Thursday 24 August 2017

That shady link between Big Tobacco and nicotine gum

Just when you think the world of tobacco control can't get any crazier we get headlines like this:

The Shady Link Between Big Tobacco and Nicotine Gum

This represents a new narrative opening up. The story now is that Nicotine Replacement Therapies (NRT - gums, patches, etc.) are not very effective and this somehow the fault of the tobacco industry, rather than the pharmaceutical industry.

Stanton Glantz - for it is he - jumped the shark a long time ago so I am reluctant to say that this is a turning point for him. Nevertheless, this is quite a pivot. Not only does he say that NRT doesn't work, he says that it keeps people smoking.

“The problem is, without the behavioral support, they actually inhibit quitting,” he said. “Unfortunately, a lot of people think they are making progress and quitting when that’s not so. That’s what tobacco companies have known for decades. They’re developing products under the guise of nicotine replacement therapy.”

Glantz's co-author on this occasion is one Dorie Apollonio from San Francisco's bonkers Center for Tobacco Control and Research.

“It was surprising to discover the industry came to view NRT (nicotine replacement therapy) as just another product,” said Dorie Apollonio, an associate professor in clinical pharmacy at UCSF and lead author of the study. “The tobacco companies want people to get nicotine — and they’re open-minded about how they get it.”

Are they really though, Dorie? Do they really not prefer you to get nicotine from tobacco products that they sell for a profit rather than from pharmaceutical products made by the pharmaceutical industry? Or, for that matter, e-cigarette products made by the vaping industry? If you can't see the difference, you should probably keep your views about business to yourself.

In the press release, she says:

“Tobacco companies put out these products as a way to sidestep policies, by giving people a way to ‘smoke without smoking’. 

The tobacco industry - I knew it was them! Even when it was Big Pharma, I knew it was them!

It is unclear which policies are being 'sidestepped'. If they are anti-smoking policies then it should be considered a success that people are 'smoking without smoking' (ie. not smoking).

It is also unclear which products they are talking about. NRT is almost entirely manufactured and sold by Big Pharma. Always has been. Glantz and Apollonio suggest that FDA regulation of tobacco under the 2009 Family Smoking Prevention and Tobacco Control Act has opened the door to Big Tobacco selling NRT on a grand scale, but their only example is Zonnic, an obscure nicotine gum company that RJ Reynolds bought before the Family Smoking Prevention and Tobacco Control Act was passed.

To shore up their hypothesis, they also mention a nicotine lozenge called Verve but this is not marketed as a stop-smoking product and is only sold in the state of Virginia. They have no other examples and they ignore the rest of the world where FDA regulation does not apply.

Have tobacco companies gone wild with NRT outside the USA? No they haven't. The only 'therapeutic' product from a tobacco company that springs to mind is BAT's e-cigarette (sort of) Voke, which was licensed as a medicine in the UK a few years ago when it looked like the government was going to demand that all e-cigs be medically licensed. When the government changed its mind about this, BAT gave up on Voke and it never came to market. So much for the tobacco industry riding the NRT bandwagon. 

Obviously, it is Big Pharma that sells NRT and it is an open secret that they make the most money when people use patches and gum indefinitely, rather than for the six months that are recommended on the pack. I know at least two people who have been using Nicorette gum for twenty years. The problem with NRT is clear to anyone who has tried it: it is good enough to relieve cravings a little, but not enjoyable enough to make you want to switch full-time and give up smoking (this is one of the big differences between NRT and vaping - and vaping doesn't require counselling to work).

Rather sweetly, the authors claim to only have just realised this:

Now, a new study conducted by scientists at UC San Francisco reports that tobacco companies have known for decades that, without counseling, NRT hardly ever works and that consumers often use it to complement smoking. 

You don't say! If you've got a problem with this - and you would be justified in complaining - take it up with the pharmaceutical industry (who make them) or the FDA (who approved them as efficacious stop-smoking medicines) or the anti-smoking groups (who have ceaselessly touted NRT to consumers and governments). And if Glantz and Apollonio are alleging fraud, misconduct and deceit, they should encourage the tobacco control community to reject any further funding from Big Pharma.

(Incidentally, the best explanation for the failure of NRT seems to be Carl Phillips and colleagues' observations about second-order preferences: It is marketed to people who want to smoke but want to not want to smoke, with the message that it will indeed change their preference to smoke. It doesn't, and so they start smoking again. In so far as it works better in the presence of counseling, this is probably just self-selection: smokers who are inclined to volunteer to be in studies of cessation counseling are an odd subset of all smokers who want to quit more than average.)

This insight [!!! - CJS] from the formerly secret industry documents known as the “Tobacco Papers” reveals why companies that once viewed nicotine patches and gum as a threat to their cigarette sales now embrace them as a business opportunity, the researchers said.

One tobacco company buying up one small nicotine gum company hardly represents the tobacco industry 'embracing' nicotine replacement therapy. But even if it did embrace them, so what? Tobacco companies have bought up food and drink companies in the past, why shouldn't they invest in the alternative nicotine market?

And what are these 'insights' are whence did they come? You won't be surprised that they came from yet another cherry-picking trawl through the archives...

Apollonio’s researchers analyzed 90 million pages of documents from seven tobacco companies dating back as far as 1960, obtained in litigation against the tobacco industry.

Obviously they didn't actually analyse 90 million pages of documents. That would take several lifetimes. What they did was do a word search of the chaotically assembled industry documents hosted at UCSF, of which there are reputed to be 90 million pages, and hoped for the best. As they explain in the study, it's the kind of 'analysis' that anybody could do.

We used a snowball strategy, beginning with the keywords “nicotine patch,” “NRT,” and “nicotine gum,” and then we refined search terms and dates using named individuals, organizations, and products and adjacent (by Bates numbers) documents. 

The Legacy Documents archive is actually a very good resource. I used it a lot when I was writing Velvet Glove, Iron Fist. It is massive, however, which means that (a) no one can read enough to get the full picture, and (b) it lends itself to cherry-picking in the wrong hands. 90 million documents written by countless individuals from rival companies over seventy years cannot easily be distilled into a handful of quotes giving the definitive view of the whole industry. Some will be statements of official policy, others will be ideas brought up for debate and others will be random musings of individuals. Quotes can be illustrative, but they need to be supported by a substantial amount of other evidence before we use them to make generalisations.

The historian Virginia Berridge has something to say about the way the tobacco archives have been used in her book Marketing Health:

The enthusiasm for online industry archives is an interesting phenomenon. We are seeing a new type of family history, a Whig history revived and a rediscovery of 'the document' whose main role is to play to the policy objectives of the anti-tobacco field.  

So what does the study by Glantz and Apollonio say?

Firstly, it says that American tobacco companies began looking at alternative nicotine delivery devices in the 1950s. Glantz and Apollonio claim that they did not take any of them to market because they wanted to avoid regulation by the FDA. This is true, although they do not ask why tobacco companies outside the USA also failed to pursue them.

Secondly, they say that the tobacco industry had concluded that NRT didn't work as early as 1992. Life is too short for me to trawl the archives to see whether this is a fair judgement, but here are all of the quotes Glantz and Apollonio use in their study to prove that Big Tobacco 'knew' that NRT was a non-starter. All of them come from 1992 and all but one of them were written by the same person (Doran Stern of PMI):

'Clinical results indicate the nicotine patch was more effective against placebos. . . . It is important to keep in mind, however, that in objectively validated tests (1 full year after quitting) nicotine patch scores were less impressive vs placebos. . . . Some sort of behavior modification was administered during the clinical tests. Without some degree of psychological therapy, many experts warn that the nicotine patch is powerless [as a method of smoking cessation]... The explosive growth of nicotine patch sales has not seemed to increase rate[s] of quitting (currently holding at 6.7% for 12 [month period] ending June [1992]).'
'301 past two year quitters (out of a sample of 551 quitters identified in January–February) were reinterviewed . . . to determine their usage of and reactions to the Nicotine Patch. . . . Roper [the polling organization Philip Morris hired to track smoking trends] data through December indicate that quitting rates on a 12 [month] basis have been roughly flat.'
'Studies of the efficacy of nicotine gum or transdermal patches on smoking cessation invariably show a significant benefit in the short term, but only a small advantage (if any) over placebo in the long term (6+ months). . . .'
'Monthly and 12 [month] quitting rates have been roughly flat through April. The use of Nicotine Patch as a way to stop smoking jumped dramatically in April (8% - 26%). . . . The results seem to suggest that Nicotine Patch [use for quit attempts] evidenced growth at the expense of ‘stopped all at once’ quitting.'
'Based on the attached results from our Continuous Tracking Study [Roper polls of smokers], it appears that usage of the nicotine patch has dropped steadily since it peaked in June. . . . [A] possible explanation for the patch’s loss in popularity may relate to the difficulty quitter’s [sic] experience in adhering to the strict, but necessary, regimen prescribed for the patch treatment.'
'Almost all the men we spoke to [who used NRT patches] went back to smoking... Some believe that the novelty [of the nicotine patch] has started to wear off.'

It is reasonable to assume that other industry insiders have commented on NRT since 1992. Did they take a different view? Did they see NRT as a threat? Glantz and Appollonio do not tell us, but I reckon I could write a paper showing that tobacco companies were terrified of NRT if I spent a couple of days searching the archives and set my threshold of proof as low as they do. Nevertheless, the press release for this study baldly states that 'by 1992, the industry had determined that patches and gum by themselves do not help smokers quit.'

Even if this were true, so what? According to one newspaper, working from the press release:

They discovered that as companies knew in 1992 that patches and gum alone did not help people quit smoking but did not act on that information.

Where to begin? There is no evidence that these companies had any information about NRT that couldn't be acquired by regulators or 'public health' professionals. They certainly didn't have information in 1992 that the rest of us didn't have by, say, 2002. But let's suppose they did. What were they supposed to do about it? Imagine what would have happened if cigarette companies had launched a campaign to deter people from using smoking-cessation drugs in the 1990s. Imagine if they had accused the pharmaceutical industry of pushing junk science to support their claims of efficacy. How do you think the anti-smoking lobby - which was by then heavily funded by the pharmaceutical industry - would have reacted if Philip Morris had come out and said 'these stop-smoking products are worthless, don't use them'? They had no incentive to do this and they would have been vilified if they had.

Isn't it the job of the 'public health lobby' to do due diligence on these products? Or the pharmaceutical industry? Or the regulators? If it was so obvious that these products don't help people quit - indeed, that they reduce quit rates, as Glantz now claims - why have the 'experts' of tobacco control been sitting on their hands for the last 25 years? Why have so many studies, such as this one in the anti-smoking lobby's house journal Tobacco Control, concluded that over-the-counter NRT works if it doesn't? And why does Glantz have more faith in the opinion of two random tobacco company employees than in the 'public health' lobby's finest minds?

On the howling wilderness of Planet Glantz, the tobacco industry should have been promoting nicotine gum and the 'public health' lobby should have been calling bullshit on it. The reality, of course, was pretty much the opposite. The industry quietly recognised that NRT was an unwelcome competitor but was unlikely to be an existential threat while the 'public health' lobby went around touting it despite mounting evidence that it didn't work as advertised.

It is true that NRT is largely ineffective (Glantz's study does not actually show this, but it happens to be true) and so it is the self-appointed experts of tobacco control who have to explain themselves, as do Big Pharma, the FDA, the WHO and all the governments that have been using taxpayers' money to dish out patches and gums for decades.

But Glantz does not point the finger at any of them. Instead, he comes up with an excuse that is quite something:

"The tobacco companies are generally 20 or 30 years ahead of the public health community in their thinking about their issues," Glantz says. "They have much more resources [sic] than the health community does to study their products."

This is the David and Goliath delusion on crystal meth. The 'health community' has had vastly more resources with which to research NRT than would have been available to a couple of analysts in 1992. All these guys seem to have done is look at published research, monitor smoking rates and used some common sense. The idea that the tobacco companies knew something about NRT in the early 1990s that nobody else could have known until Glantz and Apollonio published their 'insights' is laughable.

The implication of Glantz's paper is that the debate over how well NRT works has been settled by a handful of comments in some tobacco industry briefings a quarter of a century ago. It suggests that a couple of dudes working in commerce had a better understanding of nicotine, addiction and smoking cessation in 1992 than the entire global tobacco control movement has acquired in the years since. This does not reflect well on him or his colleagues and yet he seems happy to admit it.

He also seems happy to admit that NRT is not much good. Indeed, his condemnation of NRT - and over-the-counter NRT in particular - is arguably more fierce than the scientific literature justifies (that literature may be junk, but it is his colleagues' junk and he normally treats it as gospel). This is surprising, not only because so much pharmaceutical money swishes around in tobacco control, but because it makes his previous support of NRT look rather foolish. In 2005, for example, he wrote:

Individual smoking cessation is a highly cost-effective clinical medical intervention for individual smokers; nicotine replacement therapy (NRT) is a key element of this approach to combating nicotine addiction... NRT should be recommended in both clinical practice and public health practice.

When a study suggested that over-the-counter NRT didn't work in 2012, he said 'this is just one study, and it's not terribly huge', adding that 'we don't necessarily want to throw out the baby with the bathwater'.

He has now thrown the baby halfway across the bathroom. Why? What has possessed him to do a screeching U-turn on NRT which will embarrass his colleagues and upset Big Pharma?

As with most of his activity these days, it can be explained by his fanatical opposition to e-cigarettes. He insists that e-cigarettes do not help smokers quit and now he is saying the same about NRT. He says that 'dual users' of e-cigarettes are less likely to quit and now he is saying the same about dual users of NRT. He claims that the tobacco industry likes e-cigarettes because they sustain smoking rates and nicotine addiction - now he is saying the same about NRT.

The purpose of the study is to draw a parallel between the tobacco industry's supposed attitude to NRT in the 1990s and its supposed attitude to e-cigarettes and other alternative nicotine devices today. Never mind that it was the pharmaceutical industry that brought NRT to market and his own colleagues who hawked it. Never mind that the tobacco industry has never supported NRT and has never made any serious effort to take an NRT product to market.

When Glanz and Apollonio make the (dubious) assertion in the conclusion of their study that 'NRT can expand nicotine use while maintaining smoking rates' it is done with a nod and a wink to the FDA. What they are really saying is that e-cigarettes and any other safer nicotine device that smokers might switch to can expand nicotine use while maintaining smoking rates.

The purpose of the study becomes clear in the final line when they write:

These findings suggest that the least harmful way to sell nicotine delivery products is to restrict them to smokers whose quit attempts are medically supervised, consistent with the original studies of NRT for smoking cessation. 

This is a complete non-sequitur. Nothing in what has come before leads to this conclusion. Nowhere in the study do they discuss the vastly different risk profiles of the various nicotine products. There is no reason to think that the 'least harmful way' of regulating the nicotine market is to restrict access to the least harmful products. Quite the reverse.

This is just another thinly-disguised, puritanical attack on harm reduction approaches. It is a nonsensical conclusion, but it is whole purpose of the study from Glantz and Apollonio's perspective and they hammer the point home again in the press release, saying: 

“Our study shows that by not regulating nicotine in all tobacco products, including NRT, the FDA could be walking into a trap.”

There is method in Glantz's apparent madness of severing of relations with the pharmaceutical industry. By turning on NRT, he can be consistent in his opposition to all alternative nicotine products and demand consistent regulation, ie. medical licensing and a ban on over-the-counter sales.

If I may speculate for a moment, it has another possible consequence. By rejecting all nicotine products, it opens the door to the full demonisation of nicotine. Nicotine underwent an image change when Big Pharma started selling it. The public had often assumed that it was carcinogenic because of its connection with smoking, but this myth had to be debunked once it was being sold as medicine. The scientific consensus is that nicotine is addictive and can be toxic in large doses but is basically harmless when consumed at the levels found in recreational tobacco products. Smokers smoke for the nicotine but die from the tar, as Michael Russell said back in 1976.

Opponents of vaping have an incentive to resurrect the old myths. Lacking evidence that vaping kills, bottom feeders such as Simon Chapman have been scrambling around for any crumb of evidence implicating nicotine as a health threat. The existence of medically licensed NRT is a problem for these fanatics, but if Glantz's bizarre new narrative takes hold, it will be less of an obstacle. If you can do the mental gymnastics required to believe that the tobacco industry loves the pharmaceutical industry's stop-smoking products because they make people smoke, you can easily believe that same is true of e-cigarettes, snus, lozenges etc.

These people do not just want a tobacco-free world, they want a nicotine-free world, and this extraordinary rewriting of history is another step towards it.

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