DATA BASED MEDICINE

David Healy, MD, is an internationally known psychiatrist, psychopharmacologist, scientist, and author. A professor of psychiatry in Wales, he studied medicine in Dublin and at Cambridge University. He is a former Secretary of the British Association for Psychopharmacology, and has authored more than 150 peer-reviewed articles, 200 other pieces, and 20 books, including The Antidepressant Era and The Creation of Psychopharmacology from Harvard University Press, The Psychopharmacologists Volumes 1-3 and Let Them Eat Prozac from New York University Press, and Mania from Johns Hopkins University Press.

David’s main areas of research are clinical trials in psychopharmacology, the history of psychopharmacology, and the impact of both trials and psychotropic drugs on our culture.

He has been involved as an expert witness in homicide and suicide trials involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators, as well raising awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion-leaders, ghost-writing their articles. His latest book is Pharmageddon, which tells of how pharmaceutical companies have hijacked healthcare in America and the life-threatening results.

David is a founder and Chief Executive Officer of Data Based Medicine Limited, which operates through its website RxISK.org, and is dedicated to making medicines safer through online direct patient reporting of drug effects.

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September 14, 2016

We would, in fact, save vast amounts of money by giving the pharmaceutical companies ten times the inflated prices they currently receive for drugs as part of a bargain that ensures only 10% of those currently taking lipid-lowering drugs, antidepressants, biphosphonate and other drugs end up on them. The savings would come from not having to treat treatment-induced disabilities.
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April 6, 2016

The best protection against bias is rigorous adherence to predetermined protocols and making data freely available. We, like everyone, are subject to the unwitting influence of our bias. The question is whether the Keller et al publication of 2001 manifests unconscious bias or deliberate misrepresentation.
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December 15, 2015

Several of us involved in RxISK.org monitor other groups setting up to offer information on medicines. Some of these, like eHealthMe, offer useful information. As ever, though, pharmaceutical companies are in there early. The Brintellix website is a masterclass in how to appear patient-centered, and patient-friendly. How to move with the times and make the new way of doing things yours.
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December 8, 2015

The strongest evidence we have as to whether a drug causes a problem does not come from RCTs or any other controlled study but rather from good clinical accounts. Even if RCTs were done by angels, so there was no hiding, no miscoding, nothing untoward, RCTs can still hide adverse events. The onus is on large and powerful corporations who have a lot of resources to pinpoint the populations where the benefit is likely to exceed the risk, if they want to continue to make money out of vulnerable people.
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November 16, 2015

Study 329 seems to fit the classic picture: It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake. But is it at fault alone? Both Big Pharma and Big Risk (the insurance industry) were once our allies in keeping our hopes alive – in keeping our children alive and well. They are now a threat. And of the two – Big Risk is the bigger threat.
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November 6, 2015

While making money from the publication of pharmaceutical company trials, and in the face of a complete failure by industry to adhere to basic scientific norms and make data available, BMJ and other journals — although BMJ in particular — have run a series of articles on supposed Academic Fraud. These articles feature instances of fraud sometimes as bizarre as researcher claiming he cannot show the data as it was eaten by termites. The universal feature is that these are academic studies, and academic fraud is an issue in academia.
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October 28, 2015

Access to data is more important than access to information about conflicts of interest. It is only when there is access to the data that we can see if interests are conflicting and take that into account. Problems don’t get solved unless someone is motivated for some reason. We need the bias that pharmaceutical companies bring to bear in their defense of a product, along with the bias of those who might have been injured by a treatment. Both of these biases can distort the picture but it’s when people with differing points of view agree on what is right in front of their noses that we can begin to have some confidence about what we have.
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October 18, 2015

The BMJ states that it takes on average eight weeks from submission of an article to publication. The review process for Restoring Study 329 took a year, with a three-month review process involving six reviewers to begin with, and then a further four reviews in a four-month process, leading to a provisional acceptance in March that was withdrawn.
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Categorized in: Adult, Antidepressants, Blogs, Children and Adolescents, Depression, Depression, Disorders, Featured Blogs, Foreign Correspondents, Psychiatric Drugs | Tagged as: , , , , , ,

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October 14, 2015

By 2002 GlaxoSmithKline had done 3 studies in children who were depressed and described all three to FDA as negative.  As an old post on Bob Fiddaman’s blog reproduced here outlines, several years later they undertook another study in children in Japan. (Editor’s note: This is a re-print, by David Healy, of a post by Bob Fiddaman)
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October 2, 2015

Good Pharma is the story of the Mario Negri Institute. Mario Negri was a wealthy patron who on his death in 1960 bequeathed a large sum of money to support independent pharmaceutical research to an upcoming researcher Silvio Garattini. Garattini and Alfredo Leonardi set about building an Institute centred on the new drugs and new techniques. They continue to grow without ever having patented any of their many discoveries or concealing any of the data from experiments that didn’t work out or accommodating any of their trials to industry’s wishes.
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September 28, 2015

It can be difficult to pinpoint transitions. The Rubicon that led from a Medical Republic to a Pharmaceutical Empire was crossed in 1962 with the passage of the Amendments to the Food and Drugs Act. This act put in place an apparatus of controlled trials, prescription-only status and disease indications that laid the basis for a global pharmaceutical hegemony, although the drift to Empire could still have been stopped at this point.
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September 21, 2015

In May 2014, the RIAT team asked GSK what the children who became suicidal in the course of Study 329 have since been told. The consent form says that anyone entering the study would be treated just the way they would be in normal clinical practice. In Study 329, the children taking imipramine were by design force titrated upwards to doses of the order of 300 mg, which is close to double the dose of imipramine given in adult trials by GSK or in normal clinical practice. In normal clinical practice it would be usual to inform somebody who had become suicidal on an SSRI that the treatment had caused their problem.
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September 18, 2015

It is appropriate to hold a company or doctors who may be aiming to make money out of vulnerable people to a high standard when it comes to efficacy, but for those interested to advance the treatment of patients with any medical condition it is not appropriate to deny the likely existence of harms on the basis of a failure to reach a significance threshold that the very process of conducting an RCT will mean cannot be met, as investigators’ attention is systematically diverted elsewhere.
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Categorized in: Adverse Effects, Antidepressants, Bias, Corruption & Accountability, Blogs, Featured Blogs, Legislation & Regulation, Psychiatric Drugs, Research, Suicidality/Homicidality | Tagged as: , , , , ,

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September 9, 2015

If someone were to ask the surviving authors of Study 329 the question: “Knowing what you know now, if you had to do it over, would you agree to participate in that study again?”, many would probably say no. Study 329’s problems started to surface right after it was published. Several doctors wrote letters to the JAACAP Editor with probing questions, mostly centred on the psychiatric side effects of paroxetine, and the measures used to claim its efficacy in treating adolescents. The authors responded and the questioners did not pursue their concerns further. Except one.

Next week, fourteen years and two months after it was published, it is about to take yet another hit, when the Restored version is published.
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September 2, 2015

In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide, initially with Prozac and subsequently with Paxil/Seroxat. The hope is to provide a comprehensive repository for anyone who wants to study SSRIs, RCTs, and Study 329 in particular.
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Categorized in: Adult, Adverse Effects, Antidepressants, Bias, Corruption & Accountability, Blogs, Children and Adolescents, Depression, Depression, Disorders, Featured Blogs, Psychiatric Drugs, Research, Suicidality/Homicidality | Tagged as: , , , , , , , , ,

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August 27, 2015

Study 329 is probably the most famous clinical trial ever. It is one of the few to attract a Fraud action and is certainly the only one with a $3 Billion fine linked to it. The study began recruiting adolescents to Paxil, imipramine or placebo in 1994 and finished up in 1998. Later in 1998, SmithKline Beecham, the marketers of Paxil (they hadn’t discovered it), acknowledged in an internal document that the study had shown that Paxil didn’t work for Children. This lack of benefit was something they were not inclined to share with the outside world. Instead they decided then they would pick the good bits out of the study and publish these.
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August 18, 2015

Arguably the most controversial drug study ever, Study 329, concluded that paroxetine was a safe and effective medication for treating major depression in adolescents. It concluded that paroxetine was a safe and effective medication for treating major depression in adolescents, and it is still widely cited in the medical literature. Though GlaxoSmithKline’s promotion based on Study 329 resulted in the biggest fine in corporate history, the study remains unretracted.
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August 4, 2015

Making even basic chemicals was beyond us for millennia. But once the process was cracked, discoveries and inventions came thick and fast. Making chemicals that could be used to treat diseases was beyond us for even longer but the pace of discovery began to pick up in the middle of the nineteenth century. The realization of what needed to be done to give a chemical a chance of becoming a medicine led to the hunt for a Magic Bullet.
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June 8, 2015

The area of politics that counts most for most of us is healthcare. Big Healthcare is now the biggest business in the United States and in the Western World. We desperately need a new compact between we the people and those who govern our healthcare – or at least a new compact between the doctors who make money for pharma by putting pills in our mouths and the pharmas of this world. Instead, we are told that to question the judgments of the scientific literature is to engage in an irrational War on Science itself.
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April 28, 2015

The BMJ article on The Marketing of Serotonin has stirred some interest. There are some  highly technical comments on the BMJ site but of course the key point behind the piece is the rather obvious fact that twenty-five years ago many people were saying it was all a myth. The extraordinary Michael Leunig nailed it twenty years ago in the sketch above. (Leunig is wonderful across the board and razor sharp on medicine and mental health).
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Categorized in: Antidepressants, Blogs, Featured Blogs, Psychiatric Drugs

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April 21, 2015

The serotonin reuptake inhibiting (SSRI) group of drugs came on stream in the late 1980s, nearly two decades after first being mooted. The delay centred on finding an indication. They did not have hoped-for lucrative antihypertensive or antiobesity profiles. Even though a 1960s idea that serotonin concentrations might be lowered in depression had been rejected, drug companies marketed SSRIs for depression even though they were weaker than older tricyclic antidepressants. They sold the idea that depression was the deeper illness behind the superficial manifestations of anxiety. The approach was an astonishing success, central to which was the notion that SSRIs restored serotonin levels to normal, a notion that later transmuted into the idea that they remedied a chemical imbalance.
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Categorized in: Antidepressants, Blogs, Featured Blogs, Foreign Correspondents, Psychiatric Drugs, Uncategorized

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March 30, 2015

The crash last week of the Germanwings plane has shocked many. In view of the apparent mental health record of the co-pilot Andreas Lubitz, questions have been asked about the screening policies of airlines. The focus has generally been on the conditions pilots may have or the arguments they might be having with partners or other situational factors that might make them unstable. Even when the issue of the medication a pilot may be taking is raised, it is in the context of policies that permit pilots to continue on drugs like antidepressants to ensure any underlying conditions are effectively treated. But fewer treatments in medicine are effective in this sense than people might think and even when effective they come with effects that need to be balanced against the likely effects of the underlying condition.
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February 10, 2015

If you participate in a clinical trial, the new industry “consent” forms mean you put your children and your wider family and community in a state of legal jeopardy. Because they can hide the data of your experience in the trial, even if you have been significantly injured by the treatment, companies can declare there were no side effects and your invalidated experience can then be used to deny justice to someone who is injured in exactly the same way you have been.
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January 22, 2015

From 1951, a system designed for heroin and cocaine addicts – prescription-only status – was applied to all new drugs. Why? These were after all the first truly effective drugs in medicine. But the ability to do good came with a likelihood of doing harm. There was a trade-off to be made between risks and benefits. The new complex trade-offs could not be put on to the label of a drug or even captured in a forty page package insert. They needed to be individual to each person.
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