Zantac Lawsuit

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

Monday, September 21, 2020

The Cinderella Mock Exam


Just when you thought you'd seen all the madness for the year 2020 comes a shocking document that was released on Twitter last week that defies belief!

The upload came from Marie Bismark, a Psychiatry registrar and Principal Research Fellow - Public Health Law at the Melbourne School Of Population And Global Health.

Bismark told almost 6,000 of her followers she was questioning her entire profession after she stumbled upon a mock exam guidance question (below)


The document received backlash from many on Twitter. Both medical professionals and patients alike found it stigmatizing. Remember, this is an example of the kind of question a trainee psychiatrist would expect when sitting an exam.

The tweet has been liked and shared many times, some have even chipped in with their own diagnosis for poor old Cinders, although in the main this is Twitter psychiatrists and psychologists.

One offered the following advice: "Adjustment Disorder with resulting depression and anxiety. Main defence fantasy.  Requires psychosis support and ego strengthening."

I had to pinch myself.

Former Royal College of Psychiatrists president, Wendy Burn even chimed in with:

Dr Kate Lovett, Dean of Royal College of Psychiatrists, however, did not see it as a 'misguided idea of a joke' when she tweeted directly to Bismark: "Hi Marie. Was extremely disturbed to see this. I know you are based in Australia but I am sure colleagues @RANZCP would be very concerned too. Would you DM me the context so we can make sure this is dealt with. There is no place for such stigmatising & harmful attitudes anywhere."

The document, as far as I can see, has caused a lot of red faces in the field of psychiatry. If this is how they guide trainees then it would appear that any future patient will be almost immediately stigmatized as soon as they visit a psychiatrist, some would argue that this goes on today. The Cinderella question isn't really that bad, I guess they had to pick a fictional character. It's the options for answers that I find troublesome and, it appears, Bismark did too.

I really like the following tweet of hers describing the morals of the story of Cinderella. Sadly, psychiatrist, David Foreman, who is well known to this blog, couldn't help but post something negative as a reply to Bismark's heartfelt message.

Schadenfreude, if you didn't know, is pleasure derived by someone from another person's misfortune.

The general consensus is Cinderella teaches the morals of kindness towards all, forgiving others for doing wrong, and never letting bad things ruin your heart. The themes of the story are good versus evil and luck changing your life.

Quite why Foreman chose to piss in Bismark's Cornflakes is anyone's guess but it does highlight his negative thinking and rationale.

Many patient safety advocates were astounded by the mock exam question and decided to throw out their own questions and possible answers. Here's just a small collection of them.

I, myself, somewhat flippantly, came up with...

Marie Bismark's original tweet can be found here.

Bob Fiddaman

Hat-tip to Ann Marcos for bringing this to my attention

Thursday, September 17, 2020

Californian Law Firm Lead the Way in Gardasil Litigation


In 2009 an FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts.

So, it must be safe then because the FDA granted it a licence, right?

Well, there's been much debate regarding the safety of HPV vaccines over the years. Those that have questioned the safety have often been labelled 'anti-vaxxers'. This is standard protocol for drug companies who often fund pro-vaccine movements who viciously target vaccine safety advocates.

Not many people know that Gardasil has been approved for boys, most think the vaccine was for girls. 

On recommending its approval in 2009, the FDA said, "No serious side effects were seen."

Gardasil allegedly protects boys against the HPV infections that can cause cancers of the anus, penis, and mouth/throat, at least that's the way it was driven to market in various television ads.

One such person who saw these marketing ads was Jennifer Otto whose son, Zach, was just 16 at the time.

She relied on the information in the ads and various online print. She was convinced by the vaccine-maker, Merck, that all was above board.

Zach received his first shot of Gardasil in 2012 and his second some two years later in 2014, shortly after which he started experiencing body pains, headaches, cold-like symptoms, unexplained rashes, joint pains, ear pain, and enhanced lymph nodes in his neck.

In 2015, he received his third Gardasil shot and things went rapidly downhill. Here's a snapshot of the conditions Zach, now a wheelchair bound 24-year-old, is having to deal with:

Fiber Neuropathy (SNF), chronic fatigue syndrome (CFS), mast cell activation syndrome, autoimmune disease, and fibromyalgia

Dysautonomia - a condition in which the autonomic nervous system (ANS) does not work properly. This may affect the functioning of the heart, bladder, intestines, sweat glands, pupils, and blood vessels.

Postural Orthostatic Tachycardia Syndrome - a blood circulation disorder

Orthostatic Intolerance - a disorder of the autonomic nervous system occurring when an individual stands up

Small Fiber Neuropathy - a type of peripheral neuropathy that affects the small nerve fibers in the skin.

Chronic Fatigue Syndrome -  a complicated disorder characterized by extreme fatigue that lasts for at least six months and that can't be fully explained by an underlying medical condition

Mast Cell Activation Syndrome - a condition in which the patient experiences repeated episodes of the symptoms of anaphylaxis – allergic symptoms such as hives, swelling, low blood pressure, difficulty breathing and severe diarrhea

Autoimmune Disease - a condition in which your immune system mistakenly attacks your body

Fibromyalgia - a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues

Zach is now represented by Attorneys from the national law firm of Baum Hedlund Aristei & Goldman who, on his behalf, have filed a lawsuit against Gardasil manufacturers, Merck, claiming, amongst other things that:

 - Merck allegedly presented misleading data to the FDA suggesting that human papillomavirus (HPV) infections and some abnormal cervical tissue—cervical interepithelial neoplasia (CIN) lesions inexorably result in cancer

- Merck failed to disclose to regulators and consumers that Gardasil contained host of hazardous ingredients

- In the Gardasil clinical trials, Merck did not use a true placebo, the complaint alleges. Instead, the company “spiked” the placebo with AAHS and the vaccine’s other additives, which resulted in approximately equal numbers of subjects in the vaccine group and the placebo group suffering adverse reactions.

This should be concerning to us all given the current climate and the rush to find a vaccine for Covid-19. If a drug company can hide host of hazardous ingredients from those who approve vaccines then this seriously puts the general public in danger.

Moreover, vaccine-makers have been given indemnity regarding any Covid-19 vaccines that come to market.

Fortunately, for Zach Otto at least, Merck were not afforded that indemnity when they launched Gardasil on an unsuspecting public.

You can read more about Zach's plight on the Baum Hedlund website here.

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 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:


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
Gait disturbance
Peripheral swelling
Face oedema
Chest pain
Drug withdrawal syndrome
Hepatic disorders
Immune system disorders
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
Nervous system disorders
Seizures and seizure disorders
Foetal growth complications
Ectopic pregnancy
Foetal death
Abnormal behaviour
Homicidal ideation
Personality change
Violence-related symptoms
Confusion and disorientation
Depersonalisation/derealisation disorders
Eating disorders
Emotional and mood disturbances
Fluctuating mood symptoms
Impulsive behaviour
Mental disorders
Orgasmic disorders and disturbances
Panic attacks
Nightmares and abnormal dreams
Personality disorders
Acute psychosis
Psychotic behaviour
Psychotic disorders
Libido decrease
Libido increase
Loss of libido
Sleep disorders
Alcohol abuse
Completed suicide
Intentional self-injury
Suicidal ideation
Thinking abnormal
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

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