1 Boring Old Man

Time present and time past
Are both perhaps present in time future,
And time future contained in time past.
If all time is eternally present
All time is unredeemable.
What might have been is an abstraction
Remaining a perpetual possibility
Only in a world of speculation.
What might have been and what has been
Point to one end, which is always present…

The pharmaceutical industry as a whole is opposing unrestricted access to clinical trial data – with some citing concern for subject confidentiality, others claiming infringement on trade secrets [and their competitive edge]. And there’s a fault line developing among those fighting for Data Transparency. Some seem willing to compromise with industry’s concerns while others hold fast for complete access to the data from clinical trials. It’s hard not to personify this fault line. On one side, Ben Goldacre, Iain Chalmers, and the AllTrials movement are negotiating with GSK and the other pharmaceutical companies – aiming, it seems, at a treaty, temporizing on how transparent is transparent and who controls access. On the other side, David Healy leads joined by Peter Gøtzsche of the Nordic Cochrane Centre warning of the dangers of anything this side of full access to clinical trial data. I have enormous respect for the accomplishments and good sense of the proponents of both points of view, and I don’t really think there’s a vindictive Marcel Clemenceau [the Treaty of Versailles that crushed Germany] or a conciliatory Neville Chamberlain [the Munich Agreement that appeased Hitler] in the mix. Ben Goldacre, Iain Chalmers, David Healy, Peter Gøtzsche, AllTrials, RIAT, the Nordic Cochrane Centre are all heros of the realm to me – even when they disagree. But personified or not, there’s a long history of erroneous attempts at solving what seems the impossible dilemma when entrepreneurialism collides with rational health care and medical ethics, and the territory between scorched earth and sleeping with the enemy remains to be defined.

Footfalls echo in the memory
Down the passage which we did not take
Towards the door we never opened…

One message from history is clear. A dilemma is, by definition, an unsolvable problem, what Fiona Godlee called an irreducible conflict [a sticky wicket…].  Previous approaches have aimed at definitive solutions. Whatever happens this time should be informed by the naïveté of that approach. The goals of a commercial enterprise and those of health care are doomed to frequently remain at odds. So there is no final solution. It’s an ongoing conflict that needs to be under more or less constant observation – something like putting a criminal on parole with an attentive parole officer or auditing financial institutions. ClinicalTrials.gov wasn’t enforced. It wasn’t even monitored. So many ignored it, at least for results. Our history says that  no matter what we do, it has to include both the resources and the  mandate for oversight – indefinite, ongoing oversight. No more honor system and grand rhetoric. There’s just not enough honor in the marketplace to get the job done. The reason that Data Transparency is so important is that it’s the only tool that guarantees that oversight of clinical trials can occur, but transparency is immaterial if nobody’s looking.

The enabling of corporate malfeasance by highly visible KOLs is another dark chapter in this story. Where are the professional and academic societies when we need them to speak publicly about this stain?

The pharmaceutical industry itself is a relative newcomer to our commercial enterprises, emerging from the early makers of patent medicines and home remedies. We now inspect their facilities, assay their products for quality, and if they don’t live up the our codes, we shut them down. We see manufacturing pharmaceuticals as a privilege, not a right. If their plants are dirty, we close them. Hiding behind closed doors is verboten. How is distorting or withholding clinical trials any less essential than the quality of their their manufacturing processes? It isn’t, and it begs for the same scrutiny and the consequences needed to match the infractions.

But there’s a glaring omission in this history we all already know. Companies don’t commit fraud – people do. It’s part of that "cost of doing business" argument that’s so regularly mentioned that it’s become a figure of speech. This is the door we haven’t opened that can’t continue to stay closed. We don’t have a surrogate legal system. We don’t fine the Mafia or drug cartels, we punish their criminals. We don’t impound the cars in vehicular homicides, we indict the drivers. And there’s plenty of out-right crime accompanying the distortions in clinical trial reporting, libraries filled with incriminating subpoenaed documents, but no punishment of the perpetrators on the books. The only pertinent question here is why hasn’t it happened?