French Doctor Denounces Routine Alzheimer Medications

Monday, September 21, 2015, was World Alzheimer Day and also marked the culmination of World Alzheimer Month. Alzheimer’s disease is a tragically progressive condition afflicting the elderly, involving memory loss, dementia and serious health complications. There is no cure and research has shown that currently employed pharmaceutical treatment brings no results and may be harmful. Yet these medications continue to be employed on a daily basis in both North America and Europe.

At a conference in honour of the day in France, Professor Olivier Saint-Jean, head of geriatrics at Georges Pompidou European Hospital in Paris, reiterated his warning that ineffective and sometimes dangerous pharmaceuticals are continuing to be prescribed for Alzheimer patients. He also stated emphatically that there are no drugs yet developed for Alzheimers that have proven effective and recommended other modalities of care for the time being.

Both the five FDA-approved drugs aimed at slowing the progression of dementia as well as other drugs generally prescribed to relieve distress in those afflicted with Alzheimers disease have been proven time and again for more than ten years in international studies to not only be ineffective, but to also incur harmful side effects. And yet these drugs are still routinely, even necessarily, prescribed at the outset and throughout the course of the disease. Additionally, new classes of drugs have also been shown to be ineffective over the last few years.

Speaking at another conference last year, Professor Saint-Jean had this to say:

“These medications came out of the 1990s and are still in use today as part of the national therapeutic arsenal with, in hindsight, a very questionable efficacy. The French Health Authority reevaluated them two years ago, and globally it was found that these medications have effects that are so weak as to be considered, speaking frankly, that they are probably close to doing practically nothing at all. But they are not so innocent, especially considering that they are used in a very elderly population who have other illnesses and take other medications, provoking other interactions. So this was a path that has today been proven to be ineffective and should be abandoned were it not for the lack of new developments by the pharmaceutical industry involving these types of molecules. Perhaps this path will be reborn one day, but for now it is ineffective.” [1]

According to Prof. Saint-Jean, the repetitive nature of study after study of all of these drugs belies a certain reluctance on the part of health authorities, industry and doctors. In an interview with Eric Favereau published in today’s Libération, when asked why doctors have continued to prescribe these medications, Prof. Saint-Jean responded without hesitation:

“If we leave aside the massive conflicts of interest, there is also the medical attitude of how to give an Alzheimer’s diagnosis without following up with, ‘but I’m giving you a treatment’. We now have global care that we can offer, with overnight care centres, memory centres, home health teams. Nothing justifies the continuing prescription of useless medications.”[2]

From a business perspective, however, promoting and researching Alzheimer’s drugs makes a perverse kind of sense. “Some people look at it as the golden lottery ticket,” wrote John Carroll, of FiercePharma, in an email to CBS News in January. “The odds against success are incredible, but if you come up with some winning data for an FDA that would like to approve something and millions of desperate patients with no real options, it would be worth a fortune, even if it’s not very good.”

CBS also interviewed pharmaceutical industry consultant Daniel Hoffman, “Just imagine what people would pay or have to pay for something to ward off Alzheimer’s. You would get every person in the developed world taking it every night.” According to the report, Hoffman sees such a market as being in the billions of dollars. [3]

There are five current medications approved and prescribed for Alzheimers sufferers, and doctors usually also prescribe anti-psychotic medications off-label to reduce agitation. Four of the first five drugs are acetylcholineresterase inhibitors (namely donepezil, galantamine, tacrine and rivastigmine), the other being glutamate receptor antagonist memantine. Study upon study have declared them to be no more effective than placebo. Four other recent drugs, gantenerumab, flurizan, bapineuzemab and semagacestate, have all seen their research and development projects halted and defunded for lack of evidence that they were providing any benefits to those suffering from the disease.

Antipsychotics such as olanzapine (Zyprexa), quetiapine (Seroquel) and risperidone (Risperdal), used to placate conditions like schizophrenia, are commonly prescribed to relieve agitation and aggression in Alzheimers, but have also been found to be no more effective than placebo, with the added harm of inducing insomnia, Parkinson’s, and contradictorially increasing mania.

All this has been known for years. The knowledge is so common amongst the informed that Consumer Reports, in their May 2012 edition of “Best Buy Drugs: Evaluating Prescription Drugs to Treat: Alzheimer’s Disease,” declares:

“The medications used to treat mental decline in people with Alzheimer’s disease are not particularly effective. When compared to a placebo, most people who take one will not experience a meaningful benefit. And it is the rare person who has a significant delay in the worsening of their symptoms over time….

Because most people who take an Alzheimer’s medication will receive no meaningful benefit, together with the relatively high price tag and the risk of rare but important safety concerns, we are unable to choose any of these drugs as a Best Buy.” (emphasis author) [4]

In 2011, memantine (brand name Namenda) was shown to be ineffective in a study at the University of Southern California. “We conclude that there is a lack of efficacy in mild Alzheimer’s,” says the lead researcher, Lon Schneider, M.D., professor of psychiatry, neurology, and gerontology. “We think physicians, patients, and caregivers should simply know this.”[5]

On 30 Nov 2007, Italian reseachers at the National Institute of Health in Rome wrote that:

“Acetylcholinesterase inhibitor drugs are unable to slow progression from mild cognitive impairment (MCI) to dementia. Reviewing available data, published and unpublished, from six different clinical trials, Roberto Raschetti and colleagues at the National Institute of Health, Rome, Italy, including Emiliano Albanese, Nicola Vanacore, and Marina Maggini, conclude that MCI patients taking the drugs succumb to dementia at about the same rate as those taking placebo. The results may rekindle the debate on whether MCI should be treated, and if so, how.”[6]

A study in early 2005 shows that galantamine (brand name Reminyl) did “not delay the appearance of dementia and increased the risk of cardiac arret, according to the results of a study that was conducted over the course of two years. More than 2,000 patients…were followed in Europe, Australia, Argentina and the United States…. Results showed that the treatment was not more effective than placebo in delaying the onset of dementia. In addition the number of deaths of those in the group treated with galantamine (15) was higher than those on placebo (5).”[7]

In 2004, donepezil (Aricept) was shown to have a very slight ameliorative effect, although an earlier study in the UK that year showed no improvement.[8]

According to Harvard Medical School’s Harvard Mental Health Newsletter:

It was hoped that a medication normally given to Alzheimer’s disease patients might help people with delirium, but a study found that it made the delirium worse.[9]

And finally, the 2006 New England Journal of Medicine study on off-label usage of anti-psychotics in the Alzheimer population concluded that:

“Adverse effects offset advantages in the efficacy of atypical antipsychotic drugs for the treatment of psychosis, aggression, or agitation in patients with Alzheimer’s disease.”[10]

A New York Times article on the NEJM study had this to say:

“The report, based on a large government comparison of the drugs’ effectiveness, challenges current practice so sharply that it could quickly alter prescribing habits, some experts said (emphasis author). About 4.5 million Americans suffer from the progressive dementia of Alzheimer’s disease, and most patients with the advanced disease exhibit agitation or delusions at some point.”

Sadly almost a decade later, it appears that nothing has changed. But there is a movement in Europe that is slowly gaining traction. In a move away from pharmaceutical treatment, the Dutch created Hogeway in the town of Weesp, a so-called dementia village, offering care at a cost similar to traditional nursing homes but in a setting providing far more autonomy.[12] The French government today announced funding for an Alzheimer Village in the Landes region, providing it a yearly award of 3 million euros towards operations. Its projected completion will be in 2018.[13]

References:

[1] https://www.youtube.com/watch?v=lqhPnRAYy5g (transcription and translation by author)
[2] http://www.liberation.fr/politiques/2015/09/20/alzheimer-le-pr-olivier-saint-jean-veut-en-finir-avec-les-medicaments-inefficaces_1386908 (translation by author)
[3] http://www.cbsnews.com/news/will-a-cure-for-alzheimers-ever-be-found/

[4] “Evaluating Prescription Drugs Used to Treat: Alzheimer’s Disease • Consumer Reports Best Buy Drugs.” Report updated May 2012 https://www.consumerreports.org/…drugs/AlzheimersF…

[5] http://www.cnn.com/2011/HEALTH/04/11/alzheimer.drug.ineffective/

[6] http://www.alzforum.org/news/research-news/researchers-conclude-cholinesterase-inhibitors-dont-delay-alzheimers

[7][8] http://www.afpap.org/Alzheimer_medicament_27012004.htm (translation by author)

[9] http://www.health.harvard.edu/newsletter_article/alzheimers-drug-proves-ineffective-for-delirium

[10] ClinicalTrials.gov number, NCT00015548. http://www.nejm.org/doi/full/10.1056/NEJMoa061240

[11] http://www.nytimes.com/2006/10/12/health/12dementia.html
[12] http://www.theguardian.com/society/2012/aug/27/dementia-village-residents-have-fun
[13] http://www.english.rfi.fr/france/20150921-alzheimers-village-france-given-green-light