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...]

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...]

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...]

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...]

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...]

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...]

RxISK STORIES: If you’re going to look after patients, Man up

Pharmalot has just posted a piece - 'Controversial FDA official, Tom Laughren, retires.' This is a must read for anyone with anything to do with mental health - both the post and the comments afterwards where some have posted that they still believe the Black Box warnings on antidepressants arose because of pressure from the Church of Scientology rather than in response to the data. Despite … [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 Hidden Gorilla

Three weeks ago What would Batman do Now covered the issue of suicide in the military – an issue that had Batman missing in action, and the Joker suffering the adverse effects of psychotropic drugs. Then along came James Holmes to the premiere of Dark Knight Rises in Aurora. Most drugs that can cause suicide, including the antidepressants, mood-stabilizers, antipsychotics, smoking cessation … [Read more...]

What would Batman do now?

Johanna Ryan in her post Dependence Day points to serious problems linked to psychotropic drug use in the military and what seem to be recent alarming developments, but there is a 60 year history here. In the 1950s, the VA hospital system commissioned Norman Farberow to look at rising rates of suicides among veterans. He studied veterans hospitalized for either medical or psychiatric conditions … [Read more...]

The unbearable lightness of being

This is the last of 3 posts laying out the philosophical basis for Rxisk.org which will be live in the next few weeks. The others are Cri de Coeur & Once is Never. In his masterpiece on love and life The Unbearable Lightness of Being, Milan Kundera faces us with a dilemma about the important things in life “einmal ist keinmal” – “once is never”. Academics need lovers But Kundera doesn’t mean … [Read more...]

Once is Never

This is the second of 3 posts laying out the philosophical basis for Rxisk.org which will be live in the next few weeks. The others are Cri de coeur & the Unbearable lightness of being. In Cri du Coeur I outlined a scenario in which a treatment that causes suicide when put into good trials without any manipulation of the data, any statistical artifice, or any ghostwriting might give rise to a … [Read more...]

Cri de coeur

This is the first of 3 posts laying out the philosophical basis for Rxisk.org which will be live in the next few weeks. The others are Once is Never & the Unbearable lightness of being. “[I suggest] a meeting with yourself and your reviewers. I have spoken in public on these issues and offered to speak on any platform. I’ve visited the MHRA [British equivalent of FDA]. Part of my motivation … [Read more...]

Coincidence a fine thing

Coincidence can be a fine thing. No sooner had I finished The tricks that drug companies do live after them, asking for examples of maneuvers to add to a generally available repository of tricks, than up pops Robert Gibbons' paper, Suicidal Thoughts and Behavior With Antidepressant Treatment, with not one but two maneuvers and reminders of others.‎ Dangerous liaisons First off, the reminders. … [Read more...]

The tricks that drug companies do live after them, their patients are oft interred with their trials

One of the hopes of this blog is to create a repository of maneuvers through which clinical trials can be gamed to get results. The series of posts laying out some of the less well known tricks are filed under the Hiding the Bodies blog category. To be more generally useful, this repository needs others to contribute further maneuvers to make it comprehensive and to contribute examples from areas … [Read more...]

Where were the adults?

Along with Lilly and GlaxoSmithKline (see Drug companies use studies the way a drunk uses a lamppost), Pfizer created ghost suicidal acts on placebo. Other companies did further things that concealed the suicide problem. Did Pfizer? In 2004, following the lead of the British Regulator (MHRA), the FDA put a Black Box warning about the risk of suicide on the pediatric use of antidepressants. The … [Read more...]

Heads we win, tails you lose

In the late 1980s, Eli Lilly, when faced with an excess of suicidal behaviors in Prozac trials, set up a trial of Prozac in an interesting group of patients. These patients had what is often called borderline personality disorder or intermittent brief depressive disorder or recurrent brief depressive disorder. The trial terminated early. Placebo was sweepingly statistically superior to Prozac. … [Read more...]

Burn in Hell

In my last post, Psychotic doubt, we saw the most successful maneuver that has ever been devised for hiding dead bodies and silencing us when we are injured. We saw a mechanism that acts like the authority of a psychoanalyst (when Freud was still in vogue), or an ecclesiastical authority (until recently), to silence dissent and cause someone who has been abused to doubt their sanity and blame … [Read more...]

Psychotic doubt

Toward the end of the 1990s, hiding the suicide risk on antidepressants by unearthing ghost suicides and suicidal acts from the early washout phase of trials looks like it might have seemed to company and FDA officials as problematic as Macbeth’s invitation to Banquo to make sure he came back to the feast later that evening. A new strategy came to the fore. Again one of the earliest versions of … [Read more...]

The bureaucrat that didn’t bark

Prozac’s commercial success after its launch in 1987 spurred SmithKline Beecham, Pfizer, and others to bring Paxil (Seroxat, Deroxat, Aropax), Zoloft (Lustral), and other Selective serotonin reuptake inhibitors (SSRIs) to market. En route there was the tricky problem of managing what was recognized within companies by the early 1980s but denied in public, namely, that these drugs could cause … [Read more...]

Drug companies use studies the way a drunk uses a lamppost

Drug companies use studies the way a drunk uses a lamppost — for support rather than illumination. This quote adapted from English romcom author Jilly Cooper (who adapted it from others before her) seems an appropriate preface for a series of company approaches to data handling that have concealed rather than revealed treatment-induced problems. In another galaxy, far, far away, somewhere in … [Read more...]