It’s real simple: Drug companies own doctors and the federal agencies in charge of protecting the public. They all should be charged convicted and jailed for criminal negligence.

A physician and top smoking cessation researcher says U.S. regulators and a drugmaker brushed aside his concerns a year ago about possibly dangerous side effects from longer-term use of the stop-smoking drug Chantix. Spangler says the safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects — a total of only 251 taking the drug — to determine whether or not the drug is safe when used over that duration.

Yet, the conclusion of the study reads, “Varenicline 1 mg BID can be safely administered for up to 1 year” — a conclusion, Spangler says, that is not supported by the data. “[Making this conclusion] would be like me balancing my checkbook without looking at any of the checks I wrote or the deposits I made,” Spangler says. “They’ve got to look at the data.” Furthermore, Spangler says when he analyzed the data in the Pfizer study, he found that the authors ignored possible signals of safety concerns. More

Sphere: Related Content

Posted by markw, filed under Health. Date: June 12, 2008, 1:34 pm |

Leave a Comment

Your comment

You can use these tags: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

Please note: Comment moderation is enabled and may delay your comment. There is no need to resubmit your comment.