|Blogs||Articles||Organizations||Biography||Jack's Book||Contact Information||Links|
Navigation: SOS Sisson > Traumatic Injury Blog
Jack Sisson's TBI Blog
A hug is duct tape for the soul.
Saturday, March 24, 2012
Drug Dosage Was Approved Despite Warning
From The New York Times:
Four months before a best-selling Alzheimer’s drug was set to lose its patent protection, its makers received approval for a higher dosage that extended their exclusive right to sell the drug. But the higher dosage caused potentially dangerous side effects and worked only slightly better than the existing drugs, according to an article published Thursday in the British Medical Journal.
The drug, Aricept 23, was approved in July 2010 against the advice of reviewers at the Food and Drug Administration.
They noted that the clinical trial had failed to show that the higher dosage — 23 milligrams versus the previous dosages of 5 and 10 milligrams — met its goals of improving both cognitive and overall functioning in people with moderate to severe Alzheimer’s disease.
The single clinical trial of 1,400 patients also found that the larger dosage led to substantially more nausea and vomiting, potentially dangerous side effects for elderly patients struggling with advanced Alzheimer’s disease. The drug was developed by the Japanese pharmaceutical company Eisai but is marketed in the United States in a partnership with Pfizer.
“It doesn’t really have much benefit, but does substantially more harm,” said Dr. Steven Woloshin, one of the co-authors of the journal article and a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice.
Aricept generated more than $2 billion in annual sales since its first approval in 1996, according to the journal article, but it was set to lose its patent protection in November 2010, opening the door to cheaper generic versions of the drug.
In 2009, Eisai applied for a 23-milligram version of Aricept, a dosage that, the journal authors note, cannot be reached by combining the 5 and 10 milligram dosages, which are available in generic form. “It’s kind of an odd number,” Dr. Woloshin said.
Drug makers often try to fend off competition from generic makers by finding novel ways of extending their exclusive rights to sell a drug — by altering its chemistry slightly, for example, or offering it in extended-release versions. Applying for a new dosage on the same drug is a relatively new tactic and — in the case of Aricept 23 — a dangerous one, said Sidney M. Wolfe, director of Public Citizen’s Health Research Group, which last year asked the F.D.A. to remove the drug from the market.
The F.D.A. 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. But the clinical trial found only a slight improvement on the cognitive measure and no improvement on the global measure.
As a result, a clinical and a statistical reviewer for the F.D.A. each recommended against approving the higher dosage. Nevertheless, the drug was eventually approved by Dr. Russell Katz, director of the F.D.A.’s neurology products division, who 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.
“Rarely do we see such a dangerous difference between what pretty much everyone in the neurological division thought and what its leader thought,” Dr. Wolfe said. “That’s a huge slap in the face to all the people who spent much more time reviewing this drug than he did.”
Sandy Walsh, a spokeswoman for the F.D.A., declined to comment because she said the agency was in the process of responding to Public Citizen’s petition.
LinksTBI Film Reviews
TBI Book Reviews
Traumatic Brain Injury Law Blog
SoapBlox/Chicago: Protecting Our Troops
Head Injury Survival Journal
Losing the Physical Self
Tower of Hanoi: Instructions for this popular puzzle can be viewed simply by clicking the Instructions button on that page.
May 2005 June 2005 July 2005 August 2005 September 2005 October 2005 November 2005 August 2006 September 2006 October 2006 December 2006 January 2007 February 2007 March 2007 April 2007 May 2007 June 2007 July 2007 August 2007 September 2007 October 2007 November 2007 December 2007 January 2008 February 2008 March 2008 January 2009 March 2009 April 2009 December 2009 April 2010 May 2010 June 2010 July 2010 August 2010 September 2010 October 2010 November 2010 January 2011 February 2011 March 2011 April 2011 May 2011 June 2011 July 2011 August 2011 September 2011 October 2011 November 2011 December 2011 January 2012 February 2012 March 2012 April 2012 May 2012 June 2012 October 2012 November 2012 December 2012 January 2013 February 2013 March 2013 April 2013 May 2013 June 2013 October 2013