full speed ahead…

Posted on Saturday 3 August 2013

I smell a strategy coming from PhRMA about this business of AllTrials and RIAT. Two recent articles address the public version. In do the time…, I looked at GSK’s white paper in the New England Journal of Medicine [available via Medscape’s write-up GSK Opens Access to Data From More Than 200 Clinical Trials]. Later, in the spice must flow…, I reviewed the head-to-head article from PhRMA in the British Medical Journal [Are clinical trial data shared sufficiently today? Yes]. The private version comes from the leaked memo reviewed in a closing argument… which includes an article from the Guardian [Big pharma mobilising patients in battle over drugs trials data], a retort in eye·for·pharma [Exclusive: The Devil is in the Details], and the actual memo from EFPIA & PhRMA.

GSK is making 200 Clinical Trials [post-2007] available to qualified research teams pending a review of how they plan to use the data [including publication plans] by a panel in independent experts. Technically, that’s data sharing – using their data for an independent research project, approved by GSK. In the PhRMA piece elaborates on this theme of data sharingg and claims that data transparency is a destructive thing leading to betrayed subject privacy and access to proprietary information. In essence, they are agreeing to tightly controlled data sharing and arguing against data transparency.

Privately, their strategy is to mobilize their forces and fight  data transparency tooth and toenail:
The advocacy plan, previously approved by the two Boards is underway, and follows four strands:
  1. Mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.
  2. Engaging with scientific associations to shape the industry commitment for data sharing, and to discuss concerns about re-use of data.
  3. Work with other business sectors that are also concerned about release of trade secrets and commercially confidential data.
  4. For the long-term, build a network of academics across Europe that has the capacity to counteract mis-use of data [that is deemed to be happen in any case].
Says Ben Goldacre of these recent developments:
Ben Goldacre, author and co-founder of AllTrials:“The industry commitments suggested here are weak and filled with loopholes. They fall way short of the concrete commitments the European Medicines Agency has already made about sharing trial information, and also fall short of recent commitments from GSK and Roche.

The loopholes are especially concerning. EFPIA and PhRMA seem to be suggesting that transparency should only happen for new trials, and reports submitted to regulators after 2014. This will do nothing to remedy the incomplete evidence that doctors and patients are being forced to use right now, on the medicines we use every day and came to market over the past few decades. Sharing trial information going back for at least two decades is vital.

It is also a retrograde step that they suggest only releasing Clinical Study Reports on demand, after a long review process by the company, where they will decide if the applicant is appropriately qualified. The Cochrane Collaboration faced a four year battle to get Clinical Study Reports from Roche on Tamiflu, during which time the company attempted to argue that the Cochrane Collaboration – 14,000 academics producing more systematic reviews than any other organisation in history – were not competent to conduct a systematic review.

There are also some bizarre peculiarities in the details. For example, the suggestion that trial protocols should only be released voluntarily, and on request, after going through a panel run by the company, is extraordinary. This suggests the EFPIA/PhRMA document may not have been thought through carefully. A trial protocol is simply a detailed description of what will be done in a trial, and how it will be analysed. It should be a routinely available public document and, by best practice, made available before the trial even begins.

Overall the proposals here are no meaningful alternative to simple, clear transparency on all trials. Doctors, regulators, and policy makers cannot barter away from the simple full transparency that patients need. All results from all trials for all uses of currently prescribed treatments must be made available, if doctors and patients are to make informed decisions about which treatment is best. Where we have anything short of this, patients are exposed to unnecessary harm.”
The time for talking is over. Pharma has no intention of cooperating with any meaningful version of data transparency. It was naive to think they would. So "damn the torpedoes, full speed ahead"…
    August 4, 2013 | 2:38 AM

    Re: “data transparency into data sharing”

    A company will always use the terminology to obfuscate the issues at hand. Turn to Richard Stallmen to understand this:
    “Stallman argues that the term intellectual property is designed to confuse people, and is used to prevent intelligent discussion on the specifics of copyright, patent, trademark, and other laws by lumping together areas of law that are more dissimilar, than similar.[69] He also argues that by referring to these laws as property laws, the term biases the discussion when thinking about how to treat these issues.

    These laws originated separately, evolved differently, cover different activities, have different rules, and raise different public policy issues. Copyright law was designed to promote authorship and art, and covers the details of a work of authorship or art. Patent law was intended to encourage publication of ideas, at the price of finite monopolies over these ideas — a price that may be worth paying in some fields and not in others. Trademark law was not intended to promote any business activity, but simply to enable buyers to know what they are buying.
    — [70]

    An example of cautioning others to avoid other terminology while also offering suggestions for possible alternatives, is this sentence of an e-mail by Stallman to a public mailing list:

    I think it is ok for authors (please let’s not call them creators, they are not gods) to ask for money for copies of their works (please let’s not devalue these works by calling them content) in order to gain income (the term compensation falsely implies it is a matter of making up for some kind of damages).”

    Steve Lucas
    August 4, 2013 | 8:49 AM

    Pharma will continue to offer up straw man arguments in an effort to delay the release of data. The reality is that the data does not support the use of many drugs and the push is then on for off label prescribing by sympathetic doctors.

    The resulting sales then cover any fines for marketing infractions or worse, death. Time and time again we see drugs become the standard of treatment only to be removed from the market place due to adverse affects.

    Pharma is the first to claim First Amendment rights to sell, sell, sell, promote their products with false television commercials and then turn and state: “pay no attention to that man behind the curtain.”

    This will be an uphill battle and the results will be shocking as drugs are found to be of no or little use in the prescribed treatment regime. Billions will be taken from our national economy, millions will go to compensation for the executives of these companies and patients will be left wondering if they received anything of value, or was this all a placebo effect.

    Steve Lucas

    August 4, 2013 | 3:44 PM


    How Heart Guidelines Based On Disgraced Research May Have Caused Thousands Of Deaths

    What if doctors kept prescribing drugs based on large clinical trials that had been discredited? That is exactly what is happening in Europe, as guidelines for physicians have remained unchanged even as the studies they are based on were caught up in a two-year-old scandal. Some researchers say thousands of patients may have died as a result in the United Kingdom alone…..

    August 4, 2013 | 3:49 PM


    A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices

    We expect that new medical practices gain popularity over older standards of care on the basis of robust evidence indicating clinical superiority or noninferiority with alternative benefits (eg, easier administration and fewer adverse effects). The history of medicine, however, reveals numerous exceptions to this rule. Stenting for stable coronary artery disease was a multibillion dollar a year industry when it was found to be no better than medical management for most patients with stable coronary artery disease.1 Hormone therapy for postmenopausal women intended to improve cardiovascular outcomes was found to be worse than no intervention,2 and the routine use of the pulmonary artery catheter in patients in shock was found to be inferior to less invasive management strategies.3 Previously, we have called this phenomenon (when a medical practice is found to be inferior to some lesser or prior standard of care) a medical reversal.4, 5, 6 Medical reversals occur when new studies—better powered, controlled, or designed than their predecessors—contradict current practice.4 In a prior investigation of 1 year of publications in a high-impact journal, we found that of 35 studies testing standard of care, 16 (46%) constituted medical reversals.4 Another review of 45 highly cited studies that claimed some therapeutic benefit found that 7 (16%) were contradicted by subsequent research.7….

    August 4, 2013 | 8:54 PM

    One possibility is that physicians can refuse to prescribe medications for which full trial data is not available, on the grounds that without full transparency, there is no way to know if a medication is harmful, or even effective.

    It would take some serious banding together, and not all physicians would be willing to do this, but even so, it would still take a bite out of sales.

    We keep forgetting that we have leverage.

    August 5, 2013 | 12:36 AM


    No US physician groups have even officially endorsed the AllTrials campaign. The idea that physicians are going to band together to do what you suggest, given they can’t even band together to simply sign an internet document, seems doubtful.

    Steve Lucas
    August 5, 2013 | 5:30 AM

    I feel it would be helpful if doctors stepped back, took a deep breath, and acknowledged that pharma and the device companies are marketing corporations. Once this is done their actions become more transparent and understanding the psychology and corporate culture becomes less frustrating.

    The corporate culture of a marketing company is very different than a R&D company as the focus is on selling product, not developing product. We see this in that pharma purchases new drug ideas from researchers who have often been working on NIH grants, our tax dollars at work

    A manufacturing company is interested in product production and quality, not how cheaply they can produce a product. The result of this is some of the basic health and content violations recently found.

    Doctors also need to understand that a few of them have embraced this culture and the need for a salesman’s acceptance has driven them to the top of some medical societies. These societies have over time moved away from representing their members to having a political agenda suited to promote their corporate leadership.

    I think it is safe to say that when a group is based in Washington, and meets and interacts with the Washington crowd, they will take on some of those same behaviors.

    Above all else doctors need to understand that in the business world money is the way to keep score. You can never have enough, and you always want more than the other guy.

    Steve Lucas

    August 5, 2013 | 12:18 PM

    MDs don’t even know what’s in the PDR regarding the medications they prescribe, much less which are fully “evidence-based.”

    August 7, 2013 | 3:59 AM

    RE: “data transparency”
    Used out of context to wanting to get raw data about clinical trials though proper means:
    “hackers and transparency groups”

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