Tag Archives: Dr Scott Gottlieb

The perfect ‘product’ for nicotine addiction

The US Food and Drug Administration (FDA) recently announced it has awakened to the interesting idea that the way to help people quit smoking is for them to have a wider range of ‘products’ available in addition to so-called nicotine replacement therapy (NRT).

The FDA recognises that NRT (nicotine-containing gum, patches and lozenges) is of limited effectiveness and so it now wants the smoking public to have access to more options, in particular, e-cigarettes. Further, it wants to have NRT and e-cigarettes approved as medical products and possibly even have them covered by health insurance.

Let’s pause for a moment to consider this curious situation. In the US cigarettes are freely and legally available for sale to anyone over 18 (21 in some states). As a result many people become addicted to smoking and because of this there are about 480,000 deaths from smoking-related diseases in the US every year. And the way the government is trying to deal with this is that when people are already addicted to the nicotine in cigarettes and find it difficult to stop smoking, they should be offered nicotine in some other form as a ‘therapy’ to help them. But because NRT doesn’t work very well they need to have other products or options available as quit smoking aids.

Isn’t there something a bit odd about this? Either nicotine-containing consumer products (especially cigarettes) should cease to be available, in which case the problem wouldn’t arise for those who don’t yet smoke, or we need a radical new approach to treating nicotine addiction for those already in this unfortunate position.

It gets worse. The FDA is contemplating new measures that would enable cigarette companies to get non-cigarette nicotine-containing products approved as medicines to treat the nicotine addiction that their primary product, cigarettes, caused in the first place.

Big Tobacco must love this. They can present themselves as part of the solution to the smoking problem – a win-win situation for them because they can anticipate their income will be protected as sales of cigarettes fall while sales of alternative nicotine products rise. This might just about be acceptable if they were to announce, for example, that at the stroke of midnight on 31st December 2020 all cigarette production in the US will cease. Of course they won’t commit themselves – any suggestion of phasing out combustible tobacco products is projected to some vague time in the fairly distant future.

Tobacco companies should be seen for what they are: the whole of the problem. And the only role they can have solving it – and it would be a very big role which would virtually eliminate the problem – would be to stop making cigarettes.

Instead of pushing for this obvious measure, or even mentioning it, the FDA Commissioner, Dr Scott Gottlieb, verbosely talks about ‘what we can do to create additional pathways to bring additional nicotine replacement therapies to the market’.

By the time smokers are addicted to nicotine it’s too late. Dr Gottlieb is pursuing a non-existent goal. You have to remove the cause of nicotine addiction, not treat it when it’s happened. Why aren’t smokers clamouring for relief, for a ‘product’ or even for a range of options to help them escape their thraldom to nicotine?

Because the tragedy of nicotine addiction is that many sufferers don’t want to escape.

Text © Gabriel Symonds

Cruel, unnecessary, shameful

Jane Goodall and friend

The words in the title were used by Dr Jane Goodall, the distinguished primatologist and animal welfare campaigner, in a letter to the FDA Commissioner, Dr Scott Gottlieb, protesting about nicotine addiction experiments on monkeys.

This is an extract:

I was disturbed–and quite honestly shocked– to learn that in 2017 the U.S. FDA is still, in 2017, performing cruel and unnecessary nicotine addiction experiments on monkeys…

I have been told that FDA researchers implant squirrel monkeys as young as one-year-old with devices to deliver nicotine directly into their bloodstreams. The young primates are then placed in restraint devices and trained to press levers to receive doses of nicotine. This apparently enables them to determine at what point they become addicted…

To continue performing nicotine experiments on monkeys when the results of smoking are well-known in humans—whose smoking habits can still be studied directly—is shameful.

As a result of Jane Goodall’s letter the research has been suspended.

However, ‘scientists and leaders in the addiction community’ responded to the suspension with an open letter in which they attempted to justify animal experiments in addiction research. Among other claims, they say we need answers to the following questions that only animals testing can provide:

Why are some individuals vulnerable to addiction and others not?

Why does relapse after any kind of treatment occur at such phenomenally high rates?

Why do drug abusers persist in seeking and taking substances that so clearly will lead to incarceration, poverty, even death?

Let us suppose that we had a complete answer to all these questions; that we knew everything that could possibly be known about the underlying behavioural, physiological, neurochemical and molecular changes, etc., that occur in addiction – what then? What would, or could, the scientists and leaders in the addiction research community do with this knowledge?

These questions are of purely academic interest; they are not of the slightest use in a practical sense for helping people with substance addictions.

The scientists and leaders go on:

With more than 440,000 people in the United States dying from tobacco use each year, clearly nicotine addiction remains a significant public health problem and it is quite evident that we do not understand this disorder well enough to eradicate it.

Really? What more understanding are they seeking that could possibly help them to eradicate the shocking death toll from tobacco use?

I trust these ivory tower dwellers, in the same way that I suggested to Dr Gottlieb in a previous post (http://nicotinemonkey.com/?p=1708), will allow me to lead them back down to earth.

There exists a mountain of research on smoking and addiction. Those who call for yet more research do not appear to understand that we have already an overabundance of information to take the one necessary step that would virtually eradicate the death toll from tobacco use: abolish tobacco.

Further, the scientists and leaders cannot resist making ad hominem attacks on Dr Goodall, referring to her pejoratively as a ‘celebrity’ and even questioning her scientific credentials when she points out the self-evident truth that it is ‘extremely cruel to restrain the monkeys’.

In reply to this charge they say:

Despite her scientific background—which should result in knowing that evidence and citations matter—Goodall cites no evidence for her claim that restraint is ‘extremely cruel’…In reality, empirical evidence—that is data – show that restraint devices used in such studies do not cause severe stress to the animals, because they are slowly trained to be familiar with and calmly enter and remain in the restraint devices.

So that’s all right then.

Restraint devices don’t cause severe distress, they say, but this is an admission that they do cause distress. Monkeys, being intelligent animals, no doubt realise that resistance is futile and they have no choice but to submit to their cruel fate.

There is another word one could add to Jane Goodall’s apt description of these experiments as cruel, unnecessary and shameful.

That word is: repulsive.

Text © Gabriel Symonds

How many smoking deaths in the US would be acceptable?

You would think, would you not, that the US Food and Drugs Administration (FDA) Commissioner, Scott Gottlieb, MD, would understand a few basic facts about smoking and nicotine addiction. Yet, although he acknowledges that smoking is a pretty serious problem, causing more than 480,000 deaths in the US every year, in a press release of 28 July 2017 he said he wants to have ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.’

Let us dissect this statement. If he wants to ‘regulate’ cigarettes, rather than abolish them, this implies there are some circumstances where smoking is legitimate or acceptable. And what, I wonder, might those be? Then he wants the regulation, such as it may turn out, to encourage the development of new tobacco products that may (or, presumably, may not) be less dangerous than ordinary cancer sticks.

And his idea to achieve this, as he somewhat clumsily puts it, is by:

Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.

Now, who are these adults who ‘need or want nicotine’? No one needs nicotine – except those who are addicted to it – and these are the very people who want it for that reason. So what the brave Dr Gottlieb envisages is:

…lowering nicotine levels [in cigarettes which] could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.

Let me lead Dr Gottlieb back to reality. If we wait generations for the decreased likelihood of people being addicted to cigarettes, how many will die from smoking in the meantime? All smokers are currently addicted (to nicotine) – that’s why they smoke. Further, they don’t need to be ‘allowed’ to quit; they just need to quit! And the only thing that will allow the happy state of universal non-smoking to come about within the foreseeable future is to abolish tobacco.

Instead, the envisioning goes on to:

…afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive.

Presumably it is not their intention to explore unclear and meaningless measures, but this is in effect what all the envisioning will amount to. In any case, I wonder what degree of reduction in toxicity, appealability and addictiveness they have in mind?

Even if such unspecified degrees of reduction in these three attributes were possible, how many people dying in the US every year from tobacco-related diseases would Dr Gottlieb find acceptable? All tobacco products are addictive because they contain nicotine. If the nicotine is somehow reduced so that cigarettes are ‘less addictive’ no one will want to smoke them. Or is that the idea? If so, this would in effect be the same thing as cigarette prohibition. Then why not say so?

Anyway, addiction is addiction; it makes no sense to talk of degrees of addiction. And even if this were true, someone who is deemed to be only lightly addicted may think he doesn’t have a problem and therefore has no need to quit, and someone who is regarded as being heavily addicted may think quitting will be too difficult so she won’t want to try to quit.

We are back to the basic problem: why envisage only reducing tobacco related disease and death rather than abolishing them by abolishing tobacco?

Text © Gabriel Symonds