Back in April this year my blog reached a milestone. It was the ten year anniversary of when I first launched this blog and as part of its 10 year birthday I decided to run a series of Q&A's with fellow advocates and people who have been part of my 10 ...

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"FIDDAMAN BLOG" - 5 new articles

  1. Q&A With Kristina Kaiser Gehrki
  2. The Mechanics of the MHRA
  3. Prozac - Benefits Vs Risks - MHRA Correspondence
  4. Dolin Vs GSK - More Motions Denied
  5. ChinaWhys Vs GSK - The Claims - Part 2
  6. More Recent Articles

Q&A With Kristina Kaiser Gehrki







Back in April this year my blog reached a milestone. It was the ten year anniversary of when I first launched this blog and as part of its 10 year birthday I decided to run a series of Q&A's with fellow advocates and people who have been part of my 10 year journey. Previous Q&A's can be seen at the foot of Kristina's (Pictured above) Q&A session.

I fist became aware of Kristina after I had read the history surrounding her daughter, Natalie, whom at the age of 19 took her life, shortly after her dosage of Zoloft was increased over the telephone by her prescribing physician. Kristina has wrote a two part series for David Healy's blog, RxISK. Kristina's two accounts of her daughter were beautifully written, so much so that it prompted me to leave a message in the comment section of RxISK commending her on her excellent writing skills. (Natalie's Story can be read here & here.)

Some months later I opened my email and saw a message in my inbox from Kristina. I knew straight away who she was as her two accounts about Natalie's prescribed death had penciled her name into my subconscious. I am a fan of writers, those who have the ability to paint pictures with words. Kristina has this ability. This prompted me to ask Kristina to write a guest post for my blog, a post which has attracted over 3,000 views to date and one which has been 'liked' and shared on Facebook hundreds of times. See - Guest Post: Let's Bring Akathisia Out of the Darkness.

Today sees the birthday of her daughter, Natalie, she would have been 23. I feel it's fitting to publish Kristina's Q&A today, much of which will astound you if you are unfamiliar with the background of Natalie's treatment of apparent health care 'professionals'.

Pay particular attention to Kristina's explanation of the state of Virginia's negligence laws - I must admit, these laws are absurd given the number of deaths by prescription drugs throughout America these days.

Also, you HAVE to see Kristina's outstanding delivery to members of an FDA Advisory Panel, a delivery that left FDA employees stunned into complete and utter silence - link to the footage is within Kristina's answers below.

We shall be meeting in person soon and both heading off to Chicago for a showdown with a major pharmaceutical company. We're also going to be sharing stories over a pint or two in her hometown of Virginia, hopefully not in a jazz bar though. More on that in a future post.

Anyway, here's Kristina's Q&A.

Bob Fiddaman.

--

Full Name: Kristina Kaiser Gehrki
Age: 51
Location: Fairfax, Virginia


Natalie


Q: Kristina, Natalie would have been 23 today (Dec 8, 2016), this may be a difficult question, so forgive me if it's painful for you. What is your fondest memory of Natalie?

A: There are so many fond memories it is difficult to choose just one. Natalie was a petite girl with a super-sized laugh and witty sense of humor. Overall, my fondest memory is simply hearing the beautiful sound of my daughter's laughter. It is something I dearly miss.

Natalie often used humor to spotlight the cruel ironies of the world. My fondest special memory is a letter to the editor she wrote our local paper, the Washington Post. Natalie was sixteen at that time, and the U.S. planned to execute a man whose IQ was so low he was legally “mentally retarded.” Natalie shared her death penalty views and pointed out the absurdity of killing a person who was “mentally retarded.” She said the execution clearly reflected the lowest IQ’s— that of the politicians who made this decision.

I still have her letter and reading it encourages me as I advocate for fully Informed Consent. Informed Consent is a fundamental human right. Consumers have a right to know what they are consuming, whether it’s a genetically-modified tomato or a Black Box drug that can cause violent death. Fully Informed Consent should be provided by prescribing doctors and by pharmacies. It is critical and something we, unfortunately, never received.

Q: What do you say to people who believe that antidepressants are safe and effective?

A: I have several family members who work in the health care field. I am not anti-drug, I am simply pro-information. The fact is “antidepressant” drugs are neither safe nor effective for children. This has, belatedly, been reported in scholarly journals and by some of the few remaining independent journalists. My daughter was prescribed SSRI drugs (Prozac and Zoloft) not for depression but for what the doctor labeled “OCD-like symptoms.” Natalie didn’t receive a specific diagnosis; she was assigned a rather ambiguous billable code that enables doctors to collect insurance money. We asked for a specific diagnosis many times and our questions were often met with excuses. The intense anxiety (Akathisia), confusion, memory loss, change of gait, nausea, etc., Natalie experienced after consuming the products were not presenting symptoms: They were adverse drug reactions.

I’ve learned a lot about unethical pharmaceutical marketing tactics and FDA failures since my daughter’s death. Unfortunately, like many parents who unwittingly gave their children dangerous, ineffective drugs, I learned too many facts far too late, despite that I asked all the right questions I knew to ask. Ironically, my academic and professional background is in communication and marketing. Before Natalie’s death, I presented conference workshops regarding how to communicate crisis and risk. I share this information only to stress that if this tragedy can happen to us, it can happen to anyone. And when I say “tragedy” I am not speaking only of Natalie’s akathisia-induced death. Rather, Natalie was poisoned for many years. Even when she stopped taking the drugs, many of the adverse drug side effects were still present. We simply didn’t recognize then what was happening nor why.

It is difficult if not impossible to recognize signs of adverse drug reactions given we were intentionally left in the dark. Several internal memos from Eli Lily (Prozac), Pfizer (Zoloft) and Glaxo Smith Kline (Paxil) show these companies knew their respective products were dangerous and no more effective than a sugar pill. The FDA also appears to have known about these risks long before my daughter was ever conceived and before the Black Box warning. Natalie was first prescribed Prozac prior to the Black Box warning. The FDA warning came out while she was taking the drug, but the doctor never informed us. Years later when she was prescribed Zoloft, the doctor assured us "Zoloft is a different drug than Prozac.” This doctor communicated nothing at all about the existence of a Black Box warning. The pharmacy never communicated it. While I believe Black Box warnings have saved lives, I also have spoken to many parents who stated their doctors actively discounted the Black Box warning, claiming the warning is overblown and unnecessary. One doctor dismissed it by telling the parent, whose son later died an SSRI-induced death, “Don’t worry. The FDA puts that label on everything.”


Q: What advice would you give to Coroners faced with suspected suicides of teenagers?

A: It seems many coroners don’t speak for the dead. Too often they seem to protect fellow doctors and the pharmaceutical companies by failing to recognize and/or report adverse drug reactions associated with polypharmacy and metabolism. My daughter died a horrifically violent death within days of taking 200 mg. of Zoloft, a dose prescribed over the phone, by a doctor who never physically saw Natalie. The doctor never informed me that she had directed such an increase.

After Natalie died, I asked the coroner for blood samples because I wanted my daughter's blood tested for metabolism. The coroner rather casually declared she might not have enough of my child’s blood left after she was done conducting the state’s tests. The state of Virginia would not test for metabolism when I requested it. I was able to obtain a small sample of Natalie's blood which was sent to an independent lab. The results showed Natalie was not a very effective metabolizer of SSRI drugs.


Q: What advice would you give to parents whose children/teenagers are on antidepressant medication?

A: I’ve previously stated it seems our society has gone from one in which “Mother knows best” to “Mother knows nothing.” I believe “modern medicine,” the pharmaceutical and psychiatric industries and government regulators have helped create this paradigm shift. My first advice to mothers is, "Don't be intimidated and coerced. Take back your motherly instinct and parental power. Recognize that it is you who knows your child best. Follow your gut instinct.

My second piece of advice is do not believe the “chemical imbalance” theory, and that so-called “antidepressant” drugs are a safe and effective treatment for children. I now have to live the rest of my days missing my child and feeling profound guilt for having believed such fallacies.

My third piece of advice to parents is to reflect on your child’s presenting symptoms vs. your child’s current symptoms. It is sometimes easy to forget what your child was like before the drugging began, particularly when these adverse drug reactions create more desperation to help your child. Doctors, many of whom are also duped, may convince parents that they are doing a great job parenting because they are actively “treating” their child. My daughter’s personality changed dramatically after consuming these drugs. They robbed her of her soul, her spirit and, in the end, took her very life. It was a slow, painful death.

Lastly, I'd like to encourage parents not to buy into the medicalization of anxiety, sadness and worries. Try safer, more effective ways to reduce such feeling such as exercise, diet, art therapy, etc.

Q: You are in the process of writing a book, can you, without giving too much away, tell me a little bit about the whole process of book writing, and in particular, the difficulties you face as a parent who has lost a child.

A: The book has some similarities to the Diary of Anne Frank, considering it is Natalie, herself, speaking from the dead. She was an intelligent, prolific writer who kept a diary of sorts. You can see some of Natalie's writing in the documentary “Letters From GenerationRx.” She documented many adverse drug reactions without ever knowing she was experiencing and documenting them. She believed what the doctors repeatedly declared: that her physical and mental suffering was a sign of a disease and not signs of drug toxicity. Drug-induced psychosis and akathisia causes extreme anxiety and fear. I’m amazed Natalie did as well as she did for as long as she did considering that, as her side effects worsened, doctors routinely increased the offending drug.

The book is quite difficult for me to write and compile because it requires a careful review of Natalie’s medical records and diaries. These records clearly highlight signs of drug toxicity, yet the doctors repeatedly failed to recognize this reality. I should also add that the psychiatrist responsible for the ultimately fatal 200 mg of Zoloft did not provide us with Natalie’s complete medical records. This psychiatrist stalled, giving us only a few records at a time. Finally, the doctor called and left a voice mail message—a message I still have. She states an “office flood” destroyed Natalie’s remaining medical records.


Q: You and I have briefly discussed the state of Virginia negligence laws. For the benefit of the readers, can you explain in laypersons terms how difficult it is for residents of Virginia to file suit for negligence?

A: This is an unbelievable injustice and one I learned about only after Natalie's death. Virginia is one of only three states in the U.S. that has an archaic law called contributory negligence. It requires a jury to find the defendant 100% responsible for the outcome or the victim gets nothing. In cases such as Natalie’s it means we must prove her death was 100% the result of the doctor’s negligence and/or the product manufacturer. Given that the general public does not want to believe the truth surrounding SSRI-induced “suicide,” it is extremely difficult to meet the Virginia requirements and also challenging to find attorneys who will take these cases. If I were a doctor, I’d choose to practice medicine in Virginia. And I do mean “practice” in the true sense of the word…

For more information about the contributory negligence law, see: Link.

Q: What advice would you give to Coroners faced with suspected suicides of teenagers?

A: Coroners should start collecting and reporting all data regarding teen suicides and openly share this data. This data is necessary to improve public health and safety. How many teens have ended their lives while taking SSRI drugs or other prescription drugs that carry an increased risk of suicidal thoughts, suicidal actions, and suicide? How much time passed after starting the SSRI or changing a dose and the teen’s death? My daughter died a day after taking the 200 mg. of Zoloft prescribed by telephone. I consider her death a chemical abduction, abduction and death by telephone.

Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant-induced suicide?

A: Bob, I don’t know enough about this to answer here.

Q: Back in September you kindly wrote a guest post for my blog, entitled, 'Let's Bring Akathisia Out of the Darkness.' The post featured a letter you wrote to Christine Moutier, Chief Medical Officer of the American Foundation for Suicide Prevention (AFSP) - Can you tell me what feedback, if any, you have had from the letter you sent them?

A: The American Foundation for Suicide Prevention (AFSP) takes a lot of money from the pharmaceutical companies, and their board of directors contains several people with direct ties to the pharmaceutical industry. These incestuous relationships remind me of the FDA’s revolving-door employment agency. AFSP has never responded to my letter in which I requested they help increase akathisia awareness and reduce drug-induced “suicides.” I put the word “suicide” in quotes because I don’t believe people who die from prescription-drug induced self-harm while suffering from SSRI-induced akathisia have died by their own hand, so to speak. These deaths are sometimes labeled ego-dystonic suicides or suicide beyond one’s will. I simply call it prescripticide.

Q: Have you ever had any correspondence with either Eli Lilly (Prozac) or Pfizer (Zoloft)?

A: No. I learned that Eli Lilly was largely responsible for starting the whole “antidepressant” industry scam by intentionally skewing the real data in their Prozac clinical trials. I consider Eli Lilly my daughter’s first killer. Pfizer comes in next as killer number two as their internal documents show Pfizer knew their product, Zoloft, caused akathisia and suicidality among healthy volunteers in their clinical trials. Glaxo Smith Klein was so impressed by the “Lilly Protocol” deceit that helped gain Prozac FDA approval they then recruited the same employee to conduct similar trials for Paxil. Natalie never was prescribed Paxil, but it is interesting to note how the pharmaceutical industry shares their top talent.

Drug company fraud and corruption—all designed to put profits before people—ought to be made into a Hollywood movie. People might not believe such evil is real. But my daughter went off in a coffin instead of off to college. Her violent death is our reality forever more.


Q: You have met many fellow advocates on your journey, many of whom who have suffered personal tragedies with regard to antidepressant induced death. How has this helped you and do you still keep in contact with this network of fellow advocates?

A: Shortly after Natalie died, I started googling “Zoloft causes suicide” and similar searches. I quickly found stories of many families, such as Woody Witzack, Stewart Dolin and Candace Downing, families whose loved ones also died SSRI-induced deaths. Mathy Downing, who lost her twelve-year-old daughter after Zoloft, told me “Ours is a sad club to belong to, but you will meet a lot of wonderful, caring people.” She was right. I’ve met many wonderful people similarly dedicated to helping others avoid our tragedies. I very much appreciate these fellow advocates and friends.


Q: I was recently privy to witness a speech/statement to you gave to members of an FDA Panel. Can you tell me what that was about and, for the benefit of the readers who never saw this, could you tell me what you said to those panel members? (Footage of Kristina's delivery to the FDA after her answer)

A: I attended the FDA’s recent hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” I had no plans to speak and wasn’t on the speakers’ list. However, after listening to hours of pharmaceutical industry propaganda and industry-funded shills, to include the National Alliance for the Mentally Ill, I felt upset and nauseous. Many of the so-called “patient advocates” were sent to the hearing by the pharmaceutical companies and their funded organizations. Few people can afford to travel to the Washington Metro area and speak up for their loved ones who were harmed or killed. I was glad I did.

I arrived with no prepared speech and simply spoke from my heart. Perhaps I could have been a bit more cordial and succinct, but, really, who can expect parents to be pleasantly deferential when speaking to the government body whose actions and inactions caused the torture and death of their child? How could the mother of a child who was tortured and killed pleasantly smile at the criminals largely responsible for ending her child’s life?

Watch Kristina's speech here.

**Instructions**

CLICK HERE - Skip to 0.45.55


Q: Where do you see yourself in 10 years’ time?

A: Like other people whose loved ones have been harmed and/or killed, I will continue advocating to help prevent this from happening to other families. Losing a child, or any family member, to avoidable death, is terribly painful. However, the best thing we can do to honor our loved ones is to cherish their memory, create happy moments and live our lives with meaningful purpose. Ten years down the road, I will still be advocating, but, hopefully living in a sunny place surrounded by lush greenery and a little garden.

Q: Finally Kristina, some personal questions...

1. What book are you currently reading?

A: Ah, this is a difficult question. I have a large stack of books I want to read, some for pleasure and others for research related to my own book. None of the research related books are happy reads, but the authors--Robert Whitaker, David Healy, and Peter Breggin--are all excellent writers.

2. What was the last CD you listened to (in full)?

A: Vienna Teng’s Waking Hour. She is a talented musician with a beautiful voice. Natalie loved Vienna Teng. Shortly before she died, she downloaded the song “Lullaby for a Stormy Night.” Natalie was suffering from Zoloft-induced psychosis, complained of violent nightmares and insomnia. I doubt she was able to truly understand she was going to die. Akathisia is so overwhelming; perhaps Natalie just wanted to go to sleep. Hence, the lullaby.

3. What is the best movie you have seen this year?

A: The Edge of Seventeen with Woody Harrelson. It’s an entertaining comedy about the awkward challenges of the teenage years. Given that I taught high school marketing for many years, the movie resonated with me. It was realistic and made me laugh. Laughter is a very important part of my life.

4. What country would you most like to visit?

A: While I’ve traveled a lot, I would like to see Ukraine. Given that my grandparents were Ukrainian, I grew up eating Ukrainian food and have fond memories of my grandfather playing the accordion and dancing the polka.

5. If you had the choice of being either a defense or prosecution lawyer, which would you choose and why?

A:  I would aim to be proficient at both, but would prefer defense. It seems the U.S. system is increasingly stacking the deck against the “common person” and not just regarding pharmaceutical fraud. Unfortunately, the U.S. imprisons more people at a higher rate than any country. Every person should have the right to adequate legal representation. The notion of the right to a fair trial, along with the “anyone can grow up to be president,” are two quaint, Disney-like notions that are U.S. fallacies.


For Natalie
December 8, 1993 - February 6, 2013

 




Previous Q&A's

Q&A With Ablechild's Sheila Matthews-Gallo

Q&A With Leonie Fennell

Q&A With the "Truthman"

10 Years of Blogging - Q&A With Neil Carlin

Q&A With My Dad

Q&A With Musician Kirk Brandon








    

The Mechanics of the MHRA





So, another response from the British medicines regulator, the MHRA, regarding the benefit vs risk ratio of the antidepressant, Prozac.

It's been painstaking trying to get to the logic behind some of their responses, in fact, it's been suggested that some of their responses to me regarding this issue have been 'obtuse'. It is, however, important that I try to keep this line of communication open with them, if only, to have their responses made public via this blog.

Regular readers will recall that I have been scratching my head regarding the MHRA's stance that one apparent benefit of taking Prozac outweighs the number of adverse events reported by Prozac users or their treating physicians - a list of which can be seen, ironically via the MHRA's own web page, here.

As suspected, the MHRA are now telling me that the list of adverse events reported for Prozac should not be "interpreted as a list of possible side effects to a medicine," furthermore, they add, "It is important to note that causality has not been proven in these reports."

Here is their full response to me - it may help if you read the previous correspondence between myself and the MHRA regarding Prozac's benefit vs risk in order - 1, 2, 3.

So, here's their latest - my response to this follows...

Dear Mr Fiddaman

Many thanks for your email of 25 November 2016.

Most medicinal products that contain one active substance exert their effect through one mechanism of action, in this case through raising the level of serotonin in the brain (which can improve symptoms of depression). In addition, most medicinal products have a range of possible side effects. It should be noted that the frequency of such side effects are considered when evaluating the benefit/risk profile of a product to determine whether it should be granted a marketing authorisation. The frequency of these side effects are also monitored after a marketing authorisation is granted to ensure that the benefit/risk profile of a product is still positive.

The Drug Analysis Print (DAP) for fluoxetine represents a listing of all suspected adverse drug reactions or side effects that have been reported to the MHRA via the Yellow Card Scheme. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies. It is important to note that causality has not been proven in these reports; reporters are asked to submit a Yellow Card report even if they only have a suspicion that the medicine may have caused the adverse drug reaction. For this reason it is very important that the information within a DAP is not interpreted as a list of possible side effects to a medicine. The data shown in our DAPs can be very useful in helping to identify possible medicine safety issues. However, this information does not present a complete overview of the potential side effects associated with specific medicines. Conclusions on the safety and risks of medicines cannot be made on the data shown in the DAP alone. Patients should instead refer to the Patient Information Leaflet for the most complete and up to date information on possible side effects.

Best regards


The FOI Licensing Team

--

My response...

Please find my following up questions in bold font below.

(MHRA's statements are in italics.)



Most medicinal products that contain one active substance exert their effect through one mechanism of action, in this case through raising the level of serotonin in the brain (which can improve symptoms of depression). 

1. Is this a definitive answer, ie; Are you saying that you (the MHRA) have clinical and scientific evidence that, in this instance, Prozac improves depression by raising the level of serotonin in the brain? If so, could you please forward me the scientific literature that clearly shows this to be true. If this is just a 'common belief' could you please state, for the record, that the evidence of Prozac improving depression by raising the level of serotonin in the brain is inconclusive.

In addition, most medicinal products have a range of possible side effects. It should be noted that the frequency of such side effects are considered when evaluating the benefit/risk profile of a product to determine whether it should be granted a marketing authorisation. 

2. Is this based on the clinical trials that last between 8 and 12 weeks?

The frequency of these side effects are also monitored after a marketing authorisation is granted to ensure that the benefit/risk profile of a product is still positive.

3. Monitored by whom? Can you please explain the system of monitoring - ie; does monitoring include reading 'anecdotal reports of adverse events ' on Prozac forums?

The Drug Analysis Print (DAP) for fluoxetine represents a listing of all suspected adverse drug reactions or side effects that have been reported to the MHRA via the Yellow Card Scheme. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies. It is important to note that causality has not been proven in these reports.

4. Out of all the adverse events reported for Prozac via the Yellow Card System, how many have been found to show that Prozac was the causality and how many have been shown that Prozac was not the causality?

...reporters are asked to submit a Yellow Card report even if they only have a suspicion that the medicine may have caused the adverse drug reaction. For this reason it is very important that the information within a DAP is not interpreted as a list of possible side effects to a medicine. 

5. How do you, the MHRA determine whether or not the adverse events reported via the Yellow Card System are caused by Prozac? 

The data shown in our DAPs can be very useful in helping to identify possible medicine safety issues. However, this information does not present a complete overview of the potential side effects associated with specific medicines. 

6. Thus far, you, the MHRA have given me just one benefit of Prozac, namely that it "can" improve symptoms of depression by raising the level of the neurotransmitter, serotonin, in the brain. When you suggest that it "can" are you saying that sometimes it can't? Please clarify what you, the MHRA, mean when you claim that it "can" improve symptoms of depression.

Conclusions on the safety and risks of medicines cannot be made on the data shown in the DAP alone. Patients should instead refer to the Patient Information Leaflet for the most complete and up to date information on possible side effects.

7. If a doctor, or patient, for that matter, files an adverse event via the Yellow Card System do you, the MHRA write back to them if you determine that Prozac was the causation? Do you, the MHRA, at any point, visit the reporter to try and gain more information - if so, in the past 12 months, how many times has the MHRA visited a reporter of an adverse event regarding Prozac?


Sincerely,

Bob Fiddaman





    

Prozac - Benefits Vs Risks - MHRA Correspondence





For a while now I've been at loggerheads with the British drug regulator, the MHRA.  (Back stories below)

I've been asking them to send me a detailed list of the benefits of taking Prozac - Yesterday they sent me the following. My response to them follows...

Dear Mr Fiddaman

Apologies for the delay in responding.

Regarding your below enquiry, benefits are considered to be the therapeutic effects of the product to improve the medical conditions for which a product licence has been granted.  These are set out as the Therapeutic Indications in the Summary of Product Characteristics (SmPC) and in the uses of the product in the Patient Information Leaflet (PIL).  To further understand these benefits, you have asked what positive thing is going to happen to alleviate your depression.  The way in which the therapeutic effects are achieved is also explained in these documents.  In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression (and the other indications listed).  The MHRA does not promote medicines, but agrees in the SmPC  a factual summary of the effects of taking a particular medicine based on the results of clinical and non-clinical studies. 

I hope this answers your question.

Best regards

The FOI Licensing Team

--

My response...

Thank you for this.

So, in essence you are telling me that,  "In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression." is the one benefit and that this one benefit has been measured against the risks and the MHRA have granted Prozac a licence because they see that this one benefit outweighs the following reported risks with Prozac use...

Please try and help me (and others) understand how one benefit of a product outweighs the following risks associated with Prozac use.

All risks taken from the MHRA fluoxetine Drug Analysis Print  (DAP)
(http://www.mhra.gov.uk/home/groups/public/documents/sentineldocuments/dap_19529665880175380.pdf)


Benefits v Risk
Prozac Use.
Benefits

It raises the level of the neurotransmitter,
serotonin, in the brain which can improve
symptoms of depression
Risks

Blood disorders
Cardiac disorders
Congenital disorders
Ear disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
Asthenic conditions
Death and sudden death
Febrile disorders
Feeling abnormal
Feeling jittery
Fibrosis
Gait disturbance
Peripheral swelling
Face oedema
Chest pain
Drug withdrawal syndrome
Hepatic disorders
Immune system disorders
Infections
Exposure during breast feeding
Foetal exposure during pregnancy
Fractures and dislocations
Electrocardiogram QT prolonged
Heart rate increased
Abnormal liver function
Blood sodium decreased
Weight decrease
Weight increase
Blood prolactin increase
Platelet count decrease
Haemoglobin decrease
Blood creatine phosphokinase increase
Blood pressure increase
Blood pressure decrease
Metabolic disorders
Muscle & tissue disorders
Neoplasms
Nervous system disorders
Seizures and seizure disorders
Tremors
Foetal growth complications
Ectopic pregnancy
Foetal death
Abnormal behaviour
Agitation
Anxiety
Nervousness
Aggression
Disinhibition
Homicidal ideation
Hostility
Paranoia
Personality change
Violence-related symptoms
Confusion and disorientation
Delusion
Depression
Depersonalisation/derealisation disorders
Insomnia
Eating disorders
Emotional and mood disturbances
Fluctuating mood symptoms
Impulsive behaviour
Restlessness
Mental disorders
Tearfulness
Apathy
Orgasmic disorders and disturbances
Panic attacks
Nightmares and abnormal dreams
Hallucinations
Personality disorders
Acute psychosis
Psychotic behaviour
Psychotic disorders
Schizophrenia
Libido decrease
Libido increase
Loss of libido
Sleep disorders
Dysphemia
Bruxism
Alcohol abuse
Akathisia
Completed suicide
Intentional self-injury
Suicidal ideation
Thinking abnormal
Tics
Renal & urinary disorders
Reproductive & breast disorders
Respiratory disorders
Skin disorders
Homicide completion
Vascular disorders




Bob Fiddaman.


Back stories

Classic Avoidance by the British Medicines Regulator, the MHRA

British Drug Regulator (MHRA) Dodging the Curve Ball








    

Dolin Vs GSK - More Motions Denied






Following on from a series of posts on this blog regarding GSK motions being denied by the Judge in charge of the Dolin v GSK case (Case: 1:12-cv-06403), comes news hot off the press that GSK have, once again, been denied further motions to get this and that pulled. Most notably is the evidence of expert witnesses for Dolin. In brief, GSK wanted to try and stop Dr Joseph Glenmullen and Dr David Healy from giving evidence. Their reasoning behind this motion bordered on desperation because GSK know that both Glenmullen and Healy have worked on Paxil litigation before, both have given evidence that has been damning for GSK.

GSK tried to exclude Healy's evidence based upon a General Medical Council (GMC) hearing that acquitted Healy. Not content with this, GSK wanted to hold their own hearing into the GMC matter, a kangaroo court, if you will. The Judge presiding over matters in the Dolin case has denied them this. GSK claimed that Healy has a "bias" against them (Insert tears here)

Other motions filed by GSK...

 - To exclude any reference to GSK’s conduct and Paxil labeling prior to 2004 is DENIED.
 - To  exclude evidence with respect to FDA’s authority or GSK’s interactions with the FDA is DENIED.
 - To  exclude hearsay statements and opinions of Dr. Joseph Glenmullen is DENIED.
 -  To exclude evidence that GSK had a duty to directly warn patients of the risk of taking paroxetine is RESERVED.
 - To exclude evidence of marketing and promotion is RESERVED.
 - To exclude certain evidence is RESERVED.


Motions Granted,,,

 - To exclude evidence of pediatric use of Paxil is GRANTED except as to the FDA’s review of the issue of suicide and the FDA’s review of GSK’s submission in 2003.
 - To exclude references to other claims, lawsuits, investigations and reports is GRANTED.
 - To exclude evidence of Any plea agreement and settlement is GRANTED.
 - To exclude any reference to the “Lilly Protocol” is GRANTED.
 - To exclude any reference to foreign labeling or warnings for Paxil is GRANTED.

What does this all mean?

For some, legal jargon is a turn off (not for me though, it's quite the opposite)

Let's break this down in laypersons terms...

GSK wanted to bar the testimony of Dolin's expert witnesses - they failed, in other words, the Judge, more or less, told them that despite filing reasons why experts testimony should not be heard - experts testimony shall be heard and there is nothing more that GSK can do about this. Furthermore, GSK wanted to see documents relating to an unrelated inquiry into Dr Healy. The inquiry was carried out by the GMC and exonerated Healy. Not, seemingly, happy with this, GSK wanted to be allowed to carry out their own interrogation of Healy relating to the GMC investigation - they, once again, failed, the Judge, more or less, told them that the GMC inquiry had nothing to do with the Dolin case, ergo, Healy shall be allowed to give his testimony without being badgered by GSK's attorneys regarding the GMC inquiry.

GSK wanted to exclude evidence relating to their interactions with the FDA, this would include emails, minutes etc. - They failed. The Judge has, more or less, told GSK that they will now have to show why they failed to sit down and discuss Paxil's propensity to induce akathisia and suicide with the American drugs regulator.

GSK wanted to exclude any evidence submitted by Dolin in relation to their conduct and Paxil labeling prior to 2004 - The evidence and conduct of GSK prior to 2004 is something they don't want the jury to see, nor, indeed, the public. In 2004 a black box warning was introduced regarding Paxil's propensity to induce suicide, they (GSK) feel that anything prior to that, ie; evidence that shows they knew long before 2004 that Paxil could induce suicide should not be submitted - they failed, in other words, the Judge, more or less, told them that evidence of them hiding the data and not warning the public about that danger shall be heard by the jury.

GSK wanted to exclude hearsay statements of Dolin's expert, Dr Joseph Glenmullen - Meaning that he would not have been able to offer an opinion based upon documents and clinical trials of Paxil - in a nutshell, GSK wished to gag him. - They failed. The Judge, more or less, told them that Glenmullen is a relevant expert in the field of Paxil inducing akathisia and suicide so they (GSK) cannot suppress his opinions.

Reserved Judgments

A reserved judgment is basically a decision that has not been made by the Judge, in other words, he may need more time and may, at a later date, deliver his judgement.

GSK asked the judge to exclude evidence that they had a duty to warn patients about the risks of taking Paxil. In essence, they don't want Dolin to show the jury that GSK had a moral and ethical duty to provide information regarding Paxil inducing akathisia and suicide. To use an analogy, it's akin to a chef preparing a meal with contaminated food. The chef knew he was using contaminated food but failed to warn the diners in the restaurant. The chef later argues that he had no duty to warn the diners. This motion has been RESERVED by the Judge.

GSK wanted to exclude evidence of the marketing and promotion of Paxil. This includes internal documents and (probably) pharmaceutical rep notes showing how they played down the risk of Paxil inducing suicide. Marketing could be anything from running an advert on television to bribing doctors to prescribe more Paxil, something that they have already been found guilty of in the US. This motion has been RESERVED by the Judge.

Granted Judgments

GSK have been granted a total of five judgments, all of which are common knowledge to the layperson. You'd have to be from the planet Zog to not know about the Paxil pediatric evidence they manipulated (Paxil 329)

They were also granted their motion to not have references to other claims, lawsuits, investigations and reports aired in the Dolin case. Again, Planet Zog inhabitants would be oblivious to GSK's dark history of Paxil causing severe withdrawal (Over 3,000 cases 'resolved' in the US) - Paxil being found responsible for a homicide and suicide - a jury arriving at this decision (See Tobin Vs SmithKline Beecham - Fig 1) - Paxil causing birth defects (Over 800 cases 'resolved' in the US)


Fig 1


Also granted was the exclusion of evidence showing plea agreements GSK have made in the past, this would, more than likely include the above mentioned cases and, of course, the recent plea of guilty and subsequent fine of over $3 billion. Planet Zog inhabitants are probably the only species not to be aware of this. More of GSK's nefarious activities can be seen in video form here, here and here.

More recently, we can see how they handled the widespread bribery and corruption in China, and how, it's alleged, their CEO, Sir Andrew Witty, lied to the media regarding his knowledge of the violations -  here and here.

GSK were also granted motions to exclude any reference to the 'Lilly protocol' and also to exclude any reference to foreign labeling or warnings for Paxil.

**Updated**
The "Lilly Protocol" involved using suicidal people in Prozac clinical trials to make it so there were a lot of placebo suicidal behavior events to offset and “hide” the elevated on drug events in meta-analyses of suicidal behavior.  Wheadon, the Lilly employee that came up with this idea, transferred to GSK and implemented the same idea which became  Paxil MD-057 and 106 which for years were used to undermine the suicidal behavior rates.

As for the exclusion of evidence pertaining to foreign labeling or warnings for Paxil, GSK probably don't want the jury to see how the labeling differs from country to country, or, at the very least, how it used to differ.



Since the claim was filed in 2012 GSK have sent Wendy Dolin more than 30 subpoenas, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself.

In 2010, Stewart Dolin (pictured) killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop. Dolin was just 57.

He had started taking a generic version of Paxil six days before he leaped to his death.

Dolin is represented by Baum Hedlund Aristei & Goldman, P.c.
GSK is represented by King & Spalding.

It seems quite apt to rehash this reworking of a classic soul track. (New lyrics beneath the video)

Enjoy.


 


Go Ahead And File A Motion - The Paxil Remix

Maybe to win this trial you'll cheat
But there's no denying your rap sheet.
And maybe you have reasons to stall
Your drug has killed many, after all.

In that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Ooh

Maybe you think that stalling will bring me down
And maybe you think you can run me into the ground.
Maybe you think that I'm just a fool
Knowing all along it was you who broke the rules.

In that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Ooh, ooh

Ooh, ooh

Oh GSK, in that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, GSK
Go ahead, and file a motion.
[FADES] - Ooh GSK, go ahead, and file a motion.


Pokey Fiddaman & The Satiricals - 2016
Music by Smokey Robinson & The Miracles



Bob Fiddaman.



Back Stories

Dolin v GSK



















    

ChinaWhys Vs GSK - The Claims - Part 2






Following on from the first parter, Lawsuit Alleges GSK's Witty Lied to the Media - Part I, today sees part 2 (The claims of ChinaWhys against GSK) - Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)

Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging...


 - Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur.

 - GSK set up a special "crisis management" team in order to bribe Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly.

 - GSK planned to suppress evidence of its illegal bribery activities.

 - As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities.

 - GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal causing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes.

 - GSK targeted 'persuasive doctors' in attempts to influence purchasing decisions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash.

 - GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disguised by GSK as "Conference trips."

 - Head of Chinese operations, Mark Reilly, received a bribe in the form of 'sexual relations' in return for passing business on to China Comfort Travel, a travel agency who organised 'conference sevices' for GSK.

 - GSK paid doctors based on their prescription numbers.

 - GSK's senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who's who regarding the team who were investigating GSK.

 - Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets.

 - Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and  the Public Security Bureau. Humphrey, once again, declined.

 - Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was "coming after him." (Humphrey).  Reilly then fled China the following day.

 - GSK China told its employees to "destroy all non-compliant promotional materials and gifts." They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to "reduce unnecessarily legal costs."

--

Bob Fiddaman.

Back Stories from the Fiddaman Blog

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

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing

The Penny Drops for GSK's Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK's Witty Lied to the Media - Part I
    

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