Sunday, August 11, 2013

Two recommendations for Alzheimer's medication protocols

Since becoming a caregiver for my wife, diagnosed in 2009 with early onset Alzheimer’s Disease (AD), I have participated in AD spouse caregiver support groups.  Several participants have reported that their spouses had been taking AD medication without incident for a year or more, only to then show symptoms that may have been caused by the medication.  Spouses reported that these side effects disappeared when the medication was discontinued.  A review of data that led to FDA approval for current AD medications reveal that of the 11 clinical trials conducted prior to marketing, all but two lasted for 26 weeks or less.  Not one lasted for even one full year.  Each trial noted side effects by a small percentage of users, but none were considered severe enough to prevent the medication from being approved. 1  There have also never been any follow-up studies to learn if patients who continued taking the medication exhibited worsening side effects, or developed new side effects, after those trials ended. 
 
My wife had been taking two AD medications for several years with no negative side effects.  However, despite no observable changes in diet, she suddenly began exhibiting gastrointestinal symptoms noted as side effects in the AD medication clinical trials.   I decided to slowly wean my wife off both medications to see if they might be the cause of her gastrointestinal issues, and the effects were immediate.  Within a few days, all of her gastrointestinal symptoms stopped.  No more gassiness.  No more nausea.  No more vomiting.  Cause and effect?  All I can say for sure is that her gastrointestinal issues ceased when she stopped taking AD medication that, based upon research, was no longer helping her anyway.  A 2012 study by Consumer Reports found no evidence of any of the four approved AD medications being effective beyond three months for most people. Research by the Alzheimer’s Association found that these four medications may be effective for up to a year for about half of the people using them. 3  And the NIH states in its most recent report on AD that the four currently approved AD meds “may help some people,” but even then, “only for months to a couple of years.” 4  

Despite reports doubting positive effects of AD medication over the long term, despite the fact that no clinical trial even lasted for one full year, and despite the fact that there have been no follow-up studies to gauge side effects over time, many doctors continue prescribing these medications for their AD patients year after year after year.  Perhaps this would not be so if medication were clearly labeled and marketed as having limited usefulness and should be discontinued after a limited period of time.  Therefore, I have two recommendations for future AD medication protocols:

1.  Protocols should mandate that clinical trials last for at least one full year. Should medication only prove effective for a lesser period of time, FDA approval could still be sought on the basis of demonstrated short term effectiveness.  However, all inserts and labels packaged with the medication, as well as all media advertising, should clearly state that this medication was only shown to have positive effects for some people with AD for the limited number of months such effectiveness was actually demonstrated in the clinical trial. 

2. Protocols should mandate that 18 months after the one year clinical trial ends, patients must receive a follow-up questionnaire about side effects.  If significant numbers of patients report new or worsening side effects, this data must be reported to the FDA to determine if such information should be reflected in future medication packaging and media advertising.

Too many people with AD are taking expensive medication for long periods of time when there is absolutely no clinical data demonstrating that these medications are still effective.  It is also possible that, over time, these medications may be causing unpleasant side effects.  Medication labels and media advertising should provide patients and their caregivers with truthful information to help them make the best decisions possible in consultation with their doctors.

1. “Aricept ... Highlights of Prescribing Information.” Accessed online at www.aricept.com/assets/pdf/AriceptComboFullPIFebruary2012.pdf, pp. 7-11.
 
“Razadyne” ... “Full U.S. Prescribing Information.”  Accessed online at www.razadyneer.com/sites/default/files/shared/pi/razadyne_er.pdf pp.2-4.

“Exelon” ... “Highlights of Prescribing Information.”  Accessed online at www.pharma.us.novartis.com/product/pi/pdf/exelon.pdf, pp. 13-16. 

“Namenda Full Prescribing Information.”  Accessed online at www.frx.com/pi/namenda_pi.pdf,  pp.3-8.  All four medication sites accessed on March 5, 2013.

2.  “Evaluating Prescription Drugs Used to Treat: Alzheimer’s Disease.”  Consumer Reports, May, 2012, p. 3.

3.  “Five FDA Approved Alzheimer’s Drugs.”  Research Center, Science & Progress Treatment Horizon section.  Accessed online at  www.alz.org/research/science/alzheimers_disease_treatments.asp. Accessed on March5, 2013.

4.  “A Primer on Alzheimer’s Disease and the Brain.”  NIH Alzheimer’s Disease Progress Report, 2011-2012, p. 9.  Accessed online at www.nia.nih.gov/alzheimers/publication/2010-alzheimers-disease-progress-report-deeper-understanding/brief-primer.  Accessed on March 5, 2013.
 
Published in Clinical Trials: Journal of the Society for Clinical Trials, August, 2013, Vol. 10, No. 4, pp. 637-638.  Access at: http://ctj.sagepub.com/content/8/5/679.full
 

 

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