Since the Vioxx scandal broke in late 2004, most Americans are all too familiar with the idea that prescription drugs can be dangerous and even deadly. But how would America react if it were to discover that a class of drugs being primarily prescribed to children was also dangerous and sometimes deadly?
According to a May 2006 report by the U.S. Centers for Disease Control and Prevention, side effects and "problems" with widely prescribed Attention Deficit Hyperactivity Disorder (ADHD) drugs send 3,100 people to the ER every year -- 80 percent of them children.
"Problems" most often include overdosing or accidental use, and side effects can include chest pain, high blood pressure, rapid heart rate, stroke and sudden death. Between 1999 and 2003, 25 deaths linked to ADHD drugs were reported to the FDA, 19 involving children. In addition, 54 cases of other serious heart problems were reported, including strokes and heart attacks.
Considering that roughly 3.3 million Americans who are 19 or younger, and 1.5 million who are 20 and older, are currently taking ADHD drugs -- with those numbers constantly rising -- it is safe to assume that the number of ADHD-drug-related hospitalizations will also continue to increase. Given these revelations about the risky nature of ADHD drugs, one might wonder what the U.S. Food and Drug Administration (FDA) is doing to warn consumers of these popular stimulants.
In February 2006, an FDA advisory panel voted 8-7 in favor of including its most serious "black box" warning on ADHD drugs, but the very next month, a different FDA panel instead voted to put information on cardiac and other risks in a new, special "highlights" section of prescription drug inserts.
Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic, criticized the FDA's decision in the April 6 issue of the New England Journal of Medicine: "I believe that the appearance of information in the 'highlights' section of the drug label will have virtually no effect on prescribing practices." Think back to the last time you picked up a prescription from the pharmacy. Did you look at the information pamphlet inside the bag, or did you go straight for the pill bottle, assuming that your prescription was safe?
In a letter appearing in the same NEJM issue, the heads of the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association -- Dr. Thomas Anders and Dr. Steven Sharfstein -- contradicted Nissen's argument that a "black box" warning on ADHD drugs was necessary for patient safety: "We agree that patient safety is paramount and that the long-term benefits and risks of stimulant treatment are not known definitively, yet we are concerned that such a warning will discourage patients and their families from using effective treatment."
In his rebuttal in the April 6 issue, Nissen replies, "I strongly disagree. I cannot accept the paternalistic notion that patients and caregivers are better off without information about drug risks. The presence of a black-box warning and a mandatory patient guide would probably stimulate useful discussions among patients, parents, and physicians about risks. An appropriate warning might also slow the exponential growth in the use of amphetamines and similar stimulants, which has reached epidemic proportions in the United States, resulting in the treatment of nearly 10 percent of preadolescent boys."
The "exponential growth" Nissen refers to has garnered national attention in recent years, and has left many wondering what brought it about. Was there a sudden outbreak of ADHD in the past decade? Was there something in the water causing children to suddenly fall victim to this behavioral disorder? In September 2000, PBS Frontline ran a special called "The Ritalin Explosion," during which the show interviewed child psychologist Harvey Parker, co-founder of the non-profit organization Children and Adults with ADD (CHADD). Frontline asked Parker what had changed among the general public to bring about the rise in ADHD diagnoses and prescriptions for medical treatment.
Parker replied that "several things" caused the increase in ADHD drug prescriptions, including more parents having their kids examined, and doctors understanding that "medication was an appropriate treatment for ADHD, not a last-resort treatment, but in some cases, a first-resort treatment." Parker continued, "We realized that kids with ADHD don't have to stop taking medication when they become adolescents. We used to think that stimulant medication would stunt growth. We realize that that doesn't happen. So we continued prescribing medications to these children through adolescence."
ADHD "experts" are ignoring evidence of dangerous drug side effects and defending increasing prescription rates
Apparently, medicating kids from childhood through adolescence wasn't quite enough, though. "We also realized that children could take medication more than once a day. They can take it in the morning, in the afternoon and evening, and even late in the afternoon when they come home from school. ... So all these factors combined to cause a rise in the prescription rates of medication today," Parker said.
Note the lack of any indication that the higher prescription rate is a bad thing. Also note that a recent review of previous studies on whether or not ADHD drugs stunt growth concluded that the stimulants do, in fact, stunt growth, by an average of three-quarters of an inch and about 2 pounds of body weight for 10-year-old boys.
Essentially, kids are being massively over-prescribed ADHD drugs that come with possibly deadly side effects, and the government is doing little to nothing to warn parents of those dangers. However, it seems that yet again, it's the U.S. government that is dragging its feet to protect consumers -- and in this case, millions of children -- from dangerous medications.
In late May 2006, Health Canada issued warnings of heart risks -- including sudden death -- on all drugs used to treat ADHD. "The effects are usually mild or moderate, but in some patients, this stimulation may -- in rare cases -- result in cardiac arrests, strokes or sudden death," the agency warned. Health Canada issued the warning even though no deaths caused by ADHD drugs have been reported in Canada.
The FDA is being sluggish to issue warnings on the newest risks ADHD drugs pose to users, the majority of which are children. It forms committees such as the Drug Safety and Risk Management Advisory committee, which convened in February 2006, and the Pediatric Advisory Committee, which convened in March 2006 and was attended by FDA epidemiologists and physicians, as well as two representatives from Big Pharma, to discuss if and how patients should be warned about the dangers of ADHD drugs. Notably, both committees did not find the need for a black-box warning "warranted."
One might wonder why Canada -- which has suffered zero deaths because of ADHD drugs (thus far) -- found the need for a warning "warranted" and acted quickly to issue it, while the United States, which has suffered 25 deaths (19 involving children) because of ADHD drugs, has effectively done nothing to warn its citizens of the dangers of such medications.
While the United States has a few lobbyists on the side of public health arguing for strong warnings and patient education on ADHD drugs, it seems no one has considered the third alternative: That ADHD can be prevented, rather than treated.
In an August 2004 News Target article, Mike Adams writes that ADHD is caused by harmful food additives such as the chemicals used in food coloring, as well as refined carbohydrates like white flour and the high fructose corn syrup found in soft drinks. Adams says the so-called "disease" is merely a result of children (and adults) consuming these toxic food ingredients, which eventually poison the brain and affect behavior, leading to a misdiagnosis of "ADHD."
"When you eat processed foods containing additives and artificial colors, you are introducing toxic chemicals into your bloodstream," Adams' article states. "Those chemicals find their way into the brain and alter brain function, and in the case of children who have been diagnosed with ADHD, it alters their behavior to make them restless or to have a shortened attention span. It can also cause children and adults alike to display other problems derived from their mental state."
The remedy? It's simple, according to Adams: "If you feed your children foods that enhance their health -- that is, unprocessed foods like fruits, vegetables, whole grains and superfoods -- then they won't exhibit these behavioral problems."
The sad truth is that many Americans will never subscribe to the idea that ADHD can be prevented or reversed through dietary changes. They would rather go to their doctor or psychiatrist and get a prescription for a little bottle of pills that will ostensibly "cure" their or their child's behavioral problems. It is on behalf of these people, as well as the people who never hear about the simple dietary solutions for ADHD, that the FDA and all its "advisory committees" must stand up for the public good and -- at the very least -- issue strong warnings with these drugs to warn patients that the stimulants their doctor prescribes them or their children may come with side effects ranging from stunted growth and skin irritations to strokes, heart attacks and sudden death.