Study of Studies Finds Retractions in Drug Literature Often Indicative of Misconduct

Thursday, May 31, 2012

In January 2003, The Lancet — one of the world's oldest and most respected medical journals — published an article championing the combination of two drugs (ACE inhibitors and ARBs) in treating certain types of kidney disease. More than 100,000 patients were prescribed these two drugs in combination.

But then an investigation concluded that the data in the study had been collected in a way that made it scientifically unsound. The Lancet printed a retraction, but thousands of patients still receive these drugs in combination.

This is just one case of several explored in a new study of studies by researchers at the University of Illinois at Chicago. They found that nearly three quarters of retracted drug studies were retracted because of scientific misconduct like falsified data and plagiarism. Simon Pickard is the senior author of the study. Art Caplan is a professor of medical ethics and health policy at the University of Pennsylvania.

Guests:

Dr. Arthur Caplan and Dr. A. Simon Pickard

Produced by:

John Light

Comments [2]

I partiipate in paid clinical trials, as a "lab rat." The discussion didnt exatly refer to this but I can tell you that a majority of research studies have flawed results for more-complicated reasons than mentioned by Kaplan and Pickard. Human research volunteers in phase-1 studies ( studies in which medications are tested on human volunteers usually for the first time) are paid . Frequently, "career lab rats" go to different research sites to sign up for different studies . There are some decent people who are career lab rats who only want to make some money while benefitting science but probably the majority do things that affect study accuracy. In the US the standard rule in all research is that volunteers do not do a study until 30 days after their last study . This best ensures medication from another study has "washed out." But volunteers motivated by money participate in another study before 30 days are up and lie about when they did their last one. Many volunteers do not actually swallow medication but use the trick known as "cheeking" in which they pretend to swallow a pill in front of a researcher but actually hide it in their cheek. This way the medication does not get in their system and they can do another paid study elsewhere.This is the tip of the iceburg. Often researchers themselves are under pressure from pharmaceutical companies to quickly do studies and get quick "accurate" results so that the drug can be put on the market quickly. Study personnel may know volunteers are cheating but so that the study can finish with "good" results ( no adverse events or side effects etc), the study personnel are not incentivised to make sure that volunteers are following the protocal. If volunteers do not get serious effects , it is called a "clean study" and pleases a pharmaceutical company. Some volunteers who honestly take the medication and report their adverse events are sometimes told by researchers that they ( the volunteers) would be ejected from the study meaning the volunteer won't get fully paid and won't be allowed to do other paid studies. Honest volunteers who need money sometimes do not report their symptoms to research staff . Then the study drug, in writing, has no notable side effects. There are ironic situations too. A study drug is often tested on a large group of volunteers who are to be kept inside a research facility for weeks . Once I was told that I would be banned from a certain clinic becuase I pointed out to the research staff that other volunteers may be cheating on the study . A researcher told me that though not every other volunteer may have been honest, the collective results of the group rather than of one person doing the study correctly is what the pharmaceutical company preferred. Whistle blowers are not liked here either..

May. 31 2012 12:08 PM
Jan Gilpin from Newton, MA

I listened to this story today with interest. Although it is possible that only "bad apples" falsify data, you neglected to discuss another factor. The enormous profits that "blockbuster" drugs can generate can certainly corrupt the system. Positive studies, or studies that seem positive, can give the green light to drugs and lead to their widespread use. Sometimes the editors of journals reviewing the studies have a conflict of interest because they will personally benefit from the success of the drug. Vioxx is just one example where a drug maker buried studies with less positive results and spun studies to make them seem more positive. And even studies that don't have errors can still fail to give the full picture of a drug's effectiveness and side effects. This does not occur until the drug is used in the general population. Unfortunately our current system does not do well at capturing the full picture of a drug after market, but instead continues to rely on these idealized (and sometimes falsified) studies. Senator Kirsten Gillibrand has just introduced legislation that aims to improve the system for prescription drug safety. The Cody Miller Initiative for Safer Prescriptions would require the FDA to approve and standardize information distributed to patients when they pick up their prescriptions. Current information is not subject to any review or standard. The new requirements would ensure patients are kept up to date about potential adverse side effects and dangerous drug interactions. Cody Miller became suicidal after taking an allergy/asthma medication. My son, at age five, developed severe anxiety and depression from this same medicine. This is a blockbuster drug called Singulair that is still prescribed to millions of children each year, often by doctors who have no idea that a certain percentage of people could suffer these side effects. It's time to take a closer look at how greed can corrupt the system, and how we can change things to make prescription drug safety more important that pharmaceutical profits.

May. 31 2012 10:30 AM

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