Yeah, I’m still stuck on the things that lead up to the EMA U Turn, a house that PHARMA built like so many others. I tried sitting down this afternoon and pretending I’m an AbbVie executive, and then detached from that identification and looked at what I was worried about during my moments as a pretend PHARMA mogul. Neal Ryan was very clear about his company’s 
worry [see a deal-breaker?…] – that some "Pakistani" would figure out how they make Humira [a monoclonal antibody that attacks Tumor Necrosis Factor] and begin brewing up cheap batches in the Himalayas. The racism in that comment aside, the point is well taken [they’re pretty stingy with the formula for Coca Cola too]. That is a legitimate concern for a company, the true meaning of trade secrets.
The obvious other side of that argument is the PHARMA giants like GSK who hide behind that trade secret argument, using it to keep their Clinical Trial data secret because in the light of day, the blockbuster becomes a maybe not-so-safe weak sister or near inert. We have no dog in corporate wars to hold on to trade secrets, but our duty is to know about the clinical effects of medications. I don’t mind their keeping those manufacturing secrets to themselves, but we all mind their keeping true efficacy and adverse effects under wraps. In fact, in looking at the EMA changes, in their
Press Release, the EMA said:
In light of discussions at the Board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014. Importantly, the Agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation.
As you recall, it was requests to the EMA from competitors that got AbbVie in such a wad. I don’t think that this concern justifies their blocking us from checking their Clinical Trial data, but I can understand their point. All we are asking for is the specific data that addresses "does the medication work?" if so, "how well?" and "does it harm people?" That data has nothing to do with the secrets of making anti-tumor-necrosis-factor mono-clonal antibodies. In fact, I don’t even care about that. I doubt many clinicians do.
So the compromise is fairly clear. Give us the protocol, the data we want from the outcome variables, and the CRFs to look at the AEs, and keep the how-to-make-it secrets to yourself. If that could be done and could he trusted, it’s a compromise I could live with. But keeping everything secret just to preserve trade secrets won’t do. Too many companies have cheated too regularly and too destructively to even consider continuing to do that. Actually, it looks like the EMA gave them that point – "academic and non-commercial research users" [not competitors] – which is, in fact, the second part of their venerated Article 39 [3]:
3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
Give us the right protect the public and we’ll give you protected against unfair commercial use in return, which is a legitimate concern. What we want really has nothing to do with that. Thoughts?…
There is a little good news today: EMA has reversed its on-screen restrictions following researcher and citizen protest. Here is the link.
Keep on this Mickey! I am with Peter Doshi & Tom Jefferson: let’s hold the champagne. The right to print and download would be welcome, sure, but 1) let’s make sure it’s for real, and 2) all the other restrictions seem cemented in place. “Screen-only” was only the ugly icing on that ugly cake.
While I’m on a food theme … I also agree with your analysis of Pharma’s demand for protection of “trade secrets.” If a local restaurant has a famous potato salad, then OK, they can keep the recipe to themselves. But if dozens of people in our community are falling sick from this potato salad, we expect a public warning in the news media. AND a prompt public investigation. Depending on what they find, we expect the authorities to close the whole place down if that’s warranted.
Maybe we don’t have to know whether it was the mayo, or the dill, or Cousin Ronnie spitting in the pot. We do have to know what to do to protect ourselves! Call me crazy, but I expect no less from AbbVie.
Johanna,
Great potato salad analogy!
Fears about revealing formulations are a smokescreen, playing to the cheap seats who don’t know what clinical trials are. There never was anything in this proposal that would disclose formulation, the trade secrets guarded by pharma have to do with study design and outcomes.