Dr Munchausen: Pharmacophile

Editorial Note:  This piece was first submitted to the J of Mental Health in 1997 and two other journals later that year - with Marie Savage and Phil Thomas as co-authors.  The reviewers were affronted - one figured mental health was likely no worse than the rest of medicine. Unable to find a home, it migrated to become a chapter in the third edition of Psychiatric Drugs Explained.    Those not … [Read more...]

Doctor Munchausen: Judge & Jury

Editorial Note: This is the sixth in a Dr Munchausen series of posts. It was originally going to be entitled 'Dr Munchausen joins your local Hospital Board'. Crash & Holocaust Denialism In JG Ballard's novel Crash covered in the last post, we slip from the solid world in which we think we move to a dreamworld - the dreamworld in which we are now living. In this dreamworld perceptions connect … [Read more...]

Doctor Munchausen and Sense about Science

Editorial Note:  This is the fifth in a series of Doctor Munchausen posts that include: Dr Munchausen, I presume Dying for a Cure Dear Luise Father Munchausen They followed a Sense about Science series of posts that included: Sense about Science: Follow the Rhetoric Sense about Science: First Admit no Harm Sense about Science: Follow the Lawsuit Sense about Science: Follow … [Read more...]

Father Munchausen, I presume!

calvary-trailer-brendan-gleeson-walking-on-the-beach-filmencounters.com_

Editorial Note: This is the fourth of seven Doctor Munchausen posts - Doctor Munchausen, I presume, Dying for a Cure, Dear Louise and the forthcoming Doctor Munchausen as a Sense about Science Trustee, and Doctor Munchausen Joins your local Hospital Board.   I’ve had some criticism of the recent Doctor Munchausen posts. They’re not fair on doctors. Many people have told me of lives saved by … [Read more...]

Doctor Munchausen: Dear Luise

Editorial Note: This is a third post in the six post Doctor Munchausen series. See Doctor Munchausen, I Presume and Dying for a Cure.  A variation on this post first featured on RxISK.org some months ago Dear Luise by Dorrit Cato Christensen  is one of most extraordinary books about healthcare ever written.  Medical books are usually about great discoveries, great endurance, or triumph in one … [Read more...]

Doctor Munchausen: Dying for a Cure

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Editorial Note:  This is the second in a Doctor Munchausen series of posts - meditations on the fact that medicine is likely the place where the greatest amount of abuse on earth happens - but no-one notices and no-one intervenes. The post below comes from the foreword to Dying for a Cure, Rebekah Beddoe's book on what happened her when she fell into the clutches of a doctor.  The book came out … [Read more...]

Doctor Munchausen I Presume!

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Editorial note:  As Britain descends into an orgy of handwringing about the abuse of vulnerable people, this is the first of several posts to tackle the issue In 2000 when I gave a lecture on Psychopharmacology and the Government of the Self at the invitation of the University of Toronto, I ran into a problem. In the public domain our shared difficulties were because of this lecture. In fact, … [Read more...]

Please Don’t Empower me Anymore

Editorial Note:  This is the second part of a Motivational Interviewing series crafted by Johanna Ryan and Ken Spriggs.  Do you know the locations of all the best bathrooms? Do you often take a seat near the exit, just in case? Do you excuse yourself often to use the bathroom? Do you ever skip meals, or avoid certain foods, to avoid multiple bathroom trips? Those are questions from … [Read more...]

We are the Ninety Nine Percent

Editorial Note:  This is a Coda to the four posts about Sense about Science and AllTrials - Follow the Rhetoric, First Admit no Harm, Follow the Lawsuit & Follow the Patient. The last post ended on this note: Over 18 months ago, RxISK attempted to open up a debate on the ambiguities and conflicts at its heart. Doing what it does, could it operate as a business in the marketplace or … [Read more...]

Sense about Science: Follow the Patient

Editorial Note:  This is the fourth of four posts about the links between Sense about Science and AllTrials.  The first was Follow the Rhetoric.  The Second was First Admit no Harm. The third was Follow the Lawsuit. The simple act of defining doctors or patients concerned about adverse events as “critics” is a rhetorical stroke that marginalizes concerns - makes you  a one percenter rather than … [Read more...]

Sense about Science: Follow the Lawsuit

Editorial Note:  This is a third in a series of posts about Sense about Science and Access to Clinical Trial Data that began with Follow the Rhetoric and followed up with First Admit no Harm. There are some facts in the last few posts. There are also some extrapolations that may not be right. Tracey Brown has gone on the Parliamentary Record to make clear what AllTrials are asking for - its … [Read more...]

Sense about Science: First Admit no Harm

Editorial Note: This is a second post exploring Sense about Science.  The first post Follow the Rhetoric is here. Anyone interested in Pharma will know about its ability to Astroturf – to create patient organizations whose role is to promote an illness or subvert an existing one.  Creating awareness of conditions sells drugs. On a Higher Astral Plane Less well known is what happens at a … [Read more...]

Sense about Science: Follow the Rhetoric

Editorial Note: This is the first of four posts about the link between Sense about Science and AllTrials triggered by the post Fucked and comments afterward by Ben Goldacre, Tracey Brown and others which raised these links. My first contact with Sense about Science was linked to the Simon Singh affair.  Singh had made some relatively innocuous statements about chiropractic and been sued for … [Read more...]

Trudo Lemmens of the University of Toronto critiques the recently distributed draft EMA Clinical Trials Data Release Policy.

[First published in the PLOS Blog.  Click here for the original post.] Things were looking good recently in Europe for data transparency, a necessary, albeit not sufficient, tool to promote integrity of pharmaceutical data. The European Court’s Vice-President overturned in November 2013 two lower court interim suspensions of EMA’s data access decision in relation to Abbvie’s drug Humira and … [Read more...]

Motivational Interviewing

Editorial Note:  Motivational interviewing began as a technique to help opiate or nicotine addicts or alcoholics.  The idea was to move them through contemplation of the possibility of change, to having an action plan and then acting.  It recognized that there was no point just arguing that addiction was wrong - you had to understand a person as well as the understood themselves to be able to get … [Read more...]

Fucked

Editorial Note: Apologies for the Language A year and a half ago this blog ran a series of posts about access to clinical trial data – reporting on how industry were going to engineer the appearances of transparency.  See Won't get Fooled Again, Access to Clinical Trial Data, and  The Data Access Wars. Do Academics have Wild Dreams? Several months later, soon after being fined $3 Billion, GSK … [Read more...]

Eastern Health Meets Western Industry

Editorial Note: It's common to find those behind Global Mental Health say that they might not originally have believed in the reality of mental illness and the efficacy of treatment but they do now. This and two following position pieces don't come from the same conversion perspective. I have always believed in the reality of mental illness and the efficacy of treatment. Nevertheless the … [Read more...]

Lullaby

Editorial Note: Another study published this week suggests that the issue of birth defects on antidepressants rather than suicide or homicide may yet end up as the Mark of Cain by which these drugs are remembered. This post appeared on RxISK.org first. Hush, little baby, don't say a word, Mama's gonna buy you a mockingbird. If that mockingbird won't sing, Mama's gonna buy you a diamond … [Read more...]

Welcome to Troy

A lot people it seems have been singing and dancing in the street at news last week that AbbVie the pharmaceutical company that make Humira have dropped a legal action against the European Medicine’s Agency (EMA) that was aimed at blocking any access by researchers or others to their clinical trial data. Stacey of Arc Not everyone will be pleased though. Stacey London might wonder whether she … [Read more...]

The Macbeth Test

Editorial Note: No one outside the UK may be paying any heed to the all-consuming debate within Britain about the referendum on the future of Scotland. Everything comes back to this. Corporations have been saying they'll pull out if Scotland leaves the UK (Standard Life) or that they'd prefer if Scotland left (British Airways). The EU have said Scotland would have to wait 5 years to apply to join … [Read more...]

AbbVie & GSK can buy your Data for almost nothing

Editorial Note: This prescient post written by Phil Booth was posted on OpenDemocracy.net under the title Your medical data - on sale for a pound on August 9th 2013. The original intention was to link it into the AbbVie debate about access to clinical trial data - as an ironic contrast. That opportunity passed - but a stopped clock throws up the right time twice a day. In recent weeks in … [Read more...]

Somatic Symptom Disorder

Editorial Note: Richard commented on Peter Gotzsche's recent post Psychiatry Gone Astray. He was invited to develop his comment and does so here. My name is Richard Lawhern. I advocate for nearly 5,000 chronic pain patients as a volunteer moderator and content writer at "Living With TN", a social networking website. We support people with Trigeminal Neuralgia - the worst pain known to medical … [Read more...]

Get Real: Peter Gøtzsche Responds

Editorial Note: Two weeks ago we ran Peter Gøtzsche's Psychiatry Gone Astray. There was a context - a Danish  doctor had been found responsible for the suicide of a young man put on antidepressants. This and Peter's article stirred up debate in Denmark drawing a hard to credit defensive response from senior Danish Psychiatrists. Peter's blog was critiqued by George Dawson on Real Psychiatry. An … [Read more...]

What do Women Want ?

Editorial Note: This is cross-posted from 1boringoldman - Reassure Us. It tackles the most important issue in healthcare and one of the most important in politics. GSK have clearly persuaded Ben Goldacre, Iain Chalmers and David Cameron, and J&J have persuaded Harlan Krumholz and Barack Obama that their model of Data Access - the AbbVie model - is the only game in town. See The House of … [Read more...]

The Devil’s Disclaimer

Editorial Note: The marketing of pharmaceuticals avails of something given to no other area of marketing - the product is made available on prescription-only.  In this post Johanna Ryan, from RxISK's Community Advisory Board, spells out the risks this gives rise to. This is a theme that has come up often and one we will return to.  Direct to Consumers?  If you live in the USA, I don’t have to … [Read more...]

Psychiatry Gone Astray

Editorial note: We follow up the Guilty post last week with a piece written by Peter Gotzsche that has caused a stir in Denmark and provoked some of the Danish professors he critiques to respond.   At the Nordic Cochrane Centre, we have researched antidepressants for several years and I have long wondered why leading professors of psychiatry base their practice on a number of erroneous myths. … [Read more...]

Drug Traffic Accidents: ADHD

Editorial Note: In an End of Year post on RxISK, the concept of a Drug Traffic Accident was introduced. This can refer to being run over by a drug, sometimes called side effects, or adverse events, or adverse drug reactions or it can refer to the trafficking of drugs. This post covers both types. The first part is written by David Antonuccio and the second by the Editorial Board of the New York … [Read more...]

The Snow Queen

Heart of Medicine

Crusoe and Hans grew up together. Crusoe’s father encouraged her to believe she could do anything she put her mind to. Han’s father, Peter, was a story-teller who delighted both children with his stories, especially during the long evenings at the onset of Winter. He told them about the Microbe Hunters who discovered the causes of diseases and laid the basis for new cures. But their favourite … [Read more...]

The Medicine Maker

Editorial Note: This is based on the Finnish National Epic, the Kalevala. The image comes from the series painted by Axel Gallen to illustrate the Kalevala. Crusoe spent years trying to make a Medicine Maker. She was finally successful at the end of a long Winter just as the first signs of growth appeared on the trees. Everyone for miles around came when they heard the news. People with oozing … [Read more...]

Medystopia

Editorial Note: Crusoe has not been lying low since The Shipwreck of the Singular and The Girl who Wasn't Heard When She Cried Wolf. Check these out for previous Crusoe posts. The AbbVie story calls for a decent myth. Here is a start. Sink all Vaccines to the Bottom of the Sea? Crusoe was listening to Oliver give out. "They called me yesterday evening", he said, "to tell me about the vaccination … [Read more...]

EMA v AbbVie

Editorial Note: Three months ago we launched an AbbVie campaign and followed it up with a petition calling on AbbVie ad InterMune to drop their action against EMA. The hope was to raise awareness of this critically important issue that had been sailing beneath the radar. Over 6000 of you from more than 120 countries responded. This interim judgement is not a victory. It may be more a stay of … [Read more...]

The Church of GSKology 2

Pope

A century ago Freud and Jung made us aware of the biases underpinning what patients say. Not everything should be accepted at face value. In particular claims of abuse may not be based on reality. We needed experts – analysts – they claimed to tease out what is real from what is not. The Catholic Church was once intensely hostile to Freud, but when it came to child abuse adopting a Freudian … [Read more...]

Lives Touched by GSK

Anonymous Notes of a Paxil Guinea Pig What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)? As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up. I took part in a study of Paxil back in … [Read more...]

The Church of GSKology

Editorial Note: This post is about midway through a series of posts that are broadly part of the AbbVie series. The series began with GSK's Transparency and Access Journey, moved on to The House of GSK and will have at least two more posts after this.  Reading the Minneapolis StarTribune, it was the reference to privacy that clinched it. Facing a sexual abuse lawsuit, the archdiocese of St … [Read more...]

The House of GSK

In a just published article in the BMJ, Peter Doshi notes how in recent months the English pharmaceutical company GlaxoSmithKline (GSK) have assiduously portrayed themselves as advocates of transparency and in support of access to clinical trial data. Well in support of 'Responsible Access'. Responsible essentially means that a researcher commits to the primacy of RCTs and statistical … [Read more...]

Trade Wars we have known and loved: Brand EFPIA v Korea

Editorial note: a slight variation of this appeared last week on The Conversation. In 2010, the European Ombudsman ruled that the European Medicines Agency should open access to clinical trials data when companies applied to get their drugs on the market. The ombudsman decided public health was more important than considerations of commercial confidentiality. In February this year, the US … [Read more...]

Health Action International: Access to Trial Data

Editorial Note: Leah Cowan and Ancel-la Santos from Health Action International wrote this post covering the release of a HAI position paper on Access to Clinical Trial Data. HAI have been to the forefront of the move to patient reporting of Adverse Events.  It has a position as a partner with the European Consumer Organization (BEUC) in support of EMA in the current legal action triggered by … [Read more...]

GSK’s Transparency and Access Journey

Editorial Note: This post has been put together by Peter Goetzsche and David Healy Dear Dr Goetzsche ...  "At GSK we firmly believe that making more information available, including clinical study reports and anonymised patient-level data, will enable researchers to study the science behind today’s medicines more closely, to learn more about them and how they can best be used.    For GSK … [Read more...]

SHIT Happens – 2

SHIT stands for Secret Health Ingredient in Treatment - see SHIT Happens.  In the early twentieth century SHIT was some supposedly secret magic chemical.  In the early twenty-first century SHIT is important information about adverse effects of a drug that has been kept hidden. In SHIT Happens, we reported that RxISK has adverse event data on a range of GSK, Pfizer, Lilly and Merck drugs, drawn … [Read more...]

SHIT Happens

A century ago, a distinction was drawn between the ethical pharmaceutical industry and the patent medicines industry. Ethical companies specified what was in their medicines, whereas the patent industry kept the details hidden. The Birth of Pharma The patent medicines industry flourished on the back of a promise that some Secret Health Ingredient in their Treatment (SHIT) would transform us. … [Read more...]

The Attitude of Chicks to Trojans & Horses

Editorial Note: This is a cross post from 1boringoldman's Wisdom of the Dixie Chicks. It raises questions about a Lancet editorial jointly written by GSK and AllTrials it would seem. It calls on Iain and Ben to tell us what they are up to. So far there appears to be no clear response from AllTrials. There is an ambiguous message Here. This repost omits the image of a Trojan Horse and a … [Read more...]

A Black Box Warning for Clinical Trials?

Controlled trials are universally touted as providing gold standard information on drugs. Doctors are routinely taught to disbelieve the evidence of their own eyes and trust in controlled trials instead. Governments in North America and Europe are forcing patients to participate in controlled trials — saying that you get better care in a controlled trial — and claiming that participation is also … [Read more...]

GSK’s Manifesto: Voyeurs of the World Unite!

Editorial Note: There is a widespread impression that the pharmaceutical industry are split on the issue of access to clinical trial data with the bad guys like AbbVie taking legal actions to block access and the good guys like GSK in favor of transparency. An editorial like this one from GSK's James Shannon in the Huffington Post on September 3rd might support such impressions. See Neal Parker … [Read more...]

AbbVie: Sharing the Yellow Stuff

Editorial Note:  This is the second part of our effort to "translate" Neal Parker's recent presentation in Bruxelles. The first half is here Neal Parker Avoiding Adverse Events. Reading the first half and Neal Parker's original transcript - available here - will give lots more material for the Caption Competition below. The least dramatic moment in Mr Parker's talk laying out Pharma's position on … [Read more...]

Neal Parker Avoiding Adverse Events

Editorial Note: Neal Parker, Section Head Legal, Biologics Strategic Development at AbbVie, was an industry representative on a panel organized by EFPIA - The European Federation of Pharmaceutical Industries and Associates on August 27th in Bruxelles. In two posts AbbVie's Mission to Discover New Diseases and AbbVie's Mission to Discover New Patients, we gave a transcript of his talk with some … [Read more...]

Neal Parker on AbbVie’s Mission to Discover New Patients

Editorial Note: Neal Parker, Section Head Legal, Biologics Strategic Development at AbbVie, was an industry representative on a panel organized by EFPIA - The European Federation of Pharmaceutical Industries and Associates on August 27th in Bruxelles. Parker started off with a wonderful Freudian slip saying that AbbVie's mission is to discover new diseases and ends with another - that AbbVie's … [Read more...]

Neal Parker on AbbVie’s Mission to Discover New Diseases

Editorial Note: Neal Parker, Section Head Legal, Biologics Strategic Development at AbbVie, was an industry representative on a panel organized by EFPIA - The European Federation of Pharmaceutical Industries and Associates on August 27th in Bruxelles. Parker started off with a wonderful Freudian slip saying that AbbVie's mission is to discover new diseases. A video of the meeting is linked to … [Read more...]

Trade Wars we have known and loved: Indianapolis v The World

Several weeks ago Canadians woke up to a Globe and Mail article saying that the pharmaceutical company Eli Lilly, who are based in Indianapolis, was suing their Government for $500 million for loss of revenues linked to the loss of patents on two of its drugs - Zyprexa and Strattera. "The drug giant alleges that the loss of its patents violates Canada’s obligations under international treaties, … [Read more...]

Trade Wars we have known and loved: AbbVie v China

Editorial Note: This post is taken from a more complete article published in BMJ today authored by Nigel Hawkes.  It tells of a recent European meeting on access to clinical trial data.  The meeting had input from AbbVie who it seems shocked everyone in the room shocked with their disregard for patient safety. The details here make it very clear why we need to petition AbbVie to drop their … [Read more...]

AbbVie Petition: Drug hazards are not trade secrets

RxISK has started a petition on Change.org which will go to Richard Gonzalez CEO of AbbVie, and Daniel Welch CEO of InterMune, who are at present taking a legal action to  block the  European Medicines Agency's policy of open access to clinical trial data. The reason to petition is in this post Let's do the AbbVie again and the Petition is Here. Can you take 30 seconds to sign … [Read more...]

Humira & Hope – and Despair: Annette’s Story

DSC04554

Editorial Note: Many people have wonderful responses to Humira and other biologic drugs like Enbrel (Phil Mickelson in the case of Enbrel).  Rheumatoid Arthritis, Crohn's Disease and the other conditions these drugs were first used for are debilitating disorders that need a potent treatment. But if a drug is potent it will have the capacity to cause significant harms. Lots of people take part in … [Read more...]

The Humira Trials: Judith’s Story

Editorial Note: AbbVie's current legal action against the European Medicines Agency's policy on access to clinical trial data led to the idea of an AbbVie - getting people on any drugs at all, especially new drugs and in particular biologicals, to do two things: report any of the effects they are having on RxISK.org & sign the petition below. AbbVie applied to block access to two … [Read more...]

Stacy London: What not to Take

HumiraDeathEffect

Three weeks ago Johanna Ryan and Kim Witczak wrote a letter to Stacy London about Humira and AbbVie. They were hoping for a response but there has been none so far.  There’s Something About Stacy Stacy London of What Not to Wear fame has a lot going for her. She is a successful business woman, style guru and role model for women around the world. AbbVie must be delighted to have her partner … [Read more...]

Welcome to the Humiraverse

Editorial Note: This post in the AbbVie series is by Johanna Ryan from the RxISK Community Advisory Board I recently read a legal complaint filed against AbbVie by a New York woman named Cynthia Di Bartolo. She’s a successful corporate lawyer who had undergone various treatments for psoriasis over the years, including medications and ultraviolet light therapy. In November 2008 she started … [Read more...]

Democracy in Adversity

Tibco_Spotfire_InfoGraphic

This post stands in stark contrast to EU-nuch in the Humira-m. There could not be a greater contrast between the way companies now sell drugs globally and the way they attempt to restrict the reporting of adverse events. The infographic below from Kayla brings out the point. Sales are now global. AbbVie's plans for Humira and the plans other companies have for their Biologicals will now … [Read more...]

EU-nuch in the Humira-m

No such thing as being 'European' There is no such thing as being European when you take a drug like Humira or Depakote and something goes wrong. When something goes wrong on their drug, companies go to extraordinary lengths to make it almost impossible for doctors or patients to report adverse events. It’s part of a larger mission to transform what were poisons to be used with care, into … [Read more...]

Humira in Ulcerative Colitis

Editorial Note: I have to thank Ken Spriggs for pointing out the Humira in Ulcerative Colitis Review site. For anyone interested in AbbVie-ing and in Humira this site offers some sobering reading. Humira in Ulcerative Colitis Reviews With the recent approval of Humira (Adalimumab) by the FDA, there is a growing need for ulcerative colitis patient reviews of their experiences with this … [Read more...]

Brands don’t have Side Effects: Mentions of Side Effects on crohnsforum.com

Drug-Side-Effect-Ratio-1024x923

Editorial Note: This post is by Ken Spriggs, who wrote the second ever RxISK story - on Azathiopine. This should be revisited in the light of the AbbVie Campaign. The current post is taken from his ongoing blog on Crohn's Disease - a condition that is high on the target list for the makers of biologicals including AbbVie and Humira. Drug side effect ratios explained This is the second part in a … [Read more...]

AbbVie: Humira Timeline

Editorial Note: An article in Forbes this week suggested Humira is set to become the biggest selling drug of all time. The timeline below, found by Harriet Rosenberg on the JusticeSeekers' website, covers the timeline of its elevation to the blockbuster Hall of Fame. This post and several to come are part of a sequence outlining how we can all help make Humira a better medicine by use of an … [Read more...]

Lets do the AbbVie again.

halftruths

The idea of a Boycott is an Irish invention. During the Land Wars in 1880, when Colonel Boycott on behalf of Lord Erne unscrupulously evicted tenants who didn't pay rent following a bad harvest, no one moved in to rent the vacant farms. Everyone refused to talk to Boycott. He was ostracised completely. The tactic worked so well that within months the Times of London was talking about Boycotts as a … [Read more...]

Great White Lies

BloodSugarPills

Editorial note: this post is by Dee Mangin .... just when you were looking at pancreatic cancer on Januvia and Byetta. Sugar Sugar: Less is not More Most people with diabetes now have type 2 diabetes. But for most people the high blood sugar called type 2 diabetes is not a disease. It is a risk factor. Just like blood pressure and cholesterol, the person sitting next to you with a higher blood … [Read more...]

Swimming with Great Whites? If you’ve got “Diabetes” look away now.

BloodSugarMeds

After its launch in the late 1950s, Upjohn’s Orinase (tolbutamide) became the first blockbuster hypoglycemic (blood sugar lowering) drug. Its success was born of failure. It wasn’t a replacement for insulin. Even if used early, it didn’t stop people from becoming insulin dependent. But attempts to create an early use market led to a focus on raised blood sugar levels and the creation of Type 2 … [Read more...]

Reading the RIAT Act

Editorial Note: This is a press release for a potentially important development in medicine. You can access your copy of the RIAT Act here and an assessment of its likely significance here. Restoring Invisible and Abandoned Trials (RIAT) “to correct the scientific record” Sponsors and researchers will be given one year to act before independent scientists begin publishing the results themselves … [Read more...]

We have a Dream: Getting engaged to a doctor

Still, you take the medication as prescribed. At first you imagine your body may adjust or the pills will come to understand you. It is no use. From Virginia Chase Sutton: Lithium and the Absence of Desire. Patient engagement Patient engagement is one of the mantras of current healthcare improvement efforts. Medical students and junior doctors likely think they are doing it better than … [Read more...]

When does Yes mean No

Slide 3 Consent

Editorial Note: This is the ninth piece or final third of the final triptych in the Lasagna trilogy of triptychs that started with Not So Bad Pharma and runs through to Marilyn's Curse. Marilyn died of an overdose of barbiturate sleeping pills (Tragedy). A bystander, Lou Lasagna, noted she had been denied access to a sleeping pill that was safe in overdose, the first pill of any sort that had … [Read more...]

Marilyn’s Curse

ut-Me-To-Sleep Pills. By Billiam James

Editorial Note: This an unexpected eighth part to the Lasagna Trilogy that started with Not So Bad Pharma and runs through to Witty A: Report to the President. Ondine Ondine was a nymph whose lover swore that his every waking breath was a testimony to his love of her. Finding him unfaithful, she cursed him – should he fall asleep he would stop breathing. Marilyn died of an overdose of … [Read more...]

Witty A: Report to the President

Editorial Note: This was to be the last in the Lasagna posts that began with Not So Bad Pharma, April Fool, Tragedy of Lou Lasagna, Empire of Humbug: Bad Pharma,  Empire of Humbug 2, and Brand Fascism. But the series will continue into Marilyn's Curse and When does Yes Mean No. Faced with questions about the $3 Billion fine imposed on GSK – is it just the cost of doing business? Andrew Witty … [Read more...]

Brand Fascism

Hope: Pills you can believe in. By Billiam James

Editorial Note: This is the sixth in the Lasagna series of posts that began with Not So Bad Pharma, April Fool, Tragedy of Lou Lasagna, Empire of Humbug: Bad Pharma and will continue through to Witty A: Report to the President. Faced with questions about the $3 Billion fine imposed on GSK – Is it just the cost of doing business? Andrew Witty, GSK's CEO, snapped back: “Although corporate … [Read more...]

The Empire of Humbug: Not So Bad Pharma

Sheperd & Lasagna 1992v

Editorial Note: This is the fifth is the Lasagna series of posts that began with Not So Bad Pharma, April Fool, Tragedy of Lou Lasagna, Empire of Humbug: Bad Pharma and will continue through to Brand Fascism and Witty A: Report to the President. In 1954 soon after his article with Beecher put the placebo on the map, Lasagna was recruited from Harvard to Hopkins. Beecher pleaded with him to stay … [Read more...]

The Empire of Humbug: Bad Pharma

Lasagna Shepherd 1956

Editorial Note: This is the fourth in the Lasagna series of posts - Not So Bad Pharma, April Fool and Tragedy. It will be followed by The Empire of Humbug: Not so Bad Pharma, Brand Fascism & Witty A: Report to President. The first RCT In 1956, two of the creators of the modern RCT, Lou Lasagna and Michael Shepherd, met. The randomization in randomized placebo controlled trials came from … [Read more...]

The Tragedy of Lou Lasagna

Editorial Note: This is the 3rd of 6 posts. The first two are Not So Bad Pharma, & April Fool in Harlow. The rest will be The Empire of Humbug 1 & 2 and Brand Fascism. There is an independent debate on some the issues, including my writing style, at Hearing Voices on 1boringoldman.  In 1956, Lou Lasagna was on his way to being the most famous doctor in the United States. His career had … [Read more...]

April Fool in Harlow: Anecdote Fishing in Harlow

Glaxo buys Open Science Federation. Patents Sharing. Promises full access. Created by Billiam James

This is the second of a series of six posts that began with Not So Bad Pharma and will continue with The Tragedy of Lou Lasagna, The Empire of Humbug 1, The Empire of Humbug 2 & Brand Fascism. To celebrate May Fool's Day last year The Scientist ran an article on Data Diving. This featured the work of Peter Doshi and Tom Jefferson and their efforts to get clinical trial data on Tamiflu from … [Read more...]

Not So Bad Pharma

The invitation from the London Review of Books to review Ben Goldacre’s Bad Pharma™ reads: “We were unsure, at first, what a review could add that isn't already in the book - scrappy summaries and bits of praise are not for us. The book is of sufficient importance that the main thing is to get someone who knows what they're talking about to present the material confidently.. frame the … [Read more...]

Six fired, one dead, no answers

This post was written by Alan Cassels and first appeared in Focus magazine online in early March. The full version is here. Alan was one of the creators of the Selling Sickness, or disease mongering idea. His recent book is "Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. There is an editorial comment below. A year ago this month - March 28, 2012, to be exact. British … [Read more...]

Prescription-only Homicide and Violence

These are the speaking notes for two talks given in Chicago on Monday February 18th and Tuesday February 19th. The S2, S3 in the text refers to slides which are available on the RxISK.org  Video Gallery.  Video will be posted when available. The first slides features RxISK.org  where we have created a Violence Zone and want you to get anyone who may have been made violent or had … [Read more...]

Not so Black: Ablixa and Homicidal Side Effects

If you don't want to know what happens in the movie Side Effects - do not read further. The post does not reveal all but does reveal important details. So now we know Soderbergh’s movie Side Effects is not so Black/Noir after all – more Fifty Shades of Grey. Emily Hawkins (Rooney Mara) is put on Ablixa by her psychiatrist Jonathan Banks (Jude Law) and while on it kills her husband. She … [Read more...]

Prozac and SSRIs: Twenty-fifth Anniversary

One Prescription for Every Man, Woman and Child Prozac was approved in 1987 in the US, and launched in early 1988, followed by a clutch of other SSRIs. Twenty-five years later, we now have one prescription for an antidepressant for every single person in the West per year. Twenty-five years before Prozac, 1 in 10,000 of us per year was admitted for severe depressive disorder - melancholia. … [Read more...]

The Antidepressant Era: the movie

The Antidepressant Era was written in 1995, and first published in 1997. A paperback came out in 1999. It was close to universally welcomed – see reviews 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 . It was favorably received by reviewers from the pharmaceutical industry, perhaps because it made clear that this branch of medical history had not been shaped by great men or great institutions but that other … [Read more...]

The boy with the ponytail who kicked the hornets’ nest

Who Cares in Sweden

In The boy with the ponytail who played with fire, we saw Jan Akerblom struggle up the side of a mountain in his attempt to drop the Ring of Power into Mount Doom. Where others, especially doctors, are seduced by the Precious he isn't. Why do it - because he saw lives destroyed and wonders if we are at risk of destroying society itself. Are any contracts anyone enters into while on an SSRI … [Read more...]

The boy with the ponytail who played with fire

He is 6’4” at least - 192 cm. He has blonde hair tied back in a ponytail. When he first suggested making a program about SSRIs I was not very helpful – very little of the media coverage by 60 Minutes or anything else has ever seemed to make much of a difference. They may have just increased the sales of antidepressants by keeping the names of the various drugs in the limelight. And he was … [Read more...]

The girl who was not heard when she cried wolf

Crusoe was called to see Lisbeth. The girl - young woman was mute and catatonic by day but after she fell asleep she had nightmares when she wailed piteously, rent her nightdress, walked in her sleep muttering ‘the children, the children’ or other such phrases. It was a similar pattern each night, the parents said. The dreams seemed to repeat. Crusoe came in the evening when the room was dark … [Read more...]

101 uses for a Dead Journal

There used to be a wonderful cartoon series called 101 Uses for a Dead Cat, which led me 25 years ago to give a talk at a British Association for Psychopharmacology meeting entitled 101 Uses for a Dead Psychiatrist. That was back in the days when Psychopharmacology meetings were places of debate and the British Journal of Psychiatry was guaranteed to have something of real interest in every issue. … [Read more...]

The Shipwreck of the Singular

Crusoe’s first appearance was in The Creation of Psychopharmacology, where in recognition of the tensions inherent in medicine between the numerous who enter clinical trials and the single person being treated by a doctor, the book opened with a quote from George Oppen’s Of Being Numerous, in which he notes that: “Crusoe we say was rescued”. Since Oppen wrote these lines, the idea of the … [Read more...]

The Data Access Wars

This is the first of three Crusoe posts. For background on Crusoe, see Watch where you wave that wand, The Oedipus Effect, The Tree must go. Beta Centauri was unquestionably a long way from Massachusetts. Somewhat to her surprise Crusoe found breathing no problem, and the temperature seemed just about right. The scenery as they’d come in was not unlike that of a temperate zone on … [Read more...]

Access to clinical trial data: privacy rights, property rights and phoney rights

At the European Medicines’ Agency meeting held on November 22nd convened to look at the issue of Access to Clinical Trial Data, the pharmaceutical companies came armed with an approach signaled a few weeks earlier by GSK’s Andrew Witty (see Won't get Fooled Again). The industry panelists came from Lilly and UCB along with a representative from EurorDis Francois Houyez. Possibly for the record, … [Read more...]

Access to RxISK data: conflicts of interest

Won’t get fooled again outlined a stunning propaganda coup by GSK. On the back of a campaign for open access to clinical trial data that has drawn its inspiration from efforts by the Cochrane Tamiflu reviewers to get access to Roche’s clinical trial data, Andrew Witty came out and proclaimed that GSK were all in favor of access to clinical trial data. The BMJ threw its hat in the air and said … [Read more...]

Won’t get fooled again? GlaxoSmithKline and access to data

On November 22nd the European Medicines’ Agency (EMA) is holding a workshop on access to the data from clinical trials. While there have been many efforts by many people over the years to make the clinical trial process more transparent, the EMA workshop has come about primarily following the efforts of Peter Goetsche of the Danish Cochrane Group and Peter Doshi and Tom Jefferson from another … [Read more...]

The St Bartholomew’s Day Massacre: Protestant Patients, Catholic Drugs

Margot's lover in La Reine Margot was one of the Huguenots who survived the massacre set in train by her brother Charles IX on St Bartholomew's Day in Paris in 1572. There are many politicians, bureaucrats, doctors and others, the Royalists, in a position to make a difference who know that psychotropic drugs can cause suicide or other serious problems but who instead attempt to close down any … [Read more...]

La Reine Margot: data access, ghostwriting, suicide and mad reviewers

Another study giving a first hint of the findings in our 2012 Mortality in Schizophrenia paper (See The Madness of Psychiatry) was published in the British Journal of Psychiatry in 2006 - Lifetime Rates of Suicide in Schizophrenia. It took several years and some smuggling to get it into print. In the course of exploring the issues, it seemed useful to touch base with Herb Meltzer who had links to … [Read more...]

Benefit risk madness: antipsychotics and suicide

Suicidal Acts in AntiP trials

Following the posting of The Madness of Psychiatry, there has been a flurry of activity in the twittersphere with Louis Appleby, the UK's suicide czar posting: What makes adolescents act on suicidal thoughts? New paper shows psychotic symptoms increase risk 20-fold. archpsyc.jamanetwork.com/article.aspx?a…       You might get the impression from this that all patients have to do is stay on … [Read more...]

The Madness of Psychiatry

One hundred years ago patients with psychosis were 4 times more likely than the rest of their contemporaries to be dead at the end of their first 5 years of treatment. The main cause of death was tuberculosis. The asylum was a place where if you had the wrong genetic makeup you were at great risk of catching tuberculosis, particularly if you were a young woman. the advent of the … [Read more...]

The Madness of Young People

In 1861 Benedikt Morel, a physician in France, described a terrifying new illness. It involved young people in their late teens or early twenties about to enter what should have been the prime of their lives who instead sank into a profound and seemingly incurable state of what he termed precocious dementia. Morel painted a picture of a terrifying and seemingly close to incurable loss of cognitive … [Read more...]

The Madness of Carl Jung: a dangerous method

Carl Jung was one of Freud's earliest supporters and in many respects rivaled him in terms of influence. Some of their interactions provide the basis for the story behind the book and recent movie - A Dangerous Method. Just as Freud did, he famously analyzed himself and while doing so apparently became psychotic. His psychosis was however seen as a way to sanity - a forerunner of 1960s thinking … [Read more...]

The Madness of Childbirth

The North Wales asylum made its way into my life by accident. The history department at Bangor University secured a grant to look at the social impact of the asylum. Looking at the records they collected, it was striking how people declared their madness a century ago – they tore off their clothes and escaped through windows, which they never do now. a quixotic database But when we set about … [Read more...]

The Madness of North Wales

Influenced like many of my generation by the writings of Laing, Szasz, Illich, Jung and Freud, I studied medicine to do psychiatry. At the time research was becoming mandatory for anyone hoping to engage with the field. I chose to work on the serotonin system. But this was working on the mind as much as the brain; this was the serotonin system brought into view by LSD rather than the one that … [Read more...]

Dance with Python: healthcare in peril

Figure 1

This is the last in what was once the BarMittzva Romba series aimed at Bar(ack) & Mitt.  These have now been renamed as a series of Dances - Dancing as fast as we can, Dance to the Music of  Time, Dancing in the Dark, Dance of the Sugar Plum Fairies, & Shadow Dance . Between them they reprise the plot of  Pharmageddon. In Malaysia, Dancing with Pythons is an art form. Women dance to … [Read more...]

Shadow Dance: is alcohol safer and more effective than SSRIs?

This is the fifth in the Dance series tackling the crisis in healthcare We have dug a deep hole. The regulatory hoops through which a company has to jump are now so minimal that it would be easy for us to get alcohol, nicotine, benzodiazepines or opiates on the market as antidepressants. Opiates in fact have a much better track record than SSRIs for treating severe depression - melancholia. … [Read more...]

Dance of the Sugar Plum Fairies: how prescription only keeps doctors’ healthy and wealthy but not wise

This is the fourth in the Dance series that tackles the crisis in healthcare. In 1962, politicians attempting to put things right in the pharmaceutical sector accidentally created the perfect raw material for drug development, and the basis to transform this raw material into  the perfect product. But to complete the perfect market needs one extra element - a perfect consumer. By continuing an … [Read more...]

Dancing in the Dark: how patents make drugs the perfect objects of desire

This is the third of six posts in what was the BarMittzva Romba series, now a dance series. A further step taken in 1962 made it possible to shape the raw material from clinical trials into the perfect product. This development hinged on the strategy chosen to reward pharmaceutical companies. In 1962, the options were to offer product, or process patents for drugs or some other form of reward … [Read more...]

Dance to the Music of Time: how clinical trials help pharma invent data

This is the second post in a 6-part what was the  BarMittzva Romba series, now a dance series. Every product is built from a raw material. The raw material puts constraints on a product developer. There may be difficulties fashioning the product from the material, or the material may be costly or scarce. There is the delicate matter of how the mark-up from raw ingredient to product is perceived … [Read more...]