For a brief time as a youngster, I took gymnastics quite seriously. Serious enough to be able to pull off a range of contortions and tricks and even know the actual names of them in the days before Roy and HG. Back then I thought that all the really tough balancing acts involved an apparatus. It was only some time after a request to give up my Sundays had terminated my acrobatic interests that I figured out there are far more challenging balancing acts.
Big Industries and Research Bucks
In an environment where research funds generally are hard to find, navigating the relationship with companies that sell stuff is tricky. As I’m from a medical background my instinct is to run a mile from any rep selling as much as nostril tweezers. This is because I know there’s been a long term problem with companies, particularly the ones that make various colours of pill, unduly influencing medicos with flattery and gifts. This has finally led to widespread campaigns to stop the perpetual Kris Kringle act from companies and some responses to curb unethical conduct.
I also know doctors are well trained to spot the tiniest speck of dust in someone’s eye but correspondingly terrible at noticing timber plantations wedged deep beyond their own iris. It’s described nicely in relation to advertising influence in this review – ‘Other people must be – otherwise advertisers wouldn’t bother – but I’m not’. Bizarrely, doctors seem to struggle with the idea that we’re all pretty much suckers.
In clinical research land, doctors do tend to downgrade the quality of industry-linked research. There has also been recent investigations regarding conflicts of interest that have raised the profile of what is a serious problem (although in the most prominent recent case the NEJM suggested there was more smoke than fire at their end, even if the involved company settled for $40 million).
So for the researcher the answer should be simple – when you see a company rep offering a sweet deal, pull out your handy cross and string of garlic cloves and back away, right?
The Case for Big Business
The problem with a “destroy all industry approaches” setting on your phaser is that research can’t happen without those companies being part of the picture. In Australia in particular, development of good basic ideas (research) into things that make a difference (development) is a major stumbling block (or as so well phrased here by Bill Ferris who served on the McKeon review, “Australia has internationally competitive ‘R’ and bugger all ‘D'”).
The McKeon review spent some time examining this issue and specifically pointed out the need to improve on commercialisation of research (and the delivery of research findings back into patient care). Looking at the report now (and here’s the summary version, where you may want to head to page 41) is like glimpsing a blurry alternate reality that will never come to pass (insert your own movie reference here). There is no evidence to support the idea that these recommendations will actually become policy, but the message that researchers need to engage more with industry isn’t going away.
How to strike a balance?
For this PhD project, we were confronted with this problem quite acutely. We’re trying to conduct research with a commercially available monitoring technology, Near Infrared Spectroscopy. We’re not just testing whether its useful with patients with injuries (particularly head injuries) we’re testing whether it can be used in patients with those injuries in the rough and tumble world outside the hospital. Which means trying to figure out which monitor actually fits our purpose most accurately.
To do this requires a bit of vetting of what’s being sold in the shops. Which means lots of dealing with companies and reps. We can’t feasibly do the research without a monitor, but we also need to be able to produce credible research.
So how did we do it?
A Non-Exhaustive List of Ways to Do Research with Companies
1. Check the Facts
Companies are in the business of selling stuff. They tend to present things in a way that will be best for them. That’s their job. Complaining about it is a bit like complaining that large, hairy spiders are too good at being large and hairy. It’s the job of the clinicians and researcher to check their work. Examples? The easiest one with NIRS oximetry is that companies tend to let you get away with certain inferences and assumptions.
Most of the companies making these things on the market have applied the principles in a slightly different way to produce a number on a scale that looks about equivalent. They don’t stress that there are always a few assumptions in generating the magic number. They will tell you that their technique is better. They don’t tend to point out that it’s hard to transfer every study done in NIRS to their individual monitor seeing as they use a different technique.
All the usual ploys are at play. The team that make this monitor have references to reductions in strokes using the technology without really specifying it’s from a study using another device or in which patients. The guys making this monitor probably rely on the fact you’ll never actually check their validation data which is performed against an older generation monitor with not many samples.
That’s just them doing their job. It’s the job of the research team to really check out what stacks up and understand the limitations.
2. Avoid the money
Companies know money makes research happen and are likely to offer to provide support. Pretty enticing when you’re trying to figure out how to make the dollars add up. Also a little self-defeating as anything produced in the early stages is likely to be tainted. So paying for what you get like an everyday purchase is one way to approach this and that’s what we did. It’s a decision that will cost lots of money now but the value of it will come in later.
3. Get things in writing
We paid for a version of the monitor that conceals the monitoring values at the time the monitor is on (as we know that clinicians wouldn’t be able to resist trying to look at the number and changing their care). In paying for this, we did provide guarantees that we wouldn’t try to figure out any underlying intellectual property belonging to the company. In return, we have a signed guarantee that the company will not have access to any trial data. We’ve also specified that the company cannot seek to limit publication of anything related to the study (and we specifically covered publishing unfavourable results). Once a company owns the data, objectivity can’t be assumed.
4. Disclose everything
Lack of transparency only goes one way – badly. Declare every possible relationship. Disclose that one time you smelt the smell of ink from a drug company pen. Just disclose. The last thing you want to look like if you have nothing to hide is the researcher hiding something.
5. Think about the later stages
At some point, we will have to think about engaging with some company. Our end goal (assuming we show there is a potential clinical role for the monitoring) is to have a monitor that displays useful information so clinicians can provide better patient care. Eventually that will require people who build monitors. How to plan for that is already part of our thinking.
That last one needs more thought. Nor is this list an answer for every situation or a suggestion that all research emerging from companies must automatically be mistrusted. It should be examined closely though. And for the individual researcher, the trip should be way less bumpy if the balance is right.
PS: Here’s the disclosure
We purchased a version of the Nonin EQUANOX monitor that conceals the monitor values. We paid full price for the monitor, cables required, the computers we use for the processing and every disposable sensor that gets attached to the patient. We have an agreement that we can publish anything we find, including results the technology doesn’t work in this setting and isn’t helpful, and the company will not seek to influence that in any way. The agreement covers the possibility that new intellectual property will be generated, and that intellectual property will belong to those independently assessed as having generated that new bit of stuff. We have not, and will not, accept any funding for conferences, education or presentation from the company that makes that monitor. We have no commercial agreements with that company.