Mehmet Arabaci

The importance of research

Research is the cornerstone of science. It is the way we develop new ideas, new treatments, test new theories and it’s the way that technology gets better. In the field of medicine, research is ultimately how healthcare improves. Perhaps in 100 years from now we’ll look back at the medicines of our time and think, how archaic, much like the way we think of doctors using leeches or lobotomy. Perhaps it won’t be that dramatic, but I can envision a not-so-distant future in which we look back at our systemic, non-specific oncologic immunosuppressive agents and gasp at the rudimentary approach.

Trends in research costs over time

Due to a variety of reasons, including tighter regulations, the cost of research in recent times has increased dramatically. The cost of developing a new treatment today is estimated to be five times more than it was only 20 years ago. [1]

In Europe, the data suggests that investment into research has grown over the past decade, and across multiple industries too.[1] However, with that increased spending we haven’t seen a significant jump in therapies being developed. What’s going on?

As with most things in science, a single metric cannot tell the entire story. Spending cannot be used as a sole metric for the quantity of research being done because, for one, costs will naturally increase over time due to inflation. In fact, research costs have exploded in the past five years, on average by 47% across all industries. Therefore, as inflation has been nowhere near 47% over that same time span, Inflation alone cannot explain the rise in cost.

Wage costs are said to be the most important element of R&D cost, accounting for 50% of all costs in private companies and 62% of the costs in public research organisations[1]. Yet over the past 10 years, wages have stagnated in the UK [2]. In contrast, the number of people involved in research, the volume of people, has increased.

The increased volume of people involved in research means one of two things. Either A, we are more wasteful and inefficient than ever. Or B, more people are needed due to an increased complexity in delivering clinical trials and conducting research.

The rise of contract research organisations (CRO’s) perhaps bests highlights how conducting research now requires more specialist knowledge. Navigating the regulatory landscape is more complex than ever, and perhaps approving therapies is taking longer and longer as a result of it.

There are of course other possible reasons that could contribute to rising research costs, such as the complexity of modern treatments. We’ve gone beyond simple compounds and are in the realm of advanced therapies. We’re now able to genetically engineer human cells, viruses and create treatments that go beyond what people 50 years ago would have thought to be possible

The problem with rising research costs

 One of the biggest problems with rising costs is we limit the amount of research that gets done because price becomes a barrier. High research costs stifle innovation to the point that only the biggest companies can afford to run them, and that limits the type of research being done. Research has become highly commercialised and studies that don’t lead to something that can’t be protected by a patent, are less likely to be funded. After all why spend all the money when your competitors can piggyback off your investment? Only the most commercially viable therapies get funded. This isn’t an evil pharma company conspiracy, it’s just good business sense.

That’s not to say that smaller academic studies aren’t being pursued, because they are, often funded by academic institutions and government grants. However, to take any finding from those trials to the next level, a bigger wallet is needed which involves partnering with a pharma or biotech company. Generally speaking, the number of academic research papers has increased over time, as has spending on R&D, but this investment has not been accompanied by an increase in therapies making it through to licensing[3].

Trials cost a lot of money and it is not uncommon for per-participant fees to be in excess of £50,000, and to statistically power a trial you’ll need more than a single participant. Big pharma has the money to pay for them, but they’re not going to want to spend it on something which isn’t potentially going to make money down the road. Ultimately they’re pushing products through to get them licenced and to sell them for a profit.

It would be easy to assume that funding must be the main challenge for the drug industry (and to an extent it is). However, that is not necessarily the whole story, as drug discovery is often slow even when funding is abundant[3]. Couple that with an increase in development failures and you’ll find that even big pharma need to be more selective with where they invest their money.

Nutrition, epigenetics and the commercialisation of health

In recent years we’ve started to realise that what we thought was true is more complicated than we anticipated. Nutrition and the food we eat can affect the expression of our genes and therefore a calorie is not equal to a calorie. The simple nutritional model of protein, carbohydrates and fats needs to evolve with the most recent data.

As an example, we have data that shows us that a calorie of pea protein is not equal to a calorie of protein from meat. They have different amino acid profiles and bioavailability’s, and as mentioned earlier, each affects the expression of our genes differently.

 Genes that we previously dubbed ‘junk DNA’ isn’t junk after all. That’s the thing with science, the more you research the more you know and that can break old, perhaps accepted paradigms. And perhaps one paradigm we need to move away from is the idea that drugs, or artificially produced medicines are the only solution for our health ailment.

 Perhaps driven by the success of antibiotics in the control of infectious diseases, the status quo for treating any ailment has become a prescription. Of course from a commercialisation point of view, this is the ideal narrative; take this pill once a day and your problem goes away. Feeling down, theirs a pill that. Having trouble below the belt, there’s a pill for that too.

In recent years studies have emerged that have demonstrated the benefits of ketogenic dieting for diabetics. We’ve also seen that ketogenic dieting and fasting can have an impact on our hormones and autoimmune conditions. But who’s going to fund those trials? Where’s the patentable intellectual property?

That’s a real shame because we may be missing out on a tonne of really good information that perhaps is being done in academia on a small scale, but requires more investment to run larger trials with greater statistical power. Without the statistical power and solid evidence, it’s difficult to ask our healthcare professionals to recommend those routes, not when pharma has such compelling evidence for their solution.

References:

1. Analysis of the evolution of the costs of research – trends, drivers and impacts. ETEPS Report. European techno-economic policy support network AIT Austrian Institute of Technology; 2011. Available from: https://www.researchgate.net/publication/273203269_Analysis_of_the_evolution_of_the_costs_of_research_-_trends_drivers_and_impacts
2. Office for National Statistics. Gross Domestic Product (GDP): Quarterly National Accounts. [Internet]. [cited 2023 Nov 11]. Available from: https://www.ons.gov.uk/economy/grossdomesticproductgdp/timeseries/kgq2/qna
3. University of Cambridge. Novel Clinical Trial Design in Translational Medicine. [Internet]. [cited 2023 Nov 11]. Available from:
   https://advanceonline.cam.ac.uk/courses/novel-clinical-trial-design-in-translational-medicine