How can this be? Don’t bother asking because privacy laws shield the drug company applications for PBS listing from public scrutiny.
by 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 licenced 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.”1
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.”2
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 licenced 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.3 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.”4 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?
Related Media
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
- see http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-july12-first-time-rejections ↩
- see http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-july12-first-time-rejections ↩
- see http://www.martinwhitely.com/foi/ ↩
- see http://www.medicines.org.uk/emc/medicine/8382/SPC/Concerta+XL+18+mg+-+36+mg+prolonged+release+tablets/ ↩
Tags: ADHD, Concerta, methylphenidate, PBAC, PBS, Pharmaceutical Benefits Scheme
And of course they claim that everything that is done is for the good of the population!! While I totally agree with what you have said, what is also ironical is that it can be used after the age of 18, providing they were on it before the age of 18!!
There certainly are drugs in other categories that work for children and not for adults, but in those cases you are usually looking at very young children, and they don’t work for adults, not that they are dangerous for adults, as adults would simply require too much of them to gain any theraputic benefit.
If it is OK to be on a drug at the age of 17 years and 11 months, then why not 17 years and 12 months, because that is effectively what they are saying. Actually they are saying that it is OK to be on them at the age of 50 or higher, providing they were on them before hand!!
If anything they are saying that the diagnosis is not valid after that age, and IF they truly had ADHD and it was some neurological condition, which is what proponants of these drugs believe, then in reality they would have been diagnosed long before, because they would always have been that way.
If anything the fact that the drug company is requesting it for adults diagnosed as adults they themselves are saying how flawed the diagnosis really is, and that they themselves know it!! Afterall how can someone have managed to make it to age 18 without someone knowing they had some very obvious condition!!
The drug companies are simply trying to get into a new market, that of university students, wanting the drug to cram for exams and the like!! And of course we all know how easy it is to get a diagnosis of ADHD, actually how easy it is to get a daignosis of ANY condition at all!!
I don’t think it’s a lack of clinical studies on children (compared to adults). It’s in another line. The main thing about children and ADHD drugs is that children take these drugs for someone else, not for themselves. Children are more LIKED by the adult world when they take drugs, and that’s the thing children want to be. This liking element (children noticing that adults react more friendly when they take the drugs) is the key when the children themselves are evaluating the results. (See: Frankenberger, Use of stimulant medication for treatment of attention-deficit/hyperactivity disorder: A survey of middle and high school students’ attitudes: “Students reported that the greatest single measured affect of treatment with stimulant medication was that their teachers and parents liked them more when they took their medication.”) The prescription of ADHD drugs to children and participation in clinical trials, are not for the children themselves but for adults (with scales like “Child as a burden”). It’s a compulsory treatment. It’s easier to get a “positive result”, for the quick fix, in a short term studies of children. It’s the judgement of parents and psychiatrists that create the positive results in clinical trials (and the “liking element” for the children themselves). There are other factors present in studies of the adult population. We get another picture of the results – at least when we get into studies lasting longer than a couple of weeks. Like Janssen’s best studies of Concerta on adults. No positive results after five weeks, no long term positive results in the so called “withdrawal study”, a considerable abuse potential shown in the “abuse potential studies” and many adverse events (aggression, agitation, depression, anxiety).
Clinical studies for psychotropic drugs as a whole rely on psychiatrists reports and not patient self reports. In fact it took prozac over 15 years to get on the market in Germany and then it was very limited as they insisted on studies in which patients gave self reports of feeling better, not just psychiatrist assessments. Psychiatrists had successfully argued with ALL other countries, including Australia that patients are not capable of assessing if they are better or not for any other condition, so why should they for these conditions. After all patients do not decide if they no longer have cancer, doctors do via medical tests. Problem is the only tests they use to determine if someone is unwell is the self report of the patient, so why not in this case also. There is no way at all that ANY antipsychotic would be on the market if they required patients to say that they no longer heard voices or that they even heard them less. Antipsychotics sedate people, they are so sedated they no longer talk about the voices, problem solved. In fact for the first 15 years that these drugs were on the market EVERY article in medical journals all said that they were not doing anything to treat the underlying condition, they were in effective putting into a coma of sorts, so they were puppet like and that meant the patients simply sat in hospitals without moving or asking for anything from the staff and that must be a massive improvement for the staff. NO psychotropic drug has ever been assessed as effective for longer than a few months. But the drug regulation authorities do not require that. Short term 4-6 week studies, after you have wiped out half the group via placing them all on placebo for the first month and all that is done. Placebo responses are a massive problem, so all clinical trials are conducted by placing everyone on placebo for the first month. That way those that are going to get better on there own, or respond to a placebo are not included in the results, and so you have a much higher chance of getting a positive result. Of course even then though over 80% of studies do not result in favourable results, but they do not need most studies, they just require 2 studies, even if they have done 500 studies before hand to get to those 2 it is perefectly acceptable. They are required to lodge all documents, and if you read the fine print of what they are required to make public they do say how many studies in total have been done. They also state what positve results have been obtained. While they do not say how many were not positive 2+2= 4, and it is very easy to work out.
Thanks Belinda, very sharp and interesting.
As for the Concerta affair it would be very interesting to see the investigation behind the decision from PBAC. Can it be that the Committee has read the investigation behind the disapproval of Concerta for adults in Europe? If so they know that Janssen’s submitted controlled clinical trials failed to show a positive results (longer than five weeks).
Imagine Janssen choosing their best studies, the ones the company really considers show the positive results of the drug for adults. And then the medical authorities find that two of the three must be considered failed – not showing any significant positive results compared to placebo. Imagine the company submitting “abuse potential studies”, which should show that the abuse potential of Concerta was low – but which showed the opposite, leading to the conclusion from the Dutch medical agency: “… the misuse/abuse potential of methylphenidate is considered a major safety concern: in combination with the concerns regarding the reliability of the diagnosis, adults may try to get diagnosed for ADHD to retrieve methylphenidate in a legalised manner.” One reason that Concerta and other methylphenidate products are prescribed is that they are said to improve anger outbursts. Janssen’s studies showed: “A causal relationship with Concerta was established for aggression, tics and depression.”
I guess all parents who are being told that Concerta and other stimulants have “mild and transitory side effects” would want to read what Janssen’s studies on adults really showed. If PBAC has access to the above investigation it’s a shame that they are not making it public.
People would do well to know this stuff about ALL psychotropic medications. Antipsychotics have not been shown to be of any use for more than 6 weeks. Yet people are not only told they are safe, they are also COURT ORDERED to take these medications for decades. Eventually they die from the drugs. Antidepressents have not been shown to work for more than 6 weeks, and people have also been court ordered to take them for decades on end.
I can assure you the PBAC is well aware of what all of these studies show and they know they are not as safe as we have been convinced off. They are well aware that MOST studies do not show these drugs of any use, and with huge side effects. The reality is that it will make very little to no difference.
Antidepressents are not approved for use in people under the age of 18 in Australia, or in fact anywhere in the world. The Theraputic Goods Administration has determined that there is NO evidence of there effectiveness. And that is the truth. There is NOT ONE STUDEY anywhere in the world to show they are of any use for ANY length of time. BUT they are approved by the PBAC and are covered by the PBS!!! This is not about some research being good, some being bad. NO research has EVER shown anything at all. But they are quite happy to hand them out like candy!!
The PBAC does have access to those studies, the law requires ALL studies to be released to them and the truth is they are. They just choose to ignore them. They believe that the benefits far outweigh any side effects. They believe this in relation to ANY condition. They believe that these are real brain diseases, and that these medications are simply like insulin for diabetes. One does not diagnose ANY other medical condition sitting four feet away from someone with a pen and paper.
This is much deeper than many want to believe and Australia does have the worst system. The links of medical professionals here and also associated organisations that represent these conditions have massive ties to drug companies that are not disclosed. The fines drug companies pay for false advertising are also of no consequence here. The maximum is $50,000. Compare that to the $3 BILLION dollar fine handed out to a drug company in the US for false advertising. Much like a speeding fine they had the right to go to court and fight it. They didn’t! They simply wrote out a cheque and paid it within a week, no questions asked!! And why would they. The sale of ONE of these drugs makes them more than that in a month, in the US alone. These drugs are worth big big money. This is very much like big tabacco, aspestos, etc.
Members of the PBAC are allowed to get paid by drug companies, as are those on the TGA board who approve the drugs initially. Patrick McGorry and others get paid by drug companies, not just in the research, but also as key opinion leaders. Drug companies pay them to say how good the drugs are. They do so supposedly as independent experts. That allows they to advertise, without advertising that these drugs are good and work for long periods of time. Drug companies are not going to pay someone to say the drugs don’t work, that they only work for short periods of time, etc.
ALL other countries at least require those conflicts of interest to be made public. Australia does not. We are currently “considering” a VOLUNTARY code for monies paid to organisations, not to individuals!!! The government has refused to force them to do so. Saying they don’t want too many regulations on the industry, as it then regulates and too much is spent on that and nothing on helping people!! Think of the organisations for ADHD that advertise and promote the use of these drugs. Guess where the money for them to operate comes from?? SANE Australia, again the vast majority of their funding comes from drug companies. Those with access to the books will tell you that. These places, NEVER make figures publically available for the general public. The not for profit I am with has its annual reports, which includes ALL financial reports on the website?? We are happy to hand it out. Why are these organisations not. Ask for a copy of it, I can assure you it will not be provided to you and if it is, it will not detail WHERE the money came from.
Until this is ALL open then nothing will change. The industry is not going to regulate themselves, as those in charge of it, are earning too much from it!!
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