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.

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6 Responses to “Why NIH tightening financial rules will do absolutely nothing about real COI”

  1. becca Says:

    I think the social science research is pretty clear that there is no size too small to influence decision making. Personally, I wanna know if my doctor gets a free golf umbrella with a certain drug name on it. The amount of the gift does not necessarily matter when it comes to introducing bias, therefore I don’t see any reason we should only keep track of some exchanges. In that sense, a $5,000 cutoff is better than a $10,000 cutoff.
    Nonetheless, you are correct that the critical part is not the threshold set, but how it is enforced. It seems these regulations *do* change that, but after reading your post and the Nature bit, I’m still not clear on exactly what carrots or sticks NIH is applying to the institutions. Or even what method *could* work.


  2. lowly grad student Says:

    Maybe the larger issue is that PIs who bring in large sums in grant money are untouchable for any offense. Conflict of interest is not the most common or consistently harmful behavior to which a blind eye is turned. Perhaps, NIH should be thinking about the structure of institutions in which *anyone* is untouchable. Insistence on civil and ethical behavior independent of all other factors is not beyond the realm of imagination.


  3. Alex Says:

    While Big And Obviously Wrong Ethical Violations most certainly do need to be addressed, I think that these situations are of only limited relevance for the teacher, scientist, group leader, and mentor in the field and encountering all sorts of little dilemmas, little compromises, little issues, and little shortcuts on a daily basis. These things shape the assumptions of the larger cohort of scientists in training, and they impact the validity of science published on a daily basis. However, we don’t get called into training sessions because of them, and rules are rewritten because of them. Rules are rewritten and training sessions are held because of the big things.
    So, telling me that I shouldn’t write papers on the benefits of something made by a company paying me Gigabucks (at least without disclosing it) is of marginal relevance to whether I should accept payment for reviewing a textbook.
    Telling me that I shouldn’t sleep with my students is of little relevance in figuring out whether the staff member was less helpful than usual because the help request came from my female student and he has issues with that, or because the help request came when his office is at a critical crunch time and has just lost staff.
    Telling me to report a student who might shoot up the school (obvious!) is of little relevance in dealing with the much, much, much more common case of students who are stressed at finals and need to find a way to decompress.


  4. Pascale Says:

    This discussion sort of reminds me of lowering the DUI limit to 0.08. You can arrest a lot more people for DUI so it looks like you have accomplished something, but the most problematic ones were driving with levels well above the old 0.10 limit because of tolerance from chronic alcohol use. Revoke a license? Please- like they will respect that law (or insurance requirements or anything else) anymore than the DUI law?
    Free pens, sticky notes, and flash drives MUST influence prescribing behavior, or the drug companies would not hand them out like tap water; however, lowering the threshhold to this level would make us all guilty (and I am NOT giving my Levitra pen that you push a button on and the top half “rises” for writing). We need to figure out how to deal with the bigger influences. Writing a script for Vioxx because they had an aggressive advertising campaign (when cheaper alternatives were available) is a minor offense; “massaging” data to mask a safety concern is clearly the bigger deal and something that can’t be bought for a bit of swag.
    My husband was approached by a drug company to be on their speaker board. He would go out several times a year and give a talk that included slides they had provided. It felt skanky to him, and he asked me what I thought. I asked how much of a consulting fee he got.
    “$5,000 per year.”
    “No way. If you are going to prostitute yourself, you need a hell of a lot more than that. What is your spotless reputation worth?”
    Personally, I believe that any monetary relationship with a company or corporation should be reported. Of course, no one has asked me to be on their advisory boards (and I suspect they never will).


  5. becca Says:

    If people didn’t write scripts for Vioxx because of their advertising campaign, Merck wouldn’t have such incredible incentive to produce shiny product rather than sound science.
    The older I get, the more I agree with my dad on this one- all drug company advertising should be illegal. Yes, even your pen. You’ll live.
    All of which is not to say that ‘massaging’ away safety issues isn’t worse. It’s kind of the difference between holding somebody down for a mugging vs. murdering them.


  6. Alex Says:

    While it is true that they wouldn’t do advertising if it didn’t work at all, before we attribute too much competence and omniscience to the drug company marketing departments let us remember the famous quote by some business executive (I wish I could remember the name:
    “I know that half of my advertising budget is wasted. The problem is that I don’t know which half.”
    It may very well be that the pen actually doesn’t work. However, the user is not really equipped to judged his or her own subconscious biases (almost by definition) and the company can’t get the fine-grained detail to figure out which advertising tools are working. However, they do know that the more they spend in general the better their results are overall.


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