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Clinical Trials

More Behind-the-Scenes Maneuvering. How Wonderful.

This is exactly the kind of headline the drug industry does not need. Via FierceBiotech, here’s a story in The Guardian on the recent efforts to get companies to disclose more about the clinical trial results for investigational drugs. GSK is the company that seems to have done the most in this regard, but the European Medicines Agency (EMA) is proposing mandatory disclosure of trial results into a public database. That’s a lot further than most companies are willing to go – so what to do?

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.

That’s what. Other parts of the strategy include “discussions with scientific associations” about the risks of data sharing and getting other companies in other industries that might be affected by similar proposals to lobby against this as well. None of this is to be done, it seems, under the banner of “Here’s why the drug industry opposes this idea”. It’s all a spontaneous upwelling.
Now, I don’t want to seem too shocked: this sort of thing is done all the time in politics. Every time some big regulatory or legislative idea comes along that might cramp some large group’s style, you’ll see all kinds of organizations pop up with serious-sounding names: “Public Coalition For XYZ” “United Citizens For QRS” and so on. Use of these “instant grassroots” fronts has earned the term “astroturfing” (which also means that any time some actual group of people comes together for real, their political opponents will always accuse them of being an astroturfed gang of shills).
Some of the patient advocacy groups the Guardian talks about are probably in this category. But many of them are real organizations that have been around for some time. There’s an evolutionary dance going on, though: while the advocacy groups want to get enough influence with the drug companies to steer their decisions, the drug companies want to get enough influence with the advocacy groups to steer theirs, for just the reasons we’re seeing now. And in that second half of the process, the pharma industry has a powerful offer to make: we’ll fund you. At that point, every advocacy group (in any industry) has some big decisions to make about what they’re trying to do and how best to do it. Will taking the money compromise them? Or will that be outweighed by what they can do with the funding?
But just because this is a common practice doesn’t mean that it’s right. Or a good idea. Or, at the very least, the sort of thing that the industry should be seen to be doing. Secret memos detailing a behind-the-scenes campaign of influence to avoid disclosing data? The people at PhRMA and EFPIA should apply a simple test to ideas like this: if it sounds like a bad movie plot, if it sounds like something made up by people who hate you. . .maybe it’s not such a good plan.
Update: here’s more on an effort to pull out unpublished clinical trial data. “Publish or be published” is their motto. The editors of the British Medical Journal and PLoS Medicine have endorsed the idea.

12 comments on “More Behind-the-Scenes Maneuvering. How Wonderful.”

  1. johnnyboy says:

    – cue in more Ben Goldacre histrionics about how Big Pharma is killing people…

  2. Anon says:

    I thought the FDA/EMA was supposed to look at the drugs and evaluate them since the public is not able to. It makes more sense for them to up the black labels than to generic spill raw data onto the public.

  3. qetzal says:

    The people at PhRMA and EFPIA should apply a simple test to ideas like this: if it sounds like a bad movie plot, if it sounds like something made up by people who hate you. . .maybe it’s not such a good plan.

    Or more simply, ask “How will it look when (not if) this memo shows up in The Guardian?”

  4. Dr K. says:

    This is a difficult one. On one hand, more transparency is always a good thing. But on the other hand, wider access to raw data does not necessarily mean more transparency. Politicians are very good at manipulating statistics to fit their own agenda, and the general public is generally clueless about statistics altogether.
    What is required, is full access of statistically trained regulators that put patient safety first. But isn’t that what we have already?

  5. Hap says:

    No, but there are a lot of trained scientists who could other than at FDA. It might help if people could understand why trials failed, and analyzing them en masse might be a good way (and isn’t within FDA’s bailiwick, I don’t think). Waiting for the data to be voluntarily released hasn’t helped make that possible.
    I think the problem is that if pharma doesn’t like the idea, there isn’t much it can do that won’t make it look bad. Direct attack might work, but would probably be derided for the source of the money that makes it possible. Behind the governmental scenes is standard (health care/Obamacare, for example) but looks slimy (because it is) if you agree and looks even worse if you don’t. Astroturfing and various other ways of getting spontaneous-appearing opposition is dishonest and worthy of disrespect, but probably not more than the earlier options. Of course, the best way would be to honestly explain why this might not be good, but that requires people to believe you, to be willing to listen, to have enough logical skills to verify it for themselves, and to actually care about the arguments. Based on the people we keep choosing for office (not the ones I choose, of course), you would be better off buying lottery tickets.
    The biggest issue, I think, is that having a bad reputation makes everything that you do look bad. I’m guessing the DTC marketeers and upper management didn’t estimate how much their companies’ reputations were worth, and now their successors (and their employees) get to find out.

  6. MattC says:

    jonnyboy – would you be happy with the statement “Pharmaceutical companies have a significant bias towards not releasing trials that show their drugs perform worse than already existing standards, and that in the case that those drugs are targeted towards life-threatening illnesses, they are likely to produce worse outcomes i.e. increased mortality.’

  7. Bernard Munos says:

    When I joined Lilly in the 1980s, new employees were sternly told “we do not want to do anything that will get us on the front page of the newspaper, even if it is legal!”. This was a clear principle all employees could use to guide their behavior. Over the years, much of the industry (including Lilly) has walked away from such principles, and replaced them with hundreds of mind-numbing standard operating procedures that few employees really care about. In the process, the industry has lost its soul. Not a shining example of leadership. I should commend in passing GSK and Roche for their contrarian and courageous stance on data sharing and transparency. It is a shame that, in GSK’s case, this overshadowed by the mess in China.

  8. NoDrugsNoJobs says:

    I think some companies legally filed directly to prevent the release of confidential data as a matter of its right to protect trade secrets under the contract of understanding they had with the regulators when they filed for approval. While the companys acknowledged the importance of available safety and clinical information, there is a hell of a lot more that goes into these regulatory filings than simply clinical patient data. Its insane that a governemnt agency would decide unilaterally to release confidential information without working carefully to make sure that trade secret and commercially important data are not protected. Right now, the EMA is saying trust us, we will separate what is commercially sensitive and trade secret property from everything else. This is not nearly as easy as it sounds because much of what is even in clinical data can be IP-protected as long as it remains confidential. This really needs to be worked out between all the parties and not a unilateral agency decision because much damage and legal fall out is guaranteed to occur.

  9. Carlos Danger says:

    Pharma in the age of Wikileaks. There is hope.
    P.S., To Bernard @7. Please recall that the Lilly principle of which you speak also extended to their position on the development of AIDS drugs. Queers and junkies were too controversial.

  10. pgwu says:

    Even data are available, some people twist interpretations. The Statistics in Medicine online course currently offered by Stanford University has a case study of Vioxx paper where the heart attach data were presented. The data were there in plain sight but the authors discussed them in a way that hide the negatives. So many MDs on the author list, so little truth. Of course, ghost-writers are to blame.

  11. Sili says:

    Politicians are very good at manipulating statistics to fit their own agenda, and the general public is generally clueless about statistics altogether.
    What is required, is full access of statistically trained regulators that put patient safety first. But isn’t that what we have already?

    So putting in high muckety-muck gatekeepers is your first idea?
    How about keeping our politicos to a higher standard and educate the public on matters statistical and scientific? As the “histrionic” Ben Goldacre does his best to.

  12. johnnyboy says:

    @6: That certainly would be a way to phrase the issue that would be more measured than Goldacre’s current writings.

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