July 29, 2010 | The fact that guest speaker Jamie Heywood dropped the first “F bomb” in Bio•IT World’s Best Practices Awards history didn’t seem to bother the 200 dinner guests.
Heywood delivered an impassioned speech advocating the role of IT in drug discovery, reliving his experiences over the past decade dealing with his brother Stephen’s diagnosis with amyotrophic lateral sclerosis (ALS). Heywood played the trailer from the documentary So Much, So Fast. “Do you feel the power of the mission we’re all on?” he asked the audience to warm applause.
Heywood, who is the founder and chairman of PatientsLikeMe, said the pharmaceutical and biotech industry was trying to make a difference in what was “a very hard and difficult process.” But his own prescription was to change the paradigm. “You all serve the scientists in your institutions… That’s backwards. IT should be running the joint!” he said. “Quite frankly, scientists don’t have any idea how to deal with data. They don’t understand what it means, how to interpret it, how to find quality in it.”
Two days after his brother’s ALS diagnosis in 1998, Heywood quit his research job and embarked on a journey to help prolong his brother’s life. He recalled typing into PubMed the keywords “prognosis” and “ALS.” “I computed what would happen to Stephen,” he said. The result was a predicted lifespan of 2-5 years. Heywood’s then wife suggested he read Tuesdays With Morrie. “No way!” he said.
Instead, he started the world’s first non-profit biotech company, the ALS Therapy Development Institute, and a few years later, injected Stephen in his spinal cord with first stem cell transplant in ALS at Jefferson University. “It didn’t do jack,” said Heywood. “He didn’t live a day longer.”
In trying to determine why it didn’t work, Heywood needed to break out of the rut that biotech had been in for 20 years, trying to translate so-so data in an animal model and turn it into a therapeutic. “I needed knowledge. I needed to compute what it meant. I needed every clinical trial that had ever been run in ALS.” Around 2000, Heywood built one of the first databases for any disease, listing every trial, the number of patients, and the outcome.
“Would a software engineer ever undertake a project if they didn’t build a database of the options? Yet scientists spend $50 billion a year and don’t even bother to list the options. So why are we [engineers] not in charge?! This is insane.”
Heywood found he couldn’t replicate published data, and simulation experiments suggested many results could be explained by random chance. “The people in our lab were not classically trained scientists… We came from industries that believed in quality, understood the rigorous collection of data.” Heywood even banned notebooks, because “if you can’t put it in the computer and compare it, it’s not really meaningful.”
The challenge now was to think about how these platforms can drive experiments “so we can compute the results in a meaningful way and no longer make bogus investments in drugs that never worked in the first place.” He said: “The challenge, the excitement, the opportunity is to stop serving and start leading.” It’s about the metadata, the comparison of data.
In the end, Stephen Heywood fought ALS for ten years in which he raised a son and lived an incredibly full life. “Not because of anything I did,” said Jamie. “Not because of the stem cell transplant. Not because of the experiments we tried but because he had an internal avenue that changed the way he lived.”
But he also helped Heywood view a new way of thinking about medicine. Quoting Marcia Angell, Heywood said “it is simply no longer possible to believe much of the clinical research currently published. Drugs cannot be trusted. Clinical decisions cannot be trusted.”
“That’s why our industry has been losing money for 20 years. The way we fix that is we bring rigorous IT and rigorous quality into a system that is a crass industry run by people who think they know the answer instead of proving it. That’s why IT should run the damn system. So go make friends with manufacturing engineers and stop losing 19/20 drugs, not because biology is hard, but because we are believing BS.”
With PatientsLikeMe, Heywood can ask hundreds or thousands of patients with the same disease the same questions. He said: “Imagine a world where in real time, every patient knows what will happen to them... the drug companies will be competing not to prove to the FDA they have some drug that modifies a signal to get through the [approval] process, but to convince the patients that they generate enough value to make their lives better.”
“That’s a world we can make real, if we measure everything, integrate it together, and think about how we connect that, which will only be driven by IT.”