When new drugs are first approved by the FDA, they are granted drug patents. A drug patent protects the company that made the drug first by not allowing anyone else to make and sell the drug for a certain number of years. However, when the patent expires, other drug companies can apply to the FDA to start selling a generic version of the drug.
Drug companies often look for ways to try to extend the profit-making life of their product. For example, they might make a slight change to a drug’s formula. Recasting the old drug as a “new” drug, the drug company can acquire another patent-protected drug that doesn’t have to compete for sales with a generic version.
The drug donepezil, first sold under the brand name Aricept, is used to treat dementia associated with Alzheimer’s disease. Aricept was developed by the Japanese pharmaceutical company Eisai and is marketed in the United States in a partnership with Pfizer. The drug was initially approved for only 5 and 10 milligram dosages
When the drug patent protection was about to expire for Aricept, the drug company took a relatively unusual step. Just months before Aricept was set to lose its patent protection, its makers received approval from the FDA for a different dosage: 23 milligrams. The different dosage is considered a new or different drug and thus the new Aricept is protected from competition with generics for a number of years. Moreover, because generic donepezil was only available in 5 and 10 milligram dosages, those dosages could not combined to compete with the “new” Aricept 23 milligram dosage.
But should the FDA have approved the new, higher dosage? In an article published in the medical journal BMJ, Drs. Steven Woloshin and Lisa Schwartz of Dartmouth Medical College wrote that Aricept 23 is no more effective than the existing dosages already on the market but is more likely to cause problems.. Woloshin and Schwartz wrote that “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.”
Dr. Marcia Angell, former editor of the New England Journal of Medicine, told the New York Times that the critique published in BMJ was important. “It 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.”
The FDA had initially said that to be approved, Aricept 23 would have to improve both cognitive and global — or overall — functioning in patients with the disease. However, a clinical trial found only a slight improvement on the cognitive measure and no improvement on the global measure. As a result, clinical and statistical reviewers for the FDA each recommended against approving Aricept 23. For some reason, the director of their division at the FDA overruled them and approved the drug anyway. Dr. Russell Katz, director of the FDA’s neurology products division, acknowledged that side effects from the higher dose “could lead to significant morbidities and even increased mortality,” but concluded that the drug most likely improved overall functioning even though the study did not show that.
The consumer group Public Citizen filed a petition in May 2011 with the FDA that urged the agency to halt sales of the 23-milligram dose of Aricept and put safety warnings about the high-dose risks on two low doses, 5 and 10 milligrams. The FDA has yet to act on the petition.
Thus, Public Citizen has filed a lawsuit against the FDA over its handling of Aricept 23. The suit claims that the FDA’s own medical and statistical reviewers found that high-dose Aricept doesn’t work better at controlling symptoms of moderate-to-severe Alzheimer’s than two low doses. Further, the high dose has more dangerous, potentially deadly side effects including vomiting, which in Alzheimer’s patients “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.” Other side effects more common at the high dose are nausea, diarrhea, anorexia and confusion.
The lawsuit, filed in federal court in Washington, asks the court to declare the FDA’s failure to act unlawful and to order the agency to decide within 30 days of the court’s ruling whether to approve Public Citizen’s request. The suit also seeks attorneys’ fees and other reasonable costs.
“By ignoring Public Citizen’s petition for more than a year, the agency has ignored (its) responsibility,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a statement. “During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23.” “Allowing Eisai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable,” Wolfe added.
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