November 29, 2012

Controversy in Science: Can We Trust the Data from Clinical Trials?

by Christine Hoekenga

“Clinical trials are powerful tools; like all powerful tools, they must be used with care.”
— From Sponsorship, Authorship, and Accountability, an editorial endorsed by The International Committee for Medical Journal Editors

Blue and white pills

Image courtesy: Lance Robotson (Flickr CC)

Clinical trials to test the safety and effectiveness of prescription drugs in humans are at the heart of developing new treatments for people suffering from everything from allergies to arthritis.  Like other scientific research, the results of clinical trials are often published in peer-reviewed journals such as The New England Journal of Medicine or The Lancet.

The stakes for publication are high. Pharmaceutical companies stand to gain a lot of publicity and revenue if studies that show their products in a positive light are published–especially in prestigious medical journals read by doctors and other medical professionals. As new drugs are tested, approved for sale, and prescribed, patients stand to gain new treatment options–but also to be exposed to new risks of potential side effects.

Solid, unbiased data are critical in clinical trials.  But as Peter Whoriskey recently reported in The Washington Post, the pharmaceutical industry is playing an increasing role in studying its own products.  While independent academic institutions and hospitals used to conduct most clinical trials and report on the effectiveness of new drugs, pharmaceutical makers are now funding and managing many of these tests.  For example, Whoriskey  found that two-thirds of the articles on new drugs published in The New England Journal of Medicine “are sponsored by pharmaceutical companies, and most of those are co-written by their employees.”

While clinical trials conducted by pharmaceutical companies are not necessarily bad science, the potential for bias is higher.  Whoriskey points out at least five cases in recent years where published studies of new, high-profile drugs that were sponsored by drug companies have either overstated the benefits of a drug or understated the risks.  At least two of these drugs, an arthritis pain reliever called Vioxx and a diabetes drug called Avandia, were ultimately pulled from the market because they increased heart attacks and other cardiovascular problems.  Documents released during legal proceedings showed that researchers had expressly designed the trials to mask cardiovascular side effects and had omitted evidence of heart problems.

Whoriskey isn’t the only one who has raised questions about the influence of drug companies and the quality of data coming out of clinical trails. In 2001, editors from well respected medical journals around the world signed onto a statement of concern about the current state of clinical trials.  They have also collaborated to implement additional safeguards, such as a public registry of clinical trials designed to make it harder for companies to hide or downplay unflattering results.

While it’s impossible to say how things would (or wonldn’t) have gone differently with particular drugs if independent researchers had conducted the trials, it’s clear that transparency, full disclosure of data, and rigorous checks and balances by the scientific community are more important than ever in clinical trials.

What do you think?  How should journals and medical researchers handle the issue of bias in data from clinical trials?

For more about the responsibilities of researchers and journals in handling data and reporting results, check out our modules on Peer Review and Scientific Ethics

Read the full statement from International Committee of Medical Journal Editors

Read the complete Washington Post story by Peter Whoriskey

Read the response to Whoriskey’s story by GlaxoSmithKline (maker of Avandi)

Christine Hoekenga

Written by

Christine is a freelance writer, editor, and content strategist, specializing in science and nature. She holds an Bachelor's degree in Environmental Science and Media Studies and a Master's of Science Writing. She has been working in science communication and education for nearly a decade as a journalist, an organizer for conservation groups, and a museum educator. Before joining the Visionlearning team, she served as the New Media and Online Community Manager for the Webby award-winning Smithsonian Ocean Portal. Christine is assisting Visionlearning with developing new modules and glossary terms, managing the blog, and outreach through social media.