Getting the drugs we need pg. 4
WOOD—I think it’s unbelievable that an industry that produces things that cure people of diseases that ail them has managed to shoot themselves so frequently in the foot and get themselves into a position where they’re now in public opinion polls regarded as somewhere down beside tobacco companies…
PAUL—This situation hasn’t escaped most of us, and it’s a problem that we’re trying to quickly correct… For example, I believe industry designs and executes clinical trials as good as anyone in the world… Having said that, we as an industry have been accused—with some justification, in my opinion—of not being as transparent and objective as we should be in presenting and publishing our data. Do we always publish all of the relevant data on a given drug? Do we highlight negative as well as positive results?
Just this past year at Lilly we reiterated a code of conduct called the Principles of Medical Research, which fundamentally says we will publish all data that patients and doctors need to know about our drug, period, including any negative results, and of course all safety data that we gather on our medicines.
To help communicate our clinical data, we’ve established a comprehensive clinical trial registry, which is on our Web site, www.lillytrials.com, so that all data on all marketed products, phase I through phase IV, are going to be on a public accessible database…
How can the government and universities help solve the problem?
WOOD—I don’t think that public money should be committed to the development of drugs. There is a total failure of any evidence that government resources have been successful in developing drugs, at least in my view.
I have some concerns that… NIH… (is) somehow going to get into drug development… (and that) is going to distract us from the fundamental reform of the licensing system in this country to incentivize the development of the drugs that we need.
PAUL—If you back and look at the top 50 marketed drugs,… almost every one of the top 50 had its origins in some research that somewhere in time was funded in the public sector, like the NIH.
However, virtually none of those drugs, with just a few exceptions, would have ever been discovered and made available to patients without enormous investments and risk on the part of the private sector. Not just in the discovery and validation of a target that these drugs work on, but all of the screening, chemistry, pharmacology, toxicology/metabolism, safety testing, etc., let alone downstream development activity and manufacturing capabilities… work that’s required to bring a drug to market, and that most people don’t really know about or appreciate…
It’s the entire body of that research that allows us to do what we do, and without that enormous investment by the NIH and other federal agencies, we wouldn’t have what I have called the incredible substrate for drug discovery and development that we currently have…
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