Monday, August 13, 2012

North American Quitline Consortium's Acceptance of Big Pharma Sponsorship is Especially Troubling Given New Evidence that Provision of NRT by Quitlines is Ineffective

Last week, I commented on the North American Quitline Consortium's (NAQC) acceptance of pharmaceutical sponsorship of its 2012 annual meeting, being held today and tomorrow in Kansas City. I opined that this sponsorship, by companies with a vested financial interest in the products whose effectiveness is being discussed at the conference, destroys the scientific objectivity and integrity of the conference.

Today, I present an additional reason why the acceptance of Big Pharma money by the conference is so troubling.

If the conference were not addressing any critical scientific issues regarding the role of NRT in quitline effectiveness, then the sponsorship by Big Pharma would not be so concerning. But today, I reveal that the scientific question of whether the provision of NRT by quitlines is effective in promoting smoking cessation is a critical one. Therefore, the sponsorship of this conference by pharmaceutical companies which manufacture NRT becomes unacceptable, as it directly interferes with the ability of quitline practitioners to objectively determine the best practices to serve their clients.

The Rest of the Story

A study recently published online ahead of print in BMJ reports found no effect of the provision of free nicotine replacement therapy by a quitline on smoking cessation rates in a multi-pronged clinical trial.

See: Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen A, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ 2012;344:e1696 doi: 10.1136/bmj.e1696 (Published 23 March 2012)

The study was conducted in a real-world, population-based setting, using the national quitline in England to recruit participants. Callers to the quitline who agreed to set a quit date were randomized to one of the following groups:

1. Usual care: standard quitline assistance
2. Intervention A: standard quitline assistance plus free NRT
3. Intervention B: standard quitline assistance plus more intense and frequent counseling

The participants were randomized in a 2 by 2 design. Thus, one group was usual care only. One group was intervention A only. One group was intervention B only. And the fourth group received Intervention A and Intervention B.

The findings were as follows: The six-month prolonged cessation rate for those who received free NRT was 17.7%, compared to a rate of 20.1% among those who did not receive free NRT. This difference was not statistically significant.

For validated smoking cessation at six months (confirmed by carbon monoxide testing), the quit rates were 6.6% for those who received free NRT and 9.4% for those who did not receive free NRT. This difference was statistically significant.

Depending on whether one relies upon the confirmed or unconfirmed smoking cessation results, the basic finding of the study is either that NRT had no effect on quitting, or that the provision of free NRT slightly impaired smoking cessation.

The study concludes: "Among smokers who were motivated enough to call the English NHS Smoking Helpline, set a quit date, and accepted an offer of support for smoking cessation, offering either additional free nicotine replacement therapy or higher intensity proactive telephone support did not increase quit rates over and above those obtained using standard quitline care."

The most important finding of the study is that the provision of NRT by the national quitline in England had no effect on smoking cessation rates.

Another important finding of this story is that under the best real-life conditions of free nicotine replacement therapy and frequent counseling, a chemically-confirmed six-month smoking cessation rate of only 6.6% was achieved. Even the non-confirmed (self-reported) quit rate of 17.7% at six months among those who received free NRT is quite dismal.

Compare these findings with those of the first electronic cigarette trial. In that study, the sustained six-month abstinence rate was 22.5%.

There was a major difference, however. In this study, the smokers were highly motivated to quit and had gone so far as to call the quitline. In the Polosa study, subjects were enrolled only if they had "no interest in quitting."

Thus, we have a real-world six-month prolonged cessation rate of 17.7% with NRT among highly motivated smokers compared to a 22.5% prolonged six-month cessation rate with electronic cigarettes among smokers with very low motivation to quit.

Given the sponsorship of the NAQC conference by Pfizer, GlaxoSmithKline, and Novartis, there is no chance that the implications of the Ferguson study will be adequately considered; nor is there any chance that the data comparing the effectiveness of NRT to electronic cigarettes will be adequately considered. After all, if conference organizers, groups, or speakers were to make any recommendations that quitlines consider not providing NRT or that quitlines start promoting electronic cigarettes, there would be a risk that the sponsorship pharmaceutical companies would withdraw their funding. By definition, the financial conflicts created by the acceptance of Big Pharma money preclude an objective consideration of these critical issues.

As the evidence continues to build that NRT is not all that it was cracked up to be, the established tobacco control institutions are not budging because they are too financially entrenched in Big Pharma. Their conferences are sponsored by Big Pharma, their organizations are heavily funded by Big Pharma, and their major reports and recommendations giving national advice or setting national policy are written largely by experts who have financial conflicts of interest with Big Pharma. This is unfortunate because it represents a disservice to the best interests of the public.

The rest of the story is that by accepting money from Big Pharma, the North American Quitline Consortium is harming more than just its scientific objectivity. It is harming the clients it is supposed to be serving by not taking an objective view of what practices would be the most effective to help its clients successfully quit smoking.

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