Why it Took 10 Years to Approve Aricept for Use On Severe Alzheimer's
by Mark Ramirez
The Health Daly News reports that Aricept (donepezil hydrochloride) has been approved by the FDA to treat severe dementia associated with Alzheimer's disease. Although Aricept was approved over 10 years ago to help mild to moderate Alzheimer's symptoms, it is now the only drug approved to treat all forms of the memory debilitating disease.
The approval was based on studies done in
Sweden and Japan that involved over 500 people with severe Alzheimer's. Aricept was found to perform better than a placebo on tests of cognitive functions including memory, language, and orientation. If this is the same drug that we have had for the last 10 years, why is it just now being utilized to its full potential? As the FDA stated it is the only drug approved to treat all forms of Alzheimer's. For the last 10 years Alzheimer's patience's with the most severe symptoms have had no help simply because we did not test it till now? Why is that?
Market exclusivity rights granted by the FDA to drug companies run out after 7 years. That means during the seven years when it has the rights, the FDA will not allow any other drug to market itself under the same category, essentially giving in this case Aricept, a monopoly for 7 years. After the exclusivity rights expire, drug companies retest their drug for a slightly different uses, and get another monopoly for 7 more years. Drug companies don't test all aspects of the drugs simply to extend its patent life in order to make more money.
The research for Aricept was done in Sweden and Japan. The reason that America has to pay so much money for our prescription medication is supposedly because we have to bear the research and development burden for the entire world. If we are paying so much extra for research and development, why is it being done in Sweden and Japan?
The FDA has long protected the interests of the large American drug companies and during the process has hurt a countless number of individuals along the way. They wait to approve drugs that would have helped millions of people, and also allow drug companies to charge so much for their "new and improved" drugs that many are forced to go without help. If you need medication but can't afford the high prices created by the American pharmacies go to PremierMexicanPharmacies.com. PMP is a database of Canadian and Mexican pharmacies that allow you to search for the lowest price on your prescription medication saving anywhere from 30 to 70 percent. Visit this Consumer Advocacy website for more information on ordering from Mexican pharmacies.
About the Author
. Mark has been in the pharmaceutical search industry since 1999 and has quickly become one of the most widely used pharmaceutical resource sites. For more information on how to order meds from Canada and Mexico safely and effectively visit our blog: Your Essential Guide to Buying Meds Online from Canadian & Mexican Pharmacies.