Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Informed consent. Show all posts
Showing posts with label Informed consent. Show all posts

Monday, August 23, 2021

Informed Consent ~ Changing the Paradigm

 


Rarely does a video cause me as much anger as one I recently viewed via Twitter. Before reading on, please view it below or here



After hearing Dr. Samuel White's story, I searched for an unedited version of the video and additional info about White, who has been a doctor in NHS for more than 17 years. White is now facing an interim orders tribunal regarding his fitness to practise. The Medical Practitioners Tribunal Service (MPTS) will carry out a tribunal to decide whether to:

1.Impose an interim order of conditions on White's medical registration.
2.Impose an interim order of suspension on White's medical registration.
3.Make no order.

As part of the ongoing process, White's licence to practise medicine within the NHS was suspended by a letter the NHS sent on 26 June 2021. His rebuttal, via his lawyers, can be seen here.

White has been temporarily suspended for telling his patients to review data provided by two government websites: the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Adverse Event Reporting website in the UK and the Vaccine Adverse Event Reporting System (VAERS) in the US.

As of 8 August 2021, MHRA states they have received 342,014 reports for all the combined vaccines and that this accounts for more than 1 million total reactions, 1,559 of which were fatal. (Fig 1)

CLICK ON IMAGE TO ENLARGE
Image courtesy of UK Column


This government-provided data is what Dr. White told his patients to read when deciding whether or not to have the COVID vaccine. The figures above change weekly and will increase as more people report their adverse reactions. It's also important to remember that because many adverse reactions and deaths are never reported to the MHRA, these figures above do not tell us the whole story.

The MHRA will argue that the reported reactions and deaths do not necessarily mean the vaccine caused them, often using the phrase, "correlation does not equal causation." They have done this throughout history with medicines that cause adverse events and even deaths.

White was giving his patients as much information as he had at his disposal; he didn't have the weekly stats for the vaccines' adverse events; hence his common-sense suggestion that patients check the two websites is appropriate. 

So what is Informed Consent?

It seems an easy question to answer, but no doctor can provide patients with all the information needed for fully informed consent because data from clinical drug trials is withheld from medical professionals and consumers. 

1. You must have the capacity (or ability) to make the decision.

2. The medical provider must disclose information on the treatment, test, or procedure in question, including the expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur.

3. You must understand the relevant information.

4. You must voluntarily grant consent, without coercion or duress.

Let's take a closer look at #2

For doctors to relay information about benefits and risks to their patients, they need all the information. But doctors and the MHRA do not receive all the data from the drug companies. Case Report Forms (CRFs) are individual patient data from clinical trials. These are all kept under lock and key--the only time one is ever granted access to CRFs is when a request for disclosure is made. Disclosure refers to a litigation procedure where each party in the suit must disclose any/all documents that may be considered relevant to the pending court case.

The likelihood of CRFs from COVID vaccine clinical trials ever seeing the light of day is slim given that AstraZeneca, Pfizer, and Moderna, have all been granted indemnity. In other words, consumers who suffer from taking these COVID-related products can never sue the company that made them. So, no litigation, no CRFs.

Having no access to CRFs is bad enough, yet we also have ghostwritten "medical literature."

Who You Gonna Call?

Most people who see the names of medical doctors or Ph.D.'s followed by affiliated academic institutions as authors of medical journal articles likely believe the drug data and product claims promoted. The pharmaceutical companies promote these erroneous assumptions using a scheme called ghostwriting.

The authors of ghostwritten articles have not written them or read all the clinical trial data. Instead, the drug companies hire PR firms to draft articles and send them to academics who lend their names as authors. A classic example of this was ghostwriting PR outfit, Scientific Therapeutics Information (STI), that worked for drug kingpins, GlaxoSmithKline (GSK).

In a nutshell, GSK's pediatric trials for Paxil returned abysmal results. However, GSK knew all was not lost. The company only needed child psychiatrists to promote Paxil for kids by claiming the drug was safe and effective. STI's ghostwritten article helped convince many doctors to convince many parents that Paxil was safe for children. Years later, we learned through litigation why GSK never shared the clinical trial data: Internal documents showed GSK was worried that their clinical trial data would reduce product sales. 

You can read more about this case here, here, and here.

Doctors, including Samuel White, are not obliged to research drug company malfeasance; moreover, even if they did their own research, they are not obliged to inform patients of their findings.

The USA

An article published in the British Medical Journal (BMJ) on 20 August 2021 highlights how the American equivalent of the MHRA, the Food and Drugs Administration (FDA), is preparing to grant full approval of the Pfizer vaccine without publicly discussing the data. Only a year ago, the FDA said it was "committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public."

So, why the sudden U-turn? Experts quoted in the BMJ article said politics drove the decision not to meet to discuss the data. Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings, said, "It's obvious that the FDA has no intention of hearing anyone else's opinion. But if you make decisions behind closed doors it can feed into hesitancy. It's important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know."

The FDA and MHRA don't want to discuss the data because, as I previously stated, they don't have all the data.

Ladies and gentlemen, this is the publicly funded smoke-and-mirrors shit show being performed for us. The truth of the matter is, everything is being hidden in plain sight. Whether you have taken these COVID drugs or not, you should question all of the above. It is easy (and lazy) to post memes on Facebook or Twitter chastising those who choose not to take these vaccines. It's easy to label people who don't get in line for pharma's new COVID products and call them "anti-vaxxers" or "conspiracy theorists.' Similar labels were assigned to folks who spoke out about the dangers of promoting and prescribing Paxil to children. Yet years later, GSK's lies were exposed during wrongful death litigation. 

Informed Consent ~ Changing the Paradigm

I'd like to see the term 'informed consent' used less frequently. It is meaningless when a doctor or patient does not have access to all the data. Instead, I'd like to use the opposite term, 'Informed refusal'.

Informed refusal is where a person has refused a recommended medical treatment based upon an understanding of the facts and implications of not following the treatment. Individuals need to be in possession of the relevant facts, all of them.

This may stick in the teeth of those who have already had the vaccine, a lot of whom claim that people who refuse the vaccine don't have any rights, 'it's not about them', we hear, 'it's about others.'

So, my right to informed refusal is based on the lack of data coming from the likes of Pfizer, Moderna and AstraZeneca and now the FDA. Based on the information they are not giving me, I refuse to be treated and if that upsets those who have been treated and limits my freedoms, then so be it.

I'm on the side of truth, not suppression, be that in the form of access to raw data or the posting of infantile memes on social media by the 'monkey see, monkey do' individuals, all, of course, designed to silence those with the ability to think freely without fear. 

Fearbook

I've never seen a divide happen so quickly. On both Facebook and Twitter I now see posts from people declaring that they are deleting friends from their list who speak out about the vaccine, all fuelled by the regular 'flags' we now see daily on Facebook anytime anyone posts something negative about treatment. Flags such as:

So, it's okay to click on the 'Get Vaccine Info' link but, seemingly, not okay to click on any information that may oppose this information.

When Facebook go a step further and actually remove opinion you have the right to ask why. Here's the standard reply you get:

As this blog of mine points out, Facebook moderators don't have access to the safety or side effect data of COVID vaccines, they couldn't possibly know what is true or false.

The best one I've seen so far is the following:

So, a post or link of yours may offer 99% truth but Facebook 'fact-checkers' flag it for containing 'partly false' information.

More Jabs

The United States will begin widely distributing Covid-19 booster shots next month as apparent new data shows that vaccine protection dwindles over time.

“We are starting to see evidence of reduced protection against mild and moderate disease,” according to the statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

U.S. agencies are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20, starting eight months after their second dose of Pfizer or Moderna’s vaccines.

So, the freedoms given to those who have currently been double-jabbed, concerts, sporting events, travel, will, seemingly, be taken away unless they have the booster.

Viruses mutate over time, they can strengthen or weaken. The majority of vaccines are developed over time and not rushed to market. Just because a vaccine gets approval (albeit 'Emergency Approval') does not make it safe. Data is collected and supposed to be assessed. This is called Post-Marketing Surveillance, designed to collect all the adverse events from the public. Most people don't know that clinical trials do not end in the lab - Any drug or vaccine that comes to market is just another phase of a clinical trial.

Dr White's bosses and, it seems, Facebook 'Fact-Checkers' are doing everything in their power to deter you and I from checking out the Post-Marketing Surveillance data. This is real-world data and not the data of a clinical trial setting.

You have to ask yourself, why the suppression?

Those who oppose members of the public who question the safety and efficacy of the COVID-19 vaccine will, no doubt, continue to post various memes supporting the use of vaccines in adults, children and expectant mothers. Their pious position will be supported with posts and links to celebrities, journalists and ghost-written articles that appear in academic journals. None of these will be flagged by Facebook.

As I said before, Monkey see, monkey do.

As a side-note, I first heard about COVID-19 on January 1st 2020 (Back then it was just known as the "Corona Virus"). I was in Central America at the time and a neighbour of mine invited me over to his place for afternoon drinks. He asked me if I'd heard about the outbreak, he had business in China so was more up-to-speed than I.

A month or so later, I was back in the UK visiting family and friends. Within weeks of me landing back in Blighty, the whole country was locked down. It was then that I wrote a series of predictions. You can see those predictions here. People back then rolled their eyes at me and no doubt those same people will be rolling their eyes at this blog post.

Bob Fiddaman






Saturday, September 05, 2020

Informed Consent ~ The Maths Don't Add Up

 



Earlier this week I posed the following question on Twitter:

Do time constraints persuade psychiatrists and GPs to prescribe brain pellets?

The question wasn't really posed for those that follow my Twitter account, it was, in the main, directed at the large number of brain pellet prescribers, one of which answered my question with:

"No, just necessity, when necessary."

This got me thinking.

70.3 million prescriptions for brain pellets were dispensed in 2019 (UK). If most of these were repeat prescriptions that's still a substantial amount, especially when the average appointment time with a GP is 9.2 mins.

How do we know the 9.2 minute statistic?

Well, in 2019, the Royal College of GPs announced that "the average length of GP consultations in the UK is 9.2 minutes, one of the lowest amongst economically advanced nations."

Further, they called for GP appointments to last "at least 15 minutes", at the same time condoning the current system as “unfit for purpose”.

Depression Assessment Instruments

*The following is from the American Psychological Association

Many of the instruments described below were used in the studies that served as the evidence base of the systematic reviews that under-gird the guideline recommendations. These instruments include both interview and self-report measures and may be used to screen, diagnose and/or track treatment outcomes. Each instrument has been demonstrated to be valid and reliable, and most are available at no cost.

In viewing the American Psychological Association I wanted to determine how long each assessment takes.

The Beck Depression Inventory (BDI) 
The Beck Depression Inventory (BDI) is widely used to screen for depression and to measure behavioral manifestations and severity of depression. The BDI can be used for ages 13 to 80. The inventory contains 21 self-report items which individuals complete using multiple choice response formats. The BDI takes approximately 10 minutes to complete.

The Center for Epidemiologic Studies Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale (CES-D) was designed for use in the general population and is now used as a screener for depression in primary care settings. The CES-D can be used for children as young as 6 and through older adulthood. It has been tested across gender and cultural populations and maintains consistent validity and reliability. The scale takes about 20 minutes to administer, including scoring.

EQ-5D
EQ-5D is a standardized, non-disease specific instrument for describing and evaluating health-related quality of life. The instrument measures quality of life in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Respondents can complete the questionnaire in under 5 minutes.

Hamilton Depression Rating Scale (HAM-D)
The Hamilton Depression Rating Scale (HAM-D) measures depression in individuals before, during and after treatment. It takes 15 to 20 minutes to complete and score.

One test not mentioned on the American Psychological Association webpage is the PHQ-9 test.

Patient Health Questionnaire (PHQ-9)
The PHQ-9 test is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. It is the 9-question depression scale from the Patient Health Questionnaire (PHQ). The results of the PHQ-9 may be used to make a depression diagnosis according to DSM-IV criteria and takes less than 3 minutes to complete. It's important to note that the Patient Health Questionnaire (PHQ) was underwritten by an educational grant from brain pellet manufacturers, Pfizer US.

Given the average GP appointment is just 9.2 minutes, only two of these assessments (EQ-5D and PHQ-9) could be being used by GPs across the UK. If others were being used then the average appointment time with a UK GP would be much higher than 9.2 minutes.

Informed Consent
Informed Consent is defined as: permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits.

I'm going to be using Prozac as an example here. Let's just say a patient takes either the EQ-5D or PHQ-9 assessment.

For the EQ-5D a GP will have approximately 4.2 minutes to relay his/her full knowledge of the possible risks to the patient. With the PHQ-9 the GP will have approximately 6.2 minutes to relay his/her full knowledge of the possible risks to the patient.

Both these figures decrease when we take into account the scenario.

Patient walks into GPs office and is asked, 'How can I help you?' - The patient then explains to the GP how they are feeling and possible reasons, work-related problems, marital problems etc. These then prompt the GP to mentally use either the EQ-5D or PHQ-9 assessment. 

Let's just see the possible risks associated with Prozac use. Remember, a GP, when giving informed consent, must give full knowledge of the possible risks to the patient.

Here is a list of risks associated with Prozac use. One has to bear in mind here that not everyone of these risks are self-explanatory and a GP would need to, if asked, explain what some of them mean. This would further eat into the average of 9.2 minutes.

**Reported Prozac Risks taken from the MHRA website:

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

As you see there are some rather vaguely named risks that would need further explanation from a GP to their patient.

Two questions:

1. Of the 70.3 million brain pellet prescriptions (2019), how many were handed over with the patient being given full knowledge of the possible risks?

2. Can a mental health 'disorder' be diagnosed and full knowledge of the possible risks of treatment be given in 9.2 minutes and under?

One needs to take into account that the above reported risks were from patients and GPs who took advantage of the MHRA Yellow Card Reporting System. As yet, no drug company has ever released individual patient data from clinical trials.

Food for thought.

Bob Fiddaman


*Hat-Tip: @QuestioningJenn


Saturday, January 18, 2014

Forest Illegally Promoting Antidepressants For Kids!





Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc. have been up to no good. Yet another pharmaceutical company who have, according to a new lawsuit, been holding back information concerning the effectiveness of two company drugs for the treatment of depression in pediatric patients. Those two drugs being the antidepressants Celexa and Lexapro.

Naughty, naughty.

The lawsuit, filed by two mothers from Missouri who are being represented by Baum, Hedlund, Aristei & Goldman, PC and Pendley, Baudin & Coffin LLP, claims that "Forest marketed antidepressants Celexa (citalopram) and Lexapro (escitalopram) as effective for use in pediatric patients, even though studies showed evidence to the contrary".

The plaintiffs, Ruth Dunham and Tanya Shippy, allege "Forest deprived consumers of the ability to make an informed decision about whether to purchase or prescribe Celexa or Lexapro for their children by withholding information about the negative efficacy studies and engaging in an aggressive marketing campaign designed to mislead consumers and physicians".

A pharmaceutical company aggressively marketing drugs for kids when they knew the drugs weren't effective in kids?

Surely not, I mean stuff like this just doesn't happen, right?

U.S. District Judge Nathaniel M. Gorton of Massachusetts stated in his ruling that the allegations are viable under the Missouri Merchandising Practices Act (MMPA). The MMPA prohibits “deception, fraud, false pretense, false promise, misrepresentation, unfair practice or the concealment, suppression, or omission of any material fact in connection with the sale or advertisement of any merchandise in trade or commerce.”

Be interesting to see how this one goes. Forest will be up against it.

Baum Hedlund have represented more than 4,000 individuals across the US in personal injury and wrongful death cases involving harmful medications. They spanked those other pediatric suppressors, GlaxoSmithKline, on more than one occasion.

Celexa and Lexapro are antidepressants in the SSRi class, they work pretty much in the same way. Some believe [myself included] that Lexapro only ever came about because the patent for Celexa was running out. Change a molecule here and there, change the name, submit to the FDA and...VOILA...a new drug hits the market that does exactly the same as the older drug... in this instance does nothing, apart from causing suicidal ideation and self harm for pediatrics who take it!

Why promote anything that doesn't work? Moreover, why promote something that is dangerous for pediatrics?

Forest have, it appears, taken a leaf out of GSK's book here. Who can forget the Paxil 329 debacle?

Be interesting to see if any evidence comes out of this trial that shows yet more ghostwriting shenanigans or if Forest's reps were just as adamant as Glaxo reps to "get the sale" at whatever cost.

Grown men and women playing with children's lives. Don't you just love the pharmaceutical industry!

The full press release can be read on the Baum Hedlund website HERE.

Bob Fiddaman






Wednesday, August 10, 2011

The Parental Consent Act - The Petition



Dear readers,

I'd be really grateful if you could head on over to a petition that I am fully behind. Although this is an American petition, it's purpose is to send out a crystal clear message to those who feel psychiatric drugs are safe to use in children.

The madness must stop, you can help by signing the petition.

Here's part of the blurb:

This petition is in support of The Parental Consent Act, a federal bill introduced by Congressman Ron Paul, which prohibits federal funds being used to establish or implement any mandatory or universal mental health/psychiatric screening of schoolchildren. It also establishes a parent's right to refuse mental health screening of their child. This is a crucial bill which must be passed to guarantee parental rights. We urge everyone to sign the petition in support of this bill. 

SIGN HERE 

For more information on The Parental Consent Act please visit Ablechild, an organisation co-founded by a good friend, Sheila Matthews.





Fid


ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE 
 





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