New Zealand Is Too ‘Insignificant’ For Pharma?
1 CommentBy Ed Silverman // August 26th, 2008 // 2:18 pm
The nation’s Health Ministry claims it had encouraged several drugmakers to supply a new thyroid treatment ut there had been no takers because the New Zealand market was too small, a ministry spokesman tells The Southland Times.
And so the National Party has joined the call for the government to subsidise a new drug as the number of people suffering side-effects from Glaxo’s Eltroxin continues to grow.
Ministry media adviser Michael Flyger says there were discussions with drugmakers to encourage them to apply for their product to be marketed in New Zealand but no applications had been received. From the informal discussions he has had, the New Zealand market was only the same as a medium-sized Asian city and considered “pretty insignificant,” he tells the paper.
The Centre of Adverse Reactions has received about 600 complaints about Eltroxin since June when the Southland Times revealed a reformulation of the government-subsidised drug was making people sick. National’s associate health spokeswoman Jackie Blue wants the government to sort it out and has tabled questions in the House for Health Minister Dave Cunliffe. A response is expected next week.
Blue tells the aperaid yesterday Medsafe and Pharmac seemed to have been ducking for cover. New Zealand has two agencies that assess medicines – Medsafe, the regulator, and PHARMAC, the funder. Both have separate and distinct roles and are independent of each other. They need to find a drugmaker willing to supply an alternative medication and fast track its registration, he says.
One pharmacist, Alan Campbell, who has championed the battle for thyroid patients, says people have lost their jobs and suffered debilitating side-effects. He was still getting up to 70 prescriptions faxed to him daily for alternative meds. “I can’t get across to the Government the gravity of the situation,” he tells the paper, adding he was “horrified” by pharmacists and doctors who continue to tell patients complaining of side-effects that there was nothing wrong with them.
Last week, Medsafe manager Stewart Jessamine said preliminary results of scientific tests revealed nothing untoward and showed the new formulation met international standards. Meanwhile, patients have set up a website.
Salmon
It’s standard practice in the industry to make changes to products and introduce the products onto the market in smaller countries regardless of whether there are regulations requiring prior approval or not.
These changes may be due to consolidate manufacturing sites as cost control measures even if different sites produce different formulations. For example Lilly’s Prozac in Europe was not the same as Lilly’s Prozac in the US and they are bioinequivalent.
The argument that a company will give is if there are problems is well most people tolerated it and / or have had their dosage readjusted if we switch it back now we’ll have the same problem again.
The classic example of this was in 1969 when Parke-Davis changed a filler in Dilantin from a calcium salt to lactose. The calcium salt was relatively insoluble and resulted in a de facto sustained release formulation, whereas lactose dissolved immediately. This resulted in significant toxicity in much of the epileptic population of Australia and I believe New Zealand.
As for passing tests, the tests look at estimates of mean values and for EU the acceptable range for the peak is 70% to 140% consequently, one change in formulation could be on average 40% higher than the original and the next change could be up to 30% lower than the original. Thus from one formulation to the next peaks could be half as much on average and individual variation can be much greater.
Plus these are just estimates of the averages and there are no limits as to the number of people you need to test. So if it doesn’t pass because it’s too variable you can just keep testing more people in another study so as to decrease the variability and meet the criteria. Another problem is if faster absorption makes you throw up. This obviously is an indication that there’s a problem with the formulation, however the rules indicate if a patient throws up you throw out the data from that patient.
I personally believe in generics, however the rules can’t be applied indiscriminantly without regard to an understanding of the potential clinical implications.
Salmon