ADHD Drugs Don’t Help Kids Perform Better in School

I blogged last April that almost 1 in 5 American high school boys are diagnosed with ADHD. According to Consumer Reports, 59% of children get prescribed medications immediately after an ADHD diagnosis. Approximately 2.7 million children were taking medication for ADHD in the U.S. as of 2007, according to the Centers for Disease Control and Prevention. Millions of children are being diagnosed and treated for a psychiatric condition that impairs their ability to function in school. This is a positive thing, right? It would be if ADHD drugs (stimulant medications like Ritalin or Adderall) actually improved school performance. But the evidence base is growing that these drugs don’t improve academic outcomes in the long term, according to a recent Wall Street Journal article.

One study examined medication usage and educational outcomes of nearly 4,000 students in Quebec.  It found that medication use was associated with increases in emotional problems among girls, and reductions in educational attainment among boys. Princeton economics professor Janet Curie, an author of the study, said that "the possibility that [medication] won't help them [in school] needs to be acknowledged and needs to be closely monitored."

The lack of long-term benefits of medication for children with ADHD is a conclusion from a major U.S. government-funded study known as the MTA. In this study, 579 children with the condition were randomized to one of three different kinds of treatment (medication alone, psychosocial/behavioral treatment alone, a combination of both) or to routine community care (control group) for 14 months.

Initial results of the study, published in 1999, indicated that 8- and 9-year old children who received medication and a combination treatment saw greater improvements in ADHD symptoms than the other two groups. Kids taking medicine also exhibited some improvement in educational outcomes in that first year.

The benefits of taking medication dissipated by the third year, however. The most recent set of assessments, the eight-year follow-up published in 2007, indicated that there were no differences in symptoms or functioning among the youths assigned to the different treatment groups as children. Some other conclusions from the follow up study were:

• Youths with ADHD had more academic, social, and conduct problems, more depression, and more hospitalizations than their peers without ADHD.
• Youths with ADHD who responded well to treatment and maintained their gains for 3 years functioned the best after 8 years.
• 61.5% of the children who were medicated at the end of 14 months had stopped taking their medication by the 8 year follow-up. The reason for so many children stopping their medication is unknown.
• Children who were no longer taking medication at the 8 year follow-up were functioning as well as children who were still medicated.

It’s interesting that more than half of the medicated children stopped taking their medication by the 8 year follow up. Is it because they outgrew their ADHD? Or is it because the families couldn't find enough of a benefit in continuing the drug? The study results showed that children who stopped taking their medication did as well as children who were still medicated. Also children who were randomized in the initial study for no medication did as well after 8 years as children who were randomized in one of the drug groups.

From the Wall Street Journal article, “One way of interpreting the findings is that the medicine proves effective on immediate classroom behaviors like sitting still and interrupting the teacher less, but it doesn't help with other factors important to successful completion of homework or test-taking, like family encouragement.”

There’s certainly no evidence in the above studies supporting the use of stimulant drugs for ADHD. Children are being exposed to dangerous side effects, and parents, insurance companies, and the taxpayers are purchasing drugs that have no proven long-term benefit.

Due to the fact that 15% to 30% of ADHD drugs end up being used by children who don’t have ADHD, do the drugs benefit these children in any way? Although children without ADHD believe that stimulants enhance their cognitive ability, a recent study that examined objective measures like episodic memory, working memory, inhibitory control, intelligence, and scholastic achievement could find very little cognitive benefit from the stimulant Adderall. These children without an ADHD diagnosis are getting high and being exposed to dangerous side effects from stimulant drugs they obtain from friends, but the drugs are not helping them perform better in school.

The burden of proof is on the drug companies and doctors to show any long-term benefit of stimulant drugs for ADHD. The evidence presented in this article clearly indicates little to no benefit. In the absence of any benefits, prescribing these drugs to children should be banned.

Getting Drug Companies to Release Clinical Trial Data

There’s a tension in our society between openness and confidentiality. On the one hand, we celebrate openness and full disclosure. Men like Julian Assange and Edward Snowden who allegedly break laws and release confidential or classified information are lauded as anti-establishment heroes. The media doesn't allow politicians, celebrities, and other people in the public eye any privacy. On the other hand, laws like HIPAA restrict our ability to acquire health care information about other people. I recently blogged about the inability of parents to find out about their children’s mental health treatment.

A change has been occurring regarding public access to pharmaceutical clinical trial data. A recent New York Times article talks about the efforts of researchers to push drug companies to release unpublished clinical trial data.

The article profiles Peter Doshi, a M.I.T.-educated researcher, and Dr. Tom Jefferson, a British epidemiologist. They collaborated to determine if the anti-flu drug Tamiflu was effective. Jefferson had earlier concluded that Tamiflu reduced the complications of flu. His review was based on a study that pooled the results of 10 clinical trials. Only 2 out of these 10 trials had been published in medical journals, however. Taking another look at the data, Jefferson approached Roche, the manufacturer of Tamiflu, for the results of the 8 missing trials. Roche declined to cooperate, citing Jefferson’s refusal to sign a confidentiality agreement.

Due to the missing data, Jefferson’s team published an article in the British Medical Journal that concluded that Tamiflu was only moderately effective against influenza-like symptoms, and cannot be shown to reduce complications of influenza (e.g. pneumonia and hospitalization). The journal also did its own investigation, concluding that Roche had hired ghost writers to author some of the articles involving Tamiflu, pressuring the writers to highlight positive aspects of the drug.

After the British Medical Journal articles appeared, Roche turned over partial copies of study reports. The European Medicines Agency also turned over documents from 19 trial reports to Jefferson and colleagues. These documents allowed researchers to discover the importance of clinical study reports, which are thousands of pages long, and contain details such as descriptions of trial protocol and design, and ingredients of placebo pills. This April, Roche further relented, agreeing to make available clinical study reports for all Roche-sponsored trials of Tamiflu.

“All these years later, and we still don’t know if Tamiflu is effective,” said Dr. Harlan Krumholz, a Yale cardiologist. “It’s perplexing to have a billion-dollar drug, and you’re not willing to share everything you’ve got to know whether this thing is effective and safe.”

Prodding from Doshi and others led the pharmaceutical company GlaxoSmithKline to announce that it will share detailed data from all company-sponsored trials dating to 2000. This would amount to more than 1000 trials involving more than 90 drugs. Due to past misdeeds, Glaxo needed an image rehabilitation. Last year, it pleaded guilty to criminal charges and agreed to pay $3 billion in fines. It had been accused by the U.S. Justice Department of failing to report safety data about its diabetes drug Avandia, and publishing misleading information about the antidepressant Paxil. The settlement, which also involved civil penalties over marketing of other drugs, was the largest ever involving a pharmaceutical company.

Publication bias of studies involving antidepressant drugs is a topic in Irving Kirsh’s book The Emperor's New Drugs (which I review here). Kirsh had used the Freedom of Information Act to obtain unpublished clinical trial studies of antidepressants from the FDA.

Not everyone in the pharmaceutical industry is happy with the new openness. The Pharmaceutical Research and Manufacturers of America (PhRMA), a major industry group, and other drug companies oppose releasing clinical trial data. John J. Castellani, chief executive of PhRMA, said that “[i]f you dump onto the sidewalk all the data and you include commercially protected information, then you’re essentially giving to competitors what we invested billions of dollars in.” U.S. federal law restricts what information can be released, especially data that can reveal personal or commercially confidential information.

My view is that the public has a right to know all the results of studies of a particular drug, both positive and negative. It’s the pharmaceutical company’s obligation to provide this data. They certainly have a right to withhold commercially protected information, and private research participant data, but they don’t have the right to only publish positive studies, and hide negative studies. I applaud Doshi, Jefferson, Kirsh and others who have helped push drug companies to release clinical trial data.

Parents Denied Information on Their Children's Mental Health Care

Imagine being a parent of a child with serious mental illness. You’re anxious about your child’s well-being. You’re concerned about his future. You feel stressed out having to cope with his mood swings, meltdowns, tantrums, antisocial or violent behavior, etc. You’re disappointed that your child’s future isn't as bright as you once imagined. On top of these sources of anguish, what you don’t need is a mental health system that denies you information on your child’s treatment. This is what many American parents of mentally ill people are faced with, according to a recent Wall Street Journal article.

The article describes several parents of violent mentally ill men. Suzanne Lankford's adult son allegedly knocked her out with a blow to a head, participated in an armed robbery of a mall, and assaulted a nurse and law enforcement officer. He has exhibited paranoid symptoms, phoning in reports of people stalking him, and barricading himself inside a room to ward off imaginary assassins. Ms. Lankford is unable to get any information on her son’s treatment, due to privacy concerns.

Pat Milan's adult son, diagnosed with paranoid schizophrenia, had cut his throat and dug his own grave in his backyard. His son was admitted to a treatment facility in 2011, but released eight days later despite protests from his father. Professionals at the treatment facility noted homicidal and suicidal ideation, and that he had a suicide plan. Pat Milan was denied access to these treatment records. After being brought home, Mr. Milan’s son attached a shotgun shell to a steel pipe, put the combination in his mouth, and exploded the shell via a fuse (the article didn't say if he died).

Being denied access to treatment information isn't only a problem for parents of adult children. Pennsylvania has a law that allows a child as young as 14 to prevent his parents from receiving information about his care. Quoting Rep. Tim Murphy (R, Pa.), "So you have a seventh- or eighth-grader making decisions on their mental illness. I wouldn't let a 14-year-old decide much of anything."

What is the reasoning behind this denial of access to information about immediate family members? Ira Burnim of the David L. Bazelon Center for Mental Health Law, a Washington, D.C., advocacy group, says that confidentiality is vital to ensure that patients seek treatment. According to Burnim, "the current system discourages patients" from seeking care because of the stigma of mental illness. HIPAA is the legal framework that restricts access to protected mental health care information.

The article also talks about the obstacles to involuntary commit mentally ill individuals to treatment. Five states don’t allow involuntary mental health treatment at all, Nevada has a bill pending that would allow it in some circumstances, and the other 44 states have stringent requirements for involuntary treatment.

E. Fuller Torrey, founder of the Treatment Advocacy Center, estimates that 216,000 of the homeless population, or about 1/3, are adults with severe untreated mental illness. He also estimates that there are 400,000 untreated mentally ill adults in jails and prisons.

I think that immediate family members should by default have access to health information. Parents should be given access to their adult children’s mental health treatment records. This access should only be taken away if the child specifically requests it. There’s no reason to deny parents information. In most cases, parents are trying to do their best for their children. They need to be informed to either make decisions on behalf of their children, or assist their children in making the correct decision. Mental illness impairs judgment and rational decision making. People with mental illness need all the help they can get from their family.

I have a personal example to relate about this. When I was a freshman in college, I had some serious mental health issues. I saw someone at the student health center, who referred me to an outside therapist. To pay for this therapy I would have had to tell my parents about it, since I needed their financial assistance. I didn't want them to know about my problems, so I decided not to pursue treatment. I have no idea whether or not therapy would have been helpful at the time. But the rational decision would have been to try treatment, even if it meant that my parents would know that I was having problems. The problems eventually got worse, and my parents found out about them anyway.

Involuntary treatment is another issue. The article combines mental health information and involuntary treatment, but I see them as separate. I used to be in favor of involuntary treatment for the mentally ill. That was when I believed that drug treatment was effective and safe. I don’t believe that any more, after reading Anatomy of an Epidemic (which I review here). Drug treatment has never been proven to be long-term effective for psychiatric disorders. Depending on the drug, side effects can be severe and debilitating. Antipsychotics have some of the worst side effect profiles, with the older ones causing movement disorders like tardive dyskinesia, and the newer ones causing metabolic disorders like weight gain and type-2 diabetes. The people most likely to be involuntary committed are those with schizophrenia and other psychotic disorders. They are almost guaranteed to be prescribed antipsychotic drugs. I don’t think that people should be coerced to take drugs that have never been shown to improve their long-term functioning, and which have such serious side effects.

In conclusion, let’s allow parents to be informed about their adult children’s mental health treatment, but let’s not allow parents to involuntarily commit their children to forced drugging and hospitalization.