Innovation, Implementation, and a Voice for Patients… on the other side of the planet

“Of course, engineers are the best at framing a problem and solving it. I only have two medical specialists on my team, the rest are from engineering and other disciplines.” You would think I was talking to Tenley Albright, but these words were uttered by Dr. Ayeesha Kamal, Associate Professor of Neurology at Aga Khan University, who designs and runs her own clinical trials… on stroke… in Pakistan. In all the time I have spent on this project, I have never met someone who preempts my spiel about what the Collaborative does, let alone practice it. “It’s because the United States has too much regulation, not only inclinical trials, but in universities, departments, and every other facet of professional life. If I was doing trials like this in the United States, I would never get tenure.” This was hitting a little too close to home, and it was great. She proceeded to tell me about her innovative stroke trials, showing stroke patients movies and focusing on implementation. “99 cents of every medical research dollar is spent on new medicine; less than one cent is spent on implementation. No wonder the task ahead of you is so difficult, the goal for everyone is new drugs as opposed to focusing on what makes patients better.” This echoed Clay Christensen’s sentiment when me met him last month: for our healthcare problems, we don’t know the job to be done and we are letting profits drive solutions to problems that have not been identified.

She continued to explain how we can make it better for the patients: Realize that there’s a difference between a patient and a research subject. A patient wants care, doctors provide it, and there are established ethical standards for that transaction. When a patient turns into a research subject, as in many clinical trials, suddenly it’s the patient who’s now providing the sponsor, the PI, the society something. This research subject then needs to be respected at a whole other level. We as a society have not thought about the ethics of this relationship. If a patient becomes a research subject, and does not get more agency, more benefits, and more comfort, it is criminal. It is exploitation at the highest level.

When is a patient likely to be the same as a research subject? The more life-threatening the disease, the poorer the patient, and the more expensive the treatment will result in patients being coaxed, or forced, into becoming research subjects. In a country like Pakistan where research subjects are not paid, this is exacerbated. From an ethical perspective, the worse the condition for the research subject, the more they and their communities should be compensated. Giving them (free) standard of care is not enough. Taking it away when the trial finishes is nothing but cruel.

“A clinical trial should not burden the patient. That needs to be the first design element of a trial,” said Dr. El-Nasir Lalani, Dean of Research and Graduate Studies at Aga Khan University. They have an amazing facility for clinical trials; right down to the Purell hand sanitizer, it transports you back to the United States. They want more trials, but are refusing to compromise on patient rights. “People think this is Pakistan, and everything flies. It doesn’t. These people and families give up their lives to help the sponsor run successful trials. If we don’t stand up for the patient, who will?”

Here are my thoughts now: We develop clinical trial protocols in a country which restricts innovation, spends next to nothing on implementation, and is driven by the profits and academic benefits of new drugs that are supposed to solve problems that haven’t been correctly identified. We then proceed to implement these trials for new drugs locally and internationally on research subjects, whose vulnerability increases with increasing chance of profits. The more the chance for profits, the easier to take advantage of patients and turn them into research subjects. The ethical implication of turning patients into research subjects has not been explored, especially in developing countries. Maybe abroad is where we can look for advice and solutions. After all, we trust their researchers to conduct our trials, their communities to sacrifice their time, and their bodies to test drugs for us that they might never get. Listening to how we are doing it incorrectly is the least we can do.

Sauleh Siddiqui