Zantac Lawsuit


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

Monday, April 23, 2018

Prescribing Death



People who suffer from allergies, medical disorders, and disease usually know best what medications and/or food they can and cannot tolerate.  For example, I suffer from a type of inflammatory arthritis called gout. There are many foods and drinks that my body cannot tolerate. I realize, as do medical specialists, that foods high in purines, such as shellfish, will likely increase the risk that I will suffer a painful gout attack. Therefore, I avoid or reduce my consumption of specific foods and beverages in order to stay healthy.

I'm of sound mind, but if I wasn't, I'd have to rely on my loved ones to ensure foods high in purines are eliminated from my diet. Good health and medical care is often a family affair for all of us, whether we suffer from gout or medication allergies. Most doctors would agree that concerned family members play a vital role in patient care, particularly when the patient is a minor or might need assistance in decision making.


Thomas "Oliver" McGowan (18)

The Poisoning of Oliver McGowan

Eighteen-year-old Thomas Oliver McGowan, known as Oliver, died on November 11, 2016. He lived with cerebral palsy, epilepsy and autism, which began after contracting meningitis twice during childhood. On Saturday, October 22, Oliver was suffering from simple partial seizures and taken by ambulance to Southmead Hospital in Bristol, UK.

Upon arrival, Oliver was intubated, a process of inserting an endotracheal tube through the mouth and into the airway. This was apparently done to place Oliver on a ventilator to assist with his breathing. Oliver was sedated with Lorazepam, a drug indicated to treat seizure disorders. He was then taken for a CT scan which did not show any changes to his brain.

As doctors at Southmead Hospital eased the Lorazepam, Oliver's seizures returned. Instead of reinstating the Lorazepam, the doctors made a decision that ultimately killed Oliver. They prescribed him the antipsychotic, Olanzapine, a drug indicated to treat schizophrenia and bipolar disorder. It is better known in the US by its brand name Zyprexa. Oliver developed Neuroleptic Malignant Syndrome (NMS), an adverse effect of the drug, his temperature rose to 43C and his brain swelled to the point that it was coming out of the base of his skull.


Dr. Monica Mohan

Dr. Monica Mohan's Arrogant Destruction

The consultant neuropsychologist who made the decision to administer Olanzapine is Dr. Monica Mohan. It appears she made a calculation of risks and benefits but ignored more than 500 citations assessing the impact of antipsychotic drugs on challenging behavior. Of these 500 citations, only 3 were methodologically sound randomized controlled trials, and even these were unable to show whether antipsychotic drugs were beneficial in controlling challenging behavior. (1)

Neuropsychology and publications aside, doctors and staff at Southmead Hospital were repeatedly told by both Oliver and his parents, Paula and Tom,  not to give him antipsychotic medications because he was allergic to them.

Oliver's avoidable prescription-drug death and last week's inquest has been covered by the British media. The week-long inquiry showed how doctors, after learning of Oliver's adverse drug reaction to the drug that was administered, performed a CT scan on his brain which showed Oliver’s brain had swelled to the point doctors said there was no “meaningful recovery”.

During the inquiry, consultant neuropsychologist, Dr. Mohan, told the inquest she would do it again because she believed it was in “his (Oliver's ) best interest”.

I kept an eye on the proceedings and, like the majority of the public, I was gobsmacked at last Friday's verdict delivered by Assistant Coroner Dr. Peter Harrowing.

Harrowing, a former Director of Pharmacy Services to the University Hospitals Bristol NHS Foundation Trust, concluded Olanzapine had been properly prescribed and that NMS could not be predicted as it was a “very rare adverse effect”. Further, Harrowing said he agreed with Dr. Mohan. He said the doctors were right to prescribe the drug that precipitated Oliver’s death. Dr. Harrowing also ruled against a Prevention of Future Death.

I reached out to the McGowan family who told me, "The coroner argued that it wasn’t an allergy but a sensitivity or intolerance. Of note, Oliver had previously suffered oculogyric crisis (a dystonic reaction to certain drugs) in Bristol Children’s Hospital with his seizures increasing from one per fortnight to 30 a day.  Sean Collins, safeguarding lead at Southmead Hospital, had consulted with ICU staff about using a non-pharmaceutical approach for when sedation was refused but was not consulted by Mohan."

Smoke-and-mirrors

I'm never shocked anymore by Inquest verdicts. I've long been a fan of the website AntiDepAware, moreover its author Brian. AntiDepAware includes links to reports of inquests held in England and Wales since 2003. It's a great window into the world of coroners and how they don't really work for nor represent the dead. Coroners are often just doctors protecting doctors and the majority repeatedly fail to protect the living by being honest about what happened to the dead. Oliver's case is, tragically, no exception to the medical industry's business-as-usual model. Loved ones who question the medical industry in order to help protect others from suffering avoidable harms are often shocked to see the medical industry's chief concern is to protect their colleagues and business systems.

It's difficult enough to lose a beautiful child who had his whole life ahead of him. But to then endure more smoke-and-mirrors deception from a pharmacist-cum-assistant coroner is beyond the pale. Further, Oliver's parents had to pay for the ordeal following Oliver's death whereas Southmead Hospital was supported throughout the inquest by public funding. (Yes, folks, this is where your hard-earned tax money goes.)

When I think about the avoidable death of the talented and handsome young man named Oliver McGowan, I can't help but also think about thousands of other "Olivers" and "Olivias" out there whose prescribed deaths aren't covered by the news. While they remain faceless to the public, they are not faceless to family and friends.

Nothing will bring Oliver back to life. The inquest that could have reduced future avoidable deaths by improving crisis communication and medical safety instead seem to have increased the likelihood that doctors will practice medicine however they choose, parents be damned.

Arrogance among doctors is a deadly flaw. A 2002 journal article by Allan S. Berger (2) states, "...the most critical variable in the development of arrogance is a physician's knowledge and thereby his or her power over the patient. This can delude some physicians into imagining that they are all-powerful." He continues, "...we should not exaggerate our own importance. We are but an instrument of healing and not its source."

I couldn't agree more.

Bob Fiddaman

(1) Are antipsychotic drugs the right treatment for challenging behaviour in learning disability?: The place of a randomised trial

(2) Arrogance among physicians ~ Berger AS




Thursday, April 19, 2018

Stop It!



Dr. Clare Gerada ~ "Stop it"

Louis Appleby, Government Advisor on the prevention of suicide, opened a can of worms on Twitter last month when he tweeted:


What followed were some jaw-dropping tweets from, Clare Gerada, the person Appleby was promoting.

Who is Clare Gerada?

Clare Gerada is one-half of a psych drug promotion pair. She's married to Simon Wessely, a psychiatrist and professor of psychological medicine at the Institute of Psychiatry, King's College London. Gerada was the chairperson of the Council of the Royal College of General Practitioners from 2010 to 2013. She is also a partner in the Hurley Group which runs a number of GP practices and walk-in centers across London. She was made a Member of the Order of the British Empire in the 2000 Birthday Honours "for service to medicine and to drug misusers"

Nice.

Now let's take a look at Clare's attempts to stifle conversation about the side effects surrounding 'antidepressants'.

First up to tweet opposition to her views was Australian Army Major Stuart McCarthy. He joined the Australian Army in 1988 and in 1999 deployed to Bougainville, Papua New Guinea where he served as commander of a multi-national patrol in the Peace Monitoring Group.

Towards the end of McCarthy’s Bougainville deployment, he became a subject in an unethical drug trial for the antimalarial drug tafenoquine. In 2001, he spent six months as the deputy force engineer in the United Nations Mission in Ethiopia and Eritrea. While there he was prescribed mefloquine and experienced a variety of adverse drug effects including depression.

Despite recurrent major depression and other debilitating neurological symptoms that he now realises are the result of the undiagnosed neurotoxic brain injury he sustained in 2001, McCarthy served in the Army for 16 additional years.

His full bio is at the foot of this blog post.

McCarthy's April 16th tweet to Gerada asked her three questions. The resulting twitter exchange was priceless despite that Gerada's "responses" were dreadfully predictable.

Click on Twitter images to enlarge.


Undeterred, Major McCarthy pressed Gerada for some answers. Once again, she tried to silence the respected veteran:


I then tweeted Gerada a question asking if she would concede that, for some, they (drugs labeled antidepressants) could be dangerous? Her reply, if you could call it such, was quite puzzling:

So, now she was using her same line on me, Gerada ordered me to "stop it."

Minutes later she made a claim that these drugs save lives and told me to read the 500 clinical trials that prove it. Ahem, I hated to break the following to her:





Gerada could not answer my question because the fact is there have been no clinical trials for drugs labeled antidepressants that supported the claim Gerada made. There are no clinical trials that have found any evidence that taking these drugs saves lives. If there were, pharmaceutical companies would have already printed this bold proclamation on their product packaging. Pharma would never let such a sales and promotional opportunity slip by.

After running face first into a brick wall, Gerada's next tweet was equally lame but more bizarre:

I've previously written about how critics of patient safety advocates throw out the PR stigma line. You can read all about it here.

I then pointed out Gerada's strawman arguments and her shady goal to suppress and shame those harmed by drugs labeled antidepressants. Fiona French, who has been seriously damaged by benzo prescribing, joined the twitter conversation. What is astounding here is the way Gerada diagnoses French.




The conversation seemed to end there, but the following morning Gerada tweeted something even more delusional.

My answer was short and sweet. "Stop it", I said.

Coming late to the twitter round was Kristina Gehrki. Her tweets appeared to have ended Gerada's nonsense. Perhaps Gerada was too busy the last days with her googling "Who is Florence Nightingale?"




**STOP PRESS**

Remarkably, just minutes ago, Gerada felt the need to chip in again. This time, responding to a parent whose son died in an 'antidepressant' induced death. Telling a parent whose child died as a result of a prescription that they are 'wrong' is an affront to public health. Her reply also shows an appalling lack of human compassion.

Here's the tweet.



Gerada has now blocked me on Twitter.

Bob Fiddaman












Monday, April 16, 2018

India: GSK Whistleblower Names and Shames - Part II






"This was not just a violation of the standard operating procedures and code of conduct at GSK but also violated several sections of the Constitution of India and Penal Code."

Following on from Part I

In summary, Navneet Kumar, a rep for GSK India, is blowing the whistle on the way the company operates its business out of India.

In Part I, we learned that Kumar was told by senior management to meet his targets by "hook or by crook". Further, Kumar was paying stockists out of his own pocket so senior management would reap the monetary benefits. This despite the GSK rule book stipulating that: "a drug rep should not be involved in any money-related matters with their stockists."

Kumar filed a complaint against his Regional Business Manager, Sanjeev Jolly, who apologized and, well, that was that. GSK officials took no disciplinary action against Jolly.



Part I also highlighted how Kumar's  Area Business Manager (ABM), Jitendra Singh Chauhan (pictured above), would phone him after midnight making demands - he'd even phone Kumar whilst he was on leave. Kumar didn't comply with the demands and was summoned to a meeting at GSK's New Delhi office by Sanjeev Jolly, who asked Kumar to resign. When he refused, Jolly told him, "I will finish your career" and that, "You and your family will be out on the street."

Part II

Because Kumar didn't resign he was issued a charge sheet. It's here that he alleges GSK management created trumped up charges against him because he had brought it to their attention about violations within the company, more specifically his senior management.

Whenever a charge sheet is issued against an employee, that employee has a right to be accompanied by a co-worker or a legal representative. Kumar told me:
"After the charge- sheet was issued, I requested to GSK management to allow me legal representation because of the allegations against me. My request of legal representation was denied by GSK management. So I fought  my case alone  in the enquiry proceedings. The charge sheet alleged they had witnesses but no such witnesses were ever provided by GSK. The enquiry officer was Vipin laroia and from the early stages of the enquiry it appeared he was siding with GSK management."
In fact, according to Kumar, The investigation was trying to hide the witness statements from him. He later learned that the only witnesses GSK had were the two senior managers who had harassed him from the get-go.

Kumar wrote to senior management and asked if they could change the investigating officer, they refused.

Kumar was once again summoned, once again, he was asked to resign, once again, he refused.

Of that meeting Kumar told me:

"Somewhere I noticed that they weren't recording whatever I was saying, which was most disturbed me. Actually, as per the domestic enquiry rules, the job of recorder is to type the ongoing conversation on his laptop, but under the shadow of the enquiry officer and general manager they were acting like that they were typing but at end of enquiry proceedings they only provided me with what management had stated, and not what I had stated. They had also omitted the threats and their calls for me to resign."

Aniruddha Kunte, GSK General Manager -Employee Relations

Kumar, once again, sought help from higher management, this time writing to Aniruddha Kunte, General Manager -Employee Relations.

Kunte told him that after investigating the claims (which surmounted to asking the Inquiry Officers whether or not they were true) he (Kunte) found no evidence that suggested Kumar was being harassed, further, Kumar was told that he should "actively participate in the ongoing Inquiry."

Kumar told me he signed papers under duress as he felt intimated. He wrote, once again to Kunte:

(Email has been altered by me, Bob Fiddaman, for clarity)

Re: The last inquiry session on 10/8/2016 at the Delhi office.

The proceedings of that day were signed by me under duress. Some issues are the same as I told you earlier. But no action was ever taken by you.

The behavior of Mr. Vipin(EO) was the same. He was trying his best to harass me, he is totally under the influence of management.

During the meeting, Mr. Jolly was trying his best to put unnecessary pressure on me. Even when I told him that I was disturbed by his actions he didn't change his behavior and continued to humiliate me.

Therefore, I am requesting you to please make arrangements of a video recording of the Inquiry session.

Regards 
Navneet Yadav (Kumar)


--

Kunte never followed up and, more importantly, never provided the video recording to Kumar.

The charges against Kumar stood and at this point, he was joined in 'the field' by his ABM Jitendra Singh Chauhan. Basically, Chauhan would follow Kumar around to see if he was meeting his company objectives, which included meeting doctors and dealers as per company guidelines.

Kumar claims that on day one, Chauhan wasted 2 hours of the day in efforts to make Kumar's daily targets impossible. Kumar also alleges that Chauhan would take company vehicles off other reps which resulted in those reps not being able to meet their targets, he even, at times, according to Kumar, used to demand Kumar's car and bike for personal use. Once again, Kumar brought this to the attention of GSK's employee relations manager, once again, nothing was done.

Chauhan continued to waste time, resulting in Kumar not being able to meet his company objectives. Because of this, and because of the restrictions placed on in, Kumar invited Chauhan to ride with him in the evening - he failed to respond to any of Kumar's text messages suggesting this.

Enter the Handwriting Expert

The charges against Kumar continued, in fact, according to Kumar, he had to endure 10 inquiry sessions. On one such occasion, they accused him of not visiting a doctor that he claimed he had. GSK management claimed that the doctor was out of India at the time so Kumar could not have visited him. Kumar, in his defense, told me:
"I requested that the Inquiry Officer and Management Representative provide evidence in support of their allegation that the doctor was not present in India. After a while they produced a letter purportedly from the doctor. In it, he had written that he was indeed out of the country."
Regarding the apparent letter, Kumar told me:
"I examined that letter very carefully and I realized that it wasn’t written by the doctor. The handwriting matched that of my Area Business Manager, Jitendra Singh Chauhan. I brought this to the attention of the Enquiry Officer who quickly dismissed it."
After this, Kumar acquired the services of a certified handwriting expert who came to the conclusion that the apparent letter from the doctor was, in fact, the same handwriting as Kumar's ABM, Jitendra Singh Chauhan. Armed with this evidence, Kumar showed the Investigating Officer at yet another Inquiry session. He told me:
"In a closed inquiry session room, they abused me and threatened me. I tried to submit my expert handwriting report but they wouldn't accept it from me. Had they accepted it,  they would have seen clearly that Jitendra Singh Chauhan, with the assistance of  Sanjeev Jolly, forged the letter. This was not just a violation of the standard operating procedures and code of conduct at GSK but also violated several sections of the Constitution of India and Penal Code."
Compare two letters and judge for yourself. Were they, as the handwriting expert suggested, both written by the same hand? (Click image to enlarge)

The top is an example of Kumar's Area Business Manager, Jitendra Singh Chauhan, whilst the bottom is, apparently, from the doctor who, it is alleged, was out of the country.


Click Image to Enlarge

Kumar was dismissed from his position at GSK.

Shortly before his dismissal, Kumar sent emails to GSK's Global Head of Investigations, Jason Lord, and GSK's then chief, Andrew Witty. Included in his emails was the handwriting expert report (below) 



Those emails and responses coming up in Part III

Bob Fiddaman















Thursday, April 12, 2018

The Truth About SSRI Withdrawal/Dependence




The following legal brief has rarely been seen by members of the public. Read through it and you'll understand why.

It's a fascinating read and highlights just how GSK hid the withdrawal issues surrounding their popular antidepressant, Paxil.

Many readers will find the following PDF too much to bear. Many will be angered by it, and rightly so. I hope many of you will pass it on to family, friends and even healthcare professionals.

For me, at least, it's the most damning document to ever surface out of litigation. The litigation in question saw GlaxoSmithKline settle with over 3,000 plaintiffs who had struggled to taper off Paxil. Much of the evidence was sealed as part of the 'gagging order' - However, this legal brief gives us an insight into the incestuous relationship between GSK and the FDA. It also shows us how GSK carefully manipulated the system thus putting thousands of future patients through utter misery with debilitating side-effects of withdrawal.

The Yugoslavia trials, mentioned in the document below, are very interesting. Glaxo sponsored the two phases of these trials. In Phase I all patients were given Paxil, in Phase II some were switched to placebo. It was at this stage that the placebo patients began experiencing severe withdrawal issues. Glaxo chose to define this as "relapse" data. This would give them the ammunition to announce later that patients who stayed on Paxil continued to enjoy a normal, "depression free" life, but those abandoning the drug would suffer relapse back into a depressive state.

Back in 2015 I, under the Freedom of Information Act, requested from the MHRA the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal. The MHRA wrote me and said they "didn't hold that information."

Here's the legal brief.



Bob Fiddaman







Sunday, April 08, 2018

The NYT Addresses Antidepressant Withdrawal Issues





The Lame Defense

You'll hear many lines when discussing the problem of withdrawing from drugs labeled "antidepressants." They include the following:

"These drugs save lives."
"Without them, I wouldn't be here."
"Antidepressants benefit millions of people worldwide."
"They help people get through their daily routine."

While it's not for me to rebut all the above claims, the real issues are that none of the above lines have any relevance into discussing the challenges of "antidepressant" drug withdrawal. Comments such as the above are designed to get people to focus on the purported benefits of "antidepressants" and reduce discussion and/or dismiss discussion about the known risks. These lines are spouted by pharmaceutical companies, pharma-funded "health" and suicide organizations, drug regulators, doctors and consumers of "antidepressants." Some consumers, simply don't care about others who struggle with horrendous and life-threatening adverse drug reactions (ADRs). Perhaps these consumers of "antidepressants" are too frightened to look at the statistics for if they did, many would try to get off these drugs and would then find themselves gaining first-hand experience with SSRI ADRs.

Shifting the blame

If the above illogical responses don't work then the same people use the "shifting the blame" tactic. Some of these tactics include:

"Talk to your doctor."
"You're obviously not ready to come off them yet."
"It's not withdrawal, it's a return of your mental illness."
"Don't believe everything you read on the internet."
"Stop pill-shaming."
"You're a conspiracy theorist."
"Don't you think if these drugs were dangerous someone would have spoken up about them?"

I've heard all these retorts and imagine you've heard some, too. Once again, these retorts are thrown out willy-nilly in an illogical attempt to reduce honest discussion and purposeful action to solve the withdrawal problem caused by drugs labeled "antidepressants." It's an illogical argument and a selfish "I'm alright, Jack" response.

Many people who chant the above retorts state ADRs only happen to a "handful" of people. Even if this were true, how would the claims above help those suffering from severe "antidepressant" ADR's? Does society believe there is a certain magic number of victims that have to be reached before wanting to reduce avoidable suffering? How many people have to die from SSRI ADRs before it is deemed a public health issue worthy of positive action? Are some lives more important than other lives? Considering children and the elderly are two groups most at risk for ADRs, is this a sign our society cares less about children and the elderly?

Do we have to wait until we have inconclusive evidence that shows antidepressants cause severe ADRs in more than half of those who take them?

Time for Broader Discussions

Yesterday, the New York Times published an article entitled, "Many People Taking Antidepressants Discover They Cannot Quit." It's a decent article and the authors, Benedict Carey and Robert Gebeloff, seem to have done their homework with one exception. They stated, "withdrawal has never been a focus of drug-makers or government regulators." This is not accurate and I'll tell you why:

The Yugoslavia Trials 

The Yugoslavia Trials did, indeed, flag the issue of withdrawal surrounding paroxetine (Paxil, Seroxat).

In summary, in 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how paroxetine could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping paroxetine) could have been suffering withdrawal symptoms.With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.

One thing that irked SKB was that they had to convince the FDA that relapses shown in the study were not simply patients suffering withdrawal.
(You can read my coverage of the Yugoslavia trials at the foot of this post.)

Buck-Passing

Further, back in 2011, the British equivalent of the FDA, the MHRA, launched an "innovative" SSRI Learning Module for prescribing doctors. In it, they stated...
"Symptoms after sudden SSRI discontinuation usually last about one to two weeks and then resolve spontaneously, but they can persist for longer in some patients. Close clinical observation is required to ensure that withdrawal symptoms are not getting worse. Severe cases may call for specialist advice and possible switch to an SSRI with longer half-life before gradual tapering."
I was interested in the "specialist advice" they were recommending to doctors who had patients suffering from worsening withdrawal symptoms. I, therefore, wrote to them and asked for a list of these "specialists." I asked them what training do these specialists have, where do they get this training and by whom?

Despite many weeks of emails back and forth and the usual game of semantics played by the MHRA, they could not provide me with one specialist. The links to the launch of the SSRI Learning Module are below.

Now that is has been more than 7 years since I asked MHRA for a list of specialists and they couldn't list a single one, I pose the question again: Can MHRA provide a list of specialists who are trained to help patients safely withdraw from drugs labeled as "antidepressants."?  I also pose the same question for patients suffering from benzo withdrawal.

The New York Times article is long overdue but I suspect it may well be wrapping up someone's fish & chips tomorrow because that's how this works. Pleas for help go unanswered because the strategy from the psych and pharma industry is to shift blame and change the conversation. They aim to avoid honest discussion of these serious medical issues despite that discussion and awareness would reduce suffering and save lives.

If the Yugolslavia trials don't show you how corrupt this system is, your definition of corrupt is far different than Webster's

Bob Fiddaman


Yugoslavia Trial

The Seroxat/Paxil Yugoslavia Trial Part I

The Seroxat/Paxil Yugoslavia Trial Part II

SSRI Learning Module

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I 

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip" 

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine 

MHRA In Buck-Passing Specialist Cahoots 

MHRA - More on the Mysterious "Ghost Specialists" 

MHRA Wishing To Call The Shots






Friday, April 06, 2018

Medicide: What's It All About & What Can We Do?



Natalie Gehrki
Today marks the 12 year anniversary of this blog and with over 2 million views since its conception I find myself posting a recent radio show asking "What can we do?" Over the years I've covered many advocates and their efforts to increase awareness so others might avoid dangerous ineffective drugs. I've covered wrongful death court trials, organizations dedicated to exposing psychiatry and pharma's deceit, tragic losses of life too numerous to count.

Today, I'd like to pose a question to my readers: What can we do? We all have diverse talents, compassion, wisdom that often comes from ADR experiences, and a commitment to positive change. Perhaps there are some great ideas for collaboration out there?

The following interview with Kristina Gehrki went out live on KCAA Radio on Wednesday evening. In it, she explains how she tragically lost her daughter, Natalie (19) to prescription drugs, namely Prozac and Zoloft.

You can download the interview here

Bob Fiddaman

Back Stories

Kidnapped: Natalie’s Story

Kidnapped: Natalie’s Story 2

Netherworld

Let's Bring Akathisia Out of the Darkness

Kristina Gehrki - Twitter






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