one of the top med schools—UCSF. Humboldt is one of the poorest places in the Golden State, where unemployment is high, chronic disease is high, and insurance coverage is low. Doctors there struggle to share resources like mammography machines, or radiation therapy tools.
Drug companies often ignore areas like this, assuming that few patients are able to pay for new medicines. But small towns have one thing that’s in short supply in the big city: doctors have strong connections to their patients, Cronin says.
One company I’ve written about recently has seen the differences between “thought leaders” and community leaders. Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]) won FDA approval last fall for a new drug designed to help wean people off addictions to opioid-based painkillers. It was tested, like most new drugs, at major urban medical centers.
Once cleared for sale, an interesting thing happened. The medical thought leaders who are familiar with the Alkermes product, as it turns out, never see the majority of patients in the U.S. suffering from addictions. Yet local health officials, drug courts, and counselors from around the country—where there was little familiarity with the Alkermes drug from clinical trials—started calling the company to try to get their hands on the new drug to test how it could help in their communities.
Addictions to opioid-based painkillers like oxycodone are a serious problem in rural and urban parts of America. Alkermes is now working on a number of pilot projects around the country to help local officials ask questions about whether its drug improves health outcomes, reduces repeat criminal offenses, saves money for local healthcare and criminal justice systems, or some combination of all of the above. Much of the commercial success of this product hinges on how well Alkermes engages with physicians and officials in these territories.
Alkermes CEO Richard Pops explained in a thoughtful note to me why his company felt it was necessary to follow this path to the market. Clinical trials are highly regulated, and require staff with training and experience in running them according to strict protocol, Pops says.
“Because the lifeblood of our companies is the data we generate, we tend to be highly selective in choosing sites, particularly for pivotal studies comprising the core of the new drug application submission,” Pops says. “For these reasons, we tend to run studies in places experienced in running studies if possible. They understand good clinical practices (GCP) and, in addition, tend to have more patient flow, which speeds recruitment.”
Now that Alkermes drug is on the market, it has had to reach out into a lot of new communities. “We have had to build our understanding of the real world treatment of alcohol and now opioid addiction, which is happening in all kinds of different venues outside of where we may have conducted trials,” Pops says.
I hope for the sake of people in large swaths of the country that companies like Alkermes can figure out how to effectively bridge this gap. Pharma and biotech companies have products that could make a positive difference for many people if used properly. Small cities and rural America shouldn’t be considered flyover country. It’s time to start thinking about the people who live there as valuable customers and contributors.
