How can this be? Don’t bother asking because privacy laws shield the drug company applications for PBS listing from public scrutiny.
by Dr Martin Whitely
ADHD drug Concerta is a slow release form of methylphenidate (the active ingredient in Ritalin) that can be taken once daily. It was first licensed for use in Australia by the Therapeutic Goods Administration (TGA) in 2003 and subsidised via the Pharmaceutical Benefits Scheme (PBS) for use by children in 2007.
Recently Concerta’s manufacturer Janssen-Cilag (a subsidiary of Johnson and Johnson) applied to “extend the current Authority required listing” on the Pharmaceutical Benefits Scheme for Concerta “to include use in patients diagnosed with attention deficit hyperactivity disorder (ADHD) after the age of 18 years”. The Pharmaceutical Benefits Scheme Advisory Committee (PBAC) “rejected the application on the basis of uncertain efficacy and safety in the proposed PBS population and hence uncertain cost-effectiveness, and high and highly uncertain cost to the PBS.” In response Janssen Cilag commented that “Concerta is already available on the PBS for use in adults who were diagnosed with ADHD ≤ 18 years. This submission requested the same access for all adult patients regardless of the age at which they were diagnosed. We will consult with the PBAC with regards to a future resubmission.”
Janssen Cilag raise a valid point; How can Concerta be ok for children and yet have “uncertain efficacy and safety” for adults? They believe that contradiction should justify taxpayers subsidising Concerta available for adults. In contrast I argue that if Concerta isn’t proved to be safe enough for adults there is no way it should be given to children. However, the history of Strattera shows that once an ADHD drug is licensed and subsidised for use in children even a trail of horrific adverse events are not enough to see it removed from the market or even the PBS.
Unfortunately due to an absurd interpretation of privacy provisions in the National Health Act 1953 by the Administrative Appeals Tribunal, documents about PBS listing decisions are FOI exempt in the same way as individual patient records. Therefore the public has no way of knowing the detail of why the PBAC made its decisions to oppose Concerta’s subsidisation for adults (in 2012) and yet support it for children (in 2007). Of course Janssen Cilag has full access to these documents and can have another go at obtaining subsidisation later.
Without access to the documents the PBAC use to reach its decision we can only speculate on the reasons for the seemingly absurd inconsistency. One possible explanation is that children can’t give informed consent to participate in drug trials that establish the safety and efficacy of drugs used on children. Ironically this often results in drugs being used by millions of children worldwide without any paediatric safety and efficacy testing.
Could it be that authorities established to protect the public interest including the PBAC and the TGA, have in the absence of supporting information, simply assumed that Concerta is safe and efficacious for children?
Note: The PBAC decision mirrors a 2011 decision by European drug regulators to disallow Concerta’s use by adults unless they were originally prescribed Concerta before their 19th birthday. According to information provided by Janssen Cilag on a UK website “the safety and efficacy of long-term use of methylphenidate (by children) has not been systematically evaluated in controlled trials” and the “safety and efficacy have not been established for the initiation of treatment in adults or the routine continuation of treatment beyond 18 years of age.” However, off label prescribing is common and many adults both in Europe and Australia use methylphenidate either in Ritalin or Concerta and many children use it for years on end.
For more on the long term effects of stimulants on children diagnosed with ADHD see One year on from the Raine Study ADHD Medication Review – Will the analysis of this unique long term data source continue and if so can we trust those doing the analysis?
Australia’s News Limited Sunday papers (Perth’s Sunday Times, Sydney’s Telegraph, Melbourne’s Herald Sun etc.) carried a story about the above written by Sue Dunlevy on 9 September 2012. See http://www.heraldsun.com.au/news/national/kids-use-rejected-adhd-drug/story-fndo48ca-1226468130766