Bailed Out by Science
The US healthcare system is hurting, but research can come to its rescue.
It’s a daunting task, but the ailing beast that is the US healthcare system must be brought to heel. Its feverish appetite for dollars needs to be curbed while getting the brute to recognize everyone in society is entitled to attention.
Science won’t feature extensively in discussions over the coming weeks, but it is central to effectively rehabilitate the monster. So in this month’s Opinion articles, we offer two sets of recommendations on science to the warriors of Congress who are crusading for just reform.
In the first, Dennis Cotter and colleagues from the non-profit Medical Technology & Practice Patterns Institute...
While Epogen is highly effective in managing the debilitating effects of anemia in patients with chronic renal failure, alleviating the need for regular blood transfusions, Cotter and colleagues describe how it is being administered in high doses to large numbers of patients who arguably receive no clinical benefit, and at great cost. The system has built-in reinforcements of this bad practice so that by 2005, 99% of all hemodialysis patients received Epogen instead of just the target 16%. To Cotter et al. the solution is clear: healthcare decision-making must take cognizance of scientific evidence.
One way is through comparison of the effectiveness of different treatments for illness. The economic stimulus bill fittingly allocated $1.1 billion to this, despite efforts from industry to thwart it.
Incidentally, the other Opinion writer is Sean Harper, Chief Medical Officer of Amgen—the company that makes Epogen. (Cotter and colleagues do not apportion blame to Amgen in their article.)
Harper endorses the need for reform of the healthcare system, but cautions against losing one of its great strengths: the support for innovation. He’s right, of course: If the motivation to develop new medicines (a/k/a a competitive financial return for drug developers) isn’t retained, the flow of new treatments might cease. And new medicines are desperately needed—for cancer patients, those with neurodegenerative diseases, psychiatric diseases, and many others. Only the pharma and biotech industry can provide them, and they are businesses.
Consequently, healthcare reformers must tread a fine line, seeking to make substantial savings without stymieing innovation. There’s a complex set of issues to consider: For biologics like Epogen (which has enjoyed 20 years without competition) drugmakers would like 12 to 14 years of sales free of generic competitors, and may be offered seven years. How great an impact will this have on long-term R&D investment?
R&D intensity, defined as expenditure on research and development as a percentage of a company’s sales, runs at 10–20% for pharma, depending on the parameters used. My first reaction was that this didn’t sound too impressive, what else do they do with the money? But it is around five times the average R&D intensity for non-pharma companies, and is likely to be hard hit if profits start to slide.
The pharma industry is currently lavishing $1.4 million per day on lobbying efforts to influence the healthcare reform process—this shows where a small portion of the company’s money goes, and just how high the stakes are. (See our Community post titled "Big Pharma = Big Lobby" for an in-depth discussion of this issue.)
When all is said and done on legislation, one massive headache will remain. The sheer cost of drug discovery—$2bn to develop a new therapy—is, quite simply, unsustainable. Reduce it by, say, 50 percent, and cut the timeline in half too, from 10 to five years, and the picture would be a whole lot brighter. One step in the right direction, adaptive clinical trials, is discussed in the Biobusiness section on page 55. We need more.
Those who must reform health care find themselves, to paraphrase the philosopher Marshall Berman, “in an environment that promises (us) adventure, power, joy, growth, transformation of ourselves and the world—and, at the same time, that threatens to destroy everything we have, everything we know, everything we are”.
I wish them every success. And urge them to stay close to the science.