Wednesday, September 26, 2007

Industry sponsorship of trials

It's nice for a change to see a balanced discussion of industry-sponsored clinical trials...
This article deliberates the pros and cons of industry sponsored research and the debate around conflict of interest vs . Coming from an industry background, it's nice not to be completely beat up for doing a job you hope will help people feel better in the future by helping bring new medicines to the market.

I've attended a few industry meetings of late where there have been a greater proportion sitting on the researcher side of the fence than the industry and I have come away feeling disappointed with the level of respect for the contribution of industry to research. Industry is always the bad guy - work with them so you get money to do the REAL research you want to do. After all, industry is only interested in making profits, so have plenty of cash to throw around, right?

I don't mind saying I get a little worn out by this attitude. Can you really tell me that doctors do what they do just for the love of it? Of course not... they too expect to be paid, as does anyone who works for a living, especially when they have spent so long developing their expertise in an area. Industry is no different in this respect, and they too need to appropriately manage their resources to ensure they are able to continue to deliver new treatments, continue to employ the thousands they employ and deliver a return to their shareholders.

Yes, industry makes profit. But who are they making the profit for?... the shareholders. Why do it for the shareholders? So they can continue to fund the development of more products. Only 1 in 10,000 compounds identified will ever make it to the clinic and it costs upwords of a billion dollars today, taking into account the discovery, development, manufacture, approval, distribution and marketing to bring that new drug to market. That's quite a burn rate. We've all seen when companies development pipelines are not strong what this does to the value of companies (their share price), or for those companies starting out, the impact had when a product in development does not meet expectations and has to be canned. This can end a new company. That's alot of pressure on anyone, and one might suggest this is reason to doubt the intentions and trial results delivered by industry. However, you can't tell me that in today's litigious environment companies are all about making drugs that are knowingly going to do bad things to people's health on purpose! Where is the sense in that argument?

Things do go wrong sometimes, as we've seen with a few drugs over the past few years. Partly this is because it just took thousands and millions of people to take the drugs in the 'real world' outside controlled clinical trial conditions and patient groups to see the effects sufficiently, over a longer period of time than is possible in the drug development process with a few thousand patients over 8-10 years. Industry, researchers and regulators are continually learning from these events, and try to ensure appropriate oversight to reduce the risk of such events in the future. Maybe I'm naive, but I can't think that industry would send these drugs out onto the market knowing the benefits wouldn't outway the risks.

Anyway, back to the original subject... It would seem researchers are happy to put their hand out for industry sponsorship of studies, but don't readily publicly acknowledge very often the role industry plays in helping them progress their own research objectives. Yes, industry compensates for the time and resources needed to conduct a study, and they try to be fair about this, although this is an ongoing process of negotiation. But industry also know that this compensation helps fund a considerable amount of non-industry research, which can apparently be performed at a fraction of the cost of industry sponsored research.

I had a bit of a debate with someone at the ICTS in Sydney this week over just this. They told me industry should pay them more money for the work they do, because their research unit struggles to survive. I then asked whether the reason they couldn't survive is because the balance of investigator initiated studies to sponsor studies was out of kilter? That did cause a moment's pause, but it didn't last very long, and it was back to industry should pay us more. Oh well...

The article above suggested "Collaboration between academia and industry should be encouraged, not attacked. " I heard the same catch-cry at the ICTS on Monday. However I think before we will ever get the public and media to take on a more balanced view of industry sponsored research, we need the researchers to publicly acknowledge industry is less 'the devil' and more 'equal partners' in the advancement of medical knowledge and treatment.

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