Why NIH tightening financial rules will do absolutely nothing about real COI
May 26, 2010
NIH has been touting their new and improved reporting rules which are intended to keep their grantee PIs on the straight and narrow. A news bit in Nature has the highlights.
The proposed rules state that a “significant financial interest” exists when the combined value of an investigator’s equity holdings in, and payments from, a publicly traded company exceed US$5,000 in any given year. Under current rules, the reporting threshold is $10,000.
Got it. Somewhere between $5,000 and $9,999 per year in consulting or stock cashout or dividends or whatnot we have a big group of PIs out there doing bad things for the money. And we’re going to fix that.
Before we move on, let us review the other highlights.
Any amount of equity in a privately held company would be considered a significant financial interest under the new rules.
Principal investigators and other key personnel on NIH-funded projects would be required to report to their institutions any significant financial interest that could touch on their “institutional responsibilities”. Although current NIH rules allow investigators to decide which interests need to be reported, the new rules would put the onus on institutions to determine whether investigators’ financial ties constitute a true conflict of interest.
Okay, I dealt with this before but it is worth repeating.
Just as a frame of reference for readers, BigPharma rates for academic consulting vary but something on the order of $100 / hr or $1,000 / day is a decent start. For an average investigator, early to mid career, who comes in to present some critical advice on an assay, evaluation of some data or present some of his or her own data and methodologies. You can tell from the kind of numbers being bandied about by the press coverage of the Grassley investigations that senior people who have long term relationships might pull in $2500 – $3500 for participating in a weekend symposium on some new product. This is just by providing a bit of framework for you to consider “how involved” an investigator might be at annual compensation rates of, e.g., $1,000, $5,000 or the current reporting limit of $10,000. Again for reference, the numbers being alleged in the scandals are more substantial, in the hundreds of thousands of dollars per year range.
So, right, it is true that people can have their principles swayed by any amount of money and there is a perception thing that it is wise to deal with. But I’m sorry. When I look at some run of the mill PI making anywhere from $80,000-$120,000 per year in salary, I am just not that worked up about whether s/he takes in $5,000 or $10,000 in consulting fees to BigPharma, some local biotech startup or whatnot. One of these guys that made it into the NYT during the Grassley investigations who is pulling down $3,500 every other weekend, seemingly, and is in the $200,000+ range for the year? That, my friends, is what raises my eyebrows. Note that this level of outside cashola is well over the previous requirement for institutions to manage the conflict and note further that those previous requirements failed spectacularly.
Changing the threshold does jack squat. The problem lies with enforcement. Oh yeah, I already said this too.
On the second point, heck yeah! It appears that the egregious cases that are hitting the news and blogs involve some failures to follow the established disclosure rules. So the problem lies with enforcement rather than with the limits or reporting rules. One would think, anyway.
Look this new change in the alleged institutional responsibility to “manage” conflict and for PIs to lower the notification threshold is not bad, exactly. No big deal- at least at my institution you have to fill out the damn form even if your answer is “Zero $$ in outside consulting, stock, no equity position, etc, etc Not-Bloody-Applicable” year in and year out.
My problem is that it is the NIH trying to look busy while doing little to address the situations where there is real actual conflict of interest. Those situations in which scientists are significantly motivated to take a particular stance on a scientific issue because it keeps the outside consulting dollars flowing. If we continue to merely slap the wrists of those that make pretty egregious COI cases, we are not going to make progress. We need to learn from the egregious cases how to focus our attention on the real problems.
Institutions are going to be responsible for managing conflict now? Uh-huh. These are the entities that turn a blind eye to BigCheez’s conflicts already so as to avoid having to pare back his or her NIH portfolio. And if the really egregious cases only occur once per institution, how on earth is a given University going to be held responsible. They will ALWAYS have the excuse of “single isolated incident, we didn’t realize, that guy was lying on his reporting and how could we know…” to rely upon.
And they bloody well know it.
C’mon NIH. Try again on this one.