Experts challenge FDA approval for Alzheimer’s drug

March 25th, 2012 - 1:49 pm ICT by IANS  

Washington, March 25 (IANS) Experts have challenged approval for a new dose of a best-selling Alzheimer’s drug by the FDA which not only “breached” its own “regulatory standard” but causes greater side-effects.

Lisa Schwartz and Steven Woloshin, both professors at the Centre for Medicine and the Media at The Dartmouth Institute for Health Policy contested the claims made for the new 23 mg dose of donepezilargue, described as a blockbuster drug for Alzheimer’s.

They point to “a stunningly erroneous statement” in an advertisement aimed at doctors which claims that patients on the 23 mg dose “experienced important clinical benefit on both measures (cognition and overall functioning).”

Although the drug improved cognitive symptoms, the new dose caused more side-effects, including nausea and vomiting. Yet it will soon be under consideration for approval in 16 countries in Asia and South America, the BMJ-British Medical Journal reported.

The FDA and the manufacturer agreed that the 23 mg dose would be approved only if it was shown to be superior to the 10 mg dose on both a cognitive and a global functioning measure. Previously, the drug was only available in five mg and 10 mg doses, according to a Dartmouth Institute statement.

They said the new dose was approved “only over the objections of the FDA’s medical and statistical reviewers” and that it offers “no meaningful added benefit, just more harm.”

Alzheimer’s is an awful disease, say the authors. “Sadly, the available drugs don’t work well. But that 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.”

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