Posts Tagged innovation

Matt Ridley’s not-so-mythical “myth” of basic science

Matt Ridley: Specious arguments against government research funding.

Matt Ridley: Specious arguments against government research funding.

I’m a clinician, but I’m actually also a translational scientist. It’s not uncommon for those of us in medicine involved in some combination of basic and clinical research to argue about exactly what that means. The idea is translational science is supposed to be the process of “translating” basic science discoveries in the laboratory into medicine, be it in the form of drugs, treatments, surgical procedures, laboratory tests, diagnostic tests, or anything else that physicians use to diagnose and treat human disease. Trying to straddle the two worlds, to turn discoveries in basic science into usable medicine, is more difficult than it sounds. Many are the examples of promising discoveries that appeared as though they should have led to useful medical treatments or tests, but, for whatever reason, didn’t work when attempted in humans.

Of course, if there’s one thing that the NIH and other funding agencies have been emphasizing, it’s been “translational research,” or, as I like to call it, translation über alles. Here’s the problem. If you don’t have basic science discoveries to translate, then translational science becomes problematic, virtually impossible even. Translational research depends upon a pipeline of basic science discoveries to form the basis for translational scientists to use as the starting point for developing new treatments and tests. Indeed, like many others who appreciate this, I’ve been concerned that in recent years, particularly with tight budgets, the NIH has been overemphasizing translational research at the expense of basic research.

Posted in: History, Politics and Regulation, Science and Medicine

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What does a new drug cost? Part II: The productivity problem

A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.

The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted.  Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?


Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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