Alzheimer’s pill put profit before patients

Here’s a particularly shocking example of the kind of irresponsible and evidence-free, so-called health journalism found in sensational tabloids like the Daily Mail. It’s a story claiming that coconut oil can cure Alzheimer’s. This is the worst sort of quack claim giving false hope to vulnerable people.

 Oh whoops I am the journalist who wrote the story, which appears in the Daily Mail today. Actually I didn’t say it could cure the disease but I did report cases of nearly two hundred people on record describing how their symptoms had improved, sometimes dramatically. I also I spent quite a lot of time following up evidence for a plausible mechanism and talking to a small number of experts who were interested in finding out more about it.

I say this not because I think there is anything remarkable about it but because I think it’s shocking that, as far as I can tell, over the six years that this treatment has been in the public domain the vast majority of the Alzheimer’s experts have made no attempt to do anything similar.

Instead they first say that there is no evidence for it – which is of course true precisely because it is instantly dismissed – and that it is supported only by scientifically meaningless individual anecdotes. Then they point to the placebo effect. Some go on to accuse any one recommending it of quackery and giving false hope..

I don’t want to go into the detail of the story here – do read it and if you get interested have a look at another one in the same area that   I wrote in November which gives some more background.

Quackery and false hope

Instead I want to tell the story of Aricept 23, which is a new version of the most widely prescribed Alzheimer’s drug – Aricept – that has earned over two billion dollars a year since 1966. What happened seems to me to involved quackery and giving false hope, along with raising the risk of possibly fatal side effects.

You are unlikely to have heard about Aricept 23 because as far as I can tell no UK paper has written about it, probably because it is not available in the UK. But the companies making and selling Aricept (donepezil) 23 have a major presence in the UK. It’s marketed by Pfizer who are involved developing other drugs for the disease; last September one of their latest called bapineuzumab  failed to show benefit in a trials.

In March last year an article appeared in the BMJ  that broke the Aricept 23 story. This is what the authors wrote: “There is no excuse for manipulating vulnerable patients, desperate family members and their doctors to use a product that is most likely to cause net harm.” False hope?

Why promising treatments are ignored

The ruthless commercial approach shown by the makers of Aricept 23 seems one very plausible reason why the likes of coconut oil  and other non-drug approaches to Alzheimer’s are routinely ignored. See what happened to the high B vitamins study

Aricept 23 is manufactured by a large Japanese firm  called Eisai, with a major presence in the UK. It has a new  100 million pounds facility in Hatfield called the European Knowledge Centre and recently forged links with University College London (UCL) “to discover and develop treatments for Alzheimer’s disease.” These two companies are major players in fighting Alzheimer’s but can we trust them?

The BMJ feature was picked up by the LA Times, which quoted a response from Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of “The Truth About the Drug Companies. It was damning. “This critique illustrates very well how drug companies exaggerate the benefits of their drugs, minimize the side effects, and through misleading marketing to both doctors and the public convince them that a new version of a drug, with a new patent, is better than the old one, whose patent has expired.” Quackery?

The whole story, of course, revolved around money. The authors of the BMJ piece describe Aricept 23 as “a commercial plan to extend a brand-name medication’s profit-making life by three years.”

Marketing genius

Aricept’s patent rights were due to expire in November 2010, which would allow far cheaper generic versions to be produced. A perfectly legal option in this situation is to make a minor chemical tweak, call it a new product and get a 3 year patent extension.

The modification the company made was marketing genius. The drug was available in two doses –  5 and 10 mgs – so they produced a pill containing 23mgs – no way to prescribe that amount with the existing pills. Logically now no pill need ever come off patent – ¾ of the standard dose for lighter people, one and a half times for heavier ones and so on. Quackery?

To get the patent the FDA had said Aricept 23 had to improve both thinking and memory and “global functioning”-  noticeable changes in behaviour.  Just one trial was run which showed a small but significant improvement in thinking and memory but none in behaviour. This came with significantly more nausea and vomiting.  FDA experts in neurology and statistics advised against a patent extension but the director approved it, saying that it was “very likely” to improve a patient’s overall functioning. Evidence free?

The BMJ article also reported that once on the market the claims on the label were false since they claimed that the drug had improved both clinical and overall functioning when it hadn’t. The company claimed it was an oversight.

Vast numbers of patients want to know if coconut oil will help. It is hard to see how anyone save company coffers benefit from Aricept 23. Yet one is awarded hundreds of millions of dollars while the other is ignored. Is this the work of a system that is fit for purpose?