The saga of the discovery and marketing of insulin is a rip snorting medical adventure tale, and I urge you to read Richard Epstein’s vivid account of it (it features an unstable scientist, a ratty lab and an entrepreneur whose last name was Lilly). It required only about a year to take insulin from synthesis to the market-a miracle could not have happened today because of government regulation.
Epstein is an author, Hoover Institution Fellow, and a New York University law professor. He sums up the attitude of many about government and medical advances in the opening of his article:
One of the most pressing questions of modern biomedical research asks what the relationship between government regulation and scientific innovation is. Nothing is more common today than the plea that extensive government regulation, at every stage of the development process, is needed to protect innocent and uninformed patients and their families from exploitation by pharmaceutical companies, hospitals, and physicians. The underlying assumption is that good-faith government regulators can fill the void between ordinary people and the self-interested institutions that dominate our private lives.
But the story of insulin is evidence that this commonly-held view just isn’t right. Government doesn’t promote advances; it stifles them, delaying new medicines and procedures that save lives. It’s such a good story I can’t resist quoting some of it:
In 1920, diabetes was a condition ripe for research. For reasons that are not fully understood, some people from an early age find themselves unable to synthesize insulin, the hormone that breaks down a sugar called glucose. The result is the build-up of glucose in the bloodstream, which, if left unchecked, results in a grim death by diabetic coma.
Prior to the heroic work by Banting and Best, the standard treatment for diabetes was a relentless form of slow starvation that had been pioneered by one of the unsung early heroes of modern medicine, Dr. Frederick Allen. Around 1915, Allen discovered how to reduce the intake of food to levels so low that individuals could forestall an immediate death by diabetes for a slower death by starvation. Why make this grim choice? Allen realized that the ability to isolate and purify insulin was very much on the horizon. Diabetic children who might live just a few years longer could find themselves the recipient of a far better cure.
Epstein notes that one of the children who lucked up and was saved was Elizabeth Hughes, daughter of Charles Evans Hughes, who served as governor of New York and Supreme Court Justice. She was diagnosed with diabetes in 1918 and endured 40 months of near starvation before she was able to avail herself of the recently-discovered insulin. Today, Elizabeth Hughes, who lived into her 70s, would have died in childhood. Government regulation would have slowed the development of insulin and its commercialization by Eli Lilly and Company until it was too late for Elizabeth Hughes.
Lilly’s challenge was to develop insulin of sufficient purity and consistency for injection into human beings. Sadly, several children died. But nobody sued. Insulin became one of the great life-saving drugs on our era. It couldn’t happen today.
Today’s constant denunciation of pharmaceutical companies looks weirdly out of place, considering this story.
From start to finish, it took about three years for the conception and commercialization of insulin to occur. The painful question is whether that track record could be repeated today. In one sense, it is impossible. The near-eradication of major scourges, like diphtheria and smallpox, in the first decades of the 20th century means that thankfully we do not have the same major opportunities for medical innovation today as we once did.
Beyond that, the thought that the next insulin could move from successful synthesis to initial marketing in about a year’s time is a pipe dream. Today, before a drug is released for general use, there is an endless cycle of FDA reviews that can take years to complete. Clinical trials, for instance, are a legal necessity. All sorts of animal studies, three stages of trials, strict warnings, and market restrictions both raise the price of treatment and slow down the process of introducing the drug to the market.