Wednesday, August 27, 2014

Are Lundbeck Luring Pregnant Mothers With a Red Apple?






After turning into the Witch, the Queen declares that Snow White should suffer "a special sort of death". Looking through her spell book, she comes to the recipe for the Sleeping Death, and, reading of the Poisoned Apple's effects, decides that it's the perfect way to get rid of the princess. She brews the potion and dips an ordinary apple into the brew as the Raven watches silently. The Sleeping Death seeps into the apple, and the Witch raises the apple from the cauldron to reveal that the poison dripping from the apple has formed an image of a skull. This image fades as the apple turns red, to tempt Snow White. - Disney Wiki




I'm confused.

Can citalopram, marketed and manufactured by Lundbeck in Europe, cause birth defects?

It's a simple enough question that should be simple enough to answer. It is, when all's said and done, a very important decision to make for any pregnant mom who may be faced with a choice of taking or not taking citalopram during pregnancy.

Sadly for Scottish mom Cheryl Buchanan this is not an option.

When Cheryl was just 12 weeks pregnant she was told that scans had detected a series of anomalies in her unborn child.

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

A post-mortem revealed that Cheryl's unborn child that half of her daughter's diaphragm was absent, her lungs were very small, some of her organs had moved up into the thoracic region,  her neck had webbing, and her nose was small while her chin was recessed.

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

What follows is bizarre to say the least.

Cheryl wrote me and asked me to read through a collection of emails sent to her by Lundbeck. I asked for Cheryl's permission to contact Lundbeck directly - she agreed.

Cheryl had previously asked Lundbeck if citalopram could cause birth defects. Their answer, in a nutshell, was that here was no evidence of this.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " - Dr Andrew Jones, Medical Director, Medical Department, Lundbeck

I wrote directly to Dr Jones...

Dear Dr Jones,

I have seen the attached correspondence you wrote and sent to Cheryl Buchanan regarding citalopram and birth defects.
I understand that you will not be able to discuss with me individual cases but I feel I must press you for some clarification.
You wrote, " "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). "
Can you clarify if this is just a personal opinion or if it is the position of Lundbeck.

Initially Dr Jones did not respond so I told him I would make the question to him public. Strangely Lundbeck then checked me out [Fig 1].


Fig 1


Dr Jones replied shortly after Lundbeck had paid a visit to my blog, his reply to me was short...

Dear Mr Fiddaman,
I confirm that this is the position of Lundbeck.

 I wrote the following back to Dr Jones...

Dear Dr Jones,
Many thanks for your reply, although it has to be said that Lundbeck are misleading Ms Buchanan with their rather ambiguous statement regarding the risks of taking citalopram during pregnancy.
As you are probably aware the pregnancy risk with citalopram is classed as a 'Category C', ergo risk cannot be ruled out. To suggest otherwise to a woman of child bearing age is irresponsible and misleading.
Do you or, indeed, Lundbeck, wish to amend your response to Ms Buchanan or do you wish to stand by your position that citalopram does not cause birth defects?
Whilst waiting for a response I fired off an email to Sandy Walsh, Sandy is a press officer at the FDA, more specifically for the Center for Drug Evaluation and Research. I also sent a reminder to Dr Jones that if he did not answer my follow-up question I would make it public on my blog.

Here's the email I sent the FDA...

Dear Sandy,
I'm very confused.
Recently a reader of my blog contacted me regarding the antidepressant citalopram, marketed in Europe by Lundbeck.
She had to abort her fetus due to it developing birth defects inside the womb.
Whilst I am aware that you cannot discuss individual cases with me I'd like to bring to your attention an email that the woman received from Lundbeck.
She asked if citalopram could cause birth defects.
The answer, from Dr Andrew Jones Medical Director, Lundbeck UK, was "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population."
My question to you may clear matters. Could you tell me why the FDA have assigned citalopram to pregnancy category C and whether or not Lundbeck/Forest had any input in arriving at that decision?
Hopefully your answer may clear this confusion up.

Sandy Walsh was very helpful with her response, I've highlighted the relevant parts...

Here is the FDA-approved prescribing information (labeling) for Celexa: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf
As noted on page 18, there is a description of why Celexa is category C:   
-----
Pregnancy Category C : 
In animal reproduction studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human therapeutic doses. In two rat embryo/fetal development studies, oral administration of citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose, which is approximately 18 times the MRHD of 60 mg/day on a body surface area (mg/m2) basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental, no-effect dose of 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. In a rabbit study, no adverse effects on embryo/fetal development were observed at doses of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis. Thus, teratogenic effects were observed at a maternally toxic dose in the rat and were not observed in the rabbit.
When female rats were treated with citalopram(4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were observed at the highest dose, which is approximately 5 times the MRHD on a mg/m2 basis. The no-effect dose of 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥24 mg/kg/day, approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study. There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus.
-----
Category C means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. The pregnancy categories are assigned based on current scientific evidence and can be changed if new information is learned.
The company and the FDA both work together to add drug benefit/risk/safety information into the drug labeling.  So yes, the company plays a role in what is contained in the drug labeling.

The pregnancy categories
If a person has an adverse event, that should be reported by the doctor or patient to the FDA (or European authority), or the drug company, so that it can be properly logged into the official adverse event tracking systems.

I wrote the following back to Sandy Walsh...

Sandy,
Thank you for this.
I have found your help in this, and other matters where I have contacted you before, very helpful.
Can you explain why Lundbeck would be telling consumers/patients that there is no risk during pregnancy?
I can forward you the letter if you wish?

Sandy's response was...

I cannot speak for the company, please ask them.
As noted, the US drug labeling says, "There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus."

Not very satisfying so I pushed Sandy for something more definitive...

The company are, at this moment in time, refusing to answer any further questions from me.
This is potentially dangerous and misleading information they are handing out to women of child-bearing years.
If the company won't give me an answer and the FDA cannot speak about Lundbeck's stance then who can I ask?
Do you have a procedure whereby I can ask the FDA to ask on my behalf?

It's a strange way to safeguard human health, don't you think?

Here's Sandy's response...

Apologies, I have a number of other things I’m working on and meetings today.
The FDA is only able to provide the information I’ve given to you – the warnings in the FDA-approved drug labeling   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf.
If someone believes they’ve experienced an adverse event, they should contact the drug authority in that country. 
In the U.S., if there is adverse event information to submit, it should be submitted to our MedWatch system along with medical information from the physician, and the information from the company. Here are instructions as to how to do that: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm

In other words, sorry you are on your own.

Here we have a pharmaceutical company handing out information to a woman that claims that there is no link between citalopram use and birth defects. The American drug regulator, the FDA, inform me that during animal studies there was an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects)

They add that there are no adequate and well-controlled studies in humans and that  potential benefits may warrant use of the drug in pregnant women despite potential risks.

This is baffling?

If no adequate and well-controlled studies in humans has been carried out [and they never will be because it would be unethical to use a human fetus as a guinea pig] then how can they suggest that there is a chance of "potential benefits"?

If no adequate and well-controlled studies in humans has been carried out then why are doctor's prescribing citalopram to women who are pregnant? There is no gauge here so women just have to trust their healthcare professionals who are prescribing a drug blindly. Who informed the doctor's about the potential benefits of non-existent adequate and well-controlled studies?

How did we get to the stage where a drug that has never been through clinical testing for pregnant humans is now being prescribed on the premise that the benefits may outweigh the risks? What benefits?

You can't claim that a drug has benefits and that they must be weighed against the risk when you cannot even show clinical trials that highlight those benefits.

Bizarre.

This really is a game of Russian Roulette, right?

These findings are even more startling when you consider that Cheryl Buchanan is just one mom, how many more women of child bearing years have been told by Lundbeck that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Contrast Lundbeck's dismissal of citalopram being linked to birth defects with a 2006 warning regarding Citalopram and birth defects issued by the FDA.

Dr Andrew Jones, Medical Director, Medical Department, Lundbeck has not responded to further questions from me. If he does respond at a later date I will update this post.

Citaloptram is better known by the brand name of Cipramil in the UK and Celexa in the US.

It could be argued that it's akin to the red apple used to lure Snow White.



Bob Fiddaman

If you, or someone you know, has taken citalopram and has had birth defect issues then you may be liable to file a lawsuit [US ONLY] - HERE.





Wednesday, August 20, 2014

Paxil: The Statute of Limitations Defence






The Article

Paxil Birth Defect Action Time-Barred, Fla. Federal Judge Rules
MIAMI — A Paxil birth defect action is time-barred under Florida law because the plaintiffs knew of a possible connection between their injuries and the drug more than four years ago, a federal magistrate judge has ruled.
On Aug. 12, Magistrate Judge Jonathan Goodman of the U.S. District Court for the Southern District of Miami found the mother had notice of the possible invasion of her legal rights by Dec. 20, 1997, when her doctor noted in her medical records that her son’s condition was “apparently due” to Paxil.

The Background 

On January 27, 2012, Iolany Ferez, filed, on behalf of her minor son, Andrew Plascencia,(AP) a product liability action against GSK in Pennsylvania state court. Ferez alleged that Paxil caused A.P. to be born with Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur.

Ferez gave birth to A.P. in 1996. Doctors noted at birth that A.P. had a heart murmur, and diagnosed him with a heart defect the next day.  A.P.’s heart defect was classified as a tricuspid atresia type II‐B, a condition that has required two corrective procedures and regular cardiology visits throughout his life.

According to court documents, Ferez suspected Paxil caused A.P.’s heart defect almost immediately because she had taken it throughout the first six weeks of her pregnancy with A.P.She had not taken anything during her first two pregnancies and both children were born without defects.

Ferez asked A.P.’s cardiologist and her gynecologist whether Paxil may have caused A.P.’s heart condition. Both responded that they did not know.

On December 20, 1997, Dr. Marcio Ferez, Ferez’s father, employer, and primary care physician, noted in Ferez’s medical records that A.P.’s heart defect was “apparently due to” Paxil. In September 2005, GSK mailed a letter to Dr. Ferez and other healthcare professionals advising them of a recent study that showed Paxil was associated with an increased risk of congenital malformations, most commonly cardiovascular. A second letter was sent in December 2005, advising of an additional study showing an increased risk for cardiovascular malformations in infants born to women who had first trimester Paxil exposure.

The GSK Defence

GSK argued that the statute of limitations bars the claim of Ferez because she had actual and constructive knowledge that A.P.’s heart defect may have been caused by Paxil.

Conclusion

Although the Court was sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, “liability cannot rest on sympathy alone.”

GSK’s summary judgment motion was granted. (granting summary judgment to defendant in products liability case based on statute of limitations).

Commentary

Iolany Ferez took Paxil during her pregnancy. Her  son was born some time later and it was found that he had a number of birth defects. Ferez put two and two together and came to the conclusion that Paxil may have caused these defects because she had given birth on two previous occasions to healthy babies where, during these pregnancies, she was not taking Paxil.

GSK have claimed that because Ferez made an assumption that it could have been their product that caused her son's defects and didn't file a lawsuit against them straight away, she is out of time to make any such claim for compensation.

Can you imagine if victims of Jimmy Saville, or any other pedophile for that matter, were told that they, or the prosecuting team, couldn't bring any charges against him because they never came forward at the time of the alleged assault?

The Judge ruled in favour of Glaxo, "Although the Court is sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, liability cannot rest on sympathy alone."

So, an acknowledgement by the man with the gavel that Paxil may well be responsible for this particular child being born with a birth defect...but, um, tough shit, his mom  should have joined the dots and filed earlier.

What kind of system is this?

Sadly, Judges are bound by statute instead of common sense. Knowing the statute of limitations inside out is a must for any attorney representing the pharmaceutical industry. They cannot defend the drug because physical evidence shows the harm the drug causes - instead they rely on a statute that was, in my opinion, designed to help the mighty to continue being mighty and for the lowly to know their place.

In the meantime, the son of Ferez, who has Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur, has to go through a life of uncertainty. His mom has to pick up all the medical bills which can run into many thousands of dollars.

GSK have once again shown that their corporate motto that GSK is a  "global healthcare company that is committed to helping people to do more, feel better and live longer", is misleading and should be altered accordingly.

How have they helped the son of Iolany Ferez to do more?

How have they helped the son of Iolany Ferez to feel better?

How have they helped the son of Iolany Ferez to live longer?

This isn't the first time GSK have used a statute of limitations defence. They did so in the case of Joanne Thomas.

Thomas had to abort her fetus due to a number of defects caused by Paxil.

GSK argued she was out of time filing a lawsuit, the Judge agreed.

Research, carried out by myself and Thomas, showed that she wasn't out of time and that GSK knew that she wasn't. Attorney's involved in the case drew up a settlement between Thomas and GSK. There was no media coverage, apart from my own, about Glaxo knowing that Thomas had contacted them via email many years before she filed suit.

It's unknown if Thomas agreed to settle. Good luck to her if she did.

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



Bob Fiddaman.







Tuesday, August 19, 2014

Antidepressant Aggression, the MHRA Perspective








Last month I wrote a piece entitled, 'Antidepressants: The Power To Harm' which, basically, highlighted the Japanese drug regulator and the Japanese Ministry of Health, Labour and Welfare. [MHLW]

A 2009 review of antidepressants in Japan [1] resulted in MHLW issuing an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

They found that causality between SSRi antidepressants and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.

After reading this review I wrote to the British drug regulator, the MHRA.

Dear Sir/Madam,
I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury). 
Please state if any alerts to patients and their families have ever been sent out regarding this issue.
Please state if any revision to package inserts have been made regarding this issue.

The MHRA have now answered and, it has to be said, it would appear that patient welfare is far higher on the list in Japan than it is in the UK.

First off, their cover letter to me.




I like the final paragraph...

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

I'm not going to bother asking the MHRA if I am allowed to republish, what I deem as, important safety information regarding SSRi use and aggression. They've used this threat before with me, see 'The evidence, however, is clear, the Seroxat scandal'. [2]


The MHRA have provided me with 30 pages of information with regard to the question I put to them, much of which is redacted [blacked out]

It would be pointless to post all 30 pages but those wishing to scrutinize can request a copy from me by emailing me.

Some points...

The information sent to me from the MHRA was taken from meetings that occurred between the years 1996 and 2001.

Contrast that to the Japanese information on SSRis and aggression. Their information is more up to date, in fact it is 8 years more up to date than what the MHRA have given me.

The MHRA, or the data they sent me, points to two SSRis causing aggression. Fluoxetine and Paroxetine, namely, Prozac and Seroxat (Paxil)

Remarkably these findings of aggression with Prozac and Seroxat use have been played down by claiming that the reporting rates of aggression increased when stories started appearing in the media. The MHRA do not balance this claim, for instance, (i) the reporting rates may have increased because patients may not have known that the MHRA actually collected such reports and (ii) consumers may have attributed their aggression and suicidal thinking to their illness, opposed to it being a possible adverse reaction to the drug they were taking.

Page 23 of the 30 page document they sent me is quite telling. [Fig 1]


Fig 1

So, when there is a clear sign that aggression is occurring during Prozac and/or Seroxat treatment it has, if you believe the above, nothing to do with the drug/s, it is possibly a "separate event from the underlying illness" or it's "part of a discontinuation syndrome", or maybe the aggression has appeared because of the removal of the therapeutic benefits of the drug.

Once again, the suggestion of media reports on antidepressants and the suicide link are mentioned. It's almost as if they [the committees who reviewed the aggression link in SSRi use] are putting something in place. Rather than look at the blindingly obvious problem they chose to deflect and lay the blame on intense media reporting.

Now, contrast this stance with those of the Japanese.

2009:

The Japanese Ministry of Health, Labour and Welfare issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

The above was based on a review where they found an association with SSRis and aggression.

No pussy-footing around, no blaming the media, no blaming a discontinuation syndrome or no blaming the underlying illness causing the aggression. Moreover, the  Japanese Ministry of Health, Labour and Welfare sent an alert out to patients and their families about their findings.

I don't know about you but if one regulator flags a warning about patients becoming aggressive on antidepressants then other regulators around the world should act promptly.

Judging by the material sent to me by the MHRA, they put the SSRi aggression link to bed in 2002 and have done nothing more about it since then.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

Oh really?



Bob Fiddaman


1. 2009 Selective Serotonin Reuptake Inhibitors and Aggression [Japanese Review] [Link]
2. The evidence, however, is clear, the Seroxat scandal. [Link]

Friday, August 15, 2014

GSK Sink to New Level in Paxil Suicide Litigation







I despise lawyers who defend pharmaceutical companies. I despise their ethics and lack of compassion, nae humanity.

None more so than lawyers representing GlaxoSmithKline.

When I first read what I am about to divulge a fire erupted so violently inside me. How on earth could one human treat another human this way. Then I remembered that we are dealing with GlaxoSmithKline and a team of fat cat lawyers devoid of any conscience - hey that's my opinion of Alan S. Gilbert and Melissa A. Economy of Dentons; and Andrew T. Bayman, Todd P. Davis and Christopher R. Benson of King & Spalding LLP - if they don't like it then they can come and get me. [You hear me Todd?]

So, after taking a walk around the block, to calm me down somewhat, I find myself still reeling at the latest tactics of this corrupt company [I can say that because they are] and their hired defence lawyers.

It centres around a Paxil suicide case that GSK are trying their damnedest to not take responsibility for.

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

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

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

Stewart's wife, Wendy, filed suit against GSK who argued that the drug ingested by her husband was a generic form made by Mylan.

A ruling earlier this year by Judge James B. Zagel allowed the suit to proceed on the grounds that GSK owed a duty to Dolin. GSK should have expected generics manufacturers, like Mylan, would make paroxetine once the Paxil patent expired, and, according to the ruling, GSK knew the companies would have to follow its label for the drug.

So, round One to the Dolin family.

With their tail between their legs GSK and their lawyers have now bared their claws to Stewart Dolin's grieving wife.

Law 360 are reporting that GSK's defence lawyers have subpoenaed Wendy Dolin's cellphone and text message records, her home phone and her late husband's company phone.

Last month GSK served a subpoena on AT&T Corp which requested text messages, billing records from Wendy and Stewart's phones.

Wendy has filed a motion stating that she had already complied with what she characterized as GSK's intrusive discovery requests, and accused GSK of excessive prying that would not end without the court's intervention.

Furthermore, Wendy has claimed in her motion that  "GSK has so far sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children Stewart Dolin's confidential therapy notes despite Wendy Dolin's objections.

"GSK has also taken hours of deposition testimony from her and grilled her about her personal medical information and her romantic life since her husband's death, according to her motion."

Can you believe that a defence team would stoop to such a level?

End of the day Paxil can induce suicide in those that take it - see Tobin v SmithKline Beecham [Wrongful Death Suit]




Way I see it is that Glaxo have been spanked severely by a ruling. They expected another pharmaceutical company to face the heat because the drug was made by the other pharmaceutical company. What they failed to grasp is that they had a duty, both morally and ethically, to inform any pharmaceutical company making a generic version of paroxetine that it could induce suicide. Fact is, they didn't.

This isn't the first time Glaxo and their lawyers have shown a contempt for grief-stricken women who have been left to pick up the pieces of Paxil causing death.

Back in April I wrote a disturbing story about Joanne Thomas and her unborn fetus Ryan.

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.

Joanne Thomas contacted me and for three months we both pieced together evidence that she was not out of time at all - back stories here and here

Armed with the evidence Joanne went back to her lawyers who negotiated with GSK's defence team, King & Spalding. A monetary offer was made to Joanne. It's unknown whether or not she accepted the paltry amount.

So, are GSK merely showing others here that if you decide to go up against their mighty name that they will try to drag you through the mud?

End of the day everyone is entitled to a defence team but the levels to which Glaxo's attorney's stoop is nothing short of mental abuse. Glaxo are making Wendy Dolin's life a complete misery. First they fail to warn about Paxil's potential to induce suicide then, when a suicide occurs they try to lay blame on another pharmaceutical company - when they are ruled to be wrong on that issue they target the person making the complaint.

Alan S. Gilbert and Melissa A. Economy of Dentons; and Andrew T. Bayman, Todd P. Davis and Christopher R. Benson of King & Spalding LLP, who represent GSK in the Dolin case - Shame on you all.

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

I sincerely hope that they can, once again, kick GSK's ass.

Bob Fiddaman.








Eli Lilly to Face Cymbalta Lawsuits



Cymbalta US Lawsuits


Eli Lilly and Company are facing a number of lawsuits regarding their antidepressant Cymbalta [Duloxetine]

Consumers of the drug, which is also used to treat various pain disorders, are claiming that Eli Lilly misled them about the withdrawal side effects of Cymbalta, side effects which include, but are not limited to electric-shock like sensations in their body and brain (also known as “brain zaps”), dizziness, nausea, vomiting, vertigo, excessive sweating, insomnia, nightmares, and diarrhea.

Over 20 lawsuits have been filed in federal courts across the US which sees claims that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials.

According to the LA law firm Baum Hedlund, the label wrongly claims that Cymbalta only has a 1% withdrawal risk, when in actual fact Cymbalta studies show a much higher risk rate - between 44% to 50% withdrawal risk!

Plaintiffs also claim that Lilly manipulated medical literature and exaggerated the benefits of Cymbalta.

Plaintiffs are being represented by by Baum, Hedlund, Aristei & Goldman, P.C., along with Keller Rohrback L.L.P. and Pogust, Braslow & Millrood.

“We believe that Lilly’s warning that Cymbalta withdrawal occurs at a rate greater than or equal to 1% is deceptive.  It is just a sleight of hand.  One of Lilly’s own studies shows that over 50% of patients experience withdrawal when they stop Cymbalta.  1% is not 50%, not even close.  A drug label is not the place to play games with words.  It is a place to honestly inform doctors and patients about the benefits and risks of medicines so they can make informed choices.  Our clients feel strongly that they were betrayed by Lilly and we will do all we can to ensure their voices are heard by the courts.” - R. Brent Wisner, Baum, Hedlund, Aristei & Goldman, P.C

Struggling to come off a psychiatric drug is a scary experience, it can lead to akathisia, which is a known precursor to suicidal thoughts and acts.

The electric-like zaps are something I personally endured when coming off Seroxat [known as Paxil in the US] - basically, it feels like your head is being zapped with a cattle prod, it's your brain's way of saying 'FEED ME'... it's the reduction of the drug compound that causes this effect, something that Glaxo and, in this case Eli Lilly, kept from the consumer.


The full press release can be read here.

If you, or someone you know, has suffered the horrific side effects of Cymbalta then you may be eligible to file a personal injury lawsuit. You can contact an attorney at Baum Hedlund here.

Baum Hedlund has litigated over 4,500 antidepressant personal injury and wrongful death cases against pharmaceutical companies.


Bob Fiddaman






Wednesday, August 13, 2014

Robin Williams, a Radio Station and Misinformation.




Robin Williams



Stan Collymore is an ex Premiership footballer turned radio host. He's also an avid fan of Twitter.

Fellow ex footballer now turned radio host, Alan Brazil, works for the same radio station as Stan Collymore.

TalkSport is a confusing name for a radio station because the hosts offer up all manners of discussion. The death/suicide of Hollywood actor Robin Williams being one such subject.


Alan Brazil


Brazil made some ignorant comments regarding suicide stating that he had "no sympathy" for Williams. Speaking on his Breakfast Show, Brazil said  “I believe he’s [Williams] got a daughter as well – what’s she feeling like this morning? Now she’s got to sort the arrangements out. I think it’s just shocking, I really do. I don’t have a lot of sympathy, I’m sorry.”

Whilst I find Brazil's comments ignorant, I do feel they were a blessing in disguise. Suicide is...or rather was being discussed, albeit in a naive fashion. TalkSport have since apologised on behalf of Brazil.

Collymore took to Twitter to post about Brazil's stance on suicide.


A strange tweet given that the majority of Talksport's listeners are not professional sportsmen and women. Does this mean that Stan Collymore will only accept calls on football related subjects from professional footballers in the future?

I actually replied to Collymore with "You're not a Dr either Stan, to be fair."


Stan Collymore

I'm a fan of Collymore, he entertained me as I watched him from the stands of the Holte End at Villa Park many years ago. He was a very gifted footballer who, by his own admission, has suffered at the hands of depression.

Collymore encourages others who are battling with depression to speak out and to not hide their depression from anyone. That's quite encouraging as talking about one's depression is, in my belief, the way forward.

I do, however, object to the way Collymore throws around the term 'Mental Illness'. The term relates to disorders of the mind. So, in essence, if you are prescribed an antidepressant by your GP he is doing so because you have a mental illness, your mind is disordered.

Antidepressants are prescribed for everything these days, be it someone suffering the loss of a pet to someone who is going through a divorce. These, and all that fall in between, are not mental illnesses, they are circumstantial situations that need to be worked through, talked about.

Unfortunately, GP's have very limited time with each of their patients. If you get 10 minutes you've done well. GP's obviously don't want to turn away a crying patient so they use something that will benefit themselves - the patient is the last person on their mind when they reach for the prescription pad to write out words such as 'Prozac', 'Seroxat', 'Citalopram'.

Of course Doctors have empathy but this is shrouded by time restraints put on them to meet their targets. It's a conscience thing too. "Well, I prescribed him medication to help him, what more can I do with the limited time I have?"

I've read a lot of Collymore's tweets over the past year or so, some of which are entertaining, some of which I feel are misguided. Some time ago he was tweeting about the "chemical imbalance" - a theory that has been debunked time and time again yet one that people seem to want to believe in.

Collymore is a generous man, he has helped to raise funds for Depression Alliance, a charity in the UK for anyone affected by depression. They have, in the past, been accused of having ties to the pharmaceutical industry. Seroxat Secrets, a blog created by a former antidepressant user, exposed them back in 2008.

Seroxat Secrets wrote
It looks like Depression Alliance (DA) is up to its old tricks again… I have written about DA in the past and criticised the part it played in the marketing of Cymbalta in the UK.
In the case of Cymbalta, the medical PR agency, Packer Forbes, worked with DA on the research and campaign for DA’s annual ‘depression awareness week’ in 2005 – which was funded by Eli Lilly & Boehringer Ingelheim. Packer Forbes also worked for Eli Lilly & Boehringer Ingelheim on the UK launch and marketing of new drug Cymbalta. You can read about it here and here.

It's unknown if Depression Alliance today are the same as they was back then. If a 'charity' chose to work alongside pharmaceutical companies and help them promote antidepressant drugs then one has to look into the motives.

I'll be writing about a recently filed lawsuit regarding Cymbalta at some point this week.

If Collymore, or indeed TalkSport, wish to discuss depression/mental health then they should offer balance and get experts and former users involved, those who don't have ties to charities that promote, or once promoted, antidepressants.

In the meantime, I wish both Collymore and Brazil well. One is not better or more knowledgeable than the other, they both have their flaws, as do I.

Shall we add Robin Williams to the following list of SSRI casualties or should we, just like the mainstream media, ignore the antidepressant/suicide link?






Bob Fiddaman



Friday, August 08, 2014

So, What Do You Think, Mr Harvey Humphrey?




News that GlaxoSmithKline's hired private investigators, Peter Humphrey and his wife Yu Yingzeng have been sent to jail has been hitting media outlets since their sentences were handed down earlier today.

The verdict saw Humphrey sent to two years and six months in jail on charges of "illegally obtaining private information", a fine of 25,000 yuan, and deportation from China. His wife was sentenced to two years in prison on charges of "illegally obtaining private information", and a fine of 15,000 yuan.

The trial, which started early morning in the Shanghai First Intermediate People's Court and finished [with the verdict] late in to the night, saw both Humphrey and his wife apologise profusely for their actions. Despite this they were both handed jail sentences.

Humphrey's son, Harvey (19), had been watching proceedings and, according to The South China Morning Post, said "They were allowed to speak and present defence. I'm very sad about the court's verdict but I hope the authorities would take into account of their poor health. I'm absolutely exhausted. I'm going home tonight."

The South China Morning Post had earlier posted regular updates of the proceedings, a timeline of which can be found here.

Both Humphrey and his son have been critical of GlaxoSmithKline leading up to the trial, a trial that, bizarrely, made no reference whatsoever to Humphrey's work for GlaxoSmithKline, at least not in the summaries made by The South China Morning Post.

Earlier in the day Yu's lawyer asked Yu whose personal information she had obtained. The presiding judge interjected that such this has been dealt with at a pre-trial hearing. If these names are to be named again, then the current hearing could not be public, he said.

That was the closest we got to seeing or hearing GSK mentioned by name. Whether or not this had anything to do with GlaxoSmithKline's law team or, indeed, British Prime Minister David Cameron, remains to be seen.

Harvey Humphrey will now return home knowing that his father will face the next two and a half years behind bars.

I'm reaching out to Harvey because I believe that his father and step mother have been treated unfairly. I believe GSK washed their hands of Harvey's father the minute his private investigations firm, ChinaWhys, came under scrutiny from the Chinese authorities.

Glaxo, I believe, reeled him in, paid him handsomely to do work then spat him out and left him to the sharks.

They have clout, even in China. Why else would Mark Reilly be afforded the luxury of awaiting a future trial outside of prison bars when both Humphrey and his wife have been locked up for over a year while they face trial?

For those that don't know, Reilly, a former head of GlaxoSmithKline China, is accused of running "massive bribery network"

He remains in China but has not been incarcerated while he awaits trial.

Why?

So, if by chance Harvey Humphrey reads this then I urge him to please make contact with me. Spill the beans on GlaxoSmithKline, use this blog as a soapbox... I can promise [unlike most journalists] not to make any edits. Harvey can go for the jugular - his father deserves that.


Bob Fiddaman

BACK STORIES:

Glaxo - The Sex Tape Scandal

GSK's Mark Reilly Accused of Running a "massive bribery network"

I'm Just a Blogger - Here's GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK's Sales Reps Want Their Money Back

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

“GSK were really cagey", Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA - Bribery was Rife 13 Years Ago

GSK's Hired Detectives - Day One, As It Happened

**UPDATED**

11.00pm: The court sentences Humphrey to two years and six months in jail on charges of "illegally obtaining private information", a fine of 25,000 yuan, and deportation from China.

11.05pm: The court sentences Yu to two years and in prison on charges of "illegally obtaining private information", and a fine of 15,000 yuan.

11.07pm: The couple has five days to appeal this verdict. Court is adjourned.






No mention of GSK throughout the trial.

What is striking though is...

3.34pm: Yu's lawyer asks Yu whose personal information she had obtained. The presiding judge interjects that such this has been dealt with at a pre-trial hearing. If these names are to be named again, then the current hearing could not be public, the judge says.

Looks like GSK's lawyers may have been working behind the scenes.



Here's a summary transcript of today's events.



Courtesy of The South China Morning Post.

Back stories at foot of transcript.

8.45am: A prison van carrying Humphrey and Yu arrived at the court on Hongqiao Road

9.31am: The hearing begins, the court says on its Weibo account.

10.02am: Their son Harvey Humphrey, 19, is in the court room along with consular officials. Last month, Chinese authorities backtracked on plans to hold the trial in secret.

10.11am: The presiding prosecutor says Humphrey and Yu were criminally detained on July 11, 2013, and formally arrested on August 16, 2013.

10.16am: Prosecutor: between April 2009 and July 2013, the two defendants obtained 256 items of information including identity documents, travel records, mobile phone numbers from three Chinese sources, who are facing separate investigations. They paid between 800 and 2,000 yuan per piece of information and resold the information to foreign and domestic clients.

10.43am: Prosecutor questions Humphrey: "Are the facts as laid down in the charges against you accurate?" Humphrey replies: "In general, they look correct, but as for the charges, I don't understand Chinese law, I am therefore not in a position to comment."

Prosecutor asks again if Humphrey has objections to the charges. Humphrey says he does not object to the charges.

10.52am: Questioned by the prosecution, Humprey explains how he first registered ChinaWhys as a company in Hong Kong in late 2003 and then in May 2004 established his Shanghai-based firm, Shelian.

10.54am: Humphrey explains that he had chose a different name for his Chinese company because the Industrial and Commercial Administration in Shanghai did not approve ChinaWhys as the company's name.

10.56am: Humphrey lists the services he provided to clients.

10.57am: He said he provided background investigations on companies and potential hires for clients.

10.58am: He also researched industries to help clients understand the business environment and evaluated clients' employees, partners, suppliers in situations potentially involving corruption of fraud.

11.00am: Humphrey: "Sometimes clients would raise requests we can't handle ourselves, and we would look for companies which could accomplish it for clients."

11.01am: Humphrey: "In general, our services are to help reduce risks, especially in terms of fraud and corruption, for our clients."

Humphrey testifies in English. Quotes are translated from the court's Chinese-language transcript.

11.10am: Humphrey says he has worked for several hundred clients between 2004 and 2013.

11.14am: Humphrey lays out how he investigated for clients: internet searches, information provided by clients, interviews, on-site inspections. If that information proved to insufficient, he says he contracted other companies to obtain information, but such information accounts for a very small part of his services to clients.

11.15am: The prosecutor asks Humphrey if he had bought large amounts of citizens' individual information. Humphrey says he contracted other companies to provide such information, paying them a service fee.

11.20am: The prosecutor asks Humphrey why his testimony differed from what he told police earlier over the price of individual pieces of information. Humphrey says he never told police the exact price of each piece of information he had obtained.

11.23am: The prosecutor asks Humphrey whether he has ever tailed or monitored a citizen. Humphrey says he has never provided such services. He says he has helped clients find Chinese companies that could provide such services.

11.25am: Humphrey says the English word "monitoring" covers a wide range of activities including reading news reports.

11.28am: Prosecutor asks if Humphrey posed as a family member or client to interview target companies. He says he had sometimes used aliases in field investigations or telephone calls.

11.30am: Humphrey says he made sure facts, analysis and conjecture were clearly differentiated in his reports to clients.

11.34am: The prosecutor asks whether Humphrey recalled a project called "Blackthorn".

11.36am: Humphrey is asked whether he paid to obtain a target's mobile phone records while conducting the "Blackthorn" project conducted for a Finnish company.

11.42am: Humphrey says he could not remember whether he paid for information in this particular case. He says he acquired information from Zhou Hongbo and Liu Yu about a target who worked in Shandong and travelled frequently to Hong Kong. The client wanted to know what the target was doing in Hong Kong and what assets the target had in the territory. Humphrey says he commissioned another company in this case.

11.49am: Prosecutors ask Humphrey about an "Operation Clown" and "Operation Goose" for two German clients. He replies that he remembers these projects, but struggles to recall details.

11.50am: Prosecutors ask Humphrey whether he and his wife have paid for 256 items of information provided by Liu Yu, Cai Zhicheng, and Zhou Hongbo. He says he doesn't recall specific numbers but says it is possible they have used these services for as many times.

11.52am: Humphrey says he would call the three individuals, each of whom runs their own company, and pass on targets' names. In the beginning they would provide reports, but later they became more and more lazy, says Humphrey.

11.54am: Information provided to him included targets' identity and residency information, information on their family members, overseas travel records and mobile phone records.

11.56am: Humphrey says he and, his wife Yu and a former foreign employee have all contacted these three individuals.

12.00pm: Asked by prosecutors, Humphrey says he paid for such private information. He says he saved much of that information on his hard drives. He says all of his company's financial matters were handled by his wife.

12.01pm: Humphrey says he was aware that he had obtained private information from citizens after 2009, when a new law on the secrecy of private information was enacted.

12.04pm: Prosecutors ask Humphrey whether he changed his work tactics when Liu Yu was detained. Humphreys says he had learned in March 2013 that Liu had gotten into trouble. He says he gradually changed his company's operations, but had not completed the changes by the time he was himself detained later in the year.

12.06pm: Prosecutors ask Humphrey whether he thinks that private information could be freely sold on the market. Humphrey says he has never engaged in the business of trading private information.

12.10pm: Prosecutors ask Humphrey how much he charged for his reports. Humphrey says the price depended on the amount work the reports required and that his earlier statement saying reports cost between 40,000 and 50,000 yuan was just an approximation.

12.17pm: Prosecutors ask Humphrey about one report for which he charged 2.64 million yuan and used nine elements of private information. Humphrey says he spent almost a year working on the project.

12.18pm: Prosecutors ask Humphrey if he was detained by Shanghai police in his office. Humphry affirms. The prosecution ends its questioning of Humphrey.

12.21pm: Humphrey's defence team is now questioning him.

12.22pm: Humphrey says his company's business model has not changed much since he started the company in 2004. Internal graft and corruption increasingly became a focus of his inquiries, he says. He adds that over the last years he increasingly relied on interviews and public information.

12.26pm: Humphrey says 700 is a correct approximate estimate of the number of reports he produced for clients since 2004. He says he only started a numbered filing system in 2005.

12.28pm: Humphrey says he estimated about half of his reports contained some private information.

12.31pm: Humphrey says companies approached him to investigate their suspicions for fraud and graft. He says 90 per cent of such allegations proved correct.

12.33pm: Humphrey says he needed personal information to verify the identity of targets as, for example, company shareholders and to check whether they had conflicts of interests in their business dealings. He also needed the information to prove that targets were in contact with certain other individuals.

12.37pm: Humphrey says Liu Hong, Cai Zhicheng and Zhou Hongbo run their own companies and that he had now way of auditing their operations.

12.41pm: A defence lawyer asks Humphrey whether he paid for services or private information from Liu Hong, Cai Zhicheng and Zhou Hongbo. Humphrey says he paid for services. They provided him with feedback and additional information, he says.

12.45pm: A defence lawyer asks Humphrey whether he knew where the private information he paid for came from. Humphrey says he did not know how the information was obtained. He says he was aware that law firms could obtain some information.

12.47pm: The court directs a defence lawyer for his wife Yu Yingzeng to ask Humphrey questions. The lawyer asks Humphrey about his typical clients.

12.47pm: Humphrey says most of his clients were large or medium-sized companies. Most were foreign companies, but some were Chinese. They operated in manufacturing and finance or were law firms, he says.

12.48pm: These companies hired him to investigate merges, the hiring of senior executives and corrupt practices of employees, he says.

12.51pm: The court rests until 1.30pm.

1.33pm: The court hearing resumes.

2.07pm: Yu's defence lawyer asks Humphrey whether clients transferred his commissions to his private or to a company bank account. Humphrey says the commissions were transferred to the company's bank accounts, either in Hong Kong or Shanghai.

2.14pm: Yu's lawyer asks Humphrey when he actually tailed a target. Humphrey says he never tailed targets, but, in rare cases, commissioned another company. In one such case, Operation Blackthorn, he proved that a Finnish company's general manager was defrauding the company and saved it from incurring tens of millions of US dollars in damages, he says.

2.16pm: Judges now direct questions to Humphrey.

2.18pm: A judge asks Huphrey whether he consulted his wife Yu over each decision to obtain private information. Humphrey says they sometimes discussed what kind of information they should try to obtain.

2.20pm: A judge asks Humphrey whether he had signed contracts with the companies that provided him with personal information. Humphrey says he did not sign contracts for individual assignments, but had signed framework contracts relating to secrecy and conflicts of interest.

2.23pm: Humphrey says he did not use every bit of private information in his reports for clients. Some elements of private information helped him as background knowledge when compiling such reports.

2.24pm: Yu Yingzeng is now called to testify.

2.38pm: The presiding judge asks Yu whether she has clearly heard and understood the charges brought against her. She says she has heard and understood every word of them.

2.42pm: Asked whether the charges are accurate, Yu says she would like to clarify two points: Firstly, the price of 800 to 2,000 yuan for piece of information is only an approximation. Secondly, they did not sell public information, but used it to create reports. She says they have never bought information for their own benefit.

2.45pm: The prosecution asks whether Yu had problems when she registered their company in Shanghai, Shelian. Yu says they tasked an agency to handle the paperwork. She says she had no problems in the registration process.

2.48pm: The prosecution asks Yu whether they had compiled about 700 reports. Yu affirms, but says some reports were also compiled abroad.

2.48pm: Asked by prosecutors, Yu admitted to using citizens' private information.

2.49pm: Prosecutors ask Yu about the origin of this information. Yu says until 2009 they obtained information from Zhou Hongbo, from 2009 until 2011 from Liu Yu and most recently from Cai Zhicheng.

2.50pm: Yu says she never tried to bargain down the cost of information.

2.55pm: Yu says she never knew that the information she obtained was illegal. She says because she did not know the information's origin, she could not have committed a crime. She says she was not aware that obtaining such information was illegal in mainland China, when it possible to legally obtain the same information in Hong Kong. If she had known she was acting outside the law, she would have destroyed all evidence, she argues.

2.59pm: Yu says 90 - 95 per cent of the information she obtained from Liu Yu, Zhou Hongbo and Cai Zhicheng related to targets' identity and residency. Phone and overseas travel records have only become recently available, she says.

3.02pm: Yu says only she and her husband knew about Liu, Zhou and Cai's identities. Prosecutors ask whether she had to go through these agents to obtain information because the information she needed was not publicly available.

3.05pm: Yu says the prosecutor's assumption is incorrect. She says she knew that Zhou Hongbo was a lawyer and that lawyers could obtain information. She says she did not know how Liu and Cai obtained their information.

3.07pm: "We did not know obtaining these pieces of information was illegal in China", says Yu.

3.07pm: "Do you think it would touch your privacy if your husband's or son's private information was sold and bought?", asks the prosecutor.

3.09pm: "I have lived abroad for a very long time, my US phone number and address can be found in the yellow pages, it is very easy in the US to find such information," replies Yu.

3.10pm: Yu says she only rarely assigned another company to tail a target. "95 per cent of our employees' work was done in the office, investigating online," she said.

3.14pm: Prosecutors ask Yu whether she has ever impersonated a client, an investor or a relative of a target to obtain information.

3.15pm: Yu says they have pretended to be business contacts.

3.16pm: Asked by prosecutors, Yu says they charged clients between 20,000 and 200,000 for individual reports.

3.17pm: Asked by prosecutor show she paid Liu, Cai and Zhou, Yu says she wants to clarify that she they mostly provided company records. She then says she sometimes transferred their commissions to their private accounts in Hong Kong or the mainland.

3.29pm: The prosecution ends its questioning of Yu.

3.30pm: Yu is now questioned by her own defence lawyer. When asked, Yu says she emigrated to the US in 1981 aged 28. She returned to China in 1999.

3.34pm: Yu's lawyer asks Yu whose personal information she had obtained. The presiding judge interjects that such this has been dealt with at a pre-trial hearing. If these names are to be named again, then the current hearing could not be public, the judge says.

3.36pm: Yu's lawyer asks her whether the information she acquired was generic or targeted towards certain people. Yu says she acquired information to prevent and deal with internal corruption in companies and not use this information for individual profit.

"We helped clients solve problems that public security organs could now solve, making them more transparent and open," she says.

3.42pm: Yu's lawyer asks her what kind of information she obtained. Yu says 90 - 95 per cent of information was identity and residency information, which, she says, was required to find out whether a client's employee used a relative to open their own company.

3.44pm: Asked whether every report contained private information, Yu says those containing private information were few and much even less since 2011.

4.07pm: Yu tells the court how they used overseas travel records, including to Hong Kong, to trace fraud.

4.09pm: The presiding judge asks Humphrey's lawyer whether he wants to ask Yu any questions. Asked, Yu describes the workflow of a typical investigation.

4.12pm: Yu reiterates she obtained information from the client, from online sources or third parties.

4.15pm: Yu accepts the charges in as much as she bought information from a third party, but rejects them saying that she did not sell the information, but only used it to provide analysis to clients.

4.16pm: The defence teams end questioning. The judged ask some additional questions.

4.17pm: Asked by a judge, Yu says she did not sign contracts with Zhou, Liu or Cai, because the amount of money involved was too small.

4.19pm: Asked by a judge whether they would have been able to complete their assignments without private information, Yu says: "More is always better than less."

4.23pm: The court calls Humphrey back to the stand.

4.27pm: The prosecution submits the testimony of three foreign executives and a former employee at Shelian.

4.31pm: The prosecution submits a second set of evidence: testimony by four former Shelian employees and a technician who provided repair services to Shelian.

4.35pm: After a brief interruption debating the merits of the evidence, the prosecution continues with submitting further elements of the second set evidence: testimony by three more former employees. Humphrey interjects, saying two employees only worked with him only very briefly.

4.52pm: The prosecution submits a third set of evidence to the court: testimony by Humphrey, Yu, testimony by Zhou Hongbo, Liu Yu, Cai Zhicheng.

4.57pm: Liu Yu says she was criminally detained in January 2013 for illegally obtaining private information.

4.59pm: Cai Zhicheng says he charged Humphrey 1,500 yuan for every piece of information he provided: identity and residency papers, overseas travel records.

5.01pm: Zhou Hongbo says Humphrey paid thousands and sometimes more than 10,000 yuan for the investigation of a target, which normally lasted between half a month and a full month.

Transcript will be updated during the day.

**UPDATED**

5.41pm: The prosecuion says it can prove with its evidence that Humphrey and Yu bargained with third parties over the price of private information they acquired. It also says that private information of all citizens is covered by criminal law, not merely information handled by public organs and companies.

5.44pm: The prosecution submits the fourth set of evidence: Documents, computers and harddrives seized at their residence in Beijing and their office in Shanghai. One harddrive contained 48,849 documents that relate to the charges, one laptop contained 52,234 documents relating to the charges, the prosecution says.

5.47pm: Humphrey says many of the documents could be duplicates.

**UPDATED**

5.50pm: The prosecution says evidence proves that Humphrey tailed a target in Operation Blackthorn. Humphrey says the task was carried out by a third party.

5.53pm: A defence lawyer for Humphrey reiterates his client's point. His other lawyer says tailing a target is not necessarily illegal. There are no legal provisions banning the tailing of others to protect one's own legitimate interests, says the lawyer.

5.55pm: The court rests for a ten minute break.

**UPDATED**

5.59pm: The court releases its next transcript. A defence lawyer for Yu says monitoring is only once mentioned in the deposition and it referred to an employee standing outside an office building for over three hours.

6.01pm: The prosecution says it documented the use of private information in 27 reports in this set of evidence submitted to the court. It adds that it provided relevant information in the pre-trial hearing.

**UPDATED**

6.25pm: The court says on its Weibo post that it will hold a press conference on the trial at 7.30pm. The hearing is still ongoing.

6.37pm: Prosecutors say Shelian company had revenue of 20.96 million yuan between 2005 and 2013. The company earned 830,000 yuan for its work on the Operations Goose, Clown and Blackthorn, prosecutors say.

6.43pm: Prosecutors submit Humphrey's testimony to police in which he reportedly said that he was aware he was operating in a legal grey zone. He was counting on luck and not considering the consequences, he reportedly told police.

6.46pm: Prosecutors submit Yu's testimony to police in which Yu reportedly said she obtained hukou information, information on a target's family members, criminal records and telephone records from Zhou Hongbo. She paid 2,000 yuan for personal information and ordered 20-30 items every year, she said.

6.49pm: Yu worked with Liu Yu until Liu was detained in 2013, according to the police record. Liu provided hukou information, information on a target's family members, criminal record, overseas travel records, mobile phone records and other information. Liu charged about 800 yuan for an item of information.

6.51pm: Cai Zhicheng provided information of about 20 individuals to Humphrey and Yu, according to Yu's statement to police. Cai charged between 1,000 and 1,500 yuan.

6.53pm: Yu reportedly told police that they transfered Zhou, Cai and Liu's commission to their US dollar accounts in Hong Kong.

6.54pm: "Our buying of private information was wrong, but it was not a business operation," she reportedly told police. "We have a grey zone in this industry, at the time we used extraordinary channels to buy these citizens' personal information." Yu reportedly said they relied on luck, did not consider the consequences and regretted their actions.

**UPDATED**

6.59pm: Reacting to the evidence submitted to the court, both Humphrey and Yu say she never told police they relied on luck. Yu said she did not know about the legal environment after the 2009 criminal law reform on privacy.

7.03pm: Humphrey asks the prosecution when police received a first complaint. Prosecuters say the case file started on July 1, 2013.

7.08pm: A defence lawyer submits a third letter attesting to the couple's good character, two earlier ones' had already been submitted to the court .

7.09pm: The court concludes the examination of evidence.

7.11pm: The court moves to closing arguments. The prosecution begins.

7.15pm: The prosecution closes by saying that the couple has for nine years bought information on citizens' identity and residency, family members, vehicle registration, phone records, overseas travel records and had their staff pretend to be employees, investors, clients, or delivery personell to obtain further information. They hired agents to tail and monitor citizens to know more about their living habits and movements.

7.17pm: The prosecution says the couple's crime was particularly egregious, because they committed it over a period of nine years and because they reaped enormous benefits.

7.19pm: The prosecution closes with a plea for the sanctity of the private space. "Let's try to consider, if our citizens live in fear in such an environment, how can they feel secure, free or have human rights?"

7.30pm: The court hearing takes a break, to resume later this evening.

More to follow...

**UPDATED**

8.00pm: In his closing defence, Humphrey said the duo did not sell personal information, but rather, sold the analysis and research of such information to clients. He added that the company's main service is to investigate internal graft, fraud and help cultivate a good business environment. "They have no other ways of achieving this goal."

8:10pm: In her closing defence, Yu asked the prosecution for proof that 300 reports out of the 700 used personal information. She also disputed the company's revenue, saying that the prosecution did not calculate for profit after expenses and costs. She shared an anecdote: "Someone saw a thief steal something, but the police said there's no evidence therefore they can't arrest the thief, so the person found the evidence and arrested the thief, then the police came back and said the person broke the law. The public security organ said you violated the thief's rights."

8:15pm: The court rests for 30 minutes.

**UPDATED**

9:00pm: Both defence lawyers argue that Humphrey and Yu's actions have inflicted limited harm to society and does not constitute a crime.

9:15pm: The prosecution maintains that the duo violated citizens' rights. "Before a court ruling, those they investigated have not been deemed corrupt, how can you say the parties you are investigating are corrupt?"

**UPDATED**

10.10pm: In his closing statement, Humphrey talks about his childhood fascination and respect for China. Growing up in a poor family, he saw the China in 1979 and wanted to be a part of its development. He says he has always supported anti-corruption in China, and many of his projects dealt with helping different companies detect internal corruption and fraud. He and his wife wanted to give back to the Chinese community but failed due to their lack of understanding on the 2009 criminal law reform on privacy. Humphrey apologises for disobeying the law and expresses regret. "My wife and I still love and respect China passionately." He hopes the court will accept their apology.

10.20pm: In her short closing statement, Yu expresses regret over their crimes and begs the court to forgive her husband.

10.30pm: The verdict will be released after the court rests.

**UPDATED**

11.00pm: The court sentences Humphrey to two years and six months in jail on charges of "illegally obtaining private information", a fine of 25,000 yuan, and deportation from China.

11.05pm: The court sentences Yu to two years and in prison on charges of "illegally obtaining private information", and a fine of 15,000 yuan.

11.07pm: The couple has five days to appeal this verdict. Court is adjourned.





Bob Fiddaman.



BACK STORIES:

Glaxo - The Sex Tape Scandal

GSK's Mark Reilly Accused of Running a "massive bribery network"

I'm Just a Blogger - Here's GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK's Sales Reps Want Their Money Back

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

“GSK were really cagey", Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA - Bribery was Rife 13 Years Ago


















Tuesday, July 29, 2014

Antidepressants: The Power To Harm





Much has been said about the suicide link with antidepressant use. I think we should accept that antidepressants can induce suicide given that the manufacturers and regulators have now admitted this one small fact that they previously [conveniently] omitted.

If a person can kill themselves due to an adverse reaction to a drug then could they also harm others?

In cases of homicide the antidepressant defence has been used many times, "My client was under the influence of an antidepressant and had homicidal thoughts your Honour".

Those that use such a defence are ridiculed because those that manufacture these types of drugs refuse to admit that their products can induce acts of homicide in those who take them.

Three high profile cases involve three SSRi type drugs, namely, Citalopram [known as Celexa in the US] and Seroxat [known as Paxil in the US] and Prozac.



Shane Clancy (22) drove to the quiet residential area of Cuala Grove in Bray where he unleashed an attack of psychotic proportions on his ex-girlfriend and her new boyfriend. Sebastian Creane. Creane's brother, Dylan, was stabbed nine times when he came to his aid.

The following afternoon, August 16, 2009, Shane Clancy's body was found in the back garden at Cuala Grove. He had stabbed himself 19 times.

The inquest into Shane's death returned an open verdict. The jury wasn't satisfied that he had intended to take his own life. Shane had toxic levels of citalopram, in his system. [More here]


David Carmichael, a Canadian, took his 11-year-old son, Ian, to a hotel room in London, Ont., and strangled him to death.

Charged with first-degree murder, Carmichael was found not criminally responsible because of a mental disorder and transferred to the Brockville Mental Health Centre. In 2009 he received an absolute discharge from the Ontario Review Board.

The makers of Paxil, GlaxoSmithKline, have said they “do not believe Paxil played any part in this situation.” [More here]


David Crespi was alone with his twin daughters when he stabbed them to death, then called 911 to report the murder. The cocktail of drugs that his wife said pushed him over the edge was Prozac, Ambien, Trazadone and Lunesta. He'd been taking them for one to three weeks.

David Crespi entered guilty plea came to avoid the death penalty, but it led to a life sentence with no chance of parole. [More here]



There are those that refuse to accept that the antidepressants in the above cases played any part in the decisions of those who carried out these violent acts, opting instead to blame the 'mental illness'.

What if evidence could be provided, would it ease the pain of those left behind to pick up the pieces?

Exactly who are the victims here?

Those who were killed, the loved ones of those who were killed or those who carried out the homicide?

Well, all of them.

A 2009 review of antidepressants in Japan has been flying under the radar for some time and it was only by chance that I happened to find it via the Japanese Medicine Regulatory website.

The Japanese Ministry of Health, Labour and Welfare [MHLW]  reviewed reported adverse reactions of aggression, etc. including harmful behavior to others (including injury) associated with SSRIs or SNRIs.

MHLW issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

Here's what they found...

"After a careful review of the 39 cases of harmful behavior to others including injury (including 4 potential episodes associated with milnacipran hydrochloride that could have resulted in harmful behavior) identified from the clinical course, causality between the drug and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.  

"In light of the above findings and discussions amongst specialists, it is considered necessary to add the following precautionary statements to the “Important Precautions” section of package inserts: 1) Episodes of anxiety, irritation, excitement, panic attack, irritability, hostility, aggression, and impulsivity have been reported; 2) In patients with these symptoms or behavior, exacerbation of underlying disease, harmful behavior to others, etc. have been reported, though causality with the drugs is not clear; 3) Patients should be carefully monitored for changes in their clinical condition; 4) Patients’ families should be given full information on risks associated with changes in behavior such as excitement, aggression, irritability, etc., and an exacerbation of underlying disease, and be instructed to keep in close contact with the physician."

I wrote to the British drug regulator, the MHRA and asked them the following...

Dear Sir/Madam,
I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury).
Please state if any alerts to patients and their families have ever been sent out regarding this issue.
Please state if any revision to package inserts have been made regarding this issue.

The MHRA have deemed that my query falls under the Freedom of Information Act and that I should receive a reply within 20 working days.

I'll keep you updated of any reply they send me.

Next time you read about a gun slaying in an American school it may be worth taking this Japanese review into account.

Next time you read of a murder carried out by someone who, just like the above three cases, were your normal, average, hard working male... then take the Japanese review into account.

Here's a recent one that raises all the red flags, for me at least.

The review by the  Japanese Ministry of Health, Labour and Welfare can be downloaded here.

Bob Fiddaman.