The announcement last month (March 25th) the Alzheimer’s funding was to be doubled by 2015 is to be welcomed. But what is the money going to be spent on? Two separate developments don’t inspire confidence that it will always be the most safe and effective treatments.
The first concerns the latest developments with the drug Aricept, a drug of marginal benefit which recently got a hugely lucrative 3 year patent extension even though the only development was a new pill containing a larger dose of the drug.
Aricept is the most widely used Alzheimer’s drug but its effect is modest at best. It slows down memory decline in about 1/3 of patients for between 6 months and a year. Eighteen months ago Aricept’s patent was due to run out in America but the company Esai pulled off an outrageous coup.
They got the FDA (American drug watchdog) to agree to a very lucrative 3 year extension to the patent in return for developing a pill that contained 23 mg of the active ingredient rather than the 10mgs in the existing pills. That was the only change. The claim was that it would benefit patients with advanced Alzheimer’s. It wasn’t thought worth giving the 10mg version to these patients.
Last month the BMJ published a highly critical account of the way the company had deceived doctors and patients over the benefits and showed that the FDA had granted the extension even though the trials used to get it failed to show a big enough improvement according to the agency’s own rules.
The article stated that allowing it on the market was “perplexing” and “depressing” since there was no proof of extra benefit and that it was “most likely to cause net harm”. The greater risk of nausea and vomiting that came with Aricept 23 were described by FDA expert as “not trivial” since they can lead to pneumonia and death in these patients..
Interestingly just two weeks before this analysis, a study had been published showing that giving the regular 10mg dose of Aricept to patients with moderate to severe Alzheimer’s produced “clinically important” benefits. It had involved nearly 300 people followed for a year.
The readiness of funding bodies to find a way of extending the use of Aricept contrasts dramatically with their refusal to fund further trials of promising research that suggested it might be possible to stop people developing Alzheimer’s with an even cheaper treatment than off- patent Aricept.
( Details of this appear in Part 2)