Samizdat announces the release of Malcharist by Paul John Scott. This is a grippingly realistic page-turner about the corruption of clinical trials told through the crisis of conscience of a medical ghostwriter.
Set in Manhattan in 2010 and laced with dark humor throughout its fast 352 pages, it finds Shivani Patel in its opening chapters in a Town Car with a private driver, “off to recharge the fading hopes of the neurotransmitter era”.
The reader has already met a clinical trial participant experiencing a terrible side effect, a magazine journalist desperate for paying work of any kind, and now the highest-paid ghost writer for Krøhn-McGill Pharmaceuticals is suiting up to assist the world’s largest drug-maker with marketing a spin-off drug to a room full of Key Opinion Leaders in training.
Patel writes medical journal articles for authors TBD, doing so with data summaries generated by Contract Research Organizations. Hers is work destined to become the evidence base as we know it, including clinical study reports, letters to the editor, review articles, commentaries, published clinical trials and CME.
She is also, unfortunately, “a relic from the weak, pre-industrialized evidence base,” according to her marketing director, “a scientist first, with all the risk that entailed.”
The plot never slows, switching chapter between the viewpoints of an interconnected cast of characters who bring this panoramic tale about the industrialization of medicine in our time to life, including:
- a down on-his-luck magazine writer who is cajoled into promoting a new pill by a slick PR pitch
- a telegenic KOL who has parlayed medical ghostwriting to fame, overstaying his welcome with his well-financed masters
- a trial participant who has developed a terrifying preoccupation with death
- a pharmaceutical marketing director who needs to make another 7 figures so that he can cash out and move to Florida
- a widow who is seduced by a strangely well-endowed patient advocacy group
- a regulatory boss who pals around with drug industry goblins on his weekend cycling trips.
Their paths intersect around a new drug that is the subject of a vigorous indication creep. A drug that has been rebuilt from an old drug, one itself having been rebuilt from an even older drug, a real-life medication that may just have helped take the life of Ernest Hemingway.
We would tell you more but would rather you take the journey yourself.
We can tell you this: it is a work of fiction about subjects that never appear in fiction, including akathisia, miscoding, protocol-switching, data-dredging, me-too drugs, CRO’s, KOLs, monoamines, astroturf groups, the illusion of data transparency, all wrapped up in a thriller that will have you turning to the last page – and open doors to discussing the shortcomings of SSRIs and other drugs in polite company..
Paul has the writing skills to fold this all too real world into dialogue that will leave you in stitches in places and terrified in others. You can buy it on Samizdat and through Amazon and soon on Lulu and Indiebooks.
If you like it, please Tweet, write a review on Amazon, a riff for Samizdat, all the above or any other way you can think of that will get it into the hands of those who need to know that this is what lies behind that nice doctor who says he has just the pill for you – the latest wonder of medical science.
I haven’t read this fantastically clever exposure yet but in the meantime a top seller – teller of tall tales, Janssen and Jansen has added another chapter to Spravato the Wonder Drug
(see Spravato on Rxisk blog)
BRIEF—FDA approves new use for Spravato
The US Food and Drug Administration has approved the supplemental new drug application (sNDA) for Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
The sNDA was submitted by Johnson & Johnson subsidiary Janssen.
Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours, providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect.
The sNDA approval is based on two identical Phase III clinical trials in which Spravato plus comprehensive standard of care demonstrated a significant, rapid reduction of depressive symptoms within 24 hours, with some patients starting to respond as early as four hours.
Spravato plus comprehensive standard of care led to a 15.9 and 16.0 point decrease on the Montgomery-Åsberg Depression Rating Scale (MADRS), a tool used to assess severity of depressive symptoms, in the two trials at 24 hours after the first dose of study medication.
CNS DiseasesFocus OnJanssenJohnson & JohnsonNeurologicalPharmaceuticalRegulationSpravatoUS FDAUSA
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Janssen, Johnson & Johnson, Spravato, sNDA, Depressive disorder, Ideation, Suicidal, Behavior
recovery&renewal Retweeted
Leonie
@leoniefen
·
1h
@RxISK
@AntiDepAware
Accutane/ Roaccutane in the news once again, 24 years after Irish dad lost son to
@Roche drug. Two bereaved mothers share a shattering warning after an acne drug https://mol.im/a/8613003 via
@MailOnline
https://www.dailymail.co.uk/health/article-8613003/Two-bereaved-mothers-share-shattering-warning-acne-drug.html
AntiDepAware
@AntiDepAware
·
1h
Antidepressants are not the only prescription drugs that can induce young men to take their lives.
#Lamotrigine
https://www.thenorthernecho.co.uk/news/18640996.parents-fear-change-medication-casued-suicide/?ref=twtrec
The family also referred the coroner to information from the drug maker GlaxoSmithKline, which shows the increased risk in suicidal ideation is known and that warnings should have been given to Viktor and his parents.
The company estimates there is one case of suicidal thinking or behaviour for every 530 patients treated and said there were four suicides in drug-treated patients during trials.
David has described the case of A.C. Under ‘Stephen O’Neil and Doxycycline’
A.C. refers to Alana Cutland whose distressing death was all over the Sun and covered by the BBC.
The Coroner has made a Regulation 28 Report.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS (1)
NOTE: This form is to be used after an inquest.
REGULATION 28 REPORT TO PREVENT DEATHS
THIS REPORT IS BEING SENT TO:
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU.
1 CORONER
I am Tom OSBORNE, Senior Coroner for the area of Milton Keynes
2 CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and
regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.
3 INVESTIGATION and INQUEST
On 28/08/2019 I commenced an investigation into the death of Alana Molly CUTLAND aged 19.
The investigation concluded at the end of the inquest on 30 April 2020. The conclusion of the
inquest was:
I a Traumatic Injuries Following a Fall From A Plane
I b
I c
II
4 CIRCUMSTANCES OF THE DEATH
On the 25th of July 2019 the deceased open the door of a light aircraft that was flying from
Anjajavay to Antananarivo in Madagascar and fell to her death. She was a student from Cambridge
University carrying out research on the island. She had taken doxycycline as an antimalarial
medication and it is believed that she suffered a psychotic/delirium event that led to her behaviour
and death.
5 CORONER’S CONCERNS
The MATTERS OF CONCERNS are as follows:
The deceased was prescribed doxycycline as an antimalarial medication for used whilst in
Madagascar. It was quite apparent from the evidence that she had a psychotic reaction as a result
of taking the drug and yet there is nothing on the drug information leaflet that either highlights or
mentions this possibility. If she or her parents have been aware of this possible side-effect they
may have been able to intervene earlier to avoid her death. In my view the information sent out with
the drug should be reviewed.
6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you (and/or your
organisation) have the power to take such action.
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 30 September 2020. I, the coroner, may extend the period.
Your response must contain details of action taken or proposed to be taken, setting out the
timetable for action. Otherwise you must explain why no action is proposed.
8 COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested Persons;
The family of Miss Cutland.
I have also sent it to Professor David Healy and Dr Andrew Marriott, who may find it useful or of
interest.
I am also under a duty to send the Chief Coroner a copy of your response.
The Chief Coroner may publish either or both in a complete or redacted or summary form. He may
send a copy of this report to any person who he believes may find it useful or of interest. You may
make representations to me, the coroner, at the time of your response about the release or the
publication of your response by the Chief Coroner.