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.

Thursday, September 20, 2007

Pig cells in Humans

Just because we can, should we?

This is an interesting news article published today on a trial using pig cells to produce insulin in humans.

I imagine that the ethics committee in Russia must have had plenty to discuss when this proposal came across their desks, assuming the study underwent the same rigorous review procedure we would expect under international Good Clinical Practice guidelines. If it works, the potential benefit to diabetic patients would be enormous. However, I'm not sure how comfortable I am personally with living animal cells being transplanted into humans. I suppose in theory it is no different to taking in probiotic bacteria to boost our gut flora, another living non-human organism inside us.

I wish Living Cell the best of luck in developing this technology, and ensuring the research undergoes rigorous ethical and scientific review and debate throughout the entire clinical development process. It's never easy pushing the boundaries of medicine and public opinion.

ABC New Inventors Program 19sep07 - EzyVein by Dr Dane Horsfall

Did anyone happen to see the ABC (Australia) New Inventors Program last night?

There was quite a neat little device, the EzyVein, invented by Dr Dane Horsfall, for improving the success of cannulising veins in difficult patients. Here's a link for anyone interested...

I was pleased to see the panel refer to the process of clinical trialling for establishing appropriate design, efficacy and safety of the device. Discussions like this in open forums help remind the public that there is a process by which new medical devices and treatments come to the market, which involve testing on humans, ie clinical research. That process involves designing research studies with scientific merit, review of those studies by human research ethics committees before they are started (if there is deemed to be anything more than low risk involved in the project), then appropriate conduct, analysis and publication of the research.

We wouldn't have progress in medicine without a process for scientific discovery and translation of those ideas into clinical practice. Understanding that process is important for ensuring continued participation in research at all levels, whether as a research, research participant, or sponsor of research, or as final end user of the outcome of the research. After all, would the EzyVein have become anything more than an idea in Dr Horsfall's head if there wasn't someone willing to let him test the idea on them?

An example of the need for clinical research

I came across an interesting blog today ( by someone affected by DMD (Duchene Muscular Dystrophy). To summarise, it reflected on the process of an eye exam and the desire that going to a doctor to find the right treatment for a medical condition was as easy. It made a couple of interesting points:

"Clinical trials are not synonymous with treatment; rather clinical trials provide the vehicle for us to understand IF a certain strategy provides benefit and characterize exactly what ‘benefit’ means. "

I agree with the latter statement in that clinical trials help us understand the efficacy, safety and potential benefits against risk of a particular treatment. I think perhaps the first half of the statement is a little limiting however. There is not a treatment that is approved that has not undergone clinical trialling, so by default, clinical trials are synonomous with treatment. What we perhaps need to be reminded of is that not every treatment assessed by clinical trials will result in an approved treatment. This can be for many reasons. But it is important that this research is conducted in order to establish what works and what doesn't, and for that to happen, there needs to be willing participants.

I think the blogger summed up the problem very nicely with this: "I wish it was as simple as an eye exam – invest money in a strategy and you get an answer. The real fact is that the only way to accelerate the development of treatments is to invest in a comprehensive plan to accelerate research, develop a system to identify patients, collect specific data, organize clinical trials in the context of an international clinical trial network and pursue an aggressive legislative agenda to insure successful treatments can be delivered to all individuals and accessed over a lifetime."

Hear, hear!

Tuesday, September 18, 2007

Joining the 21st Century Community of Bloggers

I've done it... I've created a blog.

For someone who is not technologically savvy, this has been a big hurdle for me to overcome. I'm a generation X-er, so not that old, but all the new ways to communicate and connect are proving a challenge to get my head around. Thank goodness for Small Business September, and a great seminar I attended yesterday with Laurel Papworth and the Women in Business Network, for getting me over the nerves of trying this. It took 3 different seminars for me to feel comfortable enough to try, but here I am.

So where to now? I'm passionate about clinical research. As a trained scientist who has worked in academia, biotech, pharma and CRO-land, I've had a great learning journey about medical and clinical research, it's challenges and joys.

Not everyone knows the ins-and-outs of clinical research, how it is done and how that research is translated into the treatments that we all expect each time we go to the doctor. I hope that sharing just a little of that knowledge will encourage people to get involved and contribute to clinical research in whatever way they are able, as sponsors, participants, reviewers, researchers, professionals, etc. That way we can all be sure of ongoing medical discoveries being translated into positive benefits for our health for the future.

What's your clinical research story?