Champix (Chantix) Smoking Cessation Drug in the news, again.

[Guest guest]

Wow, I saw some news today on Yahoo, Reuters, and Businessweek about Chantix (Champix in Europe)It turns out this drug was approved after a teeny effectiveness (not safety) study about 350 persons on Chantix, and 350 on a placebo. Now, in addition to the suicide problem that came out a couple of weeks ago (Chantix affects dopamine, a chemical in the brain involved in controlling mood and behavior, and, apparently, the will to live in some people)...anyway, today the newspapers are reporting that there was a "small' raised risk of adverse heart events. Here's the FDA report.http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm#dataFrom the FDA report : " The trial was not designed to have statistical power to detect differences between the arms on the safety endpoints." Are they really saying that they didn't even bother to test for safety, just go ahead and unleash on the public? Even between the relatively teeny sample sizes, they saw a DOUBLE and NEARLY TRIPLE the rates of some types of adverse heart events (see the types below) .From the pharmalot newsletter: "In recent weeks, there was controversy over whether Pfizer correctly reported side effects to the FDA, which required the drugmaker to alter its methods for submitting the data"see here for more on that Still, the newspapers are only reporting a "small increase

among those who already have heart disease"http://www.reuters.com/article/2011/06/16/drugs-fda-chantix-idUSN1618502520110616Small heart disease risk! whoa. Let's look at the FDA report (link above)Event / # of persons in Chantix Group (percentage) / # in placebo group (percentage)Nonfatal myocardial infarction 7 (2.0) 3 (0.9)Need for coronary revascularization† 8 (2.3) 3 (0.9)Hospitalization

for angina pectoris 8 (2.3) 8 (2.3)New diagnosis of peripheral vascular disease (PVD) or admission for a procedure for the treatment of PVD 5 (1.4) 3 (0.9)Now, I know this wasn't designed to be a safety study exactly. But aren't these numbers troubling enough to give some pause on this drug? It already has been disallowed for Pilot and air traffic controllers, and medical examiners can also pull truck drivers who use Chantix. http://www.webmd.com/smoking-cessation/news/20080523/government-nixes-chantix-for-pilots?print=trueI hope this info helps somebody. Liora

[Guest guest]

The FDA has for some time been seen as one of the most corrupt of government agencies and it is an embarrassment to our country.  The FDA answers to its industrial constituency, big Pharma.  Not the Constitution or the well-being of the people of the United States.  In 2009, a group of fda scientists wrote a scathing letter that complained about the amount of blatent corruption within the fda, and it was news for about a week until everyone fell asleep again.  Nothing was done by the current administration and I suspect nothing will be done.  Because the people do not have the deep pockets to protect our health.  BigPharma has the deep pockets to grease the palms of anyone in control of what we are allowed to take, eat, drink, etc.  It is about time we have a leader with the courage to stand up and do what is right.  Someone who can bring back common sense.  For much too long we have elected leaders who do not care about us.  I want someone who is not an elitist, and who is like us in our values and experiences.  The ones I have identified as viable choices for that role have not decided to run yet. Anywhoo, back to the fda.  Supposedly there was a movie that covers a lot of this called Generation RX, but I have not seen it. Peace,~ Multi-faceted JulesCourage is not the absence of fear, but rather the judgement that something else is more important than fear. -Ambrose RedmoonWherever I stand, I stand with Israel. From: DownSyndromeInfoExchange [mailto:DownSyndromeInfoExchange ] On Behalf Of aliaslioraSent: Sunday, June 19, 2011 6:32 AMTo: beijing_organic_consumers ; Beijing MamasCc: gfcf; Educate-Yourself_Forum ; DS Infoexchange; dstni leichtman; einstein syndrome; ot4vax vaccinegroupSubject: [DownSyndromeInfoExchange] Champix (Chantix) Smoking Cessation Drug in the news, again. Wow, I saw some news today on Yahoo, Reuters, and Businessweek about Chantix (Champix in Europe) It turns out this drug was approved after a teeny effectiveness (not safety) study about 350 persons on Chantix, and 350 on a placebo. Now, in addition to the suicide problem that came out a couple of weeks ago (Chantix affects dopamine, a chemical in the brain involved in controlling mood and behavior, and, apparently, the will to live in some people)... anyway, today the newspapers are reporting that there was a " small' raised risk of adverse heart events. Here's the FDA report. http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm#data From the FDA report : " The trial was not designed to have statistical power to detect differences between the arms on the safety endpoints. " Are they really saying that they didn't even bother to test for safety, just go ahead and unleash on the public? Even between the relatively teeny sample sizes, they saw a DOUBLE and NEARLY TRIPLE the rates of some types of adverse heart events (see the types below) . From the pharmalot newsletter: " In recent weeks, there was controversy over whether Pfizer correctly reported side effects to the FDA, which required the drugmaker to alter its methods for submitting the data " see here for more on that Still, the newspapers are only reporting a " small increase among those who already have heart disease " http://www.reuters.com/article/2011/06/16/drugs-fda-chantix-idUSN1618502520110616 Small heart disease risk! whoa. Let's look at the FDA report (link above) Event / # of persons in Chantix Group (percentage) / # in placebo group (percentage) Nonfatal myocardial infarction    7 (2.0)       3 (0.9)Need for coronary revascularization†      8 (2.3)   3 (0.9)Hospitalization for angina pectoris         8 (2.3)   8 (2.3)New diagnosis of peripheral vascular disease (PVD) or admission for a procedure for the treatment of PVD           5 (1.4)            3 (0.9) Now, I know this wasn't designed to be a safety study exactly. But aren't these numbers troubling enough to give some pause on this drug? It already has been disallowed for Pilot and air traffic controllers, and medical examiners can also pull truck drivers who use Chantix. http://www.webmd.com/smoking-cessation/news/20080523/government-nixes-chantix-for-pilots?print=true I hope this info helps somebody. Liora