0
0
0
s2smodern

Harry Shapiro Director DrugWise

Clive Bates received an invitation from China to buy 99% strength USP nicotine. This is what was bound to happen when as Clive points out “the super-caution of regulators over hypothetical and negligible risks can turn out to be reckless abandon in real life”. Excessive regulation of the law-abiding market [will most likely] prompt people to buy their e-liquid over the internet in illegally high-strength concentrations and at very low cost and then to mix their own - or to establish a cottage industry and do it for others”.

This is one of the very real potential problems with a legal, regulated market in drugs. Whatever the merits of the idea, if it ever happened, it is almost inevitable that the bar would be set very high in terms of product safety rules and regulations imposed on the new producers in order for them to bring their drugs to markets together with the high levels of taxation that any government would seek to levy. As with Chinese nicotine liquid, there would be a ready market for high strength drugs of unknown quality and sold more cheaply – which of course is what we have now. Tricky.

Speaking at the Senate hearing concerning his nomination as the new FDA Commissioner, Scott Gottlieb said in his opening statement "In areas where there’s an inherent, obvious, and seemingly unavoidable risk related to certain consumer products - whether it is combustible tobacco or dangerously addictive opioid drugs - we have the opportunity to help consumers move to less risky alternatives.".

Gottlieb, a former FDA employee, was from March 2015 to May 2016, a director of Kure Corp, a North Carolina-based firm that distributes e-juices and vaping pens in coffee house-style lounges known as vaporiums. He has promised to sell his stake if confirmed. His involvement in the industry was picked up by Senator Murray during questioning. She started her questioning by seeking his commitment not succumb to political pressure from the Trump administration over aspects of womens' health rights, but then proceeded to put him under that same pressure to commit to banning at least those nicotine flavours which she claimed might be attractive to young people such gummy bears and cookies and cream. His response was encouraging; he said all these issues about flavouring and young people were “empirical questions” that needed to be addressed by the best available science (although it depends on exactly what science he comes to rely on) and that his primary commitment was to ensure that smokers were encouraged away from smoking cigarettes and that young people do not take up smoking.

View the entire hearing at https://www.help.senate.gov/hearings/nomination-of-scott-gottlieb-md-to-serve-as-commissioner-of-food-and-drugs

Under the headline Big Tobacco Attacks Sensible F.D.A. Rules on Vaping, an editorial in the New York Times (19th April) said “As smokers turned to electronic cigarettes to reduce the health risks of smoking, big tobacco companies started buying e-cigarette makers and producing and selling their own. Now those companies are lobbying Congress to prevent the Food and Drug Administration from regulating electronic cigarettes and cigars, as it does conventional cigarettes. If they succeed, they will be able to sell and market addictive nicotine products to young people with few restrictions”.

https://www.nytimes.com/2017/04/19/opinion/big-tobacco-attacks-sensible-fda-rules-on-vaping.html

This prompted a letter from Jeff Stier, Director of the Risk Analysis Division at the National Center for Public Policy Research making the key point that consumers and evidence-based science supports Big Tobacco in its attempt to rein in the Deeming Regulations.

“Your editorial against a congressional fix to FDA's tortured e-cigarette regulations illustrates how bereft of factual arguments opponents of tobacco harm reduction have become

Representative Cole’s legislation in no way legalizes sales of e-cigarettes to minors, something the FDA regulations, as well as almost all states, properly ban, and will continue to do under this update to the law.

The FDA’s twisted application of the law giving it authority to regulate tobacco products would have the unintended consequence of removing nearly all of these dramatically less harmful products from the marketplace, whose consumers are predominantly adult smokers who have quit smoking or are in the process of quitting and have already reduced their cigarette consumption.

You justify your support for the FDA’s upcoming de facto ban by claiming that there’s "not a lot of evidence" to support the claim that e-cigarettes "can help people quit conventional tobacco products containing harmful tar.”

Yet just last week, the CDC reported a 26 month study of nearly 16,000 smokers which found that e-cigarettes are the most popular device used for smoking cessation (35.3%), more popular than both the nicotine gum and patch combined (25.4%).

https://www.cdc.gov/pcd/issues/2017/16_0600.htm

This, despite misinformation campaigns from groups like The American Lung Association, who...are funded by pharmaceutical companies like Pfizer and GlaxoSmithKline, which sell pharmaceutical nicotine. https://www.nytimes.com/2016/09/03/us/politics/e-cigarettes-vaping-cigars-fda-altria.html

Public Health England, the Royal College of Physicians and other respected medical groups can provide your readers with a lot of additional evidence.

Despite your assertion otherwise, Congress did not envision e-cigarettes in the 2009 legislation. The word "e-cigarettes" isn’t even in the law. Certainly, it was not the intent of Congress to have the FDA ban these dramatically less harmful products which help people quit smoking.”.

Clive Bates has usefully pulled together the THR achievements from England. Glad to see that with a rubbish football team and shall we say a level of political uncertainty about the future, we are getting something right

https://www.clivebates.com/England

And on the subject of this 'sceptred isle', click here for presentations from the GFN Dialogues, although of course one was in Glasgow which I am reliably informed is not in England

https://gfn.net.co/dialogues/2017

One of the feedback comments was that there should be panellists who don’t necessarily agree with the GFN. I think it is really important to break out of the echo chamber; some people will have valid concerns which should be addressed, but it will also serve to hold up junk science and moral agendas to the light.

However, as with the drugs field, it is actually very hard to get those who vehemently hold opposing views to step up to the podium in situations that are outside their comfort zone. And part of the reason may be that they anticipate hostile reactions and personal attacks. I actually heard one academic who opposed long-term opiate substitute prescribing ask whether the organisers of a harm reduction conference he was due to address, could guarantee his personal safety. I have heard UK government officials booed and heckled at drug conferences. We should be serious about having serious and mature public debates about these issues. And maybe create 'safe spaces' in which they can be conducted.