Two drugs used to treat depression do not appear to be as safe as had been originally reported — at least in teens. So concludes a group of scientists who have reanalyzed data from a 2001 drug trial.
The data came from what’s known as Study 329. It had focused on a drug known as paroxetine (Pa-ROX-eh-teen). It’s sold in the United States under the names Paxil, Brisdelle and Pexeva. The trial had tested how well this drug helped teens cope with a type of serious mood disorder. Known as depression, its victims experience persistent sadness and apathy.
The original study included 275 teens ages 12 to 18. Some received paroxetine. Others got imipramine (Ih-MIP-rah-meen). That drug is sold under the name Tofranil. Everyone else received a placebo. That’s a pill that looks identical to a drug but contains no medicine.
Placebos act as a control. They allow researchers to determine whether any observed changes are due to the drug. It’s an important thing to test because sometimes just the act of offering treatment — any treatment, including a harmless sugar pill — can prove therapeutic.
Participants took their pills for eight weeks. Neither they nor their doctors knew who had gotten a drug or a placebo. This double-blind approach prevents doctors from interacting differently with those getting a drug.
At the start of the study, the teens completed a survey. It asked about the severity of their depression. Then the patients met weekly with their doctors for the next two months. At these visits, they discussed their symptoms. Doctors also measured each teen’s heart function using an electrocardiogram. At the end of the trial, the participants again completed a survey. Researchers compared the results for signs that a teen’s depression had changed.
The original study reported that both paroxetine and imipramine reduced depression. It also concluded that neither drug caused harm.
But those findings were inaccurate, Jon Jureidini now argues. He’s a psychiatrist at the University of Adelaide in Australia. His team did not collect new data on the drugs. Instead, it reviewed raw data from the original teen study. Those data were released recently after scientists pushed to be able to review data from studies with questionable findings.
The original study set out a protocol, or procedure, for analyzing the data collected from its participants. Jureidini’s team followed that protocol. But researchers performing the original study did not, Jureidini’s group now reports. The original research team had used a different method to analyze the data. And this alternate approach created the impression that both drugs worked. But if the researchers had stuck to their protocol, the effects of the drugs would have looked no better than those from the placebo, Jureidini’s team has now found.
What’s more, his team turned up signs that both drugs had caused worrying problems in some teens. Eleven teens taking paroxetine reported suicidal thoughts or tried to harm themselves. And 15 teens on imipramine had to withdraw from the study because of heart problems.
Many of these harmful events were not reported when the original study was published. And that incomplete reporting skewed the judgment of safety in favor of the drugs. This paved the way for the drugs to be prescribed to teens.
Jureidini’s team reported its findings September 16 in BMJ (formerly called the British Medical Journal).
It’s important for protocols and data from such studies to be made public, Jureidini says. In fact, he thinks they should be released before researchers publish any papers based on the data. Such data transparency could help to prevent similar problems in the future, he says.
“Making data available is an absolute necessity,” agrees Steven Hollon. A psychologist at Vanderbilt University in Nashville, Tenn., he was not involved with the study. Researchers should be required to release data for any study that deals with medical treatments, he says. “Human lives hang in the balance.” Still, Hollon sees no need to release those data before a study is published.
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apathy A flat mood, where one is indifferent to people, opportunities and the environment around them. It’s marked by a lack of enthusiasm for things, for not caring any more.
control A part of an experiment where there is no change from normal conditions. The control is essential to scientific experiments. It shows that any new effect is likely due only to the part of the test that a researcher has altered. For example, if scientists were testing different types of fertilizer in a garden, they would want one section of it to remain unfertilized, as the control. Its area would show how plants in this garden grow under normal conditions. And that give scientists something against which they can compare their experimental data.
data Facts and statistics collected together for analysis but not necessarily organized in a way that give them meaning. For digital information (the type stored by computers), those data typically are numbers stored in a binary code, portrayed as strings of zeros and ones.
data transparency Making raw data collected during a study available to the public, so that others can analyze them. Data transparency allows outside experts double-check reported research findings and conclusions. It may also help identify errors or fraud.
depression A mental illness characterized by persistent sadness and apathy. Although these feelings can be triggered by events, such as the death of a loved one or the move to a new city, that isn’t typically considered an “illness” — unless the symptoms are prolonged and harm an individual’s ability to perform normal daily tasks (such as working, sleeping or interacting with others). People suffering from depression often feel they lack the energy needed to get anything done. They may have difficulty concentrating on things or showing an interest in normal events. Many times, these feelings seem to be triggered by nothing; they can appear out of nowhere.
double-blind study A study in which neither the participants nor their doctors (or other people administering the study) know who is receiving a potentially therapeutic treatment.
electrocardiogram A test (or the readout of that test) that records electrical signals moving through your heart. This assay is usually abbreviated as an ECG or EKG test. Special cells in the upper right chamber of the heart emits these signals, which trigger the heart to beat.
placebo A substance that has no therapeutic effect, used as a control in testing new drugs.
protocol An accepted or agreed-upon procedure for doing something.
psychiatry A field of medicine where doctors study and treat diseases of the human mind. Treatments may consist of talking therapies, prescription drugs or both. Physicians who work in this field are known as psychiatrists.
psychology The study of the human mind, especially in relation to actions and behavior. To do this, some perform research using animals. Scientists Scientists and mental-health professionals who work in this field are known as psychologists.
therapy (adj. therapeutic) Treatment intended to relieve or heal a disorder.