Patients waiting expectantly for medical research to produce important new cures are finding bad news almost everywhere they turn.
Pharmaceutical companies are suffering from a much-discussed innovation crisis, as old drugs lose patent protection without new drugs to replace them; meanwhile, the small biotechs that could potentially bail big pharma out struggle to raise capital .
University scientists, for their part, are beset by an unseemly credibility crisis, as the intrinsic fragility of medical research is now vividly apparent from the soaring number of high-profile retractions, and the well-documented difficulty of reproducing many published findings outside the originator’s lab.
At the heart of this crisis is the misalignment of two very different cultures.
Academic scientists tend to focus on publishing papers, and usually assume that the results will eventually be useful. They place a high value on novelty, and relatively less value on whether the data are robust, easily reproducible by others, or truly relevant to human disease. Captivating data from putative laboratory models of disease generate publications, even if the model is not very predictive of human disease – and unfortunately, most models aren’t.
Conversely, big companies traditionally focus on generating efficiencies through scale, and on developing reproducible processes. This works very well for manufacturing, reasonably well for large late-stage clinical trials, and essentially not at all for early-stage (discovery) research.
A perennial topic around here has been the state of scientific research in China (and other up-and-coming nations). There’s no doubt that the number of scientific publications from China has been increasing (be sure to read the comments to that post; there’s more to it than I made of it). But many of these papers, on closer inspection, are junk, and are published in junk journals of no impact whatsoever. Mind you, that’s not an exclusively Chinese problem – Sturgeon’s Law is hard to get away from, and there’s a lot of mediocre (and worse than mediocre) stuff coming out of every country’s scientific enterprise.
But what about patents? The last couple of years have seen many people predicting that China would soon be leading the world in patent applications as well, which can be the occasion for pride or hand-wringing, depending on your own orientation. But there’s a third response: derision. And that’s what Anil Gupta and Haiyan Wang provide in the Wall Street Journal. They think that most of these filings are junk:
The “Opinionator” blog at the New York Times is trying here, but there’s something not quite right. David Bornstein, in fact, gets off on the wrong foot entirely with this opening:
Consider two numbers: 800,000 and 21. The first is the number of medical research papers that were published in 2008. The second is the number of new drugs that were approved by the Food and Drug Administration last year.
That’s an ocean of research producing treatments by the drop. Indeed, in recent decades, one of the most sobering realities in the field of biomedical research has been the fact that, despite significant increases in funding — as well as extraordinary advances in things like genomics, computerized molecular modeling, and drug screening and synthesization — the number of new treatments for illnesses that make it to market each year has flatlined at historically low levels.
Now, “synthesization” appears to be a new word, and it’s not one that we’ve been waiting for, either. “Synthesis” is what we call it in the labs; I’ve never heard of synthesization in my life, and hope never to again. That’s a minor point, perhaps, but it’s an immediate giveaway that this piece is being written by someone who knows nothing about their chosen topic. How far would you keep reading an article that talked about mental health and psychosization? A sermon on the Book of Genesization? Right.Continue reading…