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Biotech companies should expect a few ethical issues in drug development

on May 03, 2012

Among the many challenges and complexities of developing a new drug in today’s healthcare environment, a biotech company can expect a few ethical dilemmas to pop up along the way, according to Genentech Executive Vice President of Research and Early Development Richard Scheller.

In this presentation to Stanford students, he suggests that drug companies won’t always agree with the U.S. Food and Drug Administration’s processes for approving drugs, especially during clinical trials. “When we’re doing a survival trial, no one wants to be in the placebo group,” he says. “One could question whether it’s even ethical to have a placebo group or whether you should put everyone on the drug and compare it to historical standards, which of course is not as good of an experiment.”

Another dilemma that might present itself is the selection of which markets a drug should target. “Frankly, we wouldn’t try to make a drug for a third-world country disease because it’s not profitable,” Scheller says. Fortunately, there are groups and foundations that put money into efforts to bring new drugs to third-world countries, but big companies often just can’t justify targeting those markets to investors. “If it’s a growth-driven business, I have to justify at the end that there’s some return on the investment that I make.”

But that idea clashes with the way some drug companies distribute their products in the U.S., Scheller says, like companies that discount or subsidize insurance co-pays or actual costs of drugs for patients who can’t afford them. “We believe that at least in the western world where we operate, that everybody has access to our drugs, even if we just give it to them for free.”

Watch Scheller's talk on ethical issues below.

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