New Research Ethics Blog

A hearty welcome to Nancy Walton who has just started blogging on research ethics -- Nancy is an RN and PhD, and Associate Director of the School of Nursing at Ryerson University in Toronto. Chris MacDonald, author of the Business Ethics Blog, (who has been busily blogging delightfully about monkey business in the last few days) is also co-piloting the research ethics blog. By way of welcome and introduction, we are cross-posting one of their blog entries today:

Children's Cold Remedies: the Ethics of Doing Research
From Reuters: Don't use cold drugs in kids under 4, industry says

Oral cough and cold medicines sold over the counter should not be used in children younger than 4 years old because of the risk of rare complications linked to inappropriate use, manufacturers said on Tuesday.

The move seems a good one. Maybe it's step 1 towards action on the real issue:

Currently, the medicines are available under decades-old FDA rules that allow over-the-counter products to be sold without clinical trials showing their risks and benefits.

"The bottom line remains the same: that these products have never been proven to work in children," said Diana Zuckerman, president of the National Research Center for Women & Families.

Two quick, relevant, rules of thumb for business ethics, rules that seem entirely relevant here:

1) Information asymmetry matters. If customers don't understand what they're getting, they're not making fully voluntary purchases, and even the most zealous fans of free markets say that markets don't work properly in the absence of reliable information. Parents almost certainly do not know that the safety & efficacy of these products have not necessarily been proven in clinical trials.

2) All the standards get cranked up a notch where kids are concerned.

Original post here.

Big Pharma gets caught ghostwriting

From the NYT comes the news that Merck flacks were the real authors of "dozens of research studies" on Vioxx that were then shopped around to name-brand physicians. (WaPo reports as well, here.) Presumably, docs who agreed received some kind of compensation--even if it was just another publication, which is the currency of academic science--for adding their names to the papers and submitting them to journals for peer review and publication. You can read the source article from the Journal of the American Medical Association here.

What's the big deal? Well, for starters, there's the potential for conflict of interest when a drug manufacturer (or anyone else) writes up positive research results about a product in which they have a financial interest. Disclosing such interests is the usual "solution." In this case, there wasn't just non-disclosure; rather, there seem to have been purposeful steps to make it appear as though Merck wasn't involved. Moreover, from the standpoint of research ethics, it's not kosher for people to attach their names to papers they had no role in writing, or research they weren't involved in.

The news also raises the question of whether the research results reported are, in fact, valid and trustworthy. Journal articles are the primary way the medical community learns about advances in clinical care. If people or corporations are willfully putting bad information into the system, patients could suffer or be harmed as a result. The sketchy track record of Vioxx, combined with the news that at least some of the studies that encouraged its adoption in clinical practice might have been written by its manufacturer .... well, it doesn't look good for Merck.

Reducing the use of animals in research

It's cool when science turns its methods back on itself to improve its own methods. In some ways you could argue that this is what science is about, anyway; but sometimes, there's a more obvious ethical impact to such self-improving activities.

Today's example is researchers who are working to find ways of reducing the use of animals in research (AP story). Contrary to what some critics seem to believe, it's simply not true that researchers who work with animals don't care about the animals' welfare. You can listen to a pretty powerful story that illustrates what I mean here--the link you want is the first one, "Don't Fall in Love with Your Monkey."

Research that aims at reducing the number of animals used in research by finding technological substitutes, research that tries to find ways of reducing the pain and distress animal subjects experience when they are used in research--these are not super-high priorities for federal funding. (You can learn more about protections and guidelines that govern the use of animals in research here.)

It's worth noting that the push for the research referenced in the news tag above is partly a response to help corporations deal with the upcoming EU ban on animal testing. There's a lesson here: when financial incentives exist to build a better mousetrap (sorry for the unfortunate metaphor), science will focus on the problem...whether the funds come from the feds, from corporations, or from abroad.