Chinese regulators just granted conditional approval to the world’s first Alzheimer’s treatment in over 15 years.
This potential breakthrough, invented by a Shanghai startup, offers hope to Chinese patients and their families. But it also serves as a reminder that the United States could soon lose its perch as the world’s biomedical leader.
Drug development is a long, hard, and risky process that usually begins at one of America’s top universities or research institutions. Supported with funding from the National Institutes of Health or private foundations, scientists in these labs research how the genes, proteins, cells and organs in our bodies work. Their discoveries and insights serve as building blocks for new drugs.
Generally, researchers’ discoveries have no immediate or obvious medical application. But occasionally, scientists discover something with therapeutic potential. When that happens, a biopharmaceutical company — often a small start-up — typically begins investigating how to transform this research into a new drug.
If early lab experiments and animal testing show success — judged by safety and efficacy — researchers begin trials on human patients. Just 12 percent of drugs that enter phase 1 clinical trials on humans eventually gain FDA approval.
Despite these challenges, the United States has led the world in medical innovation for more than 30 years. Whereas only 31 percent of new medicines were invented in the United States in the 1970s, roughly two in three new drugs originate here today.
This success is no accident. It’s the direct result of smart policies that, for decades, have nurtured a strong public-private ecosystem for drug discovery.
As one example, America’s robust intellectual property protections reward private firms for taking risks, both scientific and financial. Just as these risks enable the development of new smartphones, they enable the development of breakthrough medical treatments.
The structure of America’s drug marketplace also gives us a leg up. Unlike governments in the United Kingdom, France, and Canada, the U.S. government doesn’t set prices for medicines. This ensures that life sciences companies can price their inventions according to the value they provide and the market, thus stimulating the enterprise of drug development.
As a country, we cannot take our global leadership for granted. Policies that look inward only — and do not consider the global context of scientific discovery — can produce unintended consequences.