Adverse Drug Events Increase: Do the Benefits Outweigh the Risks?

Imagine someone being prescribed a drug that was approved by the FDA and their doctor. They would hope that the drug would alleviate their illness in some form or fashion. However, contrary to what we may expect, certain prescription drugs may cause adverse events, such as hospitalization or even death. What is worse is that warning of these adverse events may not even be included with the prescription. One study recently concluded that there has been an increase in the number of reported deaths and injuries associated with drug therapy. As I researched this topic more I discovered two quite insightful blogs challenging the key findings of this study. The first post I examined was from Furious Seasons, written by Philip Dawdy, a skeptical journalist suffering from bipolar disorder. This post lays the blame on the FDA, doctors and the media for not doing anything to bring more light to the issue of adverse drug events. The second post comes from a blog titled Clinical Psychology and Psychiatry: a Closer Look. Here, the author, “an academic with a respectable amount of clinical experience,” explores how clinical trials do a poor job of reporting drug safety outcomes. My comments to both these blogs, which can be found below and by following the links above, mainly focus on how some people may negatively react as a result of this increase in reported adverse drug events.

“Worse Than Vioxx: Zyprexa, Risperdal, Clozaril, And Paxil Killed Thousands of Americans” comment:
I agree with a lot of what you had to say on this topic. The media should really step it up and bring more light to such issues on reported adverse events. This, in turn, would increase public awareness. However, I could not help but wonder if more media coverage on these drug related deaths would ultimately lead patients to experience feelings of betrayal and mistrust toward their health care providers. In other words, patients being handed prescriptions will no longer trust the doctors issuing them. This might even cause them to avoid seeking treatment for their illness or deny drug therapy altogether. It hurt me most to hear that “Risperdal, a drug associated with over 1,000 deaths, is used in children--and the FDA approved its use”. How can drugs such as this one (see image above), used to treat schizophrenia, continue to be prescribed? It might be true that this drug has helped many. But, the FDA has to ask itself the pressing question: do the benefits outweigh the serious risks. I believe that risks such as death and disability outweigh the benefits. More research needs to be conducted on these drugs, in order to properly label all the side effects and to determine whether it is best to simply take the drugs off the market as was the case with Vioxx.

“The Drug Safety Blindfold” comment:
When I first read this study, one of the things that immediately caught my attention was the limitation that states that the submission of an adverse event does not establish causality. An adverse drug event could be reported by anyone who felt that there was a relationship between their drug and their adverse event. Right away this signaled to me that more research is needed to be sure that these adverse events are in fact being caused by the prescription drugs. I quickly visited the FDA MedWatch website and noticed how easy it was to submit a report. The reporting system should be altered, so that opinions from second sources such as health care providers can confirm suspected relationship with the drug. I agreed with Furious Seasons’ post that the media and the FDA need to further inform the public about the serious risks their prescription drugs may elicit, but I also feel that it is essential that more research be conducted first. Bringing too much attention to these pre-mature findings could lead many people to feel trepidation when taking their drugs or may lead them to report more and more serious injuries that may not even be related to the drug effects.

Labeled and Misunderstood: A Look at the Increase of Bipolar Disorder in Youth

The Children and Adolescent Bipolar Foundation (CABF) is calling it a national wake-up call. But could an issue related to bipolar disorder really demand the attention of the nation? A study that was published at the beginning of the month by the Archives of General Psychiatry stated that there has been a dramatic increase in the number of children and adolescents being diagnosed with bipolar disorder. The disorder, also known as manic-depressive illness, may include symptoms like extreme mood changes, irritability, poor sleep, risky behavior and distractibility. Speculation among various news sources is rampant regarding the cause of the increase. However, in a Columbia University Medical Center press release, Dr. Mark Olfson, one of the doctors involved in the study, stated that “these trends likely reflect a recent tendency to over diagnose bipolar disorder in young people, a correction of historical under recognition, or a combination of both trends.” Undoubtedly, more research needs to be conducted in order to be sure that bipolar disorder is being diagnosed accurately because dismissing this issue of diagnostic uncertainty would only end up negatively affecting the youth of tomorrow.

Susan Resko, M.M., Executive Director of CABF, agrees that more research is imperative. She claims that today “children are being diagnosed and treated when they were previously dismissed as 'bad seeds' or the product of poor parenting." The truth is that over diagnoses leads us to wonder if doctors are misdiagnosing a lot of children and clumping them under labels. Bipolar disorder shares a great deal of resemblance with other illnesses such as schizophrenia and ADHD. During a lecture given by Dr. Terence Ketter, Chief of the Bipolar Disorders Clinic at the Stanford University School of Medicine, the similarities and differences between schizophrenia and bipolar disorder were the focus topic. For example, the two disorders share abnormalities in some of the same neurotransmitter systems. ADHD and bipolar disorder are also said to share many characteristics such as impulsivity, inattention, and hyperactivity. The study itself confirms that “symptomatic overlap between ADHD and pediatric bipolar disorder may be an important source of diagnostic uncertainty.” Considered like a bible to professionals who diagnose psychiatric disorders, the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) works against misdiagnoses. Unfortunately, not everyone will perfectly fit under the categories listed. Dr. Ketter suggests that we now consider a more dimensional approach to diagnosis, one aimed at treating the common symptoms and pathophysiology.

There is, however, light at the end of the tunnel. New research in genetics and brain development provide optimism for more accurately diagnosing bipolar in the future. According to the Lundbeck Institute genetic linkage studies have shown that specific regions on certain chromosomes may be associated with a family history of bipolar disorder. As seen to the image on the right, the orange areas on chromosomes 4, 12, 16, 21, and X are believed to be linked to bipolar disorder. If researchers continue to discover these genetic linkages, doctors in the future will be able to diagnose the disorder more accurately and early. Children and adolescents would benefit greatly from early diagnoses because they would be able to get the treatment they deserve. Scientists studying the brain from the University of California at Los Angeles and The National Institute of Mental Health (NIMH) also have produced groundbreaking research on the brain development of bipolar youth. A recent article published on NIMH’s website shows a time lapse of composite MRA brain scans belonging to youth, ages 7-22, as they develop symptoms of mania and depression. The video shows a complicated pattern of gray matter gain in the left hemisphere and gray matter loss in the right hemisphere and mid-front part of the brain. Scientist Nitin Gogtay, M.D. states that their findings should put an end to speculation that onset schizophrenia and bipolar disorder stem from the same underlying illness. Continued research in both genetics and brain development should help establish a clearer distinction between disorders that resemble bipolar disorder.

Based on the study, we could expect to see the number of youths being diagnosed with bipolar disorder to continue rising; it probably has risen more since 2003. However, the numbers should eventually plateau or increase less over longer periods of time. A continued increase would definitely be a red flag signaling over diagnoses. Thanks to researchers though, who are continuing to seek answers on distinguishing the genetic and mental cause of bipolar disorder, new measures will surely emerge leading to better diagnosis of the disorder in children and adolescents.