a closing argument…

Posted on Sunday 28 July 2013

I’ll have to admit that my iPhone® skills are mostly limited to receiving. Typing with thumbs is a recently evolved skill that passed me by, so I’m reduced to using an inaccurate index finger. That post from on the road a week ago was from a motel lobby computer on a very rainy day [an irreducible conflict…]. But these days, WiFi is everywhere, even on coastal Maine, so I could keep up with things of interest. Pharmagossip is a favorite site of mine, and Jack Friday has kept me riveted to the GSK China·Gate story [great reading with a harbor restaurant lobster roll]. In writing about it, I mentioned this Guardian piece from last week:
Leaked memo from industry bodies reveals strategy to combat calls by regulators to force companies to publish results
The Guardian
by Ian Sample
21 July 2013

The pharmaceutical industry has "mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials. Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs. Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.

While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle. The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.

The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee. The email describes a four-pronged campaign that starts with "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data". Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare. The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database…
I wasn’t surprised. We can hardly expect the Pharmaceutical Industry to embrace Data Transparency given their past behavior and the Billions they’ve made from their over-rated "blockbusters." Then I got home yesterday and read this [also linked by Pharmagossip]:
Exclusive: The Devil is in the Details
eye·for·pharma
Market Access
by Craig Sharp
Jul 26, 2013

The ongoing battle for clinical trial transparency took an unexpected turn this past Sunday, 21st July, when the Guardian ran a story featuring details of a leaked memo, apparently containing a plan to conceal “secret documents on drugs trials” from the public and concerned medical practitioners.

On Wednesday, 24thJuly, EFPIA and PhRMA responded to the ongoing argument with a joint set of new principles aimed at addressing these transparency concerns. Speaking exclusively to eyeforpharma, Richard Bergström, EFPIA Director General, explains the intentions of the joint position document and the real story behind that leaked memo…
The "real story" comes from an interview with the memo’s author, Richard Bergström, director general of EFPIA,:
Following the Sunday scandal and the resulting press coverage, eyeforpharma reached out to Richard Bergström to get the full story behind the memo and find out what the intention really was, and as it turns out the Guardian story wasn’t only incomplete, it was grossly biased in its assumptions…
I’ll not paraphrase it. It’s there for the reading and not that long. In essence, the memo’s author explains that the intent of the memo was not to mount a fight, but simply to find the best way to cooperate while protecting the clinical trial subject’s privacy and PHARMA’s legitimate interests. There’s a bit of confusing parsing of word meanings. It even has a response from the Guardian’s article author, Ian Sample. Their two accounts of the interaction between the author and Richard Bergström prior to the article’s publication were widely divergent. And who is eye·for·pharma anyway [the link takes you to their about·us page]?
eye·for·pharma is a hub for senior-level pharma executives, patient advocacy groups and other health experts to exchange ideas and stay up to date with shifting trends and practices within the pharmaceutical industry.
It’s The Guardian [home to Ben Goldacre's long-running Bad Science column] versus eye·for·pharma ["a hub for senior-level pharma executives, patient advocacy groups..."] each accusing the other of misbehavior. If this were an episode on Masterpiece Mystery, it would be titled "Who’s Black? The Pot or The Kettle?" [speaking of conflict of interests].

In case you haven’t noticed, both The Guardian and eye·for·pharma talk about the Memo they’ve seen without showing it to us! Which is the whole point of this post and Data Transparency in the first place.

Without the Memo, we’re left to our own biases and the biases of these two articles’ authors and their media venues. Apparently, I’m not the only person who noticed that the Memo itself was missing in action. Mercifully, in an Update, eye·for·pharma later appended it to the end of their article with this comment:

UPDATE: I’ve had a few requests now for the memo to be printed [we didn't run it originally as it's around 600 words long], for privacy reasons all names and contact details have been redacted. That aside, you can [read] the memo in it’s entirety below:
Dear members and colleagues,

please find below a message from Richard Bergstroem, EFPIA DG with respect to the various elements of the Clinical Data sharing debate, the assignment of responsibilities (including work with US PhRMA colleagues) and next steps

A. Forthcoming industry commitment, incl advocacy:
    The EFPIA Board has approved the draft position paper developed jointly by PhRMA and EFPIA. The final version is attached, and is now subject to confirmation by the PhRMA Board two weeks from now. PhRMA and EFPIA plan concomitant press releases in the week of July 22. 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).
    There will be a series of meetings in Brussels, organised jointly by PhRMA and EFPIA, in the week of August 26 to advance these strands. This work (commitment and advocacy) is coordinated by [Redacted], in close cooperation with PhRMA ([Redacted] and [Redacted]), with oversight by Richard Bergstroem and [Redacted], PhRMA.
B. EMA consultation on draft :
    On June 24th , the EMA published its revised policy on the publication and access to clinical trial data for consultation. Comments are invited and should be provided to the EMA by 30 September 2013. Whereas the press release was quite balanced, the detailed proposal raises concerns:
    1. No process outlined to discuss CCI in CSRs prior to release.
    2. Raw data: unenforceable controls to ensure robust and scientifically credible secondary analyses.
    3. Requirement for anonymised raw data to be supplied at submission negates EMA’s responsibility for release of PP information.
    4. Publication of CSRs from withdrawn or unsuccessful submissions could undermine future commercial viability of product.
    5. Identification of study personnel.
    The EMA document takes into consideration the outcome of the process run by the 5 CT advisory groups earlier in the year to which EFPIA contributed through the input prepared by the 5 Temporary Working groups (TWG) set up under the SRM PC auspices.

    A detailed response will be prepared by a joint EFPIA-PhRMA team. The work will be led by [Redacted], Lilly, [Redacted]. From the EFPIA side the EFPIA TWG chairs (Rules of engagement, Patient confidentiality, good analysis practice, CT data format, legal aspects) will be part of the drafting group: [Names of four individuals within the drafting group redacted] PhRMA will assign a small group of people from the bigger EMA data disclosure WG. The drafting group will tentatively have a TC July 9. The final draft will be shared for consultation with the broader membership later this month.
C: EFPIA-PhRMA intervention in the AbbVie case:
    [Name], Pfizer, leads this work, in close cooperation with PhRMA and external legal counsel.
D: Clinical Trial Regulation:
    Advocacy directed at Council (and EC and EP) will focus on:
    • avoiding definitions of CCI in the CTR itself,
    • seek to delete preamble text that CSRs do not "in general" include CCI (even if current text is acceptable as fall-back position).
    The EFPIA PACT(Public Affairs on Clinical Trials) is responsible and will work closely with national associations and Brussels staff.
Regards,
[Redacted]

I have rarely been afforded the luxury of writing such a satisfying post. Whether you agree with The Guardian or eye·for·pharma, or even land in some completely different place, the point remains the same. With the Memo there in front of you, you’re able to reach your own conclusions – deal with your own biases and conflicts of interest unimpeded. Your opinion is worth a whole lot more than it was before you read it. Very satisfying.

I rest my case for Data Transparency…
  1.  
    July 28, 2013 | 8:11 PM
     

    Let’s hear it for enactments.

  2.  
    July 29, 2013 | 4:52 AM
     

    Great job Mickey. :)

  3.  
    berit bj
    July 29, 2013 | 7:05 AM
     

    Excellent exposure! As expected by this biased mom, as foretold by George Orwell.
    “Advocacy” they call it, lobbying the European Council and scores of big-business-friendly politicians, media, bureaucrats, big-pharma-sponsored consumer groups NAMI with sister EUFAMI..

  4.  
    Johanna
    July 29, 2013 | 7:11 PM
     

    I ran across this joint statement on “responsible” data-sharing practices from PhRMA and its European cousin EFPIA. It is a real piece of poop, of course … we will share data only with “responsible” parties in a “responsible” format. In other words, we are committed to telling you everything we think you need to know. Trust us.

    I notice GSK is a member of both organizations. Is this GSK’s policy on data sharing as well? If so, I think it poses a real question for the AllTrials group and particularly those who have expressed enthusiasm for GSK’s data sharing initiative. (I like a number of things Ben Goldacre has done but I am really puzzled as to why he wants to “do cartwheels” over GSK’s offerings in this field so far. And I fear he and AllTrials could get manipulated into total irrelevancy, or worse, if they get too trusting.)

    So I hope they ask GSK: Are you standing behind this Orwellian piece of poop issued by your trade associations? If not, please stand up and say so. And if so, what the heck does it mean that you also “endorse” AllTrials?

  5.  
    a-non
    July 30, 2013 | 3:27 PM
     

    Is COI limited to pharma only?
    “OPINION: Health service researchers – are we blind to our own conflicts of interest?” Healthy Debate July 3, 2013 by
    Andreas Laupacis

    “It might be worthwhile articulating different degrees of conflict of interest. One scheme might go as follows, in order of increasing conflict of interest: 1) receipt of only operating funds to conduct the research from the payor, 2) receipt of personal salary or consulting fees, 3) receipt of funds for a research group or institute, so many individuals are dependent upon those funds for all or part of their salary and/or projects, and 4) potential to derive entrepreneurial profits in partnership with the payor. An important point here is that, except for the fourth conflict, the others pertain to both industry and the public sector.”
    http://healthydebate.ca/opinions/health-service-researchers-are-we-blind-to-our-own-conflicts-of-interest

Sorry, the comment form is closed at this time.