Successful Drug Discovery Means You Have To Care About The Problem

By Rob Wright

I recently had a discussion with an executive from a biotech company which focuses on developing drugs for rare diseases. As I listened to this former physician describe their company’s approach to drug discovery, I was transported mentally to an exam room, the white table paper crinkling underneath me. The aseptic smell of a doctor’s office fills my nostrils, and I catch myself mentally inventorying the jars of tongue depressors, cue tips, and cotton balls all neatly aligned on a corner cabinet Formica countertop. This person does not attribute their company’s success to any brilliant strategy, but a keen awareness of problem solving. In order to solve a problem, you have to understand the problem, and in order to understand the problem, you have to care about the problem. “I think the failing to see it as something you need to care about is often the gap between what defines success in R&D,” they stated. 

It’s Personal

Unlike other industries, healthcare has a level of intimacy that is highly personal. We expect our car salesman to not necessarily be the most trustworthy individual. But that is okay, because we are prepared for that. However, in the healthcare setting, you are vulnerable. You may be sick. Many people that participate in a clinical trial are doing so because they are seeking a cure. They are scared. According to this executive, trust is the key component to understanding the problem. In order for trust to be achieved, people enrolled in a clinical trial need to trust that those administering medications, gathering data, and conducting the trial, truly care about their specific problem. Consider the following Internet response posted to someone who asked the question, what does a typical day consist of for a clinical research assistant?

“Get up and pack for your flight. Get to the airport an hour early. Get delayed two hours. There is a 10% chance of your luggage not arriving, but your computer bag is so heavy with the laptop and protocols that you had to check your bag. Pick up your rental car, pick up some carry-out, head for the hotel, work in the hotel on reports/emails/spreadsheets until midnight, sleep just long enough to still get to your site by 9:00 a.m. Meet with the study coordinator, check everything they were supposed to do from your last visit, use Internet database or paper to ‘monitor' their data versus their medical records, issue queries (questions), check their regulatory documents, count their pills, talk to the M.D. for 3 to 5 minutes, head back to the airport (you skipped breakfast & lunch, had some trail mix from your computer bag), get home at midnight if you are lucky or more likely you took a flight to your next city to repeat the process tomorrow. On the days you don't do this, you work in the office printing letters/writing reports/responding to emails/calling sites you didn't visit recently. You have to be a good time manager for yourself — no one is doing it for you. The good points include a flexible schedule when you are not traveling, the ability to schedule your own visit dates, see new places, and independence from 8-hour/day office life. You are the moneymaker for the CRO, so you are well treated as an employee. As long as you can get your family to agree with this sort of schedule, you'll enjoy it.” 

Wow. I am sold. Where do I sign? Obviously, this person is just doing their job, as are many clinicians who have personal contact with patients. I have met those who have excellent bedside manner, and those who need a checkup from the neck up. The problem is that many clinicians executing clinical trials simply don’t care, while others are corrupt — a deadly combination to creating trust.

Corruption in Clinical Trials

In a 2010 article by Carl Elliott, The Deadly Corruption of Clinical Trials, the author describes the plight of Mary Weiss, whose 26-year son, Dan, was enrolled against her wishes in a psychiatric drug study at the University of Minnesota. Elliott believes the system of clinical research has been, “Thoroughly co-opted by market forces, that many studies have become little more than covert instruments for promoting drugs.” Keep in mind that Dr. Elliot, M.D., Ph.D., is a professor at the center for bioethics at the University of Minnesota. Unfortunately, there have been other cases of corruption and deceit in clinical trials, which further exacerbate the problem. 

According to the executive with whom I spoke, the best way to get people to care about a patient’s problem, which leads to the creation of trust, is to seek employees who not only carry a degree, but have actually cared for patients. Another tip, bring in advocacy groups to your organization with a variety of tools, so your employees can experience some of the symptoms patients experience from having their disease. Have patients visit corporate offices and share their stories so that the community of caring becomes embedded in your culture. “You have to care about the people that you treat or who may be benefiting from your medication,” they affirm. “You don’t make money in this industry by selling people something they don’t need. You need to be able to walk away if it is not in the best interest of the patient.”