Friday, October 19, 2012

Federal Government Wastes $10 Million on Nicotine Vaccine Studies; Money Would Have Been Better Spent Investigating Potential Role of Electronic Cigarettes

In 2009, the federal government awarded Nabi Pharmaceuticals a $10 million stimulus grant to conduct a clinical trial of NicVax, an injectable vaccination intended to help people quit smoking.

According to an NIH press release: "Successful completion of the study will bring the vaccine closer to final approval. Already given fast track designation by the U.S. Food and Drug Administration, NicVAX passed initial regulatory hurdles showing the basic idea is sound. Patients in the trial get six monthly shots in the arm. ... The award continues a public-private partnership between NIDA and NABI that started in 2001 with a grant to support the basic science that led to NicVAX. The effort continued in 2005 with a grant to help support early clinical trials to test the safety and efficacy of the vaccine."

At the time, the director of the National Institute on Drug Abuse (NIDA) predicted that the nicotine vaccine would be a powerful tool to promote smoking cessation: "A vaccine that limits the ability of nicotine to enter the brain, and that is effective for six to 12 months following vaccination will give smokers a fighting chance to end the addiction/relapse cycle that plagues the great majority of smokers trying to quit."

For several years, I have been arguing that the tobacco control movement's obsession with nicotine as the sole element involved in smoking addiction has been problematic and has hindered the search for a truly effective tool to promote smoking cessation. I have repeatedly pointed out that smoking addiction involves far more than just nicotine. There are many other aspects to the addiction, including physical stimuli, behavioral aspects, and even social aspects. The hand motions, blowing of smoke, holding of the cigarette, and many other physical, behavioral, and social stimuli serve as reinforcements of the overall smoking experience. A sole focus on just nicotine is not an effective strategy for finding a workable strategy.
I have also pointed out that for the first time, we now have a tool that does address the behavioral aspects of the addiction, not just the pharmacologic aspects. That tool is called the electronic cigarette. Because it looks like, feels like, and is used like a cigarette, in addition to supplying nicotine, the electronic cigarette addresses all aspects of the smoking addiction. It simulates the smoking experience. That is precisely why it has been helpful to so many smokers in quitting and why the product's use has been growing exponentially.

The Rest of the Story

As I predicted, the nicotine vaccine turned out to be a dismal failure. Yesterday, Nabi Pharmaceuticals reported the results of a phase II clinical trial in which the nicotine vaccine in combination with Chantix was found to be no more effective than Chantix alone: "Smokers who received both products quit smoking at the same rate as those treated with a placebo and varenicline, according to an initial evaluation of the study's data, Nabi reported. Those rates were similar to those involving smokers in other studies who had received only varenicline".

These results come on the heels of the revelation that the phase III clinical trial funded by the federal government was a complete failure: "the primary end point was not met and there was no statistical difference between the NicVAX and Placebo groups. As in previous trials, NicVAX was well-tolerated with a clinically acceptable safety and tolerability profile. These results are not different from the results of the first Phase III trial that were reported in July 2011, which had a similar design and protocol."

In  my opinion, the federal government put its eggs in the wrong basket. At the same time that the federal government was spending $10 million on the nicotine vaccine, it was engaging in a campaign to discourage smokers from using electronic cigarettes to quit - scaring them by grossly exaggerating information about trace levels of carcinogens detected in these products and trying to convince them that all electronic cigarettes may have anti-freeze in them.

So while the FDA gave "fast track" status to a drug that I believe was clearly doomed to failure, it essentially tried to pull off the market a new device which is perhaps the most promising innovation ever developed to treat not just nicotine addiction, but the smoking addiction as a whole.

To make matters worse, the anti-smoking researchers who had put their own eggs in the nicotine vaccine basket - showing poor judgment in their ability to evaluate the most promising strategies for smoking cessation because of their history of Big Pharma funding - were given prominent positions guiding federal smoking cessation strategy.

For example, the panel chair of the Joint Commission panel which established hospital standards for the treatment of smoking cessation was Dr. Michael Fiore. However, Dr. Fiore was receiving grant funding from Nabi Pharmaceuticals, whose nicotine vaccine had been given fast track status by the FDA "for use as a therapeutic for smoking cessation.'"

Clearly, it would have been to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge an FDA-approved smoking cessation drug. This is precisely the requirement that Dr. Fiore and his panel established.

In my opinion, it was inappropriate for Dr. Fiore to have accepted the position as chair of this panel, given his financial conflict of interest. The recommendations from the panel were clearly biased because of this financial conflict.

Another example is the appointment of not one, but two Nabi Pharmaceuticals-conflicted scientists as members of the Tobacco Products Scientific Advisory Board (TPSAC).  Dr. Neal Benowitz has consulted for Nabi Pharmaceuticals and Dr. Dorothy Hatsukami has received grant support from Nabi Pharmaceuticals for investigation of the effectiveness of NicVax.

Are these conflicted scientists really the ones we want on a panel that is supposed to be making objective, big picture recommendations on the best strategies to reduce smoking-related morbidity and mortality? NIH advisory panels are not supposed to have members with financial conflicts of interest in the first place. Why this special exception for the tobacco products advisory panel?

The rest of the story is that the detrimental effects of the financial relationships between Big Pharma and many of the leading scientists in the anti-smoking movement as well as with the federal government itself are now starting to show. The taxpayer money spent on the nicotine vaccine was a waste of money as I predicted before the trial had even begun. The bias towards a narrow "nicotine only" strategy for smoking cessation has inundated the FDA and the NIH, which has actually partnered with Big Pharma to waste taxpayer money on a strategy that was doomed to failure from the start. And now, a scientist who put her eggs in the wrong basket as well is serving as a member of a national advisory panel to the FDA on tobacco products. In the mean time, the FDA has done everything but place a formal ban on electronic cigarettes, the one product which shows promise because of its ability to address both the pharmacologic and behavioral aspects of smoking addiction.

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