Wednesday, April 30, 2014

Quit-Smoking Drug Chantix Comes Under FDA Scrutiny



Quit-Smoking Drug Chantix Comes Under FDA Scrutiny
Saturday, 26 Apr 2014 09:54 AM
The Food and Drug Administration announced Friday it will hold a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer's anti-smoking drug Chantix.

The agency said in a federal notice it will convene its panel of psychiatric drug experts to discuss the pill's risks and how to best manage them.

Since 2009 Chantix has carried the government's strongest safety warning - a "black box" label - because of links to hostility, agitation, depression and suicidal thoughts. The warning was added after the FDA received dozens of reports of suicide and hundreds of reports of suicidal behavior among patients taking the smoking-cessation drug.

At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the side effects.

A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA designed to establish the drug's safety compared with placebo and other anti-smoking therapies.

"Pfizer has proposed an update to the Chantix labeling based on these new data, which, we believe, would better reflect the product's safety profile as it pertains to neuropsychiatric symptoms," said Victoria Davis, in a statement.

The New York drugmaker's FDA submission includes data pooled from multiple Pfizer studies along with studies conducted by the U.S. Department of Defense and the Department of Veterans Affairs. The two federally-funded studies, released in 2011, did not show an increased rate of psychiatric hospitalizations among more than 26,000 Chantix patients when compared with patients using nicotine patches and other smoking cessation treatments. The studies only recorded psychiatric problems that resulted in hospitalization, meaning many issues likely went unreported, according to the authors.

Chantix works by binding to the same spots in the brain that are activated by nicotine when people smoke. The drug, known chemically as varenicline, blocks nicotine from binding to those spots and causes the release of a "feel-good" brain chemical called dopamine.

The FDA first began investigating potential side effects with Chantix in 2007, the year after the twice-a-day pill hit the market.

The drug's labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes. Doctors are advised to weigh the drug's risks against its potential benefits in helping patients quit smoking.

Chantix had global sales of $648 million last year. That was down about 26 percent from the drug's peak sales of $883 million in 2007, its first full year on the market.

U.S. Food and Drug Administration (FDA)
Mark B. McClellan was a commissioner for the U.S. Food and Drug Administration (FDA), an administrator of Medicare and Medicaid for the U.S. Department of Health and Human Services, and a senior fellow at the Brookings Institution (think tank).

Note: Foundation to Promote Open Society was a funder for the Brookings Institution (think tank), and the Committee for Economic Development.
George Soros was the chairman for the Foundation to Promote Open Society.
Vernon E. Jordan Jr. is an honorary trustee at the Brookings Institution (think tank), a senior counsel for Akin, Gump, Strauss, Hauer & Feld, LLP, Valerie B. Jarrett’s great uncle, a director at the American Friends of Bilderberg (think tank), and a 2008 Bilderberg conference participant (think tank).
Akin, Gump, Strauss, Hauer & Feld, LLP is a lobby firm for Pfizer Inc.
Constance J. Horner is a director at Pfizer Inc., and was a guest scholar at the Brookings Institution (think tank).
Suzanne Nora Johnson is a director at Pfizer Inc., and a trustee at the Brookings Institution (think tank).
Amy W. Schulman is the EVP & general counsel for Pfizer Inc., and a trustee at the Brookings Institution (think tank).
Duberstein Group, Inc. is a lobby firm for Pfizer Inc.
Kenneth M. Duberstein is the chairman & CEO for the Duberstein Group, Inc., a trustee at the Brookings Institution (think tank), and was a VP for the Committee for Economic Development.
Donna S. Morea was a trustee at the Committee for Economic Development, and the EVP for the CGI Group Inc.
CGI Group Inc. was the Obamacare contractor that developed Healthcare.gov web site.
Obamacare is Barack Obama’s signature policy initiative.
Barack Obama’s signature policy initiative is Obamacare, and was an intern at Sidley Austin LLP.
Newton N. Minow is a senior counsel at Sidley Austin LLP, and a member of the Commercial Club of Chicago.
Cyrus F. Freidheim Jr. is an honorary trustee at the Brookings Institution (think tank), and a member of the Commercial Club of Chicago.
Valerie B. Jarrett is Vernon E. Jordan Jr’s great niece, the senior adviser for the Barack Obama administration, and a member of the Commercial Club of Chicago.
R. Eden Martin is the president of the Commercial Club of Chicago, and counsel at Sidley Austin LLP
Sidley Austin LLP was a lobby firm for Pfizer Inc.
Frederick W. Telling was a VP at Pfizer Inc., and is a trustee at the Committee for Economic Development.
Stephen W. Sanger is a trustee at the Committee for Economic Development, and a director at Pfizer Inc.
Anthony J. Principi was the SVP for Pfizer Inc., and the secretary for the U.S. Department of Veterans Affairs.
Eric K. Shinseki is the secretary at the U.S. Department of Veterans Affairs for the Barack Obama administration, and was a director at the Atlantic Council of the United States (think tank).
Togo D. West Jr. was the secretary at the U.S. Department of Veterans Affairs, a general counsel for the U.S. Department of Defense, and is a director at the Atlantic Council of the United States (think tank).
Open Society Foundations was a funder for the Atlantic Council of the United States (think tank).
George Soros is the founder & chairman for the Open Society Foundations, and was the chairman for the Foundation to Promote Open Society.
Foundation to Promote Open Society was a funder for the Brookings Institution (think tank).
Chuck Hagel was the chairman for the Atlantic Council of the United States (think tank), the deputy administrator for the U.S. Veterans Administration, and is the secretary for the U.S. Department of Defense for the Barack Obama administration.
Mark B. McClellan was a senior fellow at the Brookings Institution (think tank), an administrator of Medicare and Medicaid for the U.S. Department of Health and Human Services, and a commissioner for the U.S. Food and Drug Administration (FDA).
Constance J. Horner was a guest scholar at the Brookings Institution (think tank), and is a director at Pfizer Inc.
Suzanne Nora Johnson is a trustee at the Brookings Institution (think tank), and a director at Pfizer Inc.
Amy W. Schulman is a trustee at the Brookings Institution (think tank), and the EVP & general counsel for Pfizer Inc.
Robert A. Helman was an honorary trustee at the Brookings Institution (think tank), is a member of the Commercial Club of Chicago, and a partner at Mayer Brown.
Cyrus F. Freidheim Jr. is an honorary trustee at the Brookings Institution (think tank), and a member of the Commercial Club of Chicago.
William M. Daley is a member of the Commercial Club of Chicago, was the chief of staff for the Barack Obama administration, and a partner at Mayer Brown.
William M. Daley 
Professional career 
Daley returned to the practice of law, as a partner with the firm Mayer Brown (then Mayer, Brown & Platt) from 1993 to 1997.
Mayer Brown was a lobby firm for Pfizer Inc.
Sidley Austin LLP was a lobby firm for Pfizer Inc.
Newton N. Minow is a senior counsel at Sidley Austin LLP, and a member of the Commercial Club of Chicago.
R. Eden Martin is the president of the Commercial Club of Chicago, and counsel at Sidley Austin LLP
Michelle Obama was a lawyer at Sidley Austin LLP.
Barack Obama was an intern at Sidley Austin LLP.








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