Monday, September 16, 2013

Science vs. Trade Secrets: Can Pharma Tell the Difference?

Dr. Roy Poses at Health Care Renewal first called this matter to my attention, but Dr. Poses in turn cites two posts from the “1 Boring Old Man” site, so I’ll link there straightaway:

Background: The European Medicine Agency decided some time ago that it was high time that the detailed information on the research studies performed by drug companies to justify the market approval of their products be made public, and no longer treated as the companies’ proprietary information. An American firm, AbbVie, which spun off recent from Abbott Labs, has filed suit to stop this, and has won a preliminary ruling from a European court to block the release of information.

In his first post, “1 Boring Old Man” embedded a 1-hour video of a meeting held in Brussels with both industry representatives and European regulators in attendance, at which one of the panelists was Neal Parker, an attorney for AbbVie. The blog proceeded to talk about the way several regulators jumped on Parker for his failure to understand that he was talking about drug safety and ultimately, people’s lives—and directs the viewer who doesn’t have a full hour to spare to the part of the video where the “fireworks” occur. I watched the fireworks but then reeled back a ways to try to get a sense of Parker’s full presentation.

The lawyer for AbbVie had basically this to say about the idea that regulators should be transparent with the public about Pharma-conducted scientific studies:

  • Drug companies serve an important public health interest in discovering useful new drugs.
  • Both “extreme” positions—that you disclose nothing and that you disclose everything—are bad; a “balanced” position is good.
  • Drug companies already release a ton of information about their scientific research. The question is how to approach what is now “left over” and not currently disclosed.
  • Each company is the proper decision maker as to what to do with its own “left over” information.
  • AbbVie agrees that some of this left-over information can have public health value and move science forward. But (to have “balance”) there has to be reasonable controls preventing the release of this information to other companies, who would enjoy a “tremendous competitive advantage” if they had access to it.
  • One can roughly divide information into two stacks—there’s the “objective” scientific information which is routinely released openly; but then there s the “subjective” or “tactical” information about how the company solves problems related to the research, how it chooses to take the information forward to the regulators, etc. It is the latter that ought to be protected as confidential and as giving other companies unfair advantages if released to them.

“1 Boring Old Man” draws two conclusions from this presentation and the ensuing Q&A:

  • What companies like AbbVie most want to hide is how much they are doing drug promotion under the guise of scientific research
  • People who talk like this simply cannot be trusted to negotiate in good faith; all they care about is competitive advantage, and if screwing the public provides competitive advantage, so be it

There is a third lesson highlighted by a BMJ News account from which the blog draws some of its information—the drug firms themselves are divided over this issue with other firms not wanting to go as far as AbbVie. Other firms seem to have decided that with public trust in them now down in the toilet, the only “competitive advantage” they might enjoy is tied to coming clean.

So what do I make of all this? Well, I agree at least in part with our fellow blogger, but I would add a further lesson.

First, I agree that when a guy starts a discussion by announcing that if I disagree with the position that his company takes, then I am opposed to both the public health and to “balance,” I would want to grab for my wallet and head for the door. That guy is just way too slippery for me to spend time with. So yes, whether such people could ever negotiate in good faith is a serious question.

But there is another issue here as well. I want to give Neal Parker just a little more credit than others apparently were. For all his slipperiness, he had decided that there were a couple of things at stake—preserving the public health and advancing science on the one hand; preserving his company’s competitive advantage on the other. In his own head he thought he had a formula for “balancing” these two goals. But what I think he proved is that the people in the audience who reacted with shocked disbelief to some of what he said, and Parker himself, were bound to misunderstand each other because they were speaking different languages. If you spoke Parker-ese, or Pharma-ese, then everything he said was perfectly logical and indeed irrefutable. Which shows to me one more reason why we must find a way to detach the scientific research enterprise from Pharma funding (as I argued in HOOKED). There is no way we can square the true goals of science and the public health with the clearly commercial agenda of the drug industry.

1 comment:

Michael S. Altus, PhD, ELS said...

Re: "There is no way we can square the true goals of science and the public health with the clearly commercial agenda of the drug industry."

The Big Pharma Credo: First do no harm--to profits.