a crushing setback…

Posted on Saturday 31 May 2014

When I first heard of the U-Turn in the EMA’s data transparency policy [the U-Turn…, the end game…, to be continued…, a decision to reconsider…], I naively thought that it was perhaps a misunderstanding, that they though this view-on-screen-only business was  a convenient way to display data and didn’t represent a massive change in policy. But I was, indeed, totally wrong:
PLoS Blogs
By Trudo Lemmens
May 30, 2014

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 Intermune’s Esbriet, which had stalled EMA’s data release approach. Shortly after, Abbvie withdrew the Humira lawsuit. Then in April 2014, the European Parliament approved the new Clinical Trials Regulation that introduced a requirement to register all clinical trials and make all clinical study reports in relation to EMA approved drugs publicly available. These developments put EMA again in the driver’s seat for the further implementation of its promised prospective data release policy.

Yet, when EMA recently distributed the draft policy to participants of its Clinical Trials Data Policy advisory groups, scientists and patient advocacy groups were dismayed, and the European Ombudsman sent a letter to inquire about EMA’s apparent shift: the proposed “Terms of Use” [TOU] and “Redaction Principles” impose various technical restrictions on data access, which would make it practically impossible to conduct decent research. If it were only technicalities, further discussions with the scientific community could fix the problems. But in the fracas around the technicalities, the legal booby-traps hidden in the [admittedly still draft] TOU received little attention. I therefore sent a letter to EMA’s executive director Guido Rasi outlining several legal concerns. Combining these with the technical restrictions suggests a problematic legal hijacking by industry of the transparency agenda.
"Trudo Lemmens is Associate Professor and Scholl Chair in Health Law and Policy at the Faculties of Law and Medicine of the University of Toronto. His research focuses on legal and ethical issues of biomedical research and pharmaceutical product development… He has written about data access issues in the past and participated in the consultation process on EMA’s prospective data release policy." His article lays out the story in its complexity and confirms our worst suspicions:
What are the legal traps? First, by signing the TOU, data users would “acknowledge […] that the Information is protected by copyright and proprietary rights … and can be considered commercially valuable”. Brand name pharmaceutical companies increasingly insist that clinical trials data are protected by copyright and proprietary rights, and considered commercial confidential information. In the European Court cases, companies even made the spurious claim that companies have a fundamental human right to privacy over the data. But the idea that data are protected by copyright is highly doubtful, and it is little wonder that companies like to use the vague notion of ‘proprietary rights’ and refrain from using more concrete terms. Simply put, whether they have any such rights in data remains hotly contested, and is not firmly established in law. Many have convincingly argued the opposite, that these data are public goods, and that case law supports access to data on the basis of health related human rights. Remarkably, EMA is now asking scientists to recognize these rights while it is still involved in one case before the European General Court?the Intermune case? where a company is invoking such rights to block EMA’s decision to grant access to data. In light of this case and possible future court challenges, EMA has an interest in arguing for the most narrow interpretation of companies’ rights over data.
And as to the idea of DATA as confidential property [see PhRMA’s Intellectual Property Protections Are Vital to Continuing Innovation in the Biopharmaceutical Industry]:
Second, the documents also strengthen industry’s attempt to qualify some data as commercial confidential information, which would offer industry the most far-reaching data protection. The TOU only mentions that data ‘can be considered commercially valuable’, which is indeed different than ‘confidential’. But the draft Redaction Principles, which set out how information will be made public, state that “novel statistical or other analytical methods and exploratory endpoint results about potential new uses of a medicine that are not the subject of the marketing authorization application” can qualify as “commercial confidential information.”  Here again EMA embraces a questionable legal position that favours industry. Statistical methods are part of the scientific commons. It’s hard to see how they can be ‘unique’ enough to qualify as commercially confidential information while still providing reliable evidence according to widely accepted scientific methods. The ‘endpoint results of potential new uses’ appears to include clinical trials data related to off-label prescribed drugs. Some of the most troubling controversies that underlie the widely supported calls for data transparency involve pharmaceutical companies’ misrepresentation of data related to off-label prescribed drugs. These practices have impacted on the health, life and wellbeing of thousands of patients. Even if these ‘endpoint results of potential new uses’ are obtained at an exploratory stage with new statistical methods, accessing these data is of public health importance.

The “Redaction Principles” further grant industry much leeway in deciding what will be made public: companies would submit two different clinical study reports to EMA: a full report that EMA will keep hidden; and a redacted one that will be publicly available. What kind of information was hidden, and why, will likely be very difficult to know.
And who is in the sights of legal action, the criminal or the detective?
Third, EMA is also asking researchers to contractually agree that they can be sued under UK law “in accordance with the provisions of the Contracts [Rights of Third Parties] Act 1999.” As a result, pharmaceutical companies will be able to challenge researchers directly in court for violation of EMA’s TOU. This puts companies in a comfortable legal position, particularly when this is connected with the recognition of proprietary rights, copyrights, the commercial confidential nature of some information and the severe technical restrictions on data use, which make good faith violations of the TOU much more likely. This could have a significant chilling effect. The mere risk or threats of litigation could seriously hamper open scientific debate. Researchers may think twice about publicly challenging a company’s interpretation and representation of data or about correcting the published literature on the basis of EMA held data, as called for by the recent RIAT proposal.
Trudo Lemmens’ conclusion:
In short, EMA’s approach is strengthening industry’s legal control over data, making it more difficult and legally risky for independent scientists to use them. These are in essence regulatory data, created for public interest use. For the EMA, a key public institution, to now support the privatizing of pharmaceutical knowledge through contractual affirmations of companies’ rights over these data is truly astounding. Dr. Rasi’s recent response to the Ombudsman, that EMA’s new policy is a ‘reasonable compromise’, and does not prevent researchers from asking for access to specific data sets on the basis of the existing access to information policy, does not reassure. His response does not recognize the legal concerns raised by the draft TOU and Redaction Principles, let alone justify the approach taken. And Abbvie’s withdrawal of the legal challenge of the Humira data release notwithstanding, EMA appears back in the business of imposing more extensive limits on what it gives access to in response to specific access requests.

This troubling development is not entirely surprising. Even if the transparency movement had some major victories, including the adoption of transparency requirements in the recent European Clinical Trials Regulation, opposition has been mounting. Industry may now employ other regulatory initiatives to fight transparency. The European commission recently released a draft directive aimed at streamlining and strengthening Trade Secret protection in Europe. The European Federation of Pharmaceutical Industries and Associations [EFPIA] jumped already enthusiastically on the occasion, emphasizing the need to protect the “proprietary know-how” of drug development, including in the “clinical trials phase”. In the context of ongoing and largely secret transatlantic trade negotiations between Europe and the United States and Canada, the pharmaceutical industry has also been lobbying hard to strengthen data and IP protection and to include better data protection in the package. EMA now appears to be lending a helping hand.
A crushing setback by any criteria. While it’s tempting to join in the blaming – and I think some of it’s probably justified – this is too big to have been the result of something any of us did or didn’t do. This smacks of behind the scenes wheeling and dealings done by the biggest of guys – industries, governments – not the people out here we all know or know about. The reason I call it a crushing setback is first the obvious, it makes DATA transparency into something other than DATA transparency. But second, however this happened is itself opaque, anything but transparent. I think it’s almost more important to know how this came about than anything else. With back room politics like this in the mix, medicine has left the realm of science altogether…

    May 31, 2014 | 7:26 PM

    If they want to protect the data, then their conclusions from it should be given no merit. I don’t see any other way to stop this crazy train but to publicly fund all testing for pharmaceuticals and to consider information from drug companies totally worthless and suspect. The best predictor of future behavior is past behavior, except when it comes to people having a reaction to a drug that causes them to behave in a way that is completely out of character for them or that interferes with their ability to learn from mistakes or to feel life enough to act in accordance to it.

    Plus, criminal prosecutions for damages done by pharmaceuticals that were promoted with lies and obfuscation is long overdue. People are dying and being disabled by too many drugs that they’re taking with anything but informed consent. I’m perfectly willing to accept risks with any drugs, many of which can’t be foreseen; but what’s happening now is far beyond acceptable risks.

    Jeff C
    May 31, 2014 | 8:12 PM

    Now that the dust has settled and transparency has been exposed as a sham, it’s time to take a hard look at Ben Goldacre’s role in all of this. He seemed an unlikely champion for the cause based on his history of extreme hostility to those skeptical of allopathic medicine. Under the guise of “bad science”, he and his merry band of forum trolls have harassed those pursuing alternative healing methods that didn’t originate in pharma’s labs. He has vilified concerned parents that question why children need 48 vaccine doses prior to starting kindergarten (per the CDC schedule) when the number of vaccine doses was only 22 a generation ago. (A generation ago children also didn’t have rates of 1 in 68 for autism, 1 in 15 for ADHD, 1 in 50 for life-threatening peanut anaphylaxis, and 1 in 4 for allergies but parents that point this out are also vilified.) After long sharing many traits with the pharma-shill KOLs, he suddenly became our Moses ready to lead us to the Promised Land.

    His recent behavior does make one wonder if the present “compromise” was his goal along. Look back right before Goldacre took on this cause; Senator Grassley had pharma on the ropes, KOLs were being exposed as crooks, GSK and others had been fined billions, and the journals were shown to be pharma mouthpieces. The drug companies and their enablers were in big trouble. Now thanks to Goldacre, we have sham transparency that will almost certainly let pharma off the hook while giving the appearance of corporate responsibility. Those who dare point that out get attacked as David Healy can attest. Goldacre seems rather unfazed by the recent turn of events, far busier spamming critical blogs rather than questioning what just happened. It’s time we called BS.

    May 31, 2014 | 11:38 PM


    This is an old post, but I think it is a message that bears repeating in as many sober voices as possible. In this post, Howard Brody reviews Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare by Peter C. Gøtzsche. The following are excerpts from this post:

    … Gøtzsche uses the organized crime motif to characterize the drug industry. This is quite deliberate and measured. He argues that something counts as organized crime when:

    They kill people
    They lie about what they do
    They routinely break the law as a part of their business practices
    They use their ill-gotten gains to corrupt the government regulatory apparatus so as to be allowed to continue to operate

    … If you take the trouble to go back and look (I don’t advise it), check out how long it took me to use the actual words bribery and corruption in describing Pharma behavior. I now use those words unabashedly because I am quite secure in knowing that the behavior is accurately described by such terms, and there is no point in pussyfooting around the real and serious problem the behavior poses. If we get overly obsessive about not appearing intemperate, we pay the price of failing to endorse the really basic and drastic reforms that are needed to clean up the current mess.”

    I’m sure you can relate very personally to that last paragraph, Dr. Nardo. For people who no longer believe what psychiatry says is their problem and what they should do about it, it’s very vindicating, educational, and therapeutic to read material from blogs like Hooked…, 1boringoldman, Mad in America, etc. I’ve started to recommend Fear and Loathing in Biothethics and all the links on that page in response to any comment touting the Lieberman Party line, old and new, of the bio-bio-bio/medication perspective. Intelligent people who like to read non-fiction and current events should be able to find a trove of thought provoking and cutting edge information and perspectives from that one link. Anyone who dismisses any of those sources as “woo” either hasn’t looked at it or is not as scientifically savvy as they think they are.

    I was about to lose patience with college-educated liberals who think that the DSM really is a bible and think that that’s evidence that they have scientific minds. The last mass murder has brought out those who are ready to lock up the “mentally ill” to prevent mass murder and somehow think they’re reducing the stigma of mental illness even as they do this. How many people without mental illness diagnoses are violent every day vs. the mentally ill? Sheesh. The bio-bio-bio paradigm is a thought stopping technique. Argh.

    James O'Brien, M.D.
    June 1, 2014 | 2:58 PM

    At the risk of belaboring the point, it’s scientific research in general that’s bad, not just that done by Big Pharma:


    Bottom line: science is severely dumbed down in the last fifty years. There just aren’t that many good scientists.

    Ponder this: in 1953 Watson and Crick published a two page paper in Nature that defined the basis of life. The average academic today publishes hundreds of papers that don’t make a damn bit of difference as to what we do.

    So you can have this research supervised by archangels, but they still gneerally don’t have the smarts to get it right.

    Steve Lucas
    June 1, 2014 | 4:05 PM

    All hail cut, paste, and Google!

    Steve Lucas

    June 1, 2014 | 7:09 PM

    You know what, I have been practicing for over 20 years now, and doing the Locums thing for the past 4 plus years, and those who read here need to know this from a doc who really cares about people at the end of the day, psychiatry overall sucks from most who are providing care.

    I know Dr Nardo won’t be happy with my comment here, but, you can pontificate about the pharma industry until the cows come home, however, you need to know, there are more psychiatrists than not who are just going through the motions at the very least, and just putting people at risk. And what a lot of you patients and non providers need to hear and digest is simply this:

    Care is not just about meds, or about one other intervention, but about multifactorial interventions that are biology, psychology, and socialogical. When you as a patient look at where you come from, what you are doing, and what your gene pool puts you at risk, and weigh all those factors equally and independently, then, you have a decent chance at getting better.

    I finish with the irony of what I listen to as I type this post, and that is from Pink Floyd “Wish You Were Here”, and I suggest you all listen to that album from the beginning to end, because the point of the album by the band was respect for their original band member. Syd Barrett who did too much acid and lost his way, I leave the Wikipedia link to educate you what this band was about at the end of the day:


    Floyd was good stuff, I am glad my friends in high school and college gave me the exposure. Comfortably Numb, look that one up folks!


    Hey, it is June, mellow a bit, eh?

    June 1, 2014 | 8:11 PM

    I agree with what you said, including Floyd.

    For the record, I am fine with drug companies doing whatever they are doing as long as I have the choice to not support, buy, use or listen to, whatever they are selling. But that choice is being offered to me less and less. I’m just Merck Manual (or DSM 5) opened to pg. 194, sitting in a paper gown on the bench, and the care is accordingly. Sometimes that works and many times it doesn’t.

    For your comments on care. I am now down a rabbit hole with a standard of care written by the government, managed care and pharmaceutical industry, and one that makes next to no sense to me. No, I am not a doctor, so maybe it doesn’t need to make sense to me, but you’re asking me to purchase it. Can you tell me what depression is? I thought I knew, but not anymore. All I know is there is antidepressant Rx waiting for me for every single symptom I have and every single life event I could ever possibly experience.

    I long to find providers like the ones I used to work with. One that called our pharmacy looking for cobra antivenin because he had been doing some research (it worked out; he was really looking for a low molecular weight heparin and we just started carrying Lovenox) or the surgeon that opened up a patient with hypothermia that had failed two courses of Dantrium and ran warm water through her body because he knew that was what they did in the Soviet Union when they had no meds.

    Those are extreme examples, but the point being, show my a physician willing to practice independent thought, and multifactorial interventions as you describe, and I’ll be there. But until then, I think I’ll pass on everything except emergency care. Note: I do NOT recommend this course of action for others and I’ve often gotten on my friend’s cases for this very attitude.

    Also note that pg. 194 is illustrative only. I have no idea what is on this page in either manual.

    June 1, 2014 | 8:31 PM

    Correction to my comment above, it was hyperthermia that the patient had where the Dantrium failed not hypothermia. Memory fails me, but I am positive on the Dantrium, because we darn near ran out of it that night.

    donald klein
    June 2, 2014 | 3:46 AM

    The helpful report on boring old man
    is upsetting but not surprising. Amazing that the EMA (a regulatory agency) fostering a transparency movement had done so well– in the context of industry dominated conservative governments.
    The –single screen-no download-restriction is clearly aimed at making independent analysis impossible. It is telling.
    Mickey says,” I think it’s almost more important to know how this came about than anything else”. I don’t think that is difficult , the EMA U turn is a product of dominant national and industrial interests. Focused attention is unlikely to eke out the grimy details nor is it important.That’s tactics , not strategy. Centrally, the whole movement gained strategic momentum from the Ombudsman essentially saying public health trumped trade secrets It’s likely that the same pressures applied to the EMA are being applied to her.Too bad . Our rallying point should be that the principle (slogan) that public health trumps private interests has achieved substantial,growing,public support.Even if the Ombudsman is forced to back down –which is unpredictable–this simple principle should survive as an activist focus. It is very easy to understand. Public health trumps private interests .

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