Drug Discovery – Is innovation sustainable?

The pharmaceutical industry is often regarded as an industry filled with unaccountable large corporations whose sole purpose is making money. What drives this perception? Why is there a level of distrust towards these companies and can this attitude change? How do drugs get from the lab to the shelves of the pharmacy? Why are drugs so expensive? Are drug prices sustainable? (1)

It seems that the general public does not connect with the drug discovery process until a bill for medication needs to be paid. However, in the current political climate, informed individuals need to understand, at least in principle, an industry that is at the centre of debate in the UK as decisions that they will make as voters and consumers will impact the medical landscape in the UK for generations to come. It is now more important than ever to understand the drug development process.

Every drug starts with an idea. These ideas can have very different origins, and many drugs find their source in the labs of universities (2). The individuals involved in these labs will often publish their findings in general terms and present them at conferences for feedback from peers. Here the process could still be considered relatively open and transparent. It is at this point that small biotechnology companies are founded. 

The purpose of a biotechnology company is to develop an idea into a marketable drug. It is a precarious business, and many have failed in their quest (3). At the same time, there are vast sums of money to be made, which attracts a considerable number of investors. These investors often come with their agenda and with one clear goal – to make money. “What is the exit strategy?”, is a question that will often feature in the board rooms of these small companies. As a result, these companies are driven to deliver results and to push their product through clinical trials. 

Usually, there are four stages in the clinical trial pipeline. Each of these has a clearly defined purpose. All drugs that ultimately reach the bedside of the patient undergo these trials, as they show details of the safety and effectiveness of the treatment in large populations. The idea is that a systematic approach should justify the use of the drug above currently available treatments (4). The patient is and rightly should be at the centre of this process. 

Is the drug generally safe? What are the drug’s side effects? Does the drug work and is it well tolerated by all patients? These are questions that these trials should answer. Often these trials include hundreds and sometimes thousands of patients (5). All of this comes with a price tag. The process of pushing a drug through the clinical trial pipeline can take a considerable number of years and cost a substantial amount of money. Some companies report having spent over $1 billion on this process, and many companies have reported it to take them 15 years to complete the process (6). These facts add another complication to the mix – intellectual property.

Patents often have a lifetime of 20 years (7). If it takes a company 15 years to develop a drug, the company must recover the costs and generate a profit for its investors within the remaining five years. In the case of a small biotechnology company, this is often unrealistic. It is usually impractical to assume that a small biotechnology company can fund the completion of clinical trials on its own due to lack of funding. Therefore, these companies partner with larger pharmaceutical companies by way of trade sales, joint ventures, or licensing deals (8). These arrangements impose targets and deliverables on the companies, which need to be met to ensure the lifespan of the agreement. 

It is at this point that companies often need to discard their perception of patients and focus on the profitability of their operation. What initially could have been solely regarded as a revolutionary treatment, now is part of a machine that generates large amounts of cash. Investors want a return on their money. The large pharmaceutical partners need to plan the marketability of the drug and the original scientists, are stuck in the middle, hoping to make a difference to patients. At this stage, national health systems, insurance companies, and ultimately patients bear the burden of the discovery process. 

Let’s be clear: many drugs have a profound impact on patient’s lives. Some enable an extension of life while others improve the quality of life and others cure disease, but is there a more patient-centred model? Can this process be democratised? Can some of these life-saving treatments be made available more effectively and at lower costs to the patient? 

In the UK, the NHS bears the majority of the financial burden, but how long can this system be sustained? 

In the current political climate, unquestionably, some of these issues need to be addressed urgently. Politicians are asking voters to make decisions that ultimately will affect the way drugs are delivered to the market. 

Ignoring the cost of drug discovery will unequivocally lead to a collapse of health systems as we know them and in the short-term allow politicians to politicise the process as a whole often without regard for the end consumer. It is, therefore, more important than ever to understand the landscape and to collectively make decisions that will benefit society as a whole.