Almost two months ago, we posted that the U.S. Food and Drug Administration, FDA, was fast-tracking a potentially promising new drug to help smokers quit smoking. In earlier clinical trials, Chantix, varenicline tartrate, worked in ways that previous smoking cessation drugs did not, indicating a higher success rate where other drugs had failed.Chantix acts on the areas of the brain affected by nicotine and helps those who smoke cigarettes to quit smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they start smoking again.
Now, according to three studies published in the July 5 Journal of the American Medical Association, it is being reported that Chantix quadruples the chances that a smoker can quit smoking and is twice as effective as the currently prescribed drug Zyban. Keep in mind though, the research was funded by the drug maker, Pfizer, and experts warn that the drug is far from a perfect solution for smokers trying to quit -- and "definitely not a panacea for smoking cessation."
According to Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, "Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit." I believe this is a more realistic assessment of the ability of a medication designed to help smokers quit smoking.
UPDATE: Chantix: quit smoking drug now available in US pharmacies.
1. "Since a substantial number of patients presenting with lung cancer either smoked in the recent past or continue to do so, it is important to make sure that the patient stops smoking as soon as possible to improve their treatment outcome," says Dr. Carolyn M. Dresler, Head, Tobacco and Cancer Group of the International Agency for Research on Cancer. She added, "the emphasis should be on improvement of treatment outcome and future health improvement."
There are guidelines regarding smoking cessation techniques that have resulted from reviews of the world's literature and are very well accepted throughout the medical and psychological fields. However, "the biggest problem remains in having healthcare providers implement them routinely," Dr. Dresler says, "Most have emphasized the role of the primary healthcare provider in providing smoking cessaton advice to patients, whereas the specialists, such as medical oncologists, radiation oncologists, thoracic surgeons or pulmonary care specialists should be dealing with the health problems resulting from the smoking as the patient faces imminent interventions such as radiation therapy, chemotherapy or surgery."
She makes the point that since ongoing smoking may significantly affect the outcome of subsequent surgery or therapy and negatively impact long-term survival, it is now the specialists' turn to provide the urgent smoking cessation treatment. With the advent of medicare changes under the new Medicare Modernization Act (MMA), the specialists will be reimbursed for providing evaluation and management services, making referrels for diagnostic testing, radiation therapy, surgery and other procedures as necessary, and offer any other support needed to reduce patient morbidity and extend patient survival, I certainly hope they add smoking cessation guidance and support.
No "pharmaceutical" trial ever followed whether patients smoked during their clinical trials, despite dosing themselves daily with cigarettes with thousands of chemicals in them. The addition of nicotine inhibits the ability of a chemo drug (like etoposide) to induce apoptosis by 61%. If a drug like nicotine, which occurs in the highest concentration of any drug in a cigarette, inhibits the ability of a major chemotherapy drug by 61%, a medical oncologist should care if it was being ingested during treatment.
The vast majority of clinical trials performed are ones that test one chemotherapeutic regimen against another. Single arm clinical trials provide the tumor response evidence that is the basis for approving new cancer drugs. Scientific, financial, and clinical support is critical to this goal. The failure to date to assess, analyze, and report smoking status has limited our ability to investigate the effect of smoking on treatment efficacy and outcome. The time has come to integrate data about the single most important lifestyle risk factor in cancer prevention into cancer treatment and survivorship trials.
Source: (Cancer Epidemiol Biomarkers Prev 2005;14(10):2287–93)
Posted at 4:14PM on Jul 5th 2006 by Gregory D. Pawelski