Here’s a trivia question: Where were the big ideas for the field of biotechnology first discussed? Answer: At a since-demolished delicatessen in Waikiki Beach, Hawaii. Go figure.
The year was 1972, and Stanley Cohen, MD, professor of medicine at Stanford University in Palo Alto, Calif., and Herbert Boyer, PhD, a former professor and biochemist at the University of California, San Francisco (UCSF), were in Honolulu to attend a meeting devoted to the study of plasmids, those ringlets of DNA found in bacteria. Dr. Cohen excitedly described a novel technique that introduced plasmid DNA into Escherichia coli, which allowed researchers to propagate and clone the plasmids in the bacteria. Dr. Boyer detailed his work using a revolutionary enzyme, EcoRI, that could cleave double-stranded DNA molecules to produce single-stranded ends with identical termini.
The two met at the deli for a late-night nosh, where they tossed around some ideas about how they might advance the field of biology by linking their two discoveries. First, they proposed using EcoRI to slice both plasmid DNA and a second DNA from another organism of choice they wished to clone. Then, with the identical DNA termini exposed, they proposed attaching this DNA fragment to the plasmid DNA and then propagating the whole assembly in E. coli.1
Using this elegant technology, Dr. Cohen’s group at Stanford University created a functioning hybrid mouse–human cell protein while at Genentech, the biotechnology company he started in San Francisco, Dr. Boyer and colleagues eventually succeeded in programming E. coli to produce the human hormone, somatostatin. The synthetic production of insulin and growth hormone followed a short time later. In just a couple of years, the breathtaking potential of these brilliant experiments energized other bioscience entrepreneurs to dive in and start their own biotechnology firms. The art, science and business of medicine were forever changed.
High drug costs are inevitable, thanks to a byzantine & highly opaque network of drug procurement involving many participants with conflicting objectives. Because insurance coverage is provided by myriad employers, government agencies & private insurers, there are countless drug formularies to contend with, each equipped with its own set of rules.
Needless to say, there were countless fits and starts along the way. It took several more years before biologic products reached the marketplace and achieved commercial success. But what a success. Now these medicines have wholly upended our once-sleepy specialty. Whereas just a few decades earlier, the best that rheumatologists could hope for might be the release of another version of another non-steroidal anti-inflammatory drug (NSAID) claiming superiority over what was already available, the 21st century has brought us exciting therapeutic novelty and innovation. Mostly.
A Costly Formula
Today, we are armed with targeted biological therapies and some highly effective generic drugs that have greatly benefited our patients. These products were developed following years of careful, painstaking research, often aided and abetted by a dollop of serendipity. Biopharmaceutical innovation is a costly pursuit that is undertaken only when there are rewards for its success. But should there be limits to these rewards? Of course, novel and innovative therapies deserve adequate compensation, but should new therapeutics that offer scant benefit over older products merit a payer’s largesse? To our chagrin and that of our patients, we have recently witnessed some dubious gamesmanship that has adversely affected the pricing of some drugs. Perversely, our tangled healthcare system abets this behavior.