Rebadge, Reinvent and Reap Rewards of ADHD Medication

One thing I've learned over the past 8 years of writing this blog is that the system that is supposed to protect us from dangerous drugs is a system that has been infiltrated by pharmaceutical dollars. Be it the FDA, MHRA or any other drug regulatory agency.

I've also learned that the only way one can change how we, as patients, view these psychiatric medications is by opposing the claims of pharmaceutical companies that they actually work and are safe for human consumption.

Be a pain in the ass, the big man doesn't like it. Ask questions, the big man doesn't like it.

I've got a lot of admiration for other folk who have dedicated their lives to getting to the truth about antidepressant type medication, be they human rights movements, professors, journalists, grieving parents or just folk who have the tenacity to never give up in their pursuit for the truth.

Janne Larsson is one such person.

Larsson, who hails from Sweden, has, for many years, been investigating the drug Concerta, an investigation that has now led him to the doors of the British drug regulator, the MHRA.

What we have here is deception of the highest order...a deception that Larsson wishes to make public.

Larsson has wrote to the new chief at the MHRA, Dr Ian Hudson. The question he has put to the former World Safety Officer for SmithKline Beecham is simple...Will the MHRA handle the Concerta scandal by approving Ritalin for adults?

Larsson, after many years of investigation, has kindly copied me in on the email to Hudson. It makes shocking reading.

He writes...

In the beginning of 2011 secret internal MHRA documents revealed: The application to get the ADHD drug Concerta approved for adults was refused; Concerta was found to have “negative benefit/risk balance” for adults.

The disapproval of the drug for adults has been a well-kept secret: NO information whatsoever has been issued by the MHRA or the other European medical agencies about the disastrous results.

Let’s look on what was hidden for doctors and the public.

This is the not published table over the Adverse Events of Concerta in clinical trials. It is part of the manufacturer Janssen’s “Response Document” (page 84) to the MHRA, from 11 January 2011.

In the Company’s three best (!) studies of Concerta on adults, the ones chosen for Janssen’s application, the following harmful events emerged in the short-term studies (up to 13 weeks), where Concerta was compared to placebo:

·         The persons who received Concerta had a 270% increased risk for heart disorders in form of Arrhythmias;

·         The persons who received Concerta had a 116% increased risk for Aggression;

·         The persons who received Concerta had a 62% increased risk for Depression;

·         The persons who received Concerta had a 225% increased risk for neurological disorders in form of Tics/Dystonias;

·         The persons who received Concerta had a 190% increased risk for Psychosis/Mania;

·         The persons who received Concerta had a 295% increased risk for Anorexia;

Meantime, in Larsson's native Sweden, Concerta prescriptions have risen by 60%, netting the manufacturer, Janssen, a cool 488 million SEK (45 million GBP)

Fear not... If one bad drug can be pushed in one country then expect the very same drug to be pushed in other countries. Step into the fray Novartis, manufacturer of Ritalin, an ADHD drug that is, in essence, exactly the same as Concerta.

Larsson finishes his email to the MHRA with the following...

I am sure Novartis has learned from the failed Concerta submission and that there is a big interest from the officials mentioned above to push through the approval of Ritalin for adults. We can expect that the submitted studies will get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results can be expected to no longer exist! Janssen will also be saved; no criminal actions will be taken.

But it’s hard to see how the above can fit with the MHRA declaration: “We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.”

So Mr Hudson, will the MHRA take part in this dirty game of approving Ritalin, so that we can forget about the Concerta scandal?

It's a fair enough question but I don't expect an immediate response from Dr Ian Hudson. I wrote him in November as I was concerned about MHRA consultant, Stephen J W Evans and his recent call for a re-evaluation of the current prescription of SSRIs in young people.

Ironically, I received a reply a few hours ago, not from Hudson but from Sarah Morgan, Group Manager, Benefit Risk Management Group, Vigilance and Risk Management of Medicines.

My query wasn't really addressed by either Hudson or Morgan [no surprise there] - it was the bog-standard "the MHRA has comprehensively reviewed evidence on the benefits and risks of SSRIs" type of email.

I have to take off my hat to Larsson for pursuing this. I hope he is made of strong stuff, my experience with the MHRA and their limp-wristed buck-passing cahoots has been highlighted on my blog and in my book on many occasions.

Good luck Janne!

The full email sent to Hudson from Larsson can be downloaded here.

Bob Fiddaman