Pfizer’s smoking cessation medication greatly increases the risk for cardio events
The results published this morning in the Canadian Medical Association Journal based on a meta-analysis which had examined 14 clinical trails involving 8,216 patients. The findings had revealed a 72% increase of cardiovascular events that include congestive heart failure and stroke.
Dr. Sonal Singh, M.D., MPH, CPH, lead author of study, doctor and professor at John Hopkins University School of Medicine, stated he has stopped prescribing the medication as soon as he heard about these new findings. He is not telling anyone they should not use it but believes people should have this information and make their own decision on the risk.
Dr. Curt D. Furberg, M.D., Ph.D, of Wake Forest University School of Medicine and co-author of this study stated the total of serious adverse events without a doubt outweighs the most positive effects of the medication. Thomas M. Burton, writer with the Wall Street Journal had noted his call for removal of this drug from the market.
Pfizer, is disagreeing about the interpretation of the data as noted by vp of medical affairs, Gail Cawkwell, in an email to Tom Randall of Bloomberg. Ms. Cawkwell had stated the benefits of stopping smoking are immediate and considerable. The company firmly believes in and supports the drug as a valuable treatment option. In her email she notes that "about one in 100 people in the studies had cardiovascular problems."
Pfizer and the FDA also in response to these latest findings remark that they have been planning on conducting a joint analysis of clinical trials on whether or not Chantix had posed cardiovascular risks. Dr. Celia Winchell, team leader with the FDA’s Center for Drug Evaluation and Research note to the New York Times, Duff Wilson, had commented that the findings would of raised a red flag if not for the fact that red flag was already flying. The report will be due next year.
According to Pfizer, Chantix, is a non-nicotine prescription medication which works in two ways. It targets the nicotine receptors in the brain and hinders the nicotine from reaching the receptors. The company also believes that the drug stimulates the receptors producing a decreased release of dopamine compared to that of nicotine.
Dr. Yoon Loke, Clinical Senior Lecturer of the University of East Anglia and also had worked on the review had stated to the BBC there a numerous options to help people to stop smoking that do not involve the use of medications. He continues even though those numbers are small it is most likely due to the fact that those studies observed healthy people. Dr. Loke has own belief of the medication noting the risk could be even higher for those smokers who already have cardiovascular issues.
Writer Matt McMillen in his writing which is on WebMDHealthNews had pointed out just last month the FDA had issued a notice citing that Chantix could be linked with a small increase of heart attacks and other cardiovascular events in smokers with cardiovascular disease.
Lily Fowler of Fair Warning had reported the fact that Pfizer never did testing of Chantix on the mentally ill or those with recent history of depression during clinical trials. This is in spite of that fact that millions of smokers do endure psychiatric problems. Chantix had been approved in May 2006 and since its approval thousands who had used Chantix, endured serious psychiatric events. Those events had included suicide and depression. As a result from this a black box warning was placed on the drug. Among users some people have endured alterations in hostility, behavior, depressed moods and suicidal thoughts or actions while using this stop smoking drug.
Chantix sales have declined by 14% bringing last years total to $755 million in comparison to $883 million in 2007 according to information gathered from Bloomberg.
According to the information gathered the risk of enduring a cardiovascular event was 1.06% among Chantix users in comparison to 0.82% among those who had used a placebo.
Dr. Tina Kaufman, Ph.D, assistant professor of medicine and smoking cessation coordinator with Oregon Health and Science University and not part of this study, noted to WebMD’s Matt McMillen, that practitioners should discuss with their patients the issues that were raised in the study but her personal belief is that cardiologist will still continue to prescribe the medication. She also believes the risk is small compared to the benefits of the drug and it is more dangerous for persons to continue smoking.
Dr. Daniel Seidman, Ph.D, director of Smoking Cessation Services at Columbia University Medical Center has stated he avoids the use of Chantix in his clinical work with smokers due to the safety concerns. Commenting “This [study] is yet another black eye for Chantix."
There are several alternative therapies to help persons in quitting smoking. One such therapy is hypnotherapy. Research has revealed a success rate of 66% based on a four stage protocol.
Do not expect immediate results it can take several sessions in order to stop smoking. It has been noted around four sessions are needed. When choosing a hypnotherapist it is wise to chose one that is a licensed psychologist or one who has received training from a qualified academic university or college in hypnotherapy.
According to sound media press hypnotherapy has received rave reviews. Consumer Reports notes that hypnotherapy can aide adult patients in pain control, weight loss, speeding up healing of bone fractures and even surgical wounds.
News Week had reported "Hypnosis can help. A growing body of research supports the ancient practice as an effective tool in the treatment of a variety of problems, from anxiety to chronic pain."
Hypnotherapy is not going to have you cluck like a chicken. It is a far cry from what many refer to as stage hypnosis. Hypnotherapy merely taps into your subconscious . It is a state of concentration and focused attention.
Even the National Institutes of Health in 1995, had officially given support for hypnosis for cancer pain and other pain conditions. Among the medical institutions that give hypnosis a thumbs up is even Harvard Medical School that shows proof that hypnosis is in fact a process of mind over matter.
Debbie Nicholson is based in Detroit, Michigan, United States of America, and is Anchor for Allvoices