Study 329: The Data Wars Cross the Rubicon

David Healy, MD
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In the late 1950s, perhaps because he was based partly in Rome, sensing a change in his native America, Gore Vidal warned that the American republic was changing into an Empire. He warned his countrymen that while the world had admired them for their values up till that point, while almost everyone aspired to be an American, they would soon face a world where an increasing number of people would cheer were the Empire to Fall.

The advent of Empire turns values inside out.  The transformation in American values was stunningly demonstrated a few years later.

Taking his inspiration from the Foundation of the American Republic, Ho Chi Minh established the Democratic Republic of Vietnam, and in his inaugural address paraphrased from the Declaration of Independence:

“All men are created equal. The Creator has given us certain inviolable Rights: the right to Life, the right to be Free, and the right to achieve Happiness”

He called on America to help him overthrow the French, but by 1963 American Legions were pouring in to put down the Republic and secure Vietnam for “Our way of life and our values.”

Crossing the Rubicon

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.

It took a while for anyone to notice the threat to the Republic.  In the 1970s, sensing a growing threat, Ivan Illich inveighed about our approaching Medical Nemesis. One of the few to have a clearer sense of the problem was Louis Lasagna, who was in significant part responsible for the 1962 amendments (See Not So Bad Pharma, The Empire of Humbug, and the following 6 posts).

Looking back at the 1980s we can now see the coming Empire as a $30 Billion clinical trials industry run by a new breed of satellite companies (CROs) that took shape as a process that was put in place that rapidly led to over 90% of academic articles about on-patent drugs being ghostwritten. As the US patent system was extended globally in the form of TRIPs (Trade-Related Aspects of Intellectual Property Rights), in 100% of cases the data from controlled trials that had previously been readily available in the Republic of Science were instead sequestered.

The new Empire swallowed the Medical Republic, And values turned inside out.

In the Medical Republic an article like that of Marty Keller and colleagues (Study 329), stating that a drug was Safe and Effective, would be taken to mean safe and effective for patients. In the Pharmaceutical Empire the words mean Safe for GlaxoSmithKline, and Effective at generating profits.

When a drug scare hits the headlines and regulators talk about the risk-benefit ratio for the drug still being favorable, they are talking about managing the risks to companies rather than to patients.

In the Republic, medicine’s reach was limited to diseases like melancholia, tuberculosis, or heart attacks.  In the Empire, healthcare manages SSRIs, Statins, and Bisphophonate deficiency disorders which, left untreated, will kill the company.

In the Republic, Controlled Trials were about limiting the use of drugs. In the Empire Controlled Trials fuel the Therapeutic Bandwagon.

In the Republic, Guidelines offered guidance about what not to do. In the Empire guidelines are Diktats about what must be done.

In the Republic, patients entering trials signed Informed Consent forms. In the Empire they sign Confidentiality Agreements.

In the Republic, the CEO of a pharmaceutical corporation might try to meet with the head of an academic medical department or professional grouping, but would not have been surprised to be left waiting at the door.  In the Empire, heads of university departments are lucky if they can get access to centurions fairly far down the Pharma pecking order.

In the Republic, the leaders of a medical group would welcome a call to the field to insist on the absolutely central notion of science – access to data. In the Empire, you can expect a recent President of the American Psychiatric Association to get ad hominem about data access:

“The group (Le Noury et al) is a self-appointed watchdog,” Jeffrey Lieberman, chair of psychiatry at the Columbia University College of Physicians and Surgeons, told BuzzFeed News. “One wonders what the motivation is, and how objective they’re going to be.”

Lisa Cosgrove and Bob Whitaker in their recent book Psychiatry under the Influence describe this effect as an illustration of economies of influence.

The change has transformed the former Medical Senators into Minions.*

And we, the former Electors, have become Consumers.  We consume the security the Empire offers.  As Margaret Atwood would say:

We have been given Freedom From in exchange for Freedom To.

Sense about Science

Simon Wessely (SW) and Clare Gerrada are the power couple of British Medicine.  He is the current President of the Royal College of Psychiatrists, and she is a recent President of the College of General Practitioners.  When faced with questions about over-prescribing of antidepressants by GPs, she is quick to insist that GPs rarely treat distress and that almost all prescribing is for genuine illness, and that the drugs work well.  He gives similar messages in respect to psychiatry.

These messages look one way in a Republic but look quite a different way in an Empire.  If the drugs work well, and Evidence-Based Medicine is all its cracked up to be, who needs doctors?  Nurses are cheaper.

Defending doctors needs a very different message. It needs an Expertise-Based Medicine.

The existence of a group like Sense about Science (SAS), of which SW is an advisor, also looks very different in an Empire setting.

Sense about Science began in Britain 15 years ago with donations from Corporations in the risk management business – from Monsanto, through Nuclear Power, to Pharma. These donations have vanished from sight now, replaced by endorsements from all major UK universities, journals like the British Medical Journal (BMJ), and support from Charitable Foundations.

SAS’s stated mission would have appealed to someone like SW, who had come under attack from a lot of fringe groups in the 1990s for taking a balanced data-driven approach to Chronic Fatigue Syndrome (M.E.).

But SAS has now become a node to handle any messages in the media that might hurt the interests of a company or corporate sector, such as anything to do with vaccination, or my recent editorial on So Long and Thanks for all the Serotonin.  BMJ sent this article (as they send all articles) to SAS, who got in touch with SW to rustle up statements from Jeff Lieberman types which could be disseminated widely to the media either for citing or as a means to close down stories, as in: You might not want to take Healy’s work seriously in the light of what these senior figures in the field are saying.

Sense about Science has since spread to Canada, Australia, and now the United States, and everywhere the mission is the same.

AllTrials & AllData

SAS was a founder of AllTrials.  This sounds like AllData – the hashtag for Restoring Study 329 – but at the moment it is quite the opposite.

There has been close to radio silence from AllTrials in the face of the call for AllData, aside from one stunning press release that more or less credits GSK with the efforts to Restore Study 329.

17th September 2015

Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression.

The new research is the first reanalysis of a drug study under the RIAT (Restoring Invisible and Abandoned Trials) initiative, which calls on companies and academic funders to publish detailed trial information for independent scrutiny. The RIAT team was able to access the original clinical trial data using GSK’s patient-level data access portal, where researchers can request access to this information.

Tracey Brown, Director, Sense About Science and co-founder of AllTrials:

“When all trials are registered and results reported, it becomes possible for researchers to work out what data are available. GSK has gone further and made its patient level data available to researchers. It is disappointing that there are still so many companies not reporting trials. Researchers, doctors, patients and, in July, their shareholders have said they want transparency about trial results. This will confirm their views.”

Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”

Pontius Andrew?

Faced in 2012 with questions about the $3 Billion fine imposed on GSK, triggered by a sequence of events starting with Study 329 – is it just the cost of doing business? – Andrew Witty snapped back:

“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.

Everything about Study 329 suggests that Andrew is comprehensively wrong. Corporate malfeasance happens when the system is set up so that the efforts of 100,000 well-meaning people get transformed into the worst of outcomes and it then takes the efforts of a few brave people within GSK to alert the outside world to how things are going wrong.

In tackling these issues, I’ve had more help from colleagues in industry and more grief from clinical colleagues so I’m sure the 100,000 people who work for GSK are at least as good as the rest of us – just as Roman legionnaires were no different to the rest of us – and that some of them are very brave indeed.

Good rather than evil is more likely to happen when people buck the system.  The Nazi Oskar Schindler may have been a much better person than Eugenio Pacelli (Pope Pius XII).

“The fault, dear Andrew, is in our stars,
Not in ourselves, that we are underlings.”

It’s the pre-ordained system (our Stars) within which we work that dictates how we behave or the outcomes of our behavior.  Systems can twist good intentions such as those of Louis Lasagna into a disaster and lead you to execute someone even when, as with Othello, your wife tells you the previous night you are making a bad mistake.

Rip van Keller

As I read it, Marty Keller and his colleagues, the authors of the first published interpretation of Study 329, figured they were operating in a Republic. Their study was designed in 1992 to address substantial issues: Were the SSRIs going to be significantly different to older antidepressants?

Their correspondence points to bewilderment at the turn of events.

But where Sally Laden — under oath — described her relationship with GSK honestly, while Marty Keller’s body language made it clear he was painfully aware of how it would look, under oath in 2006 he resorted to a convenient amnesia rather than telling it as it was.

GSK were working with the cream of the bunch.  There are some wonderful people in the group, such as Rachel Klein, Gabrielle Carlson, and Stan Kutcher.

There are many people in this group – and among their contemporaries – who could tell us more about what it’s like to go to sleep in a Republic, and wake up in an Empire.

Whether from someone in this or another generation, we need help in finding a way out of being Underlings.

* * * * *

This blog is adapted for Mad in America
from a blog on David Healy’s website.

* One of my consultants (SC) has drawn my attention to the following promotional material for the recent movie Minions:

Evolving from single-celled yellow organisms at the dawn of time, Minions live to serve, but find themselves working for a continual series of unsuccessful masters, from T. Rex to Napoleon. Without a master to grovel for, the Minions fall into a deep depression. But one minion, Kevin, has a plan – the plan does not involve taking an SSRI.

The Minions adopt Vivien Greene’s slogan:

Don’t wait for the storm to pass, learn to dance in the rain.”

It doesn’t get more ambiguous than this – “Vivien Greene has been consulted by many corporate leaders anxious to marry her visionary message with the corporate bottom line.”

9 COMMENTS

  1. 666. Sickness & Sex Sells.

    Other variations are: sickness and sex cells, sick sex sells / sick sex cells, and my personal favorite, the phonetic translation: sicks, sicks, sicks.

    A lot of people think the aim and goal is to accumulate money (money is a power in this world). But when dealing with the sciences (one of “the powers that be”), the real goals are knowledge (information) and technology. Money is just the means to achieve their goals.

    My favorite line in this article,

    “In the Republic, patients entering trials signed Informed Consent forms. In the Empire they sign Confidentiality Agreements.”

    An informed choice is the best choice. In this article, a dark flag is being waved under a banner of overburden and disheartened morale: http://www.healthline.com/health-news/doctor-shortage-we-may-need-an-additional-90000-physicians-by-2025-092715

    Maybe the solutions just are not chemical, o science.

    Maybe stellar works are alignments with that amazing thing called Honesty (the gateway to truth).

    Honestly, what are your true principals, GSK (and all you other manufacturers of chemical profits).

    Read that article at healthline.com, GSK. See the impact you have?

    • The good doctor can be incredibly abstruse and some of his articles have been way beyond my ken.

      This one I think I mostly get – it’s basically about the shift of power to the corporate sector and the co-opting of science to support the agenda of corporations and to increase their own status to the detriment of the patients, who have been relegated to mere consumers of and markets for products which do not do what they are claimed to do. Seismic shift in focus and outcome.

      …or something like that.

      I doubt I’ll read any more of his articles in the future….too abstruse.

  2. I think I understand Ted. In a round about way (I quite like the way he writes) he is saying that medicine, of which psychiatry is a part, has become part of a massive capatilist, corporate enterprise that as co-opted sicience, evidence based medicne, doctors and organistations like the FDA, APA; RCpsych, as well as goverments to do their bidding and to not give a shit about us. Indeed we are made to feel we need this stuff they do to us to feel healthy and happy and safe. It is sort of like brave new World.

    • The Republic / Empire focus seems to overshadow the other focal point of the article, the study.

      “As I read it, Marty Keller and his colleagues, the authors of the first published interpretation of Study 329, figured they were operating in a Republic. Their study was designed in 1992 to address substantial issues: Were the SSRIs going to be significantly different to older antidepressants?”

      “There are many people in this group – and among their contemporaries – who could tell us more about what it’s like to go to sleep in a Republic, and wake up in an Empire.”

      • The UK Nhs is supposed to be broke but look at all the money they’re wasting creating false mental illnesses. Most people don’t even genuinely suffer from
        the so called “major mental illnesses” to begin with:
        it’s got to be a form of money laundering.

  3. Indeed, and Thomas Jefferson forewarned us of this day, long ago.

    http://www.monticello.org/site/jefferson/private-banks-quotation

    As one from a formal ethical American banking family, and like Jefferson, I place the ultimate blame upon the “too big to fail,” “evil banks” who are funding these evil pharmacutical corporations and the psychopathic greed inspired corporatocracy we’ve found ourselves residing within. Thankfully, I am no longer alone in seeing the evil of 9.11.2001, and it’s connections to the seeming end goals of our current leaders, a possible WWIII. Millions online now share my seemingly prophetic 2001 nightmare / psychiatrically claimed “psychosis” / concerns.

    https://m.youtube.com/watch?v=NO24XmP1c5E

    https://m.youtube.com/watch?v=lEV5AFFcZ-s

    https://m.youtube.com/watch?v=HL6v8nzFiUk

    It’s a little odd to me that the psychiatric practitioners have delusions of grandeur they know more about bankers’ wars than the children of ethical American bankers.

    But God has offered humanity a solution to this evil corporate takeover of the world. This Messianic Jew is pointing out that a Jubilee year (which we’re currently in) is intended as a gift to humanity from God.

    https://m.youtube.com/watch?v=oqTKWyu8tig

    As a woman who was “moved by the Holy Spirit” on the morning of 9.12.2001, who still allows the Holy Spirit to move me, despite psychiatrists poisoning me 14 distinctly different ways with drug cocktails known to cause anticholinergic toxidrome for belief in the Holy Spirit, God, and Jesus. Drugs don’t cure people from belief in the Triune God, psychiatrists. I’m quite certain God would prefer humanity to espouse belief in God’s word, and put an end to the stupid game of monopoly being played by the evil bankers and corporations. Break these entities up, and redistribute to assets of the world to the people of the world in a just and orderly fashion. I have a theory this would be a better idea than actually taking this world to a WWIII, as would be profitable for the banks and military industrial complex.