The success story

The oft-quoted saying "Success has many fathers, but failure is an orphan" is certainly true when applied to the pharmaceutical industry. Whenever something goes well in our industry, there will be plenty of people ready to jump in and claim responsibility for it. Throughout the R&D process, as research ideas are successfully developed, clinical trials initiated and products launched, people are delighted to be involved and claim their vital contribution to the task. Success breeds confidence in the project or product which in turn fuels greater success and often an increase in funding or financial reward. Indeed, the pharmaceutical industry is so scared of making mistakes that a complex web of standards by which compliance must be achieved has been established to prevent errors. However, we all know that pharmaceutical product development is not just about success stories and someone needs to be on the lookout for the failures and take care of them. While everyone throughout the research and development process has a role in this, the full burden often falls to the quality control and quality assurance departments. Perhaps our responsibility in regulatory compliance could be described as the orphanage keeper, ever vigilant for the one piece of errant data that nobody else wants.

Looking for the orphans

Mistakes can occur at all stages of the drug development process. We must be ever vigilant for miscalibrated piece of laboratory equipment or incorrectly diluted or labeled samples. When trawling through raw data we should be on the lookout for that one piece of data that doesn’t quite fit in. We then need to concentrate our effort on identifying the origins of that result. When monitoring a clinical trial we need to be ever alert for the anomaly – the response that could become an adverse event. When a product has received regulatory approval, our work is still not complete. Product launch is the time when there is a large increase in the number of individuals exposed to the product. These patients often have co-morbid conditions and are frequently receiving concomitant medical products. Statistically this is the time that adverse events may occur.

While identifying mistakes is important what is more imperative is to look for patterns in their incidence or frequency and find remedies to prevent their future appearance. We can only do this if we accept that mistakes will occur and claim ownership for them as appropriate.

The fear and cost of failure

In addition to elaborate regulatory requirements, most companies have project management and data systems that allow failures to be tracked and managed. These systems encourage a working environment where an individual feels that to make a mistake is wrong and instill a fear of failure throughout the organization. This fear of failure can cause individuals to give less than their best effort, to avoid risk taking, and, ultimately, never achieve complete success. It is time to change our paradigm to a culture where failure is accepted and celebrated. Innovation can not be nurtured in an environment of fear. Accepting failure and learning from mistakes can often lead to more efficient processes or improved products. The ability to recognize other applications for a failed experiment also plays a significant role in product development.

A culture change from celebrating success to applauding failure is easy to say but a bit more of a challenge to accomplish. Often admitting failure can have unwanted financial repercussions for an organization. However, a change is underway in the industry aimed at accepting failure and moving towards terminating high risk projects earlier in the R&D process.

When you make a mistake you are not alone

Throughout history the medical and scientific worlds are full of stories when failure was turned into success.

Thomas Edison reportedly failed over 3,000 times to develop a working prototype of a light bulb before he succeeded. After the first thousand mistakes he said, “Well, we’re making progress - we know a thousand ways it can’t be done. We’re that much closer to getting there.”

The drug thalidomide was probably one of the worst “mistakes” of modern medicine being linked to birth defects when taken as a sleeping pill and to treat morning sickness during pregnancy. However, many countries can directly attribute the formation of their drug regulatory agencies to the lessons learnt from the thalidomide tragedy. The drug has since been approved in 1998 by the Food and Drug Administration’s (FDA) for the treatment of the debilitating and disfiguring lesions associated with erythema nodosum leprosum (ENL), a complication of Hansen’s Disease, commonly known as leprosy. Researchers are also investigating the role of the drug in cancer, tuberculosis, HIV/AIDS, and Chron's disease.

So next time you make mistake at work step back and think how you can turn your mistake into an opportunity. If your organization can't accept and build upon failure, it will never be a success.