change of heart and told Selmani that he could report to Kotler once again. Unfortunately, for Selmani, it was Kotler who was authorized to conduct his performance review.

No prizes for guessing what happened next folks.

Selmani received low performance scores and was eventually terminated from his employment with GSK on October 17, 2015.

More from the complaint...

Selmani seeks compensatory and punitive damages, attorneys' fees, costs, and such other relief as the Court deems equitable and just.
At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly were deliberate co-conspirators of the aforesaid fraudulent and/or illegal activity.
At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly knew or should have reasonably known of the aforesaid fraudulent and/or illegal activity.
At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly had a duty to properly investigate and/or address the aforesaid fraudulent and/or illegal activity.
At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly failed to properly investigate and/or address and/or report the aforesaid fraudulent and/or illegal activity.
At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly, by and through their knowledge of and/or complicity with the aforesaid fraudulent and/or illegal activity, aided and/or abetted the same. 

The full complaint can be found here.


Bob Fiddaman.