In that video [a deal-breaker?…
], Neal Parker of AbbVie, tells us that there are secrets in the Pharmaceutical Companies negotiations with regulators that might help the evil-doers in Bangladesh do a bio-equivalency study, clone his company’s product, and steal their business right out from under them. It might even be important to keep Adverse Effects secret from competitors for that reason. It wasn’t the best choice of examples for him to use, but that aside, let’s assume for the moment that outside the clumsiness and awkwardness of his presentation style, he has a point. Since I personally don’t think of Clinical Trials as research, it’s difficult for me to even understand what the things he’s referring to might be. Clinical Trials address two things – Efficacy as measured by some objective parameter, and Adverse Events, negative consequences of the drug’s use. But in the spirit of fair play, I’ll forgo those thoughts for the moment and proceed as if he’s referring to some unusual circumstance where the bad meanies could gain something of value from full access to the results of a Clinical Trial.
Is that a reason to keep the actual data for all Clinical Trials secret, proprietary, locked up in their vault or the vaults of the FDA or the EMA? Of course it isn’t. That’s like the 5th grade joke: A man stands on a corner in Birmingham clapping his hands. When asked why, he says, "To keep away the elephants." The inquirer says "There haven’t been any elephants here since the Ice Age!" to which he replies, "See, it works! Doesn’t it?" So even if Mr. Neal Parker has a real point that there are unusual circumstances where the information submitted to the FDA or EMA really might compromise his company’s product, that’s an exceptional situation – nowhere near the norm and certainly nowhere near a valid reason to hide the outcome data for all Clinical Trials. It looks to me like it’s a situation that calls for the 1boringoldman compromise.
The elements of the 1boringoldman compromise are as follows:
- The Pharmaceutical Company submits a request for some specific aspect of the trial they think they should be allowed to keep secret with a full rationale for their request, examples if necessary.
An independent panel then evaluates their request and passes judgement based on the 1boringoldman compromise guidelines for such matters [no vague hypotheticals].
The company then submits their drug, bound by that decision – a decision that becomes part of the public record.
All other data from that Clinical Trial is fair game for the 1boringoldman compromise version of data transparency [which is that everything from the trial should be public and readily accessible].
Except for the name, I’m dead serious. Why should I have to prove to them that I deserve access to the raw data from a Clinical Trial used to approve a drug that I’m recommending to a patient? That’s totally backwards. The onus should be on them to prove that they have a genuine reason not to let me and my patients see it [and there aren't many of those]. That’s my final offer…