Blogging Since 2006

Blogging Since 2006
WHEN INJUSTICE BECOMES LAW, RESISTANCE BECOMES DUTY

Wednesday, April 16, 2014

Jordan and Lebanon - The Next GSK Scandal




Coming hot on the heels of allegations of bribery in China, Iraq Poland, GSK now find themselves investigating yet more claims of bribery, this time it's the turn of Jordan and Lebanon.

Credit where credit is due, GSK are the most consistent pharmaceutical company in the world for giving writers like me something that I can get my teeth into.

The Wall Street Journal [WSJ], who, last week, broke the news about the bribery claims in Iraq, have been sent yet more emails alleging that GSK's employees bribed doctors in Jordan and Lebanon by offering perks such as flexible travel arrangements and free samples that doctors could sell on.

The WSJ are claiming that GSK has launched an internal investigation into its operations in the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and Iraq.

Furthermore, the WSJ reports that GSK were sent emails from 'a person' who alleged that...

"Sales representatives allegedly bribed doctors in Jordan to prescribe Glaxo drugs by issuing free samples that the doctors were then allowed to sell on, according to the emails. 
"Glaxo representatives also allegedly permitted Jordanian doctors to bring their spouses on business trips that Glaxo paid for, according to the emails. Doctors were issued with business-class tickets to attend conferences but would exchange them at travel agencies for two economy-class tickets, allowing their spouses or other family members to come along free, a practice local Glaxo employees were aware of, according to the emails."

The emails also allege that GSK sales reps "gave doctors free Synflorix vials as part of an incentive scheme to get them to prescribe the vaccine and not its competitors."

GSK's past era of paying key opinion leaders [KOL's] in the USA also seems to have spread across the middle east as they are accused of to making payments to "key opinion-leader" doctors--influential and leading practitioners in their field--for lectures and other speaking engagements that may not have taken place, the emails allege, in return for them prescribing more Glaxo drugs."

GlaxoSmithKline have issued a statement on their website, which reads...

“GSK can confirm we are investigating allegations regarding the activity of a small number of individuals in our operations in Jordan and Lebanon. We started investigating using internal and external teams as soon as we became aware of these claims. These investigations have not yet concluded.

“We have zero tolerance for unethical or illegal behaviour. We expect our employees to uphold our high standards and we believe the vast majority do so. GSK welcomes and respects people speaking up where they have concerns and we have a number of channels internally to enable them to do this, including hotlines and online portals.

“We implement regular training for employees in compliance matters and we continue to improve compliance processes and procedures wherever we see a need.

“We publicly disclose all cases of misconduct identified in the company. Last year there were 161 violations relating to breaches of our sales and marketing polices, resulting in 48 dismissals and 113 written warnings. These numbers are very similar to those reported by other companies in our sector.

“We are confident in our processes and controls and that we do not have a systemic issue with unethical behaviour in GSK.

“However, we recognise there are concerns regarding interactions between pharmaceutical companies and doctors, particularly related to perceptions of conflicts of interest. That’s why we are the first company to have committed to undertake fundamental reforms to our business model to eliminate this concern by stopping payments to doctors to speak about our products, stopping payments to doctors to attend medical conferences and stopping pay for our sales reps being linked to individual sales targets.”


It's an interesting statement.

Let's just assume that GSK are a person. Take a look at the statement again.

"We publicly disclose all cases of misconduct identified in the company. Last year there were 161 violations relating to breaches of our sales and marketing polices, resulting in 48 dismissals and 113 written warnings. These numbers are very similar to those reported by other companies in our sector."

The above paragraph is quite striking. What GSK are doing here is acknowledging there is a problem within their company but they are deflecting it by saying they are no worse than any other pharmaceutical company.

Saying they publicly disclose all cases of misconducted is, technically, true but they do so with minimum effect.

Glaxo pay millions and millions of dollars to promote their drugs. They also pay millions and millions of dollars to defend litigation brought against them by members of the public harmed by the very same products their senior managers have instructed their sales reps to push onto doctors.

What we have here is a walking, talking psychopathic entity that cannot stop misbehaving - it's ingrained in the culture at GSK and nobody, not even Andrew Witty, can stop the spread of this cancer.

Witty can paint the picture of how GSK are helping millions of people worldwide and how he is behind the "patient first" program but let's face it, there has not been one single cure for cancer... and the cancer that exists at GSK is the type that lays dormant then grows undetected right under their noses. When detected, they claim they have it under control... it's pretty damned obvious that they don't.

If only they could create a drug to stop people bribing others... they have the perfect subjects in-house for a clinical trial.

GSK's company tagline is "Do more, feel better, live longer" - I wonder if this is the mantra senior managers use when training their sales reps?

The WSJ article can be read here.

Bob Fiddaman


Back Stories:

Witty Plays Down China Scandal

GSK Latest Corruption Scandal in Iraq

GSK - Three Strikes...and You're Still In






AC/DC - The Band Plays On




Regular readers and friends of mine will know that I am a huge fan of AC/DC.

Rumours were abound on Tuesday that they were retiring due to a band member falling ill.

It's probably the worst kept secret in rock n' roll. Malcolm, AC/DC's founding member and rhythm guitarist, has been ill for some time. Most hardcore fans have known this, most, if not all, have remained quiet out of respect for the guy.

AC/DC were due in the studio later next month to start on a new album, it's unknown if they will be pressing ahead with the new album next month but they are going to continue making music according to their press release via the AC/DC Facebook page...

"After forty years of life dedicated to AC/DC, guitarist and founding member Malcolm Young is taking a break from the band due to ill health. Malcolm would like to thank the group’s diehard legions of fans worldwide for their never-ending love and support.
"In light of this news, AC/DC asks that Malcolm and his family’s privacy be respected during this time. The band will continue to make music."

It's pretty hard to describe my love for this band. I first heard them in 1978, I'd previously been listening to glam rock bands such as Mud, The Sweet and Slade...then I heard AC/DC and my leg took on a life of its own.

Since that point I've seen them on every tour, purchased every album, video and DVD [and bootlegs].

Safe to say, they are part of my life.

As guitarists go, Malcolm Young is probably one of the finest guitarists to ever walk the earth. It's all about timing and Malcolm has the art perfected.

So, I write about the pharmaceutical industry, drug regulators, psychiatrists and antidepressants, very dark subject matter particularly when it involves dead children.

I've escaped from those dark places many times. AC/DC bring the much needed light into my life.

I've paid my respects to Bon, AC/DC's former vocalist, when I visited his resting place in Freemantle, Perth, W. Australia, a few years ago.

I'll pay my respects to Malcolm by respecting his privacy.

You are, without a doubt, the Pele of rhythm guitarists.

I salute you.

Bob Fiddaman


Monday, April 14, 2014

UPDATED: GSK's UK Seretide Promotion





Tonight BBC Panorama exposes yet more allegations of bribery from British pharmaceutical company GlaxoSmithKline. The program, which airs on BBC One at 8.30pm, will reveal new evidence that GSK was recently paying doctors to boost prescriptions of their asthma drug Seretide in Poland.

Hmmm...

Why go as far as Poland?

The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry at arm’s length of the ABPI.

Trawling through the number of case reports on their website we can see that GlaxoSmithKline were, in 2012, being investigated due to allegations made by one of its employees regarding the promotion of, and/or staff training on, Revolade (eltrombopag), Seretide (fluticasone/salmeterol) and ReQuip XL (ropinirole).

This wasn't in Poland folks... it was in the UK.

This from the alleged breaches...

The complainant alleged that the hospital business manager’s team falsified a Seretide product certification examination. All of the managers sat the product knowledge test at the same time and the answers were read out by a team member as instructed by a manager. This deliberate action, following limited training, meant that the hospital business managers were not adequately trained on Seretide when they engaged with customers. The complainant subsequently provided additional material in support of this allegation.

The complainant alleged that it was not a bona fide training event and the answers were read out to participants. GlaxoSmithKline explained that it was a knowledge consolidation event rather than evaluation, at the end of an online product training course. The Panel noted that, according to the unsigned witness statements provided by GlaxoSmithKline, whilst at least one participant completed the test alone, the majority appeared to have completed the informal test collaboratively, with the benefit of discussion.

The Panel noted GlaxoSmithKline’s submission that when HHBMs had discussions with payer customers to support specific brands, they underwent product training. The Panel noted GlaxoSmithKline’s submission that in 2011 HHBMs received 20 days of training of which 13 were product training which GlaxoSmithKline considered provided them with knowledge above and beyond that required by their role. The Panel noted that the HHBM training for Seretide in 2011 comprised product training on two separate days (neither were full days). In addition, the HHBM team did distance learning for Seretide and brand managers delivered updates at HHBM team meetings. The Panel noted GlaxoSmithKline’s submission about the need for further training to enable HHBMs to have more detailed discussions. The Panel noted that GlaxoSmithKline had, in effect, acknowledged the need for further training on Seretide. The Panel noted that the complainant bore the burden of proof. The Panel had some concerns about the HHBM Seretide training but did not consider that the complainant had demonstrated on the balance of probabilities that the product training was inadequate given the nature of calls likely to be made; no breach of the Code was ruled.

PDF Here.

Be interesting to see if this employee, who made the allegations, is still around. Hey, if we can find the mysterious American woman, (see 1, and 2) then a UK employee of Glaxo should be a breeze.

Were you that employee?

Do you know who that employee was?

Drop me a line.

Updated: Here's the Panorama programme that aired last night.





Bob Fiddaman.











GSK - Three Strikes...and You're Still In.




What's the connection between China, Iraq and Poland?

Here's some subtle clues.


Clue Number One

Clue Number Two

Clue Number Three


Here's another clue in the form of a photograph.



Yesterday I witnessed a footballer for Swansea City being sent off by the referee for committing two fouls. He will now face a ban.

In the space of a few months British pharmaceutical company GSK have been embroiled in illegal activities in China, Iraq and Poland - They have not been punished for allowing these illegal activities to happen.

BBC's Panorama - Who's Paying Your Doctor?, airs tonight in the UK. The investigation will show how eleven doctors and a GSK regional manager have been charged over alleged corruption between 2010 and 2012.

A former sales rep said doctors were paid to promote GSK's asthma drug Seretide.

All part of an era huh?

GSK have issued a statement ahead of tonight's programme. You will note the lack of accountability.

“A GSK programme to assist in improving diagnostic standards and medical training, in order to benefit patient treatment and care with regard to respiratory disease, was run by doctors and other healthcare professionals in Poland. The programme ran from 2010 to 2012.

“Training on proper diagnostics for medical personnel and group meetings for patients were organised as part of this programme. These sessions were delivered by specialist healthcare professionals who, based on contracts signed with GSK, received payments appropriate to the scope of work as well as their level of knowledge and experience. The provision of sessions under this programme was agreed with the Polish healthcare centres.

“Following receipt of allegations regarding the conduct of the programme in the Lodz region, GSK has investigated the matter, using resources from both inside and outside the company. The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result.

“We continue to investigate these matters and are co-operating fully with the CBA.

“We agree there is a need to modernise interactions between the pharmaceutical industry and healthcare professionals to ensure patients’ interests are always put first and to eliminate even a perception of a conflict of interest. This is why we have made, and will continue to make, fundamental changes to our business such as opening up access to our clinical trial data, changing how we pay our sales representatives and stopping payments to healthcare professionals for speaking engagements and for attendance at medical conferences.”

Good old Glaxo - making an official statement AFTER they have been busted.


Bob Fiddaman







Friday, April 11, 2014

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists


Joanne Thomas - Paxil Birth Defects Mom



Continuing on from Part I...

In brief, Joanne Thomas filed a Paxil birth defect lawsuit against GSK in 2006. GSK argued that she was out of time. [Statute of Limitations] The Judge and subsequent appeal panel agreed with GSK.

What I am about to show you should have been brought to the attention of the Judge and the appeal panel. Joanne's law team, unfortunately, didn't join the dots - that was left for myself and Joanne to work out.

Before I present this new [unseen] evidence it's important to know that GSK had a golden opportunity to warn the public about Paxil's propensity to cause birth defects. The following evidence, almost verbatim, was taken from the Kilker v GlaxoSmithKline birth defect trial. A trial that saw the jury find Paxil responsible for causing the birth defects in Lyam Kilker.

A long, long time ago, as they say, Glaxo purchased the compound [paroxetine] from a Danish company called Ferrosan. Ferrosan had done the preliminary animal studies to look at teratogenicity. Study 295 saw Ferrosan give Paxil to pregnant female rats. The rats who didn't get Paxil [they were given nothing] 12% of the rat pups were dead by the fourth day after they were born. However, and here's the important bit, the rats that were given Paxil [5mg] 65% of the rat pups were dead by day 4. The ones that were dosed with 15 milligrams of Paxil, 92% of the rat pups were dead by day 4. And those given 50mg of Paxil... all the rat pups died.

Armed with this information Ferrosan, after selling the compound to GSK, then SmithKline Beecham, wrote a memo in 1980 telling GSK about the study and the high risk of embryolethality [dead fetuses]

What did Glaxo do with this information?

Well, they sat on it.

Step forward to 1994. Paxil was doing great, it was a blockbuster. 'Ka Ching' was echoing around the corridors of GSK. Glaxo, being the money-making corporate company that they are, wanted more sales though. America wasn't enough. So, they decided to target Japan. One small problem though. The Japanese have big issues when it comes to birth defects, they've seen their fair share of them over the years what with environmental disasters such as Hiroshima, Nagasaki and Minamata. If the Japanese found the Ferrosan study then that could have affected GSK's American market.

So, how could they [GSK] hide the rat pup studies from the Japanese? Well, they designed a study for them but it was a study that would have serious implications for GSK and Paxil. They autopsied one of the rat pups, hazard a guess at what they found?

One of the pups was found to have an edema, swelling around the heart, and it had a ventricular septal defect.

Now, one would have thought at this point that this particular finding would have caused alarm bells to ring. 

Not so.

They minimized it. In their conclusions they didn't even mention it. It is buried in the back of the study in an appendix.

My question is pretty simple. How can GlaxoSmithKline's lawyers argue that Joanne Thomas was late in filing her action and that her unborn son was non viable when they knew many, many years before Joanne fell pregnant with Ryan, that Paxil could cause birth defects in rat pups? They knew, the consumer didn't. How can they blame the consumer for not knowing?

Furthermore, even if Joanne did find out at the time that she was taking Paxil that it was dangerous to her unborn child, how did GlaxoSmithKline's lawyers expect her to just stop taking it when Paxil has one of the highest incidents of withdrawal rates in the SSRi group of medicines? 

Glaxo quietly settled a previous Paxil addiction lawsuit in the US back in the mid 2000's with over 3,000 claims against them.



Now Here's Twist Number One

As I mentioned above it came to light during the Kilker trial that Glaxo knew very early on that Paxil was causing rat pups to die and also causing heart defects. That was clearly established in the trial.

Also, during the Kilker trial it came to light, via GlaxoSmithKline internal emails, that Glaxo had been contacted by a consumer in 2001. Many lawyers and advocates have, for years, being trying to track down this woman. Sadly, no name was attached to the emails. Glaxo were afforded the privilege of removing the name, probably for 'data protection' reasons.

Here's the emails that were sent to Glaxo in 2001

"I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I've been taking Paxil, which is truly a miracle drug. I've been panic-free with this drug and have been able to go on with a normal life.

"I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

"The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

"To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

"My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don't want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

"Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

"Please contact me as soon as possible ... Please don't forget about me."



The woman sent a second email, on 1 June 2001.


"This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

"I am in no way insinuating your product did this to my child. I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

"I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

"Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help."

The following GSK internal memo from June 2001 refers to her emails.

"Report 2001014040-1 describes the occurrence of a terminated pregnancy in a female of unknown age prescribed paroxetine (Paxil) for panic disorder.

"This report was received from the patient and has not been confirmed by a physician or other health care professional. Concurrent medications and medical conditions were not known.

"Four-and-a-half years ago, the patient started Paxil (dose unknown). Since taking Paxil, the patient noted she has been panic-free and has been able to go on with a normal life.

"Patient discovered she was pregnant in December 2000 while being treated with Paxil. However, she reported that at six months gestation the pregnancy had to be terminated because the fetus was diagnosed as having Truncus arteriosis.

"Her physician told her that the child would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered, if he was able to make it to that time."

GSK emailed the following response to the woman on 6 June 2001.

"Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy.

"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

"Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

"We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

"Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department ..."

But an internal GSK internal document relating to the correspondence, headed "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

So, an admittance by GSK that Paxil was related to the birth defect, right?

The mystery woman, whose name was redacted on the documents presented at the Kilker trial, has been the subject of much debate ever since the emails were made public. Just exactly who was she?

Professor David Healy, who actually gave evidence in the Kilker trial, has tried hunting her down in two excellent posts of his, American Woman and American Woman 2. I'd even wrote about the mysterious woman in my book, The evidence, however, is clear, the Seroxat scandal.

For the first time I can now reveal that the mystery woman was Joanne Thomas, mother of the "non-vialble fetus". The same mother who has been told she cannot pursue her complaint against GSK because she is out of time [statute of limitations]

It makes a mockery of the law, don't you think?

  • File an adverse event to a pharmaceutical company.
  • Have that very same company admit via internal emails to one another that Paxil was the cause of the adverse event.
  • Have no feedback from that same pharmaceutical company, despite asking them if Paxil is safe to take during pregnancy.
  • Learn six years down the line that Paxil has been classed as a teratogen.
  • File suit against the company for causing birth defects.
  • Have the pharmaceutical company attorneys tell you that you are out of time.



Talk about having your cake and eating it!



So, in 2001, GSK received one spontaneous report from a mother who had terminated her pregnancy, this mother was taking Paxil at the time she terminated because her fetus was deemed to have  a rare congenital heart disease.

Why, at that point, didn't GlaxoSmithKline, change the product information labelling on Paxil?

More importantly, how can GlaxoSmithKline argue that Joanne Thomas is out of time to file a case against them [statute of limitations] when, it could be argued, that she already made Glaxo aware of her son's birth defects back in 2001?

I'd love to know if Glaxo handed over full disclosure to the attorneys representing Joanne Thomas?

Glaxo corresponded with Joanne via emails back in 2001, did they present these emails to Joanne's attorneys, if not, why not?

Twist Number Two

Glaxo had Joanne's name on file, they had it since 2001. Are we to believe that during Joanne's case they didn't know that she was the mother who contacted them back in 2001, the same woman who, through Glaxo's own internal emails, aborted her child because the Paxil  she ingested was almost certainly the cause of the birth defects?

Here's where the case takes a rather bizarre turn.

Reading the the Appellee Brief [GSK] we see that GSK claim that Joanne admitted that she had no contact with GSK until nearly four years after the Statute of Limitations expired on April 26, 2003.

I think it's fair to say that Joanne suffered a major trauma here and one could possibly argue that she cannot remember because of the trauma suffered around the time of her termination.

In any event, why did Glaxo not reply to her with their finding, "almost certain"?

What she has now is evidence that she did indeed contact GSK and they [GSK] knew that she did, although I guess they could argue that they didn't know, that's what King & Spalding are paid to do. Maybe they could use trauma as an excuse or if any of the King & Spalding team were taking Paxil  they could probably use memory loss as an excuse.

It's almost as if GSK have used Joanne's poor memory against her then made her admit to something that they knew would be an untruth as they already had evidence that she had wrote them in 2001.

Internally they blamed Paxil for her termination but never told her this. That, by anyone's standards, is fraudulent concealment, isn't it?

It's Glaxo that failed to act and not Joanne Thomas. The only course of action Joanne took was to terminate her pregnancy, a termination that Glaxo are now arguing was of a non-viable fetus, in other words Ryan, the unborn fetus, was not really a living being in the sense of the word, the word according to Glaxo and Pennsylvania law.

The internal documents, remember, revealed that Glaxo were "Almost certain" Paxil caused the birth defects in Ryan. Why, in 2013, twelve years later, are they settling other birth defect cases but refusing to compensate Joanne Thomas for her loss? [The Kilker family received  $2.5 million in compensatory damages]

So, do I, as a writer, just take what Joanne has told me at face value? Of course not, it would be unprofessional to do so. Joanne was unaware that the emails from the Kilker trial had been made public, she was unaware that the video deposition of Jane Nieman, a former GSK employee, had been made public. Joanne and I began to join the dots after reading the emails and watching the video deposition. I asked Joanne to check through her old emails. Joanne, being the astute woman that she is, went one better than that.

On the 10th December 2013, Joanne contacted GSK and spoke with Jacqueline Moniz, a Sr. Clinical Safety Scientist. She asked Moniz for her Medwatch reports. Surprisingly, Moniz emailed them to Joanne within a couple of hours of speaking to her. Here's the cover letter:

Hello Ms. Thomas,

It was a pleasure to speak with you.  Again, I appreciate your assistance with identifying duplicate reports in our safety database.

I have attached a pdf that contains all of the reports.  When we spoke, I did not realize that the last report was not completed to “MedWatch” stage.  It was identified as a duplicate prior to completing the case.  I included the narrative for this report at the end of the other reports.


Please let me know if you require further assistance with these.

Thank you,
Jackie

Jacqueline Moniz
Sr. Clinical Safety Scientist
US CMG & Operations
RD Chief Medical Office

GSK
5 Moore Drive, PO Box 13398, RTP, NC 27709-3398, United States
Email   jacqueline.x.moniz@gsk.com
Tel       +1 919 483 7116

I've seen the documents sent to Joanne by Jacqueline Moniz. The documents reveal Joanne to be the sender of the email used as evidence in the Lyam Kilker trial.

The internal documents that surfaced at the Kilker trial showed that Glaxo officials had stated  "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

The documents sent to Joanne from GSK reveal the same case number.

Finally, as with all deaths, those who are left to pick up the pieces often blame themselves. What if I did this or that, what if I turned a different corner that day, would this still have happened? It's part of the grieving process I guess, although I am not an expert in such matters, the experts are those who have had to endure such tragedies.

Joanne wrote a letter to her child that never was, it's tough to read but she has given me permission to publish here today. The letter sees Joanne apologising to Ryan for terminating him, part of which reads...

"Daddy and I went to a doctor in the city where we would take you out. I was so scared, but I hoped, I prayed that it was the best for you. You kept kicking my stomach and I felt like you were saying "Mommy, don't do this to me". But then I felt like you were saying, "Mommy, let me get home.""


This is for Glaxo and their lawyers. It also serves as a warning to expectant mothers out there, call it informed consent, if you will.





"You kept kicking my stomach and I felt like you were saying "Mommy, don't do this to me""

And here's Ryan...




Glaxo have, in my opinion, abused the law in this case. Sadly, the law, being as perverse as it is, has allowed Glaxo to use it for their benefit. They have, in essence, acknowledged Paxil caused the heart defect which, in turn, forced the hand of Joanne Thomas. But to save money they have used a statute of limitations and a non-viable human excuse as their extraordinary defence. Both arguments are deeply flawed and, maybe, could have been met with a counter-argument such as the ones laid out in Part I -  ( Though still small and fragile, the baby is growing rapidly and could possibly survive if born at this stage.) and (If born now, your baby would have a 20% chance of survival, the odds going up with each passing day.)

Former Glaxo employee, Jane Nieman, provides an insight into the pharmacovigilance at GSK.

In this video deposition she is interviewed by a US attorney who was representing Lyam Kilker [Kilker v GSK] Skip to 31 minutes of this video deposition and you will see both discussing Joanne's emails to GlaxoSmithKline, although at the time Joanne was still the 'mysterious woman'.







I sent the video to Joanne because what she was telling me during our conversations seemed to strike a bell.

As Joanne reviewed the video it became apparent that the woman being discussed by Jane Nieman was actually her.

Joanne flicked me the following email...

"Omg...Bob that's me!!!!
"Jesus Christ 31:07 ... I believe its my call!!
"I am a mess...."

In the space of just 7 days Joanne and I pieced together all the information. Her actual case had been with attorneys for 7 years - Nobody had joined the dots.

Here's Joanne's take on the video.

"They knew all along that Paxil did this to Ryan and yet they never told me or warned any other expectant mother out there.

"I heard that many attorneys had hired Private Detectives to try and hunt me down as they wanted to put a name to the mysterious woman and maybe possibly use me as a witness. 


"Luckily I got in touch with Bob Fiddaman and the mystery was finally solved."

Joanne's father, Mike, added, "When Joanne showed me the information about the "mystery woman" and the trail it brought to light, part of me thought "makes perfect sense for a company like GSK". My daughter and others are morally showing what GSK is."

It sickens me to the core that this woman has been treated so abhorrently by GlaxoSmithKline and the expensive suits team of King & Spalding attorneys hired by GSK.

The FDA failed her and her unborn son too. As for GlaxoSmithKline, they chose to sit on the rat pup studies. If they had carried out further tests, as Ferrosan suggested, then they may have just saved a human life or two. Sadly, to lose such a stranglehold on the American antidepressant market saw them opt out of the transparency they boast about today, a transparency that has TV and media doctors applauding GSK and singing their praises. For what exactly? Those same high profile doctors currently singing the praises of GSK should watch the above video in its entirety. Even when faced with a human birth defect they decide to keep the results "in-house", yet another failure to warn the public about Paxil's propensity to cause birth defects.

Glaxo had a legal duty to revise the labelling for Paxil when they, through their own pharmacovigilance, learned that Paxil was the 'almost certain' cause of the birth defects in this particular case. They didn't. Was this to cover themselves from being sued? It's a fair enough question given the circumstances surrounding the 'statute of limitations' defence used against Joanna Thomas, isn't it?

Furthermore, Joanne emailed GSK with, "My husband and I are ready to try again to get pregnant in the next month or two." Why didn't GSK warn her that their initial assessment resulted in Paxil being the cause of her first child's birth defects? What kind of person would keep this information from a woman?

GSK have a lot to answer for in this case. By simply throwing a statute of limitations defence at it is not good enough. Kudos to their law team for doing their job, bad Karma for the person who decided to go down that route.

No apology has been offered to Joanne Thomas by GSK. No admittance that they had claimed, in-house, that it was 'almost certain' that Paxil caused Ryan's birth defects.


The Appeal, Joanne's Acquiesce

Armed with this evidence Joanne gave me permission to contact her attorneys. After reviewing the evidence they have now filed an appeal in the Supreme Court. Glaxo wouldn't be Glaxo if they didn't object to such an appeal... and they have done so in remarkable fashion.

They, via King & Spalding, are, in essence, claiming that Joanne cannot charge them with fraudulent concealment just because they knew about the Paxil/pregnancy hazard and didn't tell her. In a nutshell they are claiming that  they had no legal  duty to look out for Joanne's interests.

They also claim that they asked Joanne for her medical records and she never replied. Wow! admit internally that Paxil has caused birth defects and then ask for medical records! Seems a kind of half-assed way to conduct pharmacovigilance, don't you think?

In any event, pharmaceutical companies only ask for medical records so they can blame other drugs the consumer may have been taking or, in many instances, blame the illness or genes of the consumer.

I'm left wondering why GlaxoSmithKline have, in my opinion, such a disdain for women who are pregnant?


Buying Silence



In between all the legal wrangling between Joanne's attorneys and King & Spalding a new offer was put forward - the terms of agreement didn't sit right with Joanne. In a nutshell, GSK wanted her to sign an agreement that dissolved them and Paxil from any blame. These agreements are more commonly known as 'gagging orders'. Joanne, after careful consideration, rejected GSK's offer. Had she had signed it then it would have been her acquiesce. She would have not been able to discuss this new evidence with anyone.

Begs the question then if GSK were merely offering Joanne a compensatory award in return for her silence?

Why, if this was the case, would they want to buy Joanne's silence?

I, personally, do not like GlaxoSmithKline. I do not like the lawyers that represent them. I do not like the Pennsylvania law [2 year statute of limitations] or the way that King & Spalding [Glaxo's lawyers] used it to their advantage resulting in heartache for a mother who only ever wanted to hold and love her baby.

This should not be about points of law, this should be about humanity.

GlaxoSmithKline should be bowing down before Joanne Thomas. They should be thanking her for bringing the birth defect link to their attention. Joanne's fetus was, in essence,  part of the study that they should have ran when they learned about the Ferrosan rat studies.

Ryan was the human guinea pig, he was sacrificed to warn others but, yet again, Glaxo failed to warn in time. They argue that they don't have a duty to yet expect consumers to file claims against them in time.

Let's give the little guy some respect here. Let's give his mother, Joanne, some respect too.

I am glad Joanne Thomas made contact with me. I am glad that we were able to join the dots. I'm glad the mysterious American woman who contacted GSK back in 2001 isn't so mysterious anymore. Hopefully, the mainstream press will pick up on this and Joanne will be paid handsomely for any interviews she does in the the future, she deserves it.

Furthermore, Joanne is a  valuable witness, she, to my knowledge, is the only living woman who has evidence that Paxil was almost certainly the reason why her son developed heart defects. She has this in the form of GlaxoSmithKline's own internal emails.

Put a face to the mother who GSK were discussing in emails, put that same face in the witness stand for any future Paxil birth defect litigation and you will have very powerful leverage to strike a deal between GSK and plaintiff.

Litigation isn't about justice - it's merely about striking a deal so that everyone walks away moderately happy.

The Pennsylvania law has failed Joanne here and it has failed her miserably.

GSK's  US HQ is in Pennsylvania. Nice to have their headquarters in an American state that has laws that have supported their argument, huh? Why build an igloo in Jamaica when you can have a more robust igloo in Greenland?

The GlaxoSmithKline company tagline is, "Do more. Feel better. Live longer."

Obviously this does not, and never will, apply to Ryan, the alleged non-viable fetus.


Bob Fiddaman.



Most lawyers know when their clients are guilty of the crime charged, and will work hard to represent them in order to get the best deal possible. There are some, however, who will believe every word their client says, regardless of the videotaped evidence, the confession, and the litany of witnesses who say otherwise. I suppose it relates to maintaining credibility, but if you refuse to accept a cold hard fact, and instead tell an ADA or the judge (or heaven forbid a jury) the complete opposite based only on the say-so of your client, then you are not being effective. A healthy mistrust of the State is, undoubtedly, healthy for a defense lawyer, but blind acceptance or willful ignorance of the facts is unhealthy for a positive resolution of the case. - D.A. Confidential

Glaxo and their attorneys, King & Spalding, can be contacted via Twitter. @kslaw and @GSKUS
References for Part I & 2


(1) Wolfe v. Isbell, 291 Ala. 327, 329 (Ala. 1973)
(2) Coveleski v. Bubnis, 634 A.2d 608, 610 (Pa 1993).
(3) McCaskill v. Phila. Housing Auth., 615 A.2d 382, 384 (Pa. Super. Ct. 1992) (following the U.S. Supreme Court’s holding in Planned Parenthood v. Casey, 505 U.S. 833, 860 (1992), that viability occurs at 23 to 24 weeks).


Bob Fiddaman






Tuesday, April 08, 2014

Ryan, Glaxo's Non-Viable Fetus - Part I



Joanne Thomas, disputes Glaxo's claim that her fetus was "non-viable"
Disputes the Statute of Limitations Defence used by Glaxo's attorneys.




Intro:

The following is probably one of the most complex posts I have ever written. It's been months in the making, it's been chopped, changed, edited, re-edited and even circulated among attorneys before finally making publication here today.

I've tried to simplify things as much of what is contained has to do with points of law, to be more specific, Pennsylvania law.

It's fair to say that corresponding and speaking with Joanne Thomas has been eye-opening, to say the least.

The law is the law and cases like this expose its ludicrousness.

This is the story of Joanne Thomas and her unborn child, Ryan. It's part I of II and is leading up to some pretty startling revelations regarding GlaxoSmithKline and their lawyers, King & Spalding.

Everyone is entitled to a good defence team, even GlaxoSmithKline has that right. If I was to ever step into law I'd rather work for a prosecution team, you know, go after the bad guys and not defend them when I know they have done wrong.

I'd love to be able to bring back people from the dead too, children and adults, you know those ones who had their lives cut short through no fault of their own, those who were not forewarned that their actions could, ultimately, lead to their premature deaths.

Wouldn't it be great if we, after death, did meet up with those that had passed before us. Whether we actually do or not is just a belief, one of hope.

This post is about those who didn't have a chance to walk the earth, who, through no fault of their own, were introduced to medicine before they were born. This post is also about GlaxoSmithKline and their highly paid defence lawyers and just how far they go to keep their name and products intact. It's about how they hold on to their coffers because to simply compensate a mother who aborts a fetus that was malformed due to Paxil  (Known as Seroxat in Europe and Aropax in Australia and NZ) ingestion is not a road that Glaxo or their attorneys wish to go down. They use every trick [lawfully] in the book, blame everyone and everything. They operate within a law that gives them the upper hand, that, I believe, allows them to twist a knife in the gut of a mother who has already lost something so precious, the life of a child.

Their abject denial at something so abhorrent as a life dying before it has had a chance at living sickens me. Their defence of Paxil [paroxetine] causing birth defects or forcing the arm of a pregnant mother to abort sickens me too.

Here's an insight into how GlaxoSmithKline and it's lawyers operate. I am posting this because not many people truly understand what we are dealing with here. It's a post that has taken a number of months to piece together, it's a post that highlights the tenacity of a mother driven to seek justice on her own because the law has failed her. I'd like to thank Joanne Thomas for her patience and all those who worked behind the scenes and who offered advice and support to Joanne during this difficult time.



Ryan, Glaxo's non-viable fetus

Joanne Thomas fell pregnant in 2000, during the course of which Joanne was taking 40mg of Paxil. Back in 2000 Paxil was classed as a Category C drug (Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. Or No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.), in other words Paxil, according to the FDA, may or may not cause birth defects, there was no definitive answer. In order to classify the risk to the fetus, the Food and Drug Administration (FDA) established five categories to indicate the potential of a drug which crosses the placenta to cause birth defects.

The timeline is important in this particular birth defect case as we shall see.

Joanne was sent to have an echo cardiogram by her obstetrician after a routine ultrasound.

The ultrasound had found that Ryan, Joanne's chosen name for her unborn child, had echogenic bowels and one kidney. They were unable to verify if there were issues with his heart as they could not get a good visual. An appointment was then made for Joanne to see her pediatric cardiologist.

During the echocardiogram performed on April 23, 2001, the pediatric cardiologist estimated fetal gestational age to be 22½ weeks, and notified Joanne that her baby had severe congenital heart defects. It was unknown, at the time, what caused the fetal abnormalities and Joanne was referred for another appointment some 5 to 6 weeks later.

3 days later, however, Joanne decided to abort. The fetal death certificate estimated gestational age to be 21½ weeks, which was one week different to the pediatric cardiologist's estimation.

In one of many conversations with Joanne, she told me, "What scared me was when the cardiologist drew what a normal heart looks like and another drawing of Ryan's. That is when I was told he most likely would not be able to take his first breath. He would be intubated [placement of a flexible plastic tube into the trachea] immediately, and flown to a specialty hospital for heart surgery...if he survived."

Joanne saved the drawing that her cardiologist drew and has kindly passed it on to me.


Sketch of Ryan's heart defects drawn by Joanne's Pediatric Cardiologist


Joanne put this behind her as much as she could, she never, during the following years, made any connection to heart defects and Paxil. Why would she? At the time there was no warning.

In 2006 whilst studying her nursing boards she ran across items that suggested that Paxil had now been re-categorized by the FDA. They had moved it from a 'C' to a 'D' (Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.)

Shocked, Joanne decided to ring the GSK Consumer hotline. According to court documents she asked a GSK representative manning the line if Paxil was a Cat C or D drug, she was incorrectly told that Paxil was a “Category C” drug.

Further investigation by Joanne confirmed that Paxil had indeed been moved from a Category C to D drug.

It was at this point that Joanne filed her Short Form Complaint [September 2007], alleging her Paxil ingestion during pregnancy caused her son, Ryan Swindle’s wrongful death. It was to be part of a class action lawsuit against GSK.

GSK, via their highly paid law firm, King & Spalding, moved for summary judgment. They argued that Joanne's claims should be dismissed for two fundamental reasons. First, Joanne could not bring a wrongful death or survival action because her fetus was non viable at her therapeutic abortion. (Non viable means not capable of living, growing, or developing and functioning successfully. It is antithesis of viable, which is defined as having attained such form and development of organs as to be normally capable of living outside the uterus. (1))

This is where GSK's law team really earned their corn. This from one of the court documents:

GSK argues as a matter of law there must be either [1] a child born alive; or [2] a viable fetus, capable of an independent existence at death. (2)  Under Pennsylvania law, viability occurs no earlier than 23 weeks gestational age. (3) Relying on Plaintiff’s fetal death certificate, GSK argued she cannot sustain a wrongful death or survival action because she [was] at 21½ weeks, before viability occurred.
Next, GSK argued even if the fetus was viable when aborted, any claim would be barred under Pennsylvania’s two year statute of limitations because Plaintiff filed her action November 27, 2007, more than 6 years [after] its death. GSK contends the two-year period commenced on the day Ryan Swindle died, regardless of when survivors knew, or should have known, cause of death. 

Let's tackle GSK's first argument.

Firstly, there was two estimations on the age of the fetus.


  • Joanne's pediatric cardiologist estimated fetal gestational age to be 22½ weeks.
  • The fetal death certificate estimated gestational age to be 21½ weeks


Why were Glaxo allowed to pick the one age that best suited their argument?

Let's say, for argument sake, that GSK were wrong and the actual age was what the pediatric cardiologist estimated (22½ weeks). According to Pennsylvania law the fetus still wasn't viable. Remember these are just estimations, they are not, and never have been, set in stone yet Glaxo used this to their advantage. 

Secondly, they argue "even if the fetus was viable when aborted, any claim would be barred under Pennsylvania’s two year statute of limitations because Plaintiff filed her action November 27, 2007, more than 6 years [after] its death."

So, isn't this like saying we committed a murder but you didn't know it was us during your first two years of mourning. The fact you found out it was us (some years later) holds no water because the two year statute of limitations covers our ass?

I guess all those investigating the 1888 murders of Jack the Ripper should give up. It's a pointless, dare I say it, futile exercise, according to the Glaxo mantra that is. Let's abolish all the cold case files whilst we're at it.

At a fetal age of 20 weeks here's what was probably going on inside Joanne Thomas. I just want Glaxo's lawyers to be aware of this.


  • Ryan would have reacted to loud sounds.
  • Ryan would have started having a regular sleeping and waking rhythm.
  • Joanne's movements could have woke Ryan.
  • Taste buds were forming on Ryan's tongue.
  • Ryan was around 28cm long (crown to heel) and probably weighed around 450 grams.

Non viable huh?

Furthermore, if GSK argued that Joanne's fetus was non viable what does this say about the following claim taken from the fetal development website baby2see.com.




You are 20 weeks pregnant. (fetal age 18 weeks)

Your baby now weighs about 11 ounces and at roughly 7 inches long they are filling up more and more of the womb. Though still small and fragile, the baby is growing rapidly and could possibly survive if born at this stage.


Glaxo claimed the fetus was 21½ weeks, let's say they were correct. They argued that 21½ weeks meant that the fetus was non-viable. Let's see what the fetal development website baby2see.com have to say about a fetus at 21 weeks.



You are 23 weeks pregnant. (fetal age 21 weeks)

If born now, your baby would have a 20% chance of survival, the odds going up with each passing day. By this week, your baby weighs a little over 1 pound (500g). Its crown to heel length is 11 inches (28cm).

20% chance of survival, yet Glaxo dismissed this. Joanne fetus had a 20% chance of survival ergo she terminated when Ryan had a 20% chance of life. These odds were drastically reduced because Ryan had developed  a rare congenital heart disease that was caused by the Paxil she was taking.

The court disagreed and sided with GSK's argument in July 2012. Joanne's case was lost on the grounds of the non-viability issue and the statute of limitations issue. Glaxo also successfully argued that the child either must be born alive or it must be a viable fetus, capable of an independent existence at death. Joanne appealed the decision but in Nov 2013 a three-judge Superior Court panel agreed that a Philadelphia Common Pleas Court judge was correct in July 2012 to issue summary judgment to GlaxoSmithKline.

Grounds for a second appeal seemed futile until Joanne wrote me and we spoke for many hours discussing her case. It appeared that Joanne, without actually knowing it, was someone who many lawyers and advocates had been trying to hunt down for years.

In cases like Joanne's the plaintiff bears the burden of proof and must demonstrate fraudulent concealment by clear, precise, and convincing evidence.

In Part two I shall, on behalf of Joanne, try to present that evidence.

GSK's company tagline is "We are a leading healthcare company that helps people to do more, feel better and live longer"




Coming up in Part II - **NOW ONLINE**


  • How Glaxo knew about the possible birth defect risk many years ago but failed to act.
  • I unearth new evidence that shows, I believe, how Glaxo's statute of limitation defence holds no water.
  • The link between Joanne's birth defect case and the Kilker v GlaxoSmithKline birth defect case.
  • Did Glaxo and/or their attorneys, King & Spalding, hold back items of discovery from Joanne's law team and the presiding Judge?
  • I contact Joanne's law team with new evidence, they submit an appeal to the Supreme Court.
  • Glaxo U-Turn - An offer is made to Joanne Thomas after an appeal is submitted to the Supreme Court, an offer which, after much consideration, Joanne rejected.


Bob Fiddaman


Is Witty Being Toppled in Iraq?

If a picture paints a thousand words...

An image of Glaxo Chief, Andrew Witty, being toppled in Iraq amid yet more bribery allegations against GlaxoSmithKline.




Hat Tip - Billiam James

Back story


Bob Fiddaman





Monday, April 07, 2014

GSK - Latest Corruption Scandal In Iraq




Fined over $3 billion for violating federal law in the US, part of a corruption investigation in China - What more for British pharmaceutical giant GlaxoSmithKline?

Well, a whistleblower has come forward alleging that GlaxoSmithKline employees in Iraq are up to no good.

According to the Wall Street Journal [WSJ] "A person familiar with Glaxo's Mideast operations emailed the U.K. drug company late last year and earlier this year to report what the person said were corrupt practices in Iraq, including continuing issues and alleged misconduct dating from last year and 2012."

WSJ adds, "The emails cite behavior similar to Glaxo's alleged misconduct in China, including alleged bribery of physicians."

The allegations cited include but are not limited to:

  • Hiring 16 government-employed physicians and pharmacists in Iraq as paid sales representatives for the company while they continued to work for the government.



  • A government-employed Iraqi emergency-room physician prescribing Glaxo products, even when they weren't in the hospital's pharmacy and a competitor's brand was in stock.



  • Paying expenses to government-employed doctors to attend international conferences.


The WSJ also writes... "In 2012 Glaxo Iraq won the contract to supply the company's Rotarix vaccine, Glaxo paid for a workshop in Lebanon for Iraqi Ministry of Health officials, the email said. That included paying for a doctor's family to travel to Lebanon "so it would be a family vacation for him at the hotel."

In 2011 Glaxo Iraq signed an agreement with Modern Drug Industries, an Iraqi company, to manufacture and package drugs in Baghdad. At the time GSK said producing drugs closer to the customer would improve their cost base and enable them to sell products on at an "access price".

Hmmmm.

GSK's company tagline is "We are a leading healthcare company that helps people to do more, feel better and live longer"

Bob Fiddaman



Hat tip - The Truthman




Sunday, April 06, 2014

Selfie Study Reveals Mental Illness




In what appears to be yet another attempt of widening the net of yet another 'psychiatric illness', British psychiatrists have come up with another laughable gem.

Selfies [those of us who take a post pictures of ourselves] are now under the watchful eye of the pharmafia.

A recent study, we are told, has deemed that selfies may have a mental disorder.

According to psychiatrist Dr David Veale: "Two out of three of all the patients who come to see me with Body Dysmorphic Disorder since the rise of camera phones have a compulsion to repeatedly take selfies.

"Cognitive behavioural therapy is used to help a patient to recognise the reasons for his or her compulsive behaviour and then to learn how to moderate it."

Body dysmorphic disorder (BDD), or body dysmorphia, is an anxiety disorder that causes sufferers to spend a lot of time worrying about their appearance and to have a distorted view of how they look. People that have BDD are deemed to be mentally ill.

I've searched high and low for this apparent study but I've not been able to find it - what I have found is various newspaper articles citing Dr David Veale.

Veale, pictured below [pro shot and not a selfie] is Consultant Psychiatrist In Cognitive Behaviour Therapy at the South London and Maudsley NHS Trust and The Priory Hospital North London.


Dr David Veale

He is the co-author of Body Dysmorphic Disorder: A treatment manual, a book, according to the blurb, that was written for health professionals. Part of the blurb also reads: "Body Dysmorphic Disorder: A Treatment Manual is the first publication to provide both an overview of the current knowledge of BDD and a treatment manual using cognitive behaviour therapy and medication."

Ah, there's that word again folks, 'Medication'. Body Dysmorphic Disorder: A treatment manual, retails at £36.54 on Amazon, so, someone, somewhere is making money out of this 'theory'.

Upon hearing the news that being a selfie equates to having a mental illness I started researching and disseminating information via my Facebook wall. Most, if not all of my friends, found it laughable. We only have to look through the history of psychiatric disorders to learn that the field of psychiatry like to see what they can get away with. We shouldn't forget that homosexuality was once deemed a mental illness - it was later pulled from the Diagnostic Statistical Manual of Mental Disorders [DSM] - Quite why it appeared in there in the first place baffles me.

Targeting the millions of selfies out there is nothing more than the pharmaceutical industry seeing a gap in the market and sending in the clowns to convince the public that selfies are mentally ill. They did it with shyness years ago and heavily promoted such wonder drugs as Prozac and Seroxat [Paxil] to cure the mentally afflicted [those of us that were shy].

So selfies suffer with narcissism huh? Let's take a look at a world renowned pediatric psychiatrist for one moment here. It is my opinion that Joseph Biederman opitomizes what is wrong with the field of psychiatry. He does this with signs of narcissism.

Biederman was being interviewed by attorneys and was asked, under oath, what rank he was.

Biederman: - Full Professor

Attorney: - What's after that?

Biederman: - God

Attorney: - Did you say God?

Biederman: - Yeah

Here's the footage...





video



So, be careful taking those selfies folks, you may just be deemed to have a disease of the brain that can never be proven but because psychiatry says it exists then you will have one hell of a problem disproving them...such is their grip on modern day medicine. Next stop will be to target those who feel the need to post pictures of meals they have just cooked.

Here's a collection of friends who disagree with British psychiatrist Dr David Veale.



 
  




Reports circulating with claims that the American Psychiatric Association [APA] has come out and officially declared taking a selfie to be a mental disorder are false


You can follow Dr David Veale on Twitter here - you may wish to send him your own selfie.


Bob Fiddaman






Friday, April 04, 2014

GSK Unleash Contaminated Antidepressant Into Ireland




On Wednesday I wrote how the FDA had sent GlaxoSmithKline a warning letter listing a series of violations regarding their plant in Ireland.

The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

According to the FDA's warning letter, Glaxo became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of paroxetine manufactured using the contaminated solvents on April 19, 2013. Glaxo then distributed paroxetine shipments that were potentially contaminated.

RTE News reported on Wednesday that the Irish Medicines Board had confirmed that a number of batches of Seroxat, that were being recalled by GlaxoSmithKline, had been placed on the Irish market.

So, let's get this straight.

Glaxo knew back in 2012 that batches of paroxetine had become contaminated with material from their waste tank but they did nothing?

I'd smell a lawsuit if this were America. Sadly, European law firms don't have the financial clout to go up against the likes of GlaxoSmithKline.

Inspectors from the Irish Medicines Board are now on site "to ensure that the company's investigation into what happened has been thorough."

How reassuring. Glaxo being monitored by an agency that, in 2009, received 27.08 million euro from the pharmaceutical industry.

This must come as a huge embarrassment to Glaxo Chief, Andrew Witty, who last year blamed Glaxo's fraudulent behaviour on an 'era'. This after his company his company plead guilty to violations over a number of its drugs.

This isn't the first time the FDA have had to warn GlaxoSmithKline over contaminated products.

Back in 2010 Glaxo pleaded guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.

Here's an interview with Cheryl Eckard, a former employee of GlaxoSmithKline who was fired after raising the Cidra violations with company officials..







In the words of Jim Royle [Royle Family], "Part of an era, my arse."


Bob Fiddaman



Thursday, April 03, 2014

Fort Hood Shooter - The 'Mental Illness' Excuse




34 year-old Ivan Lopez has been named as the gunman who shot and killed 3 people whilst injuring 16 before turning the pistol on himself at an army base in Fort Hood, TX.

Pro and anti gun lobbyists are actively debating on the social media networks as are the pro and anti medication lobbyists.

Reports are suggesting that Lopez was undergoing treatment for psychological and 'psychiatric problems' and that he was being treated for depression and anxiety. He'd previously been on tour to Iraq although, sources from within the army, suggested that he was not injured...ergo no head injuries.

Mainstream media are throwing around the two words that is music to the ears of the pharmaceutical industry and much of the field of psychiatry - "Mental Illness".

It's important to look at what those two words mean individually.

1. Mental - relating to the mind.

2. Illness - a disease or period of sickness.

If we combine the two words we get Mental Illness - a condition which causes serious disorder in a person's behaviour or thinking.

For years pharmaceutical companies and psychiatrists have been trying to prove that a mental illness manifests inside the brain but that is not what the definitions above tell us.

What the pharmaceutical industry and psychiatry has done here is make us all believe that the mind and brain are the same.

3. Mind -  the faculty of consciousness and thought.

4. Brain - an organ of soft nervous tissue contained in the skull of vertebrates, functioning as the coordinating centre of sensation and intellectual and nervous activity.

Key word here is 'organ'.

Any organ can fail and be treated, the liver, kidneys, the heart...even the brain. But here's the rub... Pharmaceutical companies and psychiatry have, for many years, being duping the public. Where we can visibly see [via modern technology] diseases of the liver, heart and kidneys, we have yet to see an actual "mental disease" of the brain.

It's simple really - I'm a former postman and door hanger at Land Rover and if I can spot the discrepancies then anyone can.

The brain is an organ, the mind is not.

Millions of prescriptions for mind altering drugs are written every day. What exactly is being treated?

Thoughts.

The white-coated mob are actually writing a prescription for an illness that exists in an organ that doesn't exist at all.

Remember, they are treating the mind and not the brain...two completely different things.

They will argue that it's the brain that gives you thoughts, I cannot debate that as it is true. But it's the brain that also tells us that we have pain in our toe, [gout] or we have pain causing rectal bleeding [stomach cancer]... in fact our brain tells us a whole host of things. Gout and stomach cancer are just two examples - we can see both by using x-rays, MRI Imaging or blood samples. We can't see 'mental illness' through any of these methods, nor would we attempt to scan the brain if someone had gout.

Prescriptions for powerful drugs are prescribed for thoughts of the mind - you cannot touch thoughts, you cannot see them [only if you are having them yourself].

A thought is the action or process of thinking - yet for decades modern medicine has been treating a 'thought' as if it were an organ.

To try and simplify matters here's an analogy.

The words I speak can be heard, they can be recorded and written down but they cannot be treated. No psychiatrist can catch my words, put them in a special container then treat them....yet this is what they claim they can do with mental illness - treat thoughts. It's absurd, it's the biggest confidence trick we have ever known and we have, largely, fallen for it.

So, when I see the media reports suggesting that the Fort Hood Shooter, Ivan Lopez, had a mental illness I refer to 1,2,3 and 4 [above]

Lopez, like so many other shooters [including children] was on medication... his thoughts were being treated. Chemicals, foreign to his natural brain chemicals, were being pumped into him on a daily basis...they had nowhere else to go because the thoughts that these chemicals are supposed to target just don't exist, they are not a mass, an organ, they are invisible, they are an action that leads to a process...

...and we fell for it.

Hook, line and sinker.

Regarding the situation with the military and the PTSD [another apparent thought disease treated with powerful drugs] that so many soldiers have been diagnosed with, here's something to watch. It's a video recently released by the Citizen's Commission on Human Rights [CCHR].

Now, there will be many [normally the pro-pill brigade] that will claim that the CCHR are nothing but a bunch of Scientologists with a hidden agenda. I kind of laugh when I hear this tried [and tired] and tested argument, it's been thrown around for years. To those who spew these kind of arguments I have this to say. If it were the agenda of the CCHR to convert everyone to Scientology then why don't they just come out and do that? Why create videos about the dangers of drugs when their agenda is to convert us all to Scientology?

It makes no sense whatsoever to attack a human rights movement who are standing up for human rights. It's about as logical as suggesting that thoughts can be targeted and treated by pharmaceutical drugs.

Here's the feature length documentary, The Hidden Enemy Psychiatry.




Bob Fiddaman


Wednesday, April 02, 2014

GSK Roll Out "Patient First" Program


Anti-depressant ingredient from Cork plant contaminated with waste



Reminds me of the Puerto Rico Incident.

Glaxo's Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company's sale of Paxil (Seroxat) and Paxil CR.

A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo's Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004

Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra... they didn't.

After leading her recovery team Eckard found more violations that the FDA had missed first time round.

In a nutshell, she brought this to the attention of her senior managers, her managers ignored her... then fired her.

According to Eckard's complaint: "persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. ... rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for "black market" packaging and distribution ..."

Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it's committed to continuously improving manufacturing quality. The company denied Ms. Eckard's allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.

Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.


Back in 2013 GSK, the company who have had more fines than I've had hot dinners, rolled out their "Patient First" program. At the time they said this...

"GSK has an important role to play in supporting education for healthcare professionals and in providing accurate information about its medicines to help them make the best treatment decision for their patients, such as sharing new clinical data, details of label changes or safety updates."


Now read this letter sent to Andrew Witty from the FDA on March 18, 2014


March 18, 2014


Sir Andrew Witty
CEO
GlaxoSmithKline
5 Moore Drive
Research Triangle Park, NC 27709

Dear Sir Andrew:

During our October 18-23, 2013 inspection of your pharmaceutical manufacturing facility, SmithKline Beecham (Cork) Ltd., located at Currabinny, Carrigaline, Cork, Ireland, investigator(s) from the U.S. Food and Drug Administration (FDA) identified deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). These deviations cause your APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have conducted a detailed review of your firm’s response and note that it lacks sufficient corrective actions.

Our investigator observed specific deviations during the inspection, including, but not limited to, the following:

1.    Failure to fully investigate critical deviations.

Your firm discovered that the (b)(4) used to manufacture (b)(4) batches of (b)(4) and (b)(4) batches of (b)(4) was contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents. Examples of chemicals that are collected in the waste tank include (b)(4). Your firm became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of (b)(4) manufactured using the contaminated solvents on April 19, 2013. Your firm distributed (b)(4) shipments of (b)(4) potentially contaminated (b)(4) batches after becoming aware of this significant deviation. In contrast, (b)(4) batches made with the contaminated (b)(4) were rejected.

Quality impact assessments were made for both (b)(4) and (b)(4), but we note that the approach taken in the two assessments was different. For instance, the (b)(4) assessment noted that the standard release testing did not detect significant quantities of contaminants in the potentially impacted (b)(4) batches, but that additional testing on (b)(4) from (b)(4) showed the impacted batches were exposed to significant amounts of (b)(4). The assessment states that the sample preparation used in the (b)(4) sample release testing appears to be incapable of complete extraction of the potential contaminants, and it therefore relied on results obtained from the additional testing from the (b)(4) of (b)(4) product to demonstrate that the (b)(4) batches were impacted by the pharmaceutical waste contamination event. Your firm’s assessment for (b)(4) included no such additional testing and relied on the (b)(4) samples’ passing test results, concluding that there was no quality impact to the (b)(4) batches.

Your firm’s SOP regarding communication of significant deviations states that your firm must communicate to the receiving site information concerning deviations having a potential quality impact on the product. During the inspection, your personnel informed our investigator that your firm determined that there was no potential to impact the quality of the affected products manufactured with (b)(4) and chose not to “escalate” the deviation by notifying your customers. We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact. In your response to the Form FDA-483, you acknowledged that you should have informed your customers of this incident; however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse.

In your response to this letter, please address the concerns outlined above. Please also describe why the quality assessments appear to assume uniform distribution of contaminants following addition of (b)(4) to the waste stream and before the backflow of contaminants into the (b)(4) tank. Provide a revised quality assessment for (b)(4) that clearly describes all calculations used to support the conclusions, and clearly describe any altered conclusions after addressing the issues described in this letter. For each analytical method used to support your conclusions, provide method qualification information, including the limit of detection for each potential contaminant. Also, provide a quality impact assessment for your (b)(4) product, which was also manufactured using (b)(4) around the time of the initial contamination in the (b)(4) tank. Describe any contact you have had with the customers of the potentially affected products and your plans with respect to the disposition of any potentially affected batches that remain within expiry.

2.    Failure to investigate and document out-of-specification results.

Your firm tested solvent from the (b)(4) tank in September 2011 and October 2011 to look for potential (b)(4) contamination via a gas chromatographic method. The chromatograms from both samples show large peaks for (b)(4) as well as small but detectable levels of at least ten other contaminants. These unexpected peaks should have indicated to your firm that the (b)(4) tank had been contaminated with pharmaceutical waste, as described above. Instead, your laboratory personnel ignored these unexpected peaks and conducted no investigation into what gave rise to them. As a result, your firm did not notice the (b)(4) tank contamination until a third sample from the tank was tested in January 2012.

In your response to the Form FDA-483, you stated that there was no reason to expect (b)(4) contamination and therefore the analyst did not notice the (b)(4) peak. Your response does not address why the analyst did not notice the numerous other detected contaminants in the chromatogram, nor did it address why a second reviewer did not notice the unexpected peaks in the chromatograms. Please address these issues in your response to this letter. In addition, please explain why the (b)(4) testing sample from the tank was collected in November 2011 and was not tested until January 2012, and provide supporting documentation from the method validation describing the stability of the tank samples during this lengthy storage period.

3.    Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

Your firm’s validation protocol for (b)(4) states that a minimum of three consecutive pre-nominated process performance qualification (PPQ) batches were to be produced to demonstrate initial process validation. However, your firm was unable to produce three consecutive successful batches due to (b)(4) during the production of multiple batches and therefore re-nominated the PPQ batches on two different occasions. Your firm made modifications to the equipment used in manufacturing after noticing (b)(4) during the first two batches manufactured, but these changes were not sufficient to prevent further (b)(4) during the fifth batch. Following the fifth batch, your firm replaced the(b)(4) used in the manufacturing process and produced a sixth batch. During the execution of the validation protocol, the originally “pre-nominated” PPQ batches that were rejected due to (b)(4) were assigned for reprocessing.[1]  Based on manufacture of the third, fourth, and sixth batches without this processing problem, your firm considered the process validation protocol to be successfully executed.

The process performance qualification studies described above suggest that your equipment has not been sufficiently demonstrated to reliably perform its intended function, namely (b)(4) and (b)(4) of the (b)(4) from the process stream. Demonstrating suitability of equipment used in the manufacturing process is a fundamental element of establishing the state of control of your process. Because of these equipment suitability deficiencies, we are concerned that your firm has not adequately demonstrated an ability to consistently and reproducibly manufacture (b)(4) without (b)(4).

In your response to this letter, please provide justification for the selection of non-consecutive batches during the execution of your validation protocol. Describe any revisions to your validation SOP to clarify under what specific circumstances “re-nomination” of PPQ batches would be considered acceptable. Provide any additional evidence of your firm’s ability to reproducibly manufacture (b)(4) without (b)(4) and while meeting all critical quality attributes. Specifically, provide the entire batch manufacturing history for (b)(4) following batch (b)(4), noting any other incidents of (b)(4) problems.

The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility.  You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations.

If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of finished drug products or active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER's Drug Shortages Program immediately, as you begin your internal discussions, at drugshortages@fda.hhs.gov so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Program also allows you to meet any obligations you may have to report discontinuances in the manufacture of your drug under 21 U.S.C. 356C(a)(1), and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. In appropriate cases, you may be able to take corrective action without interrupting supply, or to shorten any interruption, thereby avoiding or limiting drug shortages.

Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, your failure to correct these deviations may result in FDA refusing admission of articles manufactured at SmithKline Beecham (Cork) Ltd., Currabinny, Carrigaline, Cork, Ireland into the United States under Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3). The articles may be subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of deviations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the APIs at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 1000170338.

Please send your reply to: Mary Farbman, Ph.D., Consumer Safety Officer; 10903 New Hampshire Avenue; Building 51 Room 4234; Silver Spring, MD 20993-0002.
                                                                       

Sincerely,
/S/
Steven Lynn
Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research


cc: Finbar Whyte
Site Director
GlaxoSmithKline (GSK)
Carrabinny, Carrigaline
Cork, Ireland


GSK  is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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Bob Fiddaman.