Whether generics are really therapeutically equivalent to branded versions of drugs has long been controversial. The US Food and Drug Administration (FDA) requires that generic companies demonstrate “bioequivalence” before they can be marketed, although these studies are conducted with healthy volunteers. Nonetheless, most of our patients are taking generics, and we hardly ever hear complaints.
Rarely, the FDA itself flags problems with generics—as they recently did regarding two generic versions of Concerta (methylphenidate extended-release) (http://Lusa.goy/nVqUyF). The FDA’s action came after it re-examined previously submitted data for the three generic versions of Concerta currently on the market. They found that the generic versions manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland delivered methylphenidate (MPH) at a slower rate over 10 to 12 hours than branded Concerta. Only Janssen Pharmaceutical’s generic version (marketed as Actavis) released MPH at the same rate.
The FDA’s action included downgrading the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. That means these two generics are still approved for use and can be prescribed, but are no longer recommended as automatic substitutes for Concerta.
What this means for prescribers depends on the scenario. Scenario A: Your patient is on one of the slow versions of Concerta and is doing perfectly well—no change needed. Scenario B: Your patient is on a slow generic and isn’t doing well—switch to Concerta or Activis. Scenario C: You are newly starting a patient on Concerta, or switching from brand to generic—specify on your script that you want it to be filled with Activis.
By the way, the FDA told Mallinckrodt and Kudco Ireland in November to fix their products within six months or to voluntarily withdraw them from the market. We’ll keep you apprised.
Omega Fatty Acids Might Help Kids with Attention Deficits
Given new research from Sweden, it won’t hurt—and might help—for clinicians to suggest their patients with attention deficit disorder (ADD) take supplements of the fatty acids omega 3 and 6.
The supplements can help children and adolescents with ADD, which is the inattentive subtype of attention-deficit hyperactivity disorder (ADHD), according to the findings of a dissertation done at the Sahlgrenska Academy at the University of Gothenburg.
In a double-blind study, researchers gave 75 children diagnosed with ADHD either omega 3 and 6 or a placebo over three months. Then they gave all the participants the fatty acid supplements over the next three months. While there was no major improvement for the group as a whole, the researchers found in 35% of the participants who had ADD, there was an improvement in symptoms, including being attentive for more than short periods of time. Blood samples also showed those children with an improvement had a better balance between the two fatty acids.
The research also found that a cognitive training program, called Collaborative Problem Solving (CPS), can improve problem behavior in children with ADHD, according to a university news release (http://bit.ly/1pKwWwN). It can be a good alternative or complement in the treatment of ADHD, as well as oppositional defiant disorder (ODD), researchers found. The study included 17 children, who along with their family members, received up to 10 weeks of help in training cognitive ability and solving problematic situations. The families were then asked how much the child’s behavior problems improved immediately after treatment, as well as six months later. Half reported a large or very large improvement.
Those who still experienced severe ADHD symptoms at completion of the CPS training were given the chance to supplement treatment with stimulant medications. In a six month follow-up, 81% of all the participating families experienced a large or very large improvement, according to the university news release. Go to http://hdl.handle.net/2077/36752 to read the dissertation.
Pediatrician Policy Statement: Schools Should Start Later for Healthier Teens
School districts should move start times for middle and high schools to 8:30 a.m. or later, so that students can get at least 8.5 hours of sleep per night, according to the American Academy of Pediatrics.
In a policy statement published in August in Pediatrics, the organization that represents the nation’s pediatricians said later school start times would benefit adolescents’ health, safety, and academic performance. The evidence strongly implicates early school start times as a contributor to insufficient sleep in these teens, who need an optimum 8.5 to 9.5 hours of sleep each night (Adolescent Sleep Working Group; Committee on Adolescence; Council on School Health; Pediatrics 2014;134(3):642-649).
A National Sleep Foundation poll found 87% of high school students in the US were getting less than the recommended amount of sleep on school nights, with high school seniors averaging less than seven hours. Studies have found that a lack of sleep in teens increases the risk of traffic accidents and makes them more vulnerable to depression and obesity. Teens who get more sleep also do better academically.
It’s not just a question of kids getting to bed early. Biology plays a role, so the average teen has difficulty falling asleep before 11 p.m., according to the policy statement. Napping, trying to catch up on sleep on the weekends, and caffeine consumption can temporarily counteract sleepiness, but aren’t a substitute for regular, sufficient sleep. Physicians should make adolescents aware of the need for optimal sleep and encourage parents to get involved in setting bedtimes and supervising activities such as social networking and electronic media use in their kids’ bedrooms, the group said.
CDC Study: Kids Are Flocking to e-Cigarettes
More than a quarter-million middle school and high school students who had never smoked regular cigarettes used e-cigarettes in 2013, according to a study released by the US Centers for Disease Control and Prevention (CDC) (http://1.usa.gov/1p5Cr1v). And lots more kids—three times as many as in 2011—have used e-cigarettes.
The CDC study, published in the journal Nicotine and Tobacco Research, reported about 79,000 students used e-cigarettes in 2011, a number that increased to more than 263,000 in 2013. The data was from the 2011, 2012, and 2013 National Youth Tobacco surveys of middle and high school students. The survey asked respondents whether they had intentions to smoke regular cigarettes. Those who used e-cigarettes were more likely to indicate they have intentions to try smoking tobacco within the next year (43.9%) compared to those who never used e-cigarettes (21.5%).
The Sunshine Act is Out: Now the World Can See What Drug Companies are Paying You
Intended to create financial transparency when it comes to payments from drug manufacturers to physicians, the Centers for Medicare & Medicaid Services (CMS) released reports on Sunshine Act data for 2013 to the public September 30. You can find the reports at http://cms.gov/openpayments.
The reports are the long-awaited result of the Physician Payments Sunshine Act, which requires manufacturers of drugs, medical devices, and biologicals that participate in US federal healthcare programs to report certain payments given to physicians and teaching hospitals. CMS, charged with implementing the legislation, has called it the Open Payments Program.
Physicians are advised to check the site and know what is reported about them. By completing a three-step registration process with CMS, physicians can review their data to make sure it is accurate. You can read commentary about the Sunshine Act and the new program from our publisher Daniel Carlat, MD, on the Carlat Psychiatry Blog at http://carlatpsychiatry.blogspot.com.
Following Release from Prison, Suicide Risk Eighteen Times Higher
Many states are looking for ways to relieve overcrowding in their prisons and jails. For instance, the state of California just passed Proposition 47, which reduces penalties for drug possession and other nonviolent crimes. California is the first state in the nation to downgrade nonviolent and drug-related cases from felonies to misdemeanors. The result is that thousands of felons are now eligible for immediate release from prisons and jails.
A new study, however, reveals that people who have been in prison run a higher risk of committing suicide, particularly just after their release. The risk is 18 times higher than in the general population, according to a study done by researchers from Karolinska Institutet in Sweden (Haglund A et al, J Clin Psychiatry 2014:75(10):1047-1053). By far, the greatest risk of suicide comes in the first few months after release (with the incidence rate highest during the first 28 days). Risk is increased among individuals with a previous psychiatric disorder, a history of substance abuse, and previous suicide attempts.
While the study looked at prisoners released from Swedish prisons, researchers said the findings are consistent with those from other developed nations such as the US. They said facilitating transition to life outside prison, as well as clinical monitoring during the first few months after release, may be needed to prevent suicide (http://bit.ly/1uZ1sV8).
Debate Rages On Over ‘Black Box’ Warning on Antidepressants
It’s been 10 years since the US Food and Drug Administration (FDA) put a so-called ‘black box’ warning on certain antidepressants because of fears they can cause suicidal thoughts and behavior.
The psychiatric community continues to debate the value of that warning, and a pair of opposing viewpoints was recently featured in the New England Journal of Medicine. One called for removal of the warnings (http://bit.ly/1EC0cJb), while the other, written by a medical reviewer at the FDA and proponent of broader antidepressant labeling, challenged the safety claims of the anti-black box crowd (http://bit.l/1olxGr1).
All antidepressants carry a warning label cautioning users that the medications may increase the risk of suicidal thoughts and behaviors in children and young adults. The FDA required the black box warnings in 2004 after data emerged linking the drug paroxetine (Paxil) to suicidal thoughts. Opponents argue the warnings overstate the real risk and discourage physicians from prescribing them to patients who could really benefit from antidepressants.
A recent report in Time magazine (http://ti.me/1oHlaCw) interviewed 17 leaders in the psychiatry field and asked their opinions: 11 said the FDA should remove the warnings; two said the media has overblown the risk, resulting in more panic than is necessary; and four support the warning labels. Among those four, three were involved in the FDA’s original decision to issue the black box warnings.
Despite the controversy, the FDA has no plans to reconsider the warnings, according to the Time article.