Healthy Skepticism Library item: 3899

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pirani C, Karvelas P.
Drug chiefs called in after children suffer strokes
The Australian Newspaper 2006 Mar 28
http://www.theaustralian.news.com.au/common/story_page/0,5744,18626944%255E23289,00.html

Notes:

Ralph Faggotter’s Comments:

“Documents obtained by The Australian revealed almost 400 adverse reactions had been reported to the Therapeutic Goods Administration, some involving children as young as three.”

Since adverse drug reactions are rarely reported to the TGA in Australia, this number of adverse reactions is likely to be the tiniest tip of a very large ice-berg.

Furthermore,it is hard to believe that Mr Pyne is genuinely concerned over this when it is his government which has been bending over backwards to accomodate the desire of Big Pharma to avoid scrutiny and control by weakening and politicizing the PBAC.

It is also Mr Pyne’s government which agreed to all of Big Pharma’s requests in the Freee Trade Agreement between Australia and the USA:- to assist with fast-tracking drug approvals, skipping over possible adverse effects, and allowing Big Pharma to interfere in the Australian pharmaceutical approval and regulatory system.

It looks a bit weak if you deliberately let the genie out of the bottle and then cry foul when, as everyone with any sense anticipated, the genie runs rampant.

Similarly, it looks a bit weak if you, as a government, fail to adequately regulate an industry, worship at the alter of deregulation, and then, when the disaterous effects of this deregulation begin to mount up, look for someone else to blame for the failures of the regulatory system.

Full text: Drug chiefs called in after children suffer strokes Clara Pirani and Patricia Karvelas March 28, 2006

AN urgent investigation has been launched into claims drugs used to treat attention deficit hyperactivity disorder could be killing children.

Parliamentary Secretary for Health Christopher Pyne will also meet pharmaceutical company executives this week to discuss whether such drugs should carry stronger warnings.

Mr Pyne yesterday said he had requested an urgent meeting with Novartis Australia, in response to a report in The Australian that children as young as five had suffered strokes, heart attacks, hallucinations and convulsions after taking ADHD medication.

Documents obtained by The Australian revealed almost 400 adverse reactions had been reported to the Therapeutic Goods Administration, some involving children as young as three.

“I’ve asked the people of Novartis, who are the makers of Ritalin, to come and see me this week and explain why Ritalin shouldn’t have a black box applied to it,” Mr Pyne said.

Black box warnings signify that a drug may cause dangerous side-effects. They are the strongest warnings that can be issued by drug regulators.

“The problem is that doctors are inappropriately prescribing Ritalin because they think it’s the wonder drug for children with ADHD,” Mr Pyne said.

“I’m very concerned about this. Parents are entitled to expect the Government to protect them from those kind of (drugs) that lead to the deaths of their children. I have spoken to the head of the TGA and directed him to fast-track an investigation of the use of Ritalin, including speeding up discussions with the FDA in the United States, who are also investigating.”

A spokeswoman for TGA said there was no conclusive evidence ADHD was linked to sudden death or cardiovascular episodes. However, data obtained by The Australian showed the TGA’s reports lacked detailed information about the side-effects experienced by dozens of children. Many of the reports failed to note the patient’s age.

In more than 60 cases the TGA did not conduct any follow-up investigation to find out whether individuals recovered from the side-effects.