Is Our Government Protecting Us?Think about how hard parents work to protect their kids. They pay for the disinfectant, health insurance, pay for flu-shots and dentist visits; they usually want what is best for their children. Because of this, I find it hard to believe how much Adderall is being prescribed to children in our country. Adderall (Dextroamphetamine), as defined by drugs.com, is stimulant used in the treatment of ADHD, narcolepsy, and other disorders. (Amphetamine/ Dextroamphetamine) Adderall is approved by the FDA, but is unhealthy can cause severe health problems. This drug is also considered to be habit-forming. The FDA has deemed the risks of this drug as acceptable and allowed distribution on a large scale. The distribution of Adderall may point out the ethical lethargy of the FDA, thus we as the consumers must stay informed so that we can protect ourselves.
Adderall is prescribed to children and adults age three and older to treat the symptoms of ADHD (Brown University). Drugs.com defines Adderall as, “A central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control” (Drugs.com). Today, about one in every 20-25 children is prescribed to ADHD drugs such as Adderall, Concerta, or Ritalin (Mayes). Of these drugs, Adderall is prescribed the most (Berman 1). The active chemicals in Adderall are amphetamine and dextroamphetamine, chemicals which boosts the levels of dopamine in your brain (Drugs.com/ Basu). That definition does not tell us much, so I consulted neuroscience for kids, a website ran by Eric H. Chudler, Ph.D. for more information about what the drug does to an individual. The short term effects didn’t seem so bad and included, “increased heart rate… decreased appetite… [and] a feeling of happiness and power” (Neuroscience for Kids). The long term effects, however, were” Insomnia, restlessness "Paranoid psychosis", Hallucinations, Violent and aggressive behavior, Weight loss, and Tremors” (Neuroscience for Kids 1). These long-term effects are associated with people being on the drug for long periods of time. Steven Nissen, M.D, who works for the food and drug administration believes, “Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well”(FDA Panel Seeks Warnings 1 ). The FDA allows Adderall to be marketed, but recently has taken steps to make sure the consumers know about the risks of the drugs. One of these steps was to put warning label about heart failure in 2002 (FDA Panel Seeks Warnings). A warning label is very important, but it won’t stop the drug from getting to the public. When Canada suspended the marketing of Adderall in 2005, the FDA reported on their website that they cannot conclude that Adderall should be suspended, and they intend to update the post when “additional information or analyses become available,” but since 2005 there has been no update (FDA 1). I feel that since this is the most commonly prescribed stimulant in North America, the need for careful protection is necessary. It can be said that the FDA has taken measures to investigate the problems with Adderall, but it can also be said that not much has been done to protect the public. Further insight into the detrimental effects of Adderall will allow us to analyze the issue, and judge whether or not the FDA is effectively protecting Americans from this drug.
This Adderall advertisement depicts happiness and hope. I feel a closer look at the fine print may tell another story.
Health Concerns
One of the major concerns regarding Adderall is the health risks associated with its usage. Chronic use of Adderall (i.e. a child being prescribed to it) can lead to serious health problems, and can lead to mental irregularities. The FDA believes that use of Adderall raises the risk of cardiovascular problems, and voted to put a warning label on the prescription bottles about this risk (Basu/FDA). The FDA also found 54 other nonfatal problems associated with amphetamine usage (Basu). Cardiologist Steve Nissen of the Cleveland Clinic explains there is more risk than most people know. According to Nissen, "We know that these drugs increase heart rate and blood pressure," he says. "When you raise blood pressure, the risk of individuals, particularly adults, goes up for stroke, heart attack and sudden cardiac death." Further research about the health effects of Adderall brought me to a case study in which a 32 year old man was diagnosed with the serious heart condition cardiomyopathy after being prescribed for 2 years because of Adderall (Adderall). I can only imagine what would happen to a child after being prescribed for their entire academic career; the only difference is that the child doesn’t know what they are taking.
This photograph shows a human heart that has been deteriorated by cardiomyopathy. The opened left ventricle of heart shows a thickened, dilated left ventricle with subendocardial fibrosis manifested as increased whiteness of endocardium. Adderall Usage can lead to this.
I went to the FDA website to see if they had any warning or comments concerning these risks. I stumbled over this bit of information regarding FDA action:
"Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR. SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR. In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall. At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data" (FDA).
Canada suspended marketing, and the U.S. FDA simply said there is not enough information to prove that Adderall causes these problems. It is now four years later, and Adderall is still available. Why? This drug caused SUD (sudden unexpected death) in children (FDA). It also raises the risk for people to die from heart attack or stroke, and may cause dozens of other health issues. I feel that these are risks which some people would never impose on a loved one, but I also feel that these risks are not known by many. Adderall usage can also lead to other types of problems.
Psychological Issues
Adderall can cause changes in behavior, and other mental issues in certain individuals. I interviewed a young man that graduated from high school in 2008 about his experiences with Adderall. He told me, “At the beginning of my junior year [of high school] the Adderall stopped working, and my doctor raised my dosage from 30 [mg per day] to 60 [mg per day]. Once he raised [my dosage], I didn’t really eat or sleep much. After a while my personality started to change… I was emotional” (Jinx 1). A year few weeks later the drug made him “hear voices and [become] paranoid that someone was trying to kill [him]” (Jinx 1). Mark had to be taken to a mental hospital, and he believes it is because of the Adderall. Amphetamine-induced psychosis is a side effect of Adderall (Berman). This demonstrates a mental health issue. Another area of concern is change in behavior and mood.
This picture mocks the wide availability of ADHD drugs in our schools today. These drugs are given out to students and many are put at risk.
In an article titled “I am a Different Person” Jessi Castro interviews a fourteen year old girl who is prescribed Adderall. The girl tells her,
"Recently I've become aware of the side effects of my medicine, which are a problem. I am a totally different person on it than off it. This is called emotional lability. While on the medicine in school, I rarely ask my friends what there is to do on the weekend. At lunch, I literally sit at the table without saying a word, and because of that, I have lost a whole bunch of friends" (Castro 1).
I cannot help but feel bad for these kids. They are being victimized by a drug they got from their doctor. Imagine one of your loved ones was diagnosed with heart disease, or lost their friends, or even their minds, over a prescription drug aimed to help them concentrate. These issues are real, and millions of people are dealing with them.
Addiction
Let it be known that, “An amphetamine-containing formulation is the most commonly prescribed stimulant in North America, and it is noteworthy that amphetamines are also the most abused prescription medications” (Berman 1). Adderall (Dextro-Amphetamine) is known to have a high potential for addiction (McCabe). A survey showed that 5.8 % of male college students have illegally abused Adderall in the past year (McCabe).
Referring to Adderall, this study concludes, “The non-medical use of prescription stimulants represents a high-risk behavior that should be monitored further and intervention efforts are needed to curb this form of drug use” (McCabe 1). I cannot see how the non-medical ingestion of Adderall can be deemed a high-risk behavior, but if it is prescribed it is completely fine. Paruma Basu explains to us how it works as, “ADHD drugs such as Ritalin and Adderall are stimulants that help to enhance concentration by boosting levels of the 'feel-good' neurotransmitter dopamine—a feature they have in common with cocaine”(Basu 1). This explains why there is a demand for the drug on the street. Remember, Adderall is the most commonly abused prescription medication. Paruma Basu also reports, “The most recent report in February showed that more than 7 million people in the US have abused ADHD stimulants, and as many as 750,000 teenagers and young adults show signs of addiction” (Basu 1) People get high on Adderall all the time; it even has its own information vault on Erowid, a website which catalogs psychoactive drugs (Erowid). That information alone should throw a red-flag about the morality of its mass production and distribution. Adderall is a real drug, and can have the same consequences as real drugs. Amphetamine is a strong chemical. Addiction is a huge problem in America, and I am sure everyone is affected by it in one way or another. The FDA allows the mass distribution of time-released amphetamines, and our people are left to pay the consequences.
FDA Action
The question still remains; is the Food and Drug Administration doing its job to protect us? The FDA is taking steps to research and protect but not much is being done to slow down the distribution of Adderall. Over 7,000,000 people in our country use Adderall. (Journal of Toxicology & Environmental Health 658) In the document “Adderall Abuse in Texas”, Mathias Forrester studies the trends of Adderall abuse in Texas by consulting poison control center records. Over the past seven years 66 percent of the calls regarding non-abuse Adderall usage were for children 13 years and younger. (Journal of Toxicology & Environmental Health 658) Also, of the abuse calls, 69 percent of the callers were adolescence. (Journal of Toxicology & Environmental Health 664) It is undeniable that children and young adults are the most affected by Adderall. Forrester tells us, “Adderall abuse exposures were more likely to (1) involve adolescents, (2) occur at other residences, schools, and public areas.”(Journal of Toxicology & Environmental Health 664) College students and high school students have easy access to these drugs from their friends and families because the doctor’s make it available. Every pill that an abuser consumes pays Corporate America and our government. I see that as a very unsettling thought. The amount of money made from Adderall is huge; Forrester testifies, “The drug accounted for almost US$770 million in sales in the United States and Canada in 2004”( Journal of Toxicology & Environmental Health 658). It is safe to say that this drug is easily to get, and I think it is also safe to say that multiple corporations are making a lot of money from the Adderall industry. The FDA’s role in our protection is most likely affected by conflicts of interest, and may be more complicated than we know.
This satirical cartoon alludes to the FDA's lack of acknowledgement of their conflicts of interest. When pressure is given from multiple sides, the FDA must act accordingly.
Joanne Silberner has covered FDA committee hearings about various public health issues. She has been the health policy correspondent for NPR since 1992, and her articles concerning the FDA’s actions concerning Adderall help to show us what steps they are taking to keep people informed, and keep people safe. Since Adderall is known to raise blood pressure and heart rate, a “Black box” warning has been issued about the heart issues in adults. Children did not get the warning label. (FDA Committees Disagree) They also plan to add the risks about raised aggression and growth problems in the pamphlet that comes with the drug. ( FDA Committees Disagree) Doctor Robert Temple of the FDA expresses how he will handle the situation as, “We will turn quite quickly to, I would say, implementing the recommendations we've gotten and revise the labeling accordingly. We would like to get these matters finished of pretty quickly” (FDA Committees Disagree 3). This response seems to take the issue lightly. Joanne Silberner explains that “It's difficult to study the safety of a drug once it's on the market. Drug companies don't want to spend the money. Patients don't want to be randomly assigned to receive or not receive a drug they may feel they need. And it's laborious to look back through tens of thousands of patient records to see whether there is a pattern” ( FDA Panel Seeks Warnings 1). Maybe some of the risks were overlooked. There are professionals that hold the same position as me. Joanne tells us, Cardiologist Steven Nissen of the Cleveland Clinic declares, “There are reasons to believe that the ADHD drugs have more risk than is generally appreciated” (FDA Panel Seeks Warnings 1). Senator Chuck Grassely has held hearings because of his issues with how the FDA works. He Claims, “It fits into a pattern that the Food and Drug Administration has had in the past, of moving too slowly and not aggressively enough to protect consumers” (FDA Probes Safety 1). Another problem is that there is not enough long term data to come to any solid conclusion. Dr. Judith O'Fallon of the FDA Advisory Committee states, “We have so little long-term data available to us from these studies, that we really don't have, I don't think, we have a very good idea of how many of these develop further down the line, because the studies are so short. And that's a problem” (FDA Committees Disagree 2). These issues reflect the lack of action being done to protect Americans from Adderall, and the problems within the FDA.
Conclusion
The large scale distribution of Adderall in our country is detrimental to many people’s lives, and the vast availability of the drug exposes the negligence of our FDA. Just because it is legal, does not mean that it’s right. There is a lot of evidence here that Adderall has significant negative side effects. Adderall can cause heart failure, heart disease, psychosis depression, behavioral changes, and dozens of other problems. The FDA has acknowledged its detrimental effects on health, yet they still allow it to be prescribed. This drug leads to addiction and has the potential to cause physical harm. Our government allows this drug to be distributed on a large level, and the drug itself has become a huge industry. Money is being made, and lives are being ruined. The distribution of Adderall is unethical and dangerous. It is our responsibility to stay informed and protect our loved ones from this drug.
This photograph represents our excessive use of pharmaceutical drugs in America. Who is to blame for this excess? I feel the FDA is at Fault.
