Getting drugs to market is much harder than the media lets on.

It's Time to Fight the 'PharmaScolds'. By David A Shaywitz and Thomas P Stossel
Getting drugs to market is much harder than the media lets on.
WSJ, Apr 08, 2009

Relationships between university researchers and medical product companies are under relentless attack by critics who portray these associations as a morality play in which noble academics struggle to resist the dark, corrupting influence of industry. So why are leading disease-research foundations increasingly choosing to partner with industry rather than condemn it?

The answer is that by prioritizing the needs of patients, these medical philanthropies remain keenly aware of something academic critics of industry may have forgotten as they've scaled the university ladder. The goal of medical research is not to publish papers, but to develop new treatments for people suffering from disease. And translating laboratory research into new therapies, in the words of Robert Beall, president of the Cystic Fibrosis Foundation, is something "academics are really not good at."

After years of extensive public investment of billions of dollars in medical research, we have generated thousands of scientific papers, but few important new treatments for dreadful conditions such as pancreatic cancer and Alzheimer's disease.
To be sure, we have won some important battles. Statins and blood pressure medications have dramatically improved the prognosis of patients at risk for heart attacks, while powerful antiviral medicines mean HIV is no longer a death sentence.

But behind these spectacular achievements is an arduous, expensive and underappreciated journey, occurring largely in industry, from an original scientific concept to an effective drug or device. Most promising ideas either never pan out or result in modest, incremental advances. Human biology is maddeningly complex, laboratory models are necessarily simplistic, and scientific understanding remains painfully limited.

Discerning which ideas have value and capturing this value is extraordinarily challenging and has a depressingly high failure rate. The complexity of product development as well as the scientific sophistication, regulatory oversight, and manufacturing consistency required to pull this off are astounding. That any new useful medical products emerge at all is nearly miraculous.

Given the vital role of medical products companies and the magnitude of their challenges, one might imagine that this industry would be admired. To some extent, it is. Leading research organizations such as the Michael J. Fox Foundation for Parkinson's disease proactively build bridges with industry leaders, solicit advice from industry scientists, and fund projects in industry labs.

But this enlightened view of industry is not widespread. This is largely because of the disproportionate influence of a coterie of prominent critics we have previously dubbed "pharmascolds," who routinely vilify the medical products industry and portray academics working with it as traitors and sellouts. These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit -- it's all "corruption" in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities -- to demonize the market and portray scientific medicine as an ascetic religion, which it is not.

The pharmascolds systematically discount the difficulties of product development. Meanwhile, each new barrier -- such as the National Institutes of Health's ban on paid consulting for industry -- erected between publicly funded researchers and companies, especially cash-strapped start-ups where many of the breakthroughs occur, slows the progress of potential treatments.

In response to these attacks, drug company spokespeople seem content to offer up measly press releases. When challenged by reporters, most academic consultants to industry refuse to comment or offer a meek explanation, instead of retorting that industry pays them because they add critically important value. This evasion has only emboldened industry critics, disheartened company employees, and caused even allies to wonder if there really is something to hide.

For the sake of the many patients whose diseases require innovative treatments -- and for the medical philanthropists determined to make it happen -- it's time for the leaders of the medical products industry to take pride in their purpose and start fighting back.

And discovering a few important new medicines wouldn't hurt either.

Dr. Shaywitz is a management consultant in New Jersey. Dr. Stossel is a professor of medicine at Harvard and a fellow at the Manhattan Institute.