Zantac Lawsuit


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

Wednesday, February 24, 2016

Further Email to GlaxoSmithKline Nigeria




Uchenna Uwechia, GSK Consumer Nigeria Plc's Legal Director and Company Secretary


Following on from Glaxo's denial that any of their employers were involved in the recent allegations coming out of Nigeria regarding a promotional lottery scam.

Basically, three employees of GlaxoSmithKline Nigeria PLC have been accused of  running a promotional scam for its energy drink, Lucozade, and its soft drink, Ribena.

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, Abuja, and named Dayanand Thandalam Siram, Jonathan Murray, Uche Uwechia (all of GlaxoSmithKline Nigeria) who, along with GlaxoSmithKline Nigeria are due to be arraigned before the court next month.

I wrote to Glaxo, they told me...

"We have been advised that charges contained in the publication are unsustainable and we are taking appropriate legal steps to address the issue."

As some of you will know, I researched this alleged scam for quite a while. My research found that one of the accused, namely, Uche Uwechia, aka Uchenna Uwechia, is the current Legal Director for GlaxoSmithKline Nigeria. Further research showed that Uwechia was previously employed by the Gulf Bank of Nigeria PLC and had been arraigned on a 21 count charge that had implicated him with various fraudulent activities during his time at the bank.

Despite endless hours of research I was unable to find the outcome of that particular trial, it seems to have vanished into thin air, which would suggest that a deal was struck with the prosecution. (Complete back story here)

So, I have put the following to Noah Falana, Consumer Relations Specialist, GSK South Africa, who wrote to me regarding the alleged lottery scam.

Dear Noah Falana,
Thank you for issuing this statement.
Just one more question that you may or may not know the answer to?
In 2014 GSK Nigeria's Legal Director, Uchenna Uwechia, was arraigned on a 21 count charge with regard to his previous employment at the Gulf Bank of Nigeria.
Could you tell me the outcome of this trial? Presumably Mr. Uwechia either had the charges dropped or entered into a plea bargain with the prosecution.
Source here - How Massive Fraud Liquidated Gulf Bank - http://theunion.com.ng/crime/how-massive-fraud-liquidated-gulf-bank/
Sincerely,
Bob Fiddaman

 As yet, Glaxo have failed to respond.


Bob Fiddaman






Monday, February 22, 2016

Statement from GSK Regarding "Fake Lottery Promo"






The following is a statement sent to me from GlaxoSmithKline Nigeria PLC with regard to recent reports in the Nigerian press that three of its employees have had a ten count criminal charge (number FHC/L/478C/15) filed before a Federal high court in Lagos by the Police Legal Officer from Force Criminal Investigation Department, Force Headquarters, Abuja.

Back story at the foot of this statement.



Dear Bob Fiddaman,
Thank you for your email and for bringing this matter to our attention.
It has come to our notice from the Management Team that the names mentioned below are not on suspension.
Please find herewith the response from our management team:
T. S. Dayanand (Managing Director); Jonathan Murray (Finance Director) and Uchenna Uwechia (Legal Director) of GSK Nigeria are not on suspension. No charge has been served on GSK or any of its employees to date. 
We have been advised that charges contained in the publication (link embedded) are unsustainable and we are taking appropriate legal steps to address the issue.
GSK continues to take steps to ensure that its operations in Nigeria are in compliance with existing laws and regulations.

Best Regards Noah Falana. Consumer Relations Specialist GSK South Africa


Back story here.


Bob Fiddaman.







Thursday, February 18, 2016

EXCLUSIVE: GSK's Promo Scam & The Gulf Bank of Nigeria





When you write non-fiction, you sit down at your desk with a pile of notebooks, newspaper clippings, and books and you research and put a book together the way you would a jigsaw puzzle.
 ~ Janine di Giovanni.




GSK's Promo Scam & The Gulf Bank of Nigeria

Investigation by Bob Fiddaman
(Updates at foot of post)



No matter what part of the world GSK find themselves in there's always trouble just around the corner.

News coming out of Nigeria will add to GSK's woes after it's been alleged that employees have been running a promotional scam for its energy drink, Lucozade, and its soft drink, Ribena. (Link)

According to the charge, Dayanand Thandalam Siram, Jonathan Murray, Uchenna Uwechia, all of Glaxosmithkline Consumer Nigeria PLC, persuaded the citizens of Nigeria to buy their products using the slogan,  “BIG CASH GIVE AWAY”. (Photo above)


The offence alleged to have been committed by Glaxosmithkline Consumer Nigeria Plc and its officials are contrary to and punishable under section(1)3 of the advance fee fraud and other related offences Act laws of the Federation of Nigeria.

Section(1)3 of the Advance Fee Fraud and other Fraud Related Offences Act is defined as...

A person who, being the occupier or is concerned in the management of any premises, causes or knowingly permits the premises to be used for any purpose which constitutes an offence under this Act commits an offence and is liable on conviction to imprisonment for a term of not less more than 15 years and not less than five years without the option of a fine.

Dayanand Thandalam Siram, Jonathan Murray, Uche Uwechia, Glaxosmithkline Consumer Nigeria PLC and others, now at large, are alleged to have established and keep the premises of 1, Industrial Avenue, Ilupeju, Lagos as a place for the purpose of a lottery to be used for the purposes of obtaining by false pretense from the Nigerian public.

GSK's head office in Nigeria is located at 1, Industrial Avenue, Ilupeju, Lagos so it would appear that those who stand accused of the offences carried out those offences at GSK's Head Office in Lagos.

It's alleged that Rahul Culaco, Omolara Banjoko, Adebayo Elegbe, Shelewa Ashimi, and Friesland Campina Wamco Nigeria Plc also used GSK's Head Office to carry out offences.

Rahul Colaco's Facebook page (here) claims that he is currently living in Nigeria yet works at Dutch Lady, which is in Malaysia?

Omolara Banjoko's LinkedIn page (here) states that she is currently Senior Brand Manager at Royal FrieslandCampina in Lagos, Nigeria. Friesland Campina WAMCO Nigeria PLC is a multinational manufacturing company: it is an affiliate of Royal Friesland Campina of The Netherlands, the world’s largest dairy cooperative.

Nothing is known about Adebayo Elegbe or Shelewa Ashimi.

It's unknown exactly what sort of criminal offence was carried out here. Did Glaxo and their employees pay out cash to "winners" of the lottery who weren't really winners? A check of the Lagos Judiciary website sees no case filed.

In May 2015 it was reported that a total of 14 million naira was given out to lucky consumers of the Lucozade Ribena drink promotion. Eight winners were rewarded with the sum of N1,000,000 (roughly $5000) each, 600 winners of N10,000 (roughly $50) were also electronically drawn through the eight-week campaign period. The eight lucky millionaires, selected randomly through electronic draws held at the company’s corporate office in Lagos, were Glory Idoda, Henry Oboro, Jude Nwosu and Osawe Valentina,  Akan Essinwang, Ibe Ejike, Tomide and James Etukpo. It's unknown if any of the eight millionaires are implicated in the fraud or, indeed, if the other alleged winners were actually real or, if indeed, they were paid. See video.





I asked GSK Consumer Relations if Dayanand Thandalam Siram, Jonathan Murray and Uchenna Uwechia had been put under suspension pending an inquiry. Despite my email being addressed to Andrew Witty and GSK Board Members, a Glaxo spokesperson told me, "You have reached GSK’s Consumer Relations Department in the UK and we are only able to handle enquiries and complaints for products marketed in Great Britain and Republic of Ireland."

So, I wrote to GSK Nigeria, as yet they have not replied.

The story doesn't end here, in fact it takes a rather bizarre twist.

THREE GLAXO EMPLOYEES ACCUSED



Dayanand Thandalam Sriram - Managing Director of GlaxoSmithKline Consumer Nigeria Plc

In 2014 appointed Mr. Dayanand Thandalam Sriram (above) as the Managing Director of the Company, he'd previously joined the company in 1995 taking on Sales leadership roles. He is also on the Board of Directors at GlaxoSmithKline Consumer Nigeria Plc.




Jonathan Murray - Senior Finance Director at GlaxoSmithKline Consumer Nigeria Plc

Jonathan Murray (above) is the Senior Finance Director at GlaxoSmithKline Consumer Nigeria Plc. Previously Murray held the positions of Financial Controller and Senior Business Risk Consultant at GSK.




Uchenna Uwechia, GSK Consumer Nigeria Plc's Legal Director and Company Secretary

Uchenna Uwechia, GSK Consumer Nigeria Plc's Legal Director and Company Secretary, has quite a history. And this is where the story gets rather interesting, well, it does for me, at least, as none of the media outlets reporting on the promotional scam have mentioned what I have learned about Mr Uchenna Uwechia.

It's had me spending hours, days, weeks, trawling the internet and has been as frustrating as trying to work out the plot for the movie, Inception.

Before joining Glaxo in 2006, Uwechia was the Company Secretary & Legal Adviser of the Gulf Bank of Nigeria Plc.  (See Fig 1) Uwechia, along with seven others, were, in 2014, arraigned on an amended 21-count charge bordering on fraud and financial malpractices. All of the 8 accused were alleged to have converted over N12 billion from the defunct bank, Gulf Bank of Nigeria Plc (in the guise of granting loans and overdraft facilities to various companies, without appropriate accounting records.)

The accused were alleged to have converted and appropriated a total of $55.3million (£38million) and over N3.7billion belonging to the bank.

Uwechia held the position of Company Secretary & Legal Adviser of the Gulf Bank of Nigeria Plc between the years 2001 – April 2006 and was accused of aiding Prince Adekunle Adeyeba Johnson, the Director of the bank, in converting the landed property to personal use.


Fig 1
Snapshot LinkedIn page taken 7th Feb, 2015


Here's Commissioner of Police Tunde Ogunshakin talking about the investigation into the Gulf Bank of Nigeria...

"Investigations further revealed that the bank expended over $9.8 million and N1.8 billion through LYK Engineering Limited, for the development of Petrochemical and Refinery Project, yet the project never existed. There is no company named Akwa Ibom Refinery and Petrochemical Limited. We have a letter from the Corporate Affairs Commission (CAC) to that effect. "

Why did Glaxo employ someone from a bank that had just been liquidated amid fraud allegations, it just doesn't make any business sense?

As good as I am at research (self appointed blowing of trumpets here) I've not been able to find out the outcome of the Gulf Bank of Nigeria trial. For whatever reason, the outcome, if indeed an outcome was ever reached, has never been made public - was a plea bargain agreement with the prosecution made?

With this in mind, I wrote to both the Nigerian Deposit Insurance Corporation (NDIC) and the Nigerian Police Force and asked if a verdict was ever reached regarding this case. Neither of them replied.

If anyone should know how corruption can tarnish the image of a company then GlaxoSmithKline should, right?

In 2014, Glaxo were found guilty of bribery throughout its China operations. Glaxo were handed down a fine of almost $500 million and five of the company's managers, including Mark Reilly, its former top China executive, were convicted of bribery-related charges and received suspended prison sentences.

At the time of the guilty verdict in China various independent analysts and capital market operators, in and around Nigeria, said that the Nigerian government should also mount searchlight on the operations of GSK Nigeria to ensure that the company is not employing the same unethical practices it is being accused of in China to boost the Nigerian operations.

It appears as though they were right given the recent alleged criminal activity (Fake lotto) by GlaxoSmithKline Nigeria PLC and three of its employees.

This is not some minor blip, this is three main men at GlaxoSmithKline Nigeria PLC, one of whom has already been embroiled in fraud allegations. It's some example they appear to be setting out in Lagos.

Corruption, it seems, is a major problem in Nigeria. In 2015, Nigerian President Muhammadu Buhari took steps and cracked the whip against Nigeria's corruption. In July, he sacked all military and security chiefs. In August, he forced the resignation of the leadership suite of the national oil company.

Nigerian business analyst, Yusha'u Aliyu, has even gone on record as saying, "There's corruption everywhere in the global economy, no matter where you look. But in developing countries and especially in Nigeria, it's extreme." 

Are GlaxoSmithKline Nigeria part of the extreme corruption that Aliyu speaks of?

I took to Twitter to try and find out if GlaxoSmithKline were trying to play down the Ribena/Lucozade scam. I tweeted them a series of questions, to my surprise they replied. I asked them how I could get in touch with GSK Nigeria's Legal Counsel, Uchenna Uwechia? Their reply to me and my subsequent response can be seen in the image below.


They stopped engaging with me after my replies.


So, what we have here is GlaxoSmithKline's current legal counsel in Nigeria named in a 2016 complaint which is contrary to and punishable under section(1)3 of the advance fee fraud and other related offences Act laws of the Federation of Nigeria. What we also have is GlaxoSmithKline's current legal counsel in Nigeria implicated in fraud or theft of over N15 billion (US$75 million) (£50 million) from Gulf Bank Nigeria PLC.

What we don't appear to have is the outcome of the trial - it's not available folks and I doubt very much if the Nigerian authorities will ever release that information. I just don't have the resources to pull such information. Who knows, maybe journalists with the backing of their newspapers, will be able to pull the information that is seemingly all elusive.

Reporting in Nigeria is somewhat of a minefield. According to a BBC report from March 2015, "In Nigeria, established newspapers are paid to keep big stories off the front page. Adverts are supposed to buy silence.

"Often, Next would run a story in its popular weekend edition, only for editors to arrive at the office on Monday to meet an aggrieved marketing team - certain big advertisers had terminated their business that morning."

Ironic

How's this for irony?

In November 2013 Uchenna Uwechia spoke at a programme jointly organised by the Society for Corporate Governance Nigeria (SCGN) and the Nigerian Stock Exchange (NSE). He said...

"Complying with the legal and regulatory framework by corporate players was crucial in improving corporate governance.
"The consequences of non-compliance included disgorgement, refunds, reprimands, fines/penalties, suspension, revocation of licence, criminal prosecution, as well as loss of reputation."
I've wrote to all the editors at the top newspapers in Nigeria, I've even emailed the Lagos Judiciary asking them all the same question. What was the outcome of the Gulf Bank of Nigeria PLC trial. It's been two weeks now and not one single reply.

I even wrote to the UK Serious Fraud Office (SFO) to alert them of my findings. The SFO are currently investigating GSK and they did write back to me to thank me for the information and to tell me that it had "been forwarded to the case team."

The elusive outcome of the Gulf Bank trial may interest the American Department of Justice (DOJ) too. Commissioner of Police Tunde Ogunshakin, who was the head of  the Special Fraud Unit (SFU) who investigated the Gulf Bank fraud, said, "The investigation revealed the theft and laundering of billions of Naira and millions of U. S Dollars." 

Laundering US Dollars, huh?

I can only assume that none of those implicated in the Gulf Bank fraud were ever prosecuted, so they were either found not guilty or a secret deal was struck with the prosecution. Whatever way you slice it, it's hardly comforting for GlaxoSmithKline's shareholders knowing that the current Head of Legal/Company Secretary at GlaxoSmithKline Nigeria has been implicated in a fake lottery scam carried out on GSK's premises. Furthermore, it would appear, guilty or not, this is not the first time Glaxo's Nigerian Head of Legal has been implicated in fraudulent activities.

If anyone can find the outcome of the trial it will be the SFO or DOJ. Here's hoping they can. It may be another opportunity to raid GSK offices, seeing as one of those accused in the Gulf Bank fraud is currently employed by GlaxoSmithKline Nigeria.

To throw further worms into the can I've seemingly opened, I'll leave the last words to Segun Adeleye, Editor of WorldStage, an online news magazine in Nigeria whom I wrote to requesting the outcome of the Gulf Bank Trial. He told me...

"Sorry, we don't have new information about the story, though we will make inquiry, in fact, we lost our initial material that you sent to hackers attacks sometime ago."

The mind boggles at just how deep this case involving GSK's current Head of Legal in Nigeria goes.


**UPDATE**

Interesting development in the Gulf Bank case.

It appears the Judge who arraigned the original 8 is now the subject of an investigation regarding bribes. (Source)

Special thanks to @NeLLLieBly  for this information.

--

**2ND UPDATE**

Statement from GSK Regarding "Fake Lottery Promo" (HERE)


**3RD UPDATE**
Snapshot of blog visits 21 March 2016.
Glaxo Nigeria, Glaxo HQ in London and the US Department of Justice all visit this post within minutes of one another.


Click image to enlarge

Bob Fiddaman.










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:


















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