A recent study has found that use of antidepressants by the mother during early pregnancy did not significantly increase the risk of poor fetal growth or the child’s risk of developing Autism or ADHD as previously thought. As well, only a slight increased risk for premature birth was found. This is the largest study to date, looking at over 1.5 million infants, using all live births in Sweden from 1996 to 2012. The information was matched to data on antidepressant use, mostly SSRIs, and autism and ADHD diagnoses. The study was led by Indiana University with analysis collaboration between the researchers at Karolinska Institute in Sweden and Harvard T.H. Chan School of Public Health.
This study’s results is of particular interest, not only for its size, but that researchers were able to compare outcomes in siblings when the mother was taking medication for depression and when she was not treated. The study looked at the use of antidepressants in fathers as well as use in mothers prior to pregnancy and found increased rates of both Autism and ADHD leading researchers to believe that genetics and a history of depression were a factor rather than the use of antidepressants.
Read more about the study HERE
On April 18th BC PharmaCare announced that it was expanding its existing coverage of medications for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in the paediatric population.
Three long acting ADHD medications (Adderall XR, Vyvanse and Strattera) will be added under the Special Authority (SA) program.
During the fall of 2015, CADDRA, B.C physicians and CADDAC, called on the B.C. government to provide coverage for all long-acting medications for all age groups diagnosed with ADHD. So, CADDRA and CADDAC along with BC medical practitioners welcome these expanded medication options for children. However, British Columbia continues to lag significantly behind other provinces by denying coverage to individuals over 19, thereby discriminating against adults with ADHD.
The GOOD NEWS
Since treatment through medication is not a “one size-fits-all” scenario, adding more choice improves the ability “to get a better treatment fit.” And clinical experience tells us that long-acting medications are better tolerated, have fewer side effects, greater effectiveness, less abuse potential, and improved adherence.
The BAD NEWS
On turning 19, children who have had access to these medications through Limited Coverage will now be refused treatment under PharmaCare. To qualify for access to these newer medications as a child, they had to fail on a trial on the short acting medications. Therefore, reverting back to these medications is not an option.
This is the wrong time to remove treatment. Moving into post-secondary education, the workplace and adult life is one of the most vulnerable times. We will be setting them up to fail.
The only way that adults with ADHD, might access these newer medications is for their doctor to spend hours mining years of medical data from numerous sources, and writing lengthy reports describing symptoms and past failed medication trials.
IN SUMMARY
Increasing treatment choices for children and adolescents with ADHD using Pharmacare is good. Barring adult patients’ access to these treatment options is discriminatory. This will result in increased post-secondary school failure, more job loss and unemployment and greater overall costs to health care.
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Results of the largest ADHD brain imaging study of its kind was released this week in The Lancet Psychiatry. MRIs of 1713 people with ADHD were compared to a control group of 1529 people without ADHD, between the ages of 4 and 63, across 9 countries.
Some of the study’s findings were:
Why are these findings of interest?
To listen to our interview click HERE
To view more access, CBC Lancet ScienceDaily
A recent study by the Institute for Clinical Evaluative Sciences found almost 12 per cent of children and youth with attention deficit hyperactivity disorder, or ADHD, were prescribed antipsychotics like Risperdal, Zyprexa and Seroquel. Since the study found that 5% of Ontario children have ADHD, this means that .06% of children may be receiving antipsychotic medications. The study went on to report that 20% of children with ADHD were also receiving antidepressants for depression or anxiety which the lead researcher Dr. Paul Kurdyak, head of the mental health and addictions program at ICES, did not find surprising since these disorders frequently coexist with ADHD. However, the researchers did find it surprising, that children with ADHD would be receiving antipsychotic medications when these medications have not been shown to treat ADHD.
Unfortunately the article implies that these medications are being used to treat simple ADHD, while at the same time conceding that these medications have a sedating effect and assist with disruptive behaviour. Unfortunately what the researchers did not mention is that some children with a more severe presentation of ADHD can also have extreme forms of emotional dysregulation, in some cases so severe that they are unable to attend school or be involved in normal family life without experiencing episodes of emotional “meltdown” and sometimes aggression. This would be the common profile of the majority of children who are receiving these medications. Normal levels of ADHD disruptive behaviour would not commonly warrant a prescription of antipsychotic medication.
In addition, it makes perfect sense that more people who see a psychiatrist have these medications prescribed. It is child and adolescent psychiatrists who generally see these more severe cases. General practitioners and paediatricians refer these more difficult cases to child and adolescent psychiatrists, when they have been unable to successfully treat the child themselves. Of course, better education for front line physicians on how to assess, diagnosis and treat ADHD appropriately may be helpful as well. We know that the sooner we diagnose and treat ADHD the better chance we have of reducing co-existing disorders and the long term consequences of ADHD.
No one would argue that if there is a choice antipsychotic medication should never be given to children and that psychotherapy should always be the first choice of treatment. Unfortunately it is also true that affordable family, child and youth mental health therapy is very difficult to access across this country resulting in a two tier mental health system. However, after speaking with many of these families and the physicians who treat these children it is clear that even when parents do everything right and therapy is implemented, for some children and youth it is still not enough.
Also, no one would disagree that many of these medications have significant side effects and should not be a first line treatment. However, at this time there are no medications that have been approved to specifically treat these symptoms in children and youth so physicians are forced to use these medications off label. Obviously more research is required.
One new medication, Intuniv, has been approved by Health Canada for treating children and youth with ADHD and has been found to be very helpful for many children with emotional dysregulation and aggression issues. This medication is not an antipsychotic medication and can be prescribed along with ADHD stimulant medication or on its own for those who have difficulty tolerating stimulant medication, or have not found stimulant medication to be effective. While Intuniv does have some mild side effects, as do all medications, they seem to be far fewer than those of antipsychotic medications.
For this reason CADDAC is currently asking the Ontario Public Drug Program to include this medication on their list of approved medications making it accessible to families receiving their medication through this program. Advocacy on this issue in other provinces is also on the agenda. As this study indicates not many children will require this medication, and while it will not work for all children with these symptoms, I have spoken to many families who have indicated that it has changed their child’s life and their family’s quality of life.
Of course, better access to newer more easily tolerated once-a-day ADHD medications being covered on provincial drug programs would be helpful and may actually help to decrease prescribing of antipsychotic medication. Coverage across Canada is sporadic leaving vulnerable families unable to access a wide variety of ADHD medications. The more choices we have in ADHD medication the better chance we have of being able to achieve the best treatment options for each child and adolescents with mental health disorders. Unfortunately mental health medications are definitely not a one-size fits all scenario.
My major concern about articles on this particular study such as this CBC article, and often articles on other ADHD topics, is that writing about these very complex issues superficially and with an aim to sensationalize only increases misunderstanding about childhood mental health and the way we treat it. They also result in increased stigma, confusion and fear for parents and care givers trying their best to make informed decisions on treatment for their children.
This past week, a follow-up letter was received from Marion Law, the Director General of Health Canada’s Therapeutic Products Directorate (TPD) addressing discussions during the Oct 31 meeting with Janssen, CADDAC and ADHD medical experts.
The letter noted that:
CADDAC will continue to communicate with Health Canada, monitor the situation and report back to our stakeholders.
On October the 31st CADDAC and CADDRA, as well as other stake holders, met with Health Canada to present our activities over the past six years and express our continued concerns in regards to the bioequivalency, or more accurately the lack of therapeutic equivalence, of the generic forms of the brand name ADHD medication Concerta. Heidi Bernhardt President and Executive Director of CADDAC presented information on past advocacy efforts, patient feedback and patient surveys carried out to obtain patient feedback on this issue. In addition she addressed the continued challenges CADDAC is experiencing in having patients and caregivers report on adverse events such as the decrease in symptom control and increase in side effects of these medications. Dr. Doron Almagor, President of CADDRA, reviewed the individual and societal impact of ADHD and summarized Canadian and US adverse events and lack of efficacy reporting on these generic medications. Dr. Murray Ducharme covered the different processes and timing of absorption, peaking and elimination of the brand versus generic medications and why they are not therapeutically equivalent or bioequivalent. Dr. Judy van Stralen presented on three studies which demonstrated the difference between Concerta and the TEVA generic product. In addition she spoke about the additional wait times this issue has added to her clinic. Several of the presenters also shared specific troubling patient cases with bad outcomes due to substitution by the generic medication.
At the close of the meeting all were informed that we would receive a decision within the next month on what the Health Canada’s next steps might be.
Since CADDAC continues to receive feedback from our stakeholders about reduced symptom coverage and/or increased side effects they are experiencing with the generic forms of Concerta available in Canada we are keeping you updated on what is occurring south of the border and in Canada on this issue.
You may remember that in the fall of 2014 the US Food and Drug Administration (FDA) determined that two generic versions of Concerta one manufactured by Mallinckrodt Pharmaceuticals and the other by Kudco would be downgraded. This meant the Mallinckrodt and Kudco products were still approved and could be prescribed, but were no longer recommended to be automatically substituted for Concerta by a pharmacist. These medications are not available here in Canada, but we do have different generic versions of Concerta here that have been approved for direct substitution and remain so.
Recently, the FDA announced that "Neither Mallinckrodt nor UCB/Kremers Urban has voluntarily withdrawn its product from the market, and neither has provided data confirming its product’s bioequivalence consistent with the revised recommendations. Accordingly, the FDA is proposing to withdraw approval of the products’ ANDAs and is announcing an opportunity for the firms to request a hearing on the proposal. As part of this process, the FDA is publishing Notices of Opportunity for Hearing (NOOHs) on its Proposals to Withdraw Marketing Approval in the Federal Register. If approval of these ANDAs is withdrawn by the FDA, the products will no longer be able to be marketed in the U.S."
I will be meeting with Health Canada next week to share feedback that CADDAC has received through our past parent/adult surveys and the e-mails, calls and discussions with our stakeholders.
After our meeting I will up-date you on any feedback that we receive during the meeting or any decisions made by Health Canada.
Access the full FDA announcement HERE
If you have ever wondered how to respond when your friends and family question the validity of ADHD? Or do you get hot under the collar whenever you read another article telling you that ADHD is due to bad or lazy parenting or unmotivated or defiant kids? If so, you need to read Patricia Tomasi’s response to an article in the Huffington Post by Alyson Schafer. Not only does Patricia correct many of the mistruths in Ms. Schafer’s article she calls out the Huffington Post for publishing the article. The Huffington Post will most likely hide behind the fact that this is a commentary and not a factual piece. But let me ask you this, would they have published a commentary questioning the validity of depression as a disorder? Of course not, they would be tarred and featured. But for some strange reason people still use the fact that there is no blood test that can be used to diagnose the disorder as justification to question its existence. Well there are many conditions in mental and physical health that do not have a particular test that validates their existence, but that is why we use experienced physicians to rule out other disorders that could be causing the symptoms and validate the occurrence and history of the symptoms of the disorder, just as we do with ADHD. So the next time someone brings up the issue with you and you start to feel your blood boil, pull out Patricia’s article and know that she has it covered.
Access Patricia Tomasi’s article Here
Results of a recently published study, “A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA®) and generic novo-methylphenidate ER-C (NOVO-generic)” confirms concerns expressed to CADDAC over the past number of years by adults with ADHD, parents of children with ADHD and physicians treating patients with ADHD who have been switched to a generic medication. The objective of this study was to evaluate adult ADHD subject outcomes when they were switched from a stable dose of CONCERTA® to the same dose of generic Novo-methylphenidate ER-C®.
The small study consisted of 20 participants with a primary diagnosis of ADHD. It consisted of two phases; 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C, followed by 3 weeks where participants were crossed-over to receive the other treatment. The effectiveness of each treatment was assessed through the use of the Treatment Satisfaction Questionnaires for Medication, Version II (TSQM-II).
A pharmacist, outside of the physician’s office was used to produce the medication. In order to maintain the “blind”, both CONCERTA® and novo-methylphenidate ER-C were put into a white opaque capsule. Neither the investigator, research team, nor the participant knew which medication was being taken during which three week period.
Results:
The participants treated with CONCERTA® were more satisfied in terms of the medication’s effectiveness and lack of side effects, than those receiving an equivalent dose of the generic version novo-MPH. These results were also supported by the physician-reported Clinical Global Impression (CGI) outcomes. The Clinical Global Impression – Severity scale (CGI-S) allows a clinician to rate the severity of a patient's illness. All study subjects chose to return to treatment with CONCERTA® at the conclusion of the trial. The researcher’s interpretation of these results was that the adults with ADHD were satisfied and feeling better with CONCERTA ® treatment than with the generic form of the medication.
The paper explains that when a generic medication is deemed to be bioequivalent by Health Canada it is assumed that it will provide patients the same therapeutic effect and the same level of tolerability (number and degree of side effects) as the branded drug. The paper then goes on to explore a potentially serious issue, since the generic medication was deemed to be bioequivalent by Health Canada - if the study’s results indicate clinical differences between the generic and brand medication, at least for those patients who have been stabilized on the brand medication, is the current method of determining bioequivalency sufficient to ensure equivalent treatment when switching a person to the generic product? At this time, the only criteria requirement for bioequivalency is that - at any given time - the amount of medication in the bloodstream must be 80% to 125% of the amount of the same medication that would be in the blood stream if the brand medication was taken. Differences in the delivery system of the medications are not taken into account when determining bioequivalency.
The paper also looks at the risk of substitution with a generic product when only comparing cost benefits of generic medications. Things such as costs of increased doctor and emergency room visits, and nonadherence to the treatment may cost much more in the long run. The paper closes with a call for further investigation into all these questions and concerns.
I was just interviewed about a recent study published in the Journal of Pediatrics. This study looked at data from 378,881 children, ages 4-17, from 1997 to 2011 in Taiwan and analyzed the percentage of children who were diagnosed with ADHD and prescribed medication. Researchers compared the percentage of children diagnosed from youngest to oldest in a particular grade and found the younger the child (born closer to the cut off for enrollment in that year) the greater chance they were diagnosed with ADHD and treated with medication. The data was consistent for this finding in pre-school and school age children, but not adolescence.
Several things struck me while reviewing the study and the researcher’s conclusions. Here are my comments;
The findings are important for medical professionals, educators and perhaps parents to take note of, as are most research findings;
If the child’s age and maturity may be in question further monitoring may be a first step,
Since professionals who diagnose ADHD are trained in child development, one would think varying rates in development should already be on their radar, but reminders never hurt;
While the data is of interest, conclusions should not be drawn too quickly;
Since we know that many factors such as, higher levels of intelligence, parental support and lack of hyperactivity, to name a few, can delay or prevent the diagnosis of ADHD even when it exists, perhaps the data may be indicating that the older the child (in that school year) the greater risk of being undiagnosed and untreated. The increased age and maturation level may be masking their ADHD symptoms.
Of further interest, is that these researchers give us significant insight into their bias with their statements, ”On the basis of the aforementioned studies, we conclude that the relative age among classmates affects the academic performance of children and their risk of receiving ADHD diagnosis and medication. Furthermore, clinicians should be reminded of the potential harm of overdiagnosing and overprescribing.”
Access more information on the study HERE
