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Sunday, March 29, 2015

Drones: American Innovation Fail

So American's have gotten are trying  to get drones up and running for commercial things like package delivery, movie films, news reporting and so on.

No-doubt the drones are all Chinese made but the "big market" is the US - at least that's where all the fame and fortune will come from (think GoPro).

Er, well, at least until the FAA hammers them out of commercial existence.

So I read today in the WSJ about how drones are creating new Hollywood opportunity: flying through the spokes of a Ferris Wheel, off the edge of a cliff, shots you can't really take with human operators, zooming around in front of motorcycles, etc.

Only problem is if "mom" catches them making just a single mistake it will ruin it all for everyone (from the WSJ): "... one stupid mistake could ruin the drone business for everyone."

Who's mom?

The FAA, the whiney press, do-gooders, and an assortment of other whack-a-doodles think drones are the next satan: they are going to destroy the planet, ruin all air traffic, kill people, etc.

Good God!

Imagine a commercial business flying drones for some commercial purpose - someone might get hurt!

No, No, No...

They must be controlled - and if anyone makes a mistake - we'll take everyone's privileges away!

I haven't heard this kind of talk since I was about six (6) and my ten (10) year old cousin would sneek us cookies or read us a ghost story: "If you tell your mom I read this to you I'll never read you another ghost story!"

Really!

We are well beyond the "nanny state."

Few, for example, remember the 1900's British "red flag" laws requiring someone with a red flag to walk sixty yards in front of the car to warn people the car was coming.

Make it safe for everyone.

Funny how no one has a problem with cars killing some 40,000 people in the US a year.

But God forbid a drone might hit someone...  (Lions and tigers and bears - Oh My!)

What's sad is not that we live in the ultimate "nanny state" but that people tolerate this...

Oh no, we cannot innovate, it might be dangerous...  Like your older cousin threatening to tattle if you jump off the roof.

Spare me...

We, like the drone that's run out of power, are about to fall out of the sky...

Same with "e-cigarettes"...

Do you really need the red flag out in front of the car?

Nope, you need that to protect the buggy whip industry...

(And how well did that work...?)

No, its all dangerous...

How short would our lives be if we had no automobiles?

Thursday, February 19, 2015

Excellent Nicotine Analysis

Find it here.

Diacytel: The Real Cause of Health Problems?

 There has been a lot of discussion recently about vaping and diacetyl.  Previously I wrote this on what I considered to be the objective danger of diacetyl in vaping.

The bottom line is that I believe, and its my opinion, there is really no cause for concern.

The reasoning is simple.  Looking in detail at what's been published about the rise of "popcorn lung" and related lung disease its pretty clear that, given eighty years of diacetyl used in commercial food preparation contexts, the incidence of "popcorn lung" in some very particular types of manufacturing facilities are likely related to either A) some other causal agent or B) some specific means of manufacturing flavoring that may have involved diactyel.

Please read through the material below and draw your own conclusions:

Here is a very detailed document created by the CDC describing the prevention of lung disease as it relates to the manufacturing of flavors: "Preventing Lung Disease in Workers Who Use or Make Flavorings".  This is dated from December 2003.

Some details are provided, starting on page #3, of "Case Clusters" which describe each of the circumstances on which the entire "diacetyl" (DA) controversy is based.

Cluster #1: "... mixers of a heated soybean oil, salt, and butter flavoring mixture; the butter flavoring was poured by hand from open buckets into open mixing tanks ..."

Cluster #2: "... a 38-year-old worker who became short of breath and started coughing within seconds after adding 30 gallons of acetaldehyde to a flavoring mixture ..."

So let's note here that acetaldehyde (from Wikipedia) "... is toxic ..." "... is an irritant of the skin, eyes, mucous membranes, throat, and respiratory tract ..." and "... is a probable or possible carcinogen in humans."

Cluster #3: "...worked in a room where liquid and powdered flavorings were combined with starch and flour in large mixers..."

Cluster #4: "...became noticeably worse when he used a new butter flavoring mixture..."

Cluster #5: "...mixing and holding tanks for heated oil and butter flavoring..."

Cluster #6: "...mixing and holding tanks for heated soybean oil and flavorings..."

Firstly, while diacetyl is mentioned throughout these discussions (and below) its unclear exactly what mixtures were being used, how long they were used, what amounts of diacetyl were involved, and, to my mind most important, was there a pattern of usage involving diacytel with other chemical elements that triggered the problems.

Note, for example, that a lot of these workers were mixing diacytel and other, undefined "buttery flavoring" with oils.  Diacetyl is water solulable - so one might question the relationship between mixing it with water and oil to the problems found.

Diacetyl has been manufactured since the 1930's and used in food production extensively since then with little apparent issue.

Why all of a sudden in popcorn plants?

Second, I have not been able to discover any documentation of what the other "buttery flavors" used were.  So, again, its entirely possible that diacetyl is being singled out incorrectly.  What were these other flavors?  Its clear from the cluster report that known, problematic chemicals like acetaldehyde were also being used.

Interesting this point never seems to be questioned.

The results provided by this document are common sense: ventilate, be careful, and so on.

But if we look at the studies done at the time we see some interesting things.  (Note, I have not read all the studies, I am not any sort of official "scientist" or anything like that.  I do, however, make a living tracking down bugs and preparing for issue they cause so I am pretty good at determining causal links and also pretty good at figuring out when linkages between things or events are not causal.)

General detailed data on these cases are available by googling ("Parmet and Von Essen 2002"):

http://defendingscience.org/case-studies/documents-for-popcorn-workers-lung

http://www.ersj.org.uk/content/34/1/63.full.pdf

At the end of the linked PDF you see the following: "Any conclusions pertaining to causation are based on the assumption that diacetyl is either causal or correlated with other chemical constituents of butter flavourings.

In conclusion, increased exposure to a reactive substance such as diacetyl by itself or in combination with other constituents of butter flavouring likely increases the risk of obstructive lung diseases including BO in susceptible individuals
."

Let's understand this:  "conclusions pertaining to causation," i.e., cause is dependent on an assumption diacytel is the actual cause or correlates, e.g., is present with, another, apparently unknown, causal agent.

Effectively "we don't know what caused it but it seems like it might be diacetyl related or not."

Then we see these assumed components "likely increases" the risk of obstructive lung disease.

But what is risk?

Risk in this context is not a predictor of something and not cause something (see this).  Instead risk  "represents the numerical chance something might happen based on examination of a large group."

So, in this case, "increases the risk" means that your chance of obstructive lung disease might increase if the assumption diacetyl, or other things, might be the cause is true and they, infact, cause a probem - which is not known.

In fact, "we have no idea," would have been more accurate.

Now, based on past history it seems clear that

A) Diacetyl has been around a long time, probably centures, and, in fact, its a natural product of fermentation. During that time it apparently has not caused problems outside of the "popcorn lung" context as far as I can tell.

B) Today there's a lot of vaping-related or popcorn-lung-related studies that say to some degree "diacetyl causes substantial damage to airway epithelium."

But these two facts seem somewhat incongruous.

Why?

My personal belief, and I do vape and I do not concern myself with diacetyl, is that diacetyl is around food and beer manufacturing: it has been and always will be.

So does vaping create an "exposure" concern?

I'd have to say no based on what I have seen so far.

My guess is that what's dangerous are flavoring manufacturing labs like those uncovered in the popcorn-lung studies.  But its totally unclear what, in a chemical sense, is going on in there.

And no one seems interested in studying it.

And then, too, suddenly the "problems" all vanished...

Why?

Probably because the manufacturing process was changed.

But "buttery flavoring" is still around...

So what's different?

(EDIT: More links:

http://www.toxipedia.org/display/toxipedia/Diacetyl

http://www.professorbeer.com/articles/diacetyl.html

http://www.reddit.com/r/beer/comments/1wl0st/intentional_use_of_diacetyl_in_commercial_beer/

)

Saturday, February 14, 2015

North Dakota and "...the perverse effect of prolonging cigarette consumption"

The quote used for the title of this post is from Clive Bates (see this).

Its part of a letter written to the World Health Organization (WHO) on behalf of e-cigarettes and vaping.  The letter is authored by over a dozen health experts from around the world who say "We respectfully suggest that the following principles should underpin the public health approach to tobacco harm reduction, with global leadership from WHO:"

The quote is item #3: "On a precautionary basis, regulators should avoid support for measures that could have the perverse effect of prolonging cigarette consumption. Policies that are excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result. Every policy related to low risk, non-combustible nicotine products should be assessed for this risk."

Imagine the concept of "unintended consequences" and vaping.

I doubt very much that snuffing out vaping (no pun intended) is an "unintended consequence."

Why?

Look at this article about how the North Dakota legislature has determined that vaping is not a tobacco product.

It seems as if the truth is accidentally leaked out by Rep. Eliot Glassheim: "“The issue is this bill has a definition which preempts these devices as being considered tobacco products,” said Rep. Eliot Glassheim, D-Grand Forks. “It’s a new definition, and it seems to me it’s a stealth way of not being able to tax them in later bills" (underline my own).

Declaring vaping a "non-tobacco product" is "stealth way" of not being able to tax it...?

Hmmmm.

Poor Eliot doesn't seem to have gotten the memo here...

Eliot, please be advised that regardless of how "healthy" vaping might be your lobbyists and cronies will be very unhappy if vaping is not made into tobacco.  However, Eliot, you're not supposed to actual say this.

Instead you are supposed to say "vaping will harm children" or "no one knows what vaping will do" to someone's future. 

Those are the acceptable responses. 

Perhaps the letter, written last year, should be more carefully considered Mr. Eliot.

After all, if someone dies from a smoking related illness, it would seem Mr. Eliot has put lining his pockets ahead of saving a human life.

The signatories to the aforementioned letter, by the way, are as follow:

Signatories this statement at 26 May 2014
 
Professor David Abrams
Professor of Health Behavior and Society.
The Johns Hopkins Bloomberg School of Public Health. Maryland. USA.  
Professor of Oncology (adjunct). Georgetown University Medical Center,
Lombardi Comprehensive Cancer Center. Washington DC.
United States of America
 
Professor Tony Axéll
Emeritus Professor Geriatric Dentistry
Consultant in Oral Medicine
Sweden
 
Professor Pierre Bartsch
Respiratory physician,
Faculty of Medicine
University of Liège
Belgium
 
Professor Linda Bauld
Professor of Health Policy
Director of the Institute for Social Marketing
Deputy Director, UK Centre for Tobacco and Alcohol Studies
University of Stirling
United Kingdom
 
Professor Ron Borland
Nigel Gray Distinguished Fellow in Cancer Prevention at Cancer Council Victoria
Professorial Fellow School of Population Health and Department of Information Systems
University of Melbourne,
Australia
 
Professor John Britton
Professor of Epidemiology;
Director, UK Centre for Tobacco & Alcohol Studies,
Faculty of Medicine & Health Sciences
University of Nottingham,
United Kingdom
 
Associate Professor Chris Bullen
Director, National Institute for Health Innovation
School of Population Health,
University of Auckland,
New Zealand
 
Professor Emeritus André Castonguay
Faculty of Pharmacy
Université Laval,
Quebec,
 
Dr Lynne Dawkins
Senior Lecturer in Psychology,
Co-ordinator: Drugs and Addictive Behaviours Research Group
School of Psychology,
University of East London,
United Kingdom
 
Professor Ernest Drucker
Professor Emeritus
Department of Family and Social Medicine,
Montefiore Medical Center/Albert Einstein College of Medicine
Mailman School of Public Health
Columbia University
United States of America
 
Professor Jean François Etter
Associate Professor
Institut de santé globale,
Faculté de médecine,
Université de Genève,
Switzerland
 
Dr Karl Fagerström
President, Fagerström Consulting AB,
Vaxholm,
Sweden
 
Dr Konstantinos Farsalinos
Researcher, Onassis Cardiac Surgery Center, Athens, Greece
Researcher, University Hospital Gathuisberg, Leuven,
Belgium
 
Professor Antoine Flahault
Directeur de l’Institut de Santé Globale
Faculté de Médecine, Université de Genève, Suisse/ Institute of Global Health, University of Geneva, Switzerland
Professor of Public Health at the Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité,
France
 
Dr Coral Gartner
Senior Research Fellow
University of Queensland Centre for Clinical Research
The University of Queensland,
Australia
 
Dr Guillermo González
Psychiatrist
Comisión de Rehabilitación en Enfermedad Mental Grave
Clínica San Miguel
Madrid,
Spain
 
Dr Nigel Gray
Member of Special Advisory Committee on Tobacco Regulation of the World Health Organization
Honorary Senior Associate
Cancer Council Victoria
Australia
 
Professor Peter Hajek
Professor of Clinical Psychology and Director, Health and Lifestyle Research Unit
UK Centre for Tobacco and Alcohol Studies
Wolfson Institute of Preventive Medicine,
Barts and The London School of Medicine and Dentistry Queen Mary University of London,
United Kingdom
 
Professor Wayne Hall
Director and Inaugural Chair, Centre for Youth Substance Abuse Research
University of Queensland
Australia
 
Professor John Hughes
Professor of Psychology, Psychiatry and Family Practice
University of Vermont
United States of America
 
Professor Martin Jarvis
Emeritus Professor of Health Psychology
Department of Epidemiology & Public Health
University College London,
United Kingdom
  
Professor Didier Jayle
Professeur d’addictologie
Conservatoire National des Arts et Métiers
Paris,
France
 
Dr Martin Juneau
Directeur, Direction de la Prévention
Institut de Cardiologie de Montréal
Professeur Titulaire de Clinique
Faculté de Médecine,
Université de Montréal,
Canada
 
Dr Michel Kazatchkine
Member of the Global Commission on Drug Policy
Senior fellow, Global Health Program, Graduate institute, Geneva,
Switzerland
 
Professor Demetrios Kouretas
School of Health Sciences and Vice Rector
University of Thessaly,
Greece
 
Professor Lynn Kozlowski
Dean, School of Public Health and Health Professions,
Professor of Community Health and Health Behavior,
University at Buffalo,
State University of New York,
United States of America
 
Professor Eva Králíková
Institute of Hygiene and Epidemiology
Centre for Tobacco-Dependence
First Faculty of Medicine
Charles University in Prague and General University Hospital in Prague,
Czech Republic
 
Professor Michael Kunze
Head of the Institute for Social Medicine
Medical University of Vienna,
Austria
 
Dr Murray Laugesen
Director
Health New Zealand, Lyttelton,
Christchurch,
New Zealand
 
Dr Jacques Le Houezec
Consultant in Public Health, Tobacco dependence, Rennes,
France
Honorary Lecturer, UK Centre for Tobacco Control Studies,
University of Nottingham,
United Kingdom
 
Dr Kgosi Letlape
President of the Africa Medical Association
Former President of the World Medical Association
Former Chairman of Council of the South African Medical Association
South Africa
 
Dr Karl Erik Lund
Research director
Norwegian Institute for Alcohol and Drug Research,
Oslo,
Norway
 
Dr Gérard Mathern
Président de l’Institut Rhône-Alpes de Tabacologie
Saint-Chamond,
France
 
Professor Richard Mattick
NHMRC Principal Research Fellow
Immediate Past Director NDARC (2001-2009)
National Drug and Alcohol Research Centre (NDARC)
Faculty of Medicine
The University of New South Wales,
Australia
 
Professor Ann McNeill
Professor of Tobacco Addiction
Deputy Director, UK Centre for Tobacco and Alcohol Studies
National Addiction Centre
Institute of Psychiatry
King’s College London,
United Kingdom
 
Dr Hayden McRobbie
Reader in Public Health Interventions,
Wolfson Institute of Preventive Medicine,
Queen Mary University of London,
United Kingdom
 
Dr Anders Milton
Former President of the Swedish Red Cross
Former President and Secretary of the Swedish Medical Association
Former Chairman of the World Medical Association
Owner & Principal Milton Consulting,
Sweden
 
Professor Marcus Munafò
Professor of Biological Psychology
MRC Integrative Epidemiology Unit at the University of Bristol
UK Centre for Tobacco and Alcohol Studies
School of Experimental Psychology
University of Bristol,
United Kingdom
 
Professor David Nutt
Chair of the Independent Scientific Committee on Drugs (UK)
Edmund J Safra Professor of Neuropsychopharmacology
Head of the Department of Neuropsychopharmacology and Molecular Imaging
Imperial College London,
United Kingdom
 
Dr Gaston Ostiguy
Professeur agrégé
Directeur de la Clinique de cessation tabagique
Centre universitaire de santé McGill (CUSM)
Institut thoracique de Montréal,
Canada
 
Professor Riccardo Polosa
Director of the Institute for Internal Medicine and Clinical Immunology,
University of Catania, Italy.
 
Dr Lars Ramström
Director
Institute for Tobacco Studies
Täby,
Sweden
 
Dr Martin Raw
Special Lecturer
UK Centre for Tobacco and Alcohol Studies
Division of Epidemiology and Public Health
University of Nottingham,
United Kingdom
 
Professor Andrzej Sobczak
Department of General and Inorganic Chemistry,
Faculty of Pharmacy and Laboratory Medicine,
Medical University of Silesia, Katowice, Poland
Institute of Occupational Medicine and Environmental Health
Sosnowiec,
Poland
 
Professor Gerry Stimson
Emeritus Professor, Imperial College London;
Visiting Professor, London School of Hygiene and Tropical Medicine
United Kingdom
 
Professor Tim Stockwell
Director, Centre for Addictions Research of BC
Professor, Department of Psychology
University of Victoria, British Columbia,
Canada
 
Professor David Sweanor
Adjunct Professor, Faculty of Law, University of Ottawa
Special Lecturer, Division of Epidemiology and Public Health,
University of Nottingham,
United Kingdom
 
Professor Umberto Tirelli
Director Department of Medical Oncology
National Cancer Institute of Aviano
Italy
 
Professor Umberto Veronesi
Scientific Director
IEO Istituto Europeo di Oncologia
Former Minister of Health,
Italy
 
Professor Kenneth Warner
Avedis Donabedian Distinguished University Professor of Public Health
Professor, Health Management & Policy
School of Public Health
University of Michigan
United States of America
 
Professor Robert West
Professor of Health Psychology and Director of Tobacco Studies
Health Behaviour Research Centre,
Department of Epidemiology & Public Health,
University College London
United Kingdom
 
Professor Dan Xiao
Director of Department Epidemiology
WHO Collaborating Center for Tobacco or Health
Beijing Institute of Respiratory Medicine,
Beijing Chao-Yang Hospital,
China
 
Dr Derek Yach
Former Executive Director, Non-Communicable Diseases
Former Head of Tobacco Free Initiative,
World Health Organisation (1995-2004)
Senior Vice President Vitality Group plc
Director, Vitality Institute for Health Promotion
United States of America


Friday, February 13, 2015

The FDA's Role in Falsified Research

Almost two and a half years ago I wrote: "US Scientific Medical Studies: a 1 in 20 Accuracy Rate?"

Another post from 2011, linked in the article above, about how falsified studies are now the norm is available at "Falsified Medical Studies the Norm".

The bottom line is that most medical research, and yes, this could include research on ecigarettes and vaping, is falsified in some way.

One would hope, that in the case of things like medications, the FDA would be stepping in and weed out the problematic and false studies.

Unfortunately, according to this Slate article, it would not seem to be the case: "That misconduct [ by commercial companies ] happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct."

The Slate article is the result of this JAMA Internal Medicine article.

So if I, a big medical company, falsifies my research on a new drug the FDA helps me out by hiding this fact from everyone. 

Lies are told.

Records and research lost, falsified or hidden.

People die.

According to the linked JAMA article: "... This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct."

Now what this means is that when a study is invalidated by the FDA the FDA does not typically notify scientific journals

So articles or news stories written about the research are presented as true when, in fact, the FDA may have determined that they are invalid or outright false in any number of ways.

An article made public, therefore, may have zero scientific credibility, even with the FDA, but it won't tell anyone this.

Including you the consumer or potential consumer.

One wonders if the articles on the dangers of vaping and formaldehyde suffer from the same fate?

Are these articles reliable?

In the case of vaping and formaldehyde probably not (see this, google any number of other letters and notes on the relative problems with the original research).

Now the original JAMA article does not talk about vaping specifically and I did not check thoroughly through all the studies they examined to find out if they did but here are some interesting take-aways:

1) The FDA is a government agency.  Much of the type of information discussed here (from 483s notifications, e.g., FDA "warning letters", see this) are available though probably redacted.

Vaping should be trolling through this looking for tips and slips related to any vaping or ecig research that's on going at big tobacco and big pharma.

2) The existence of the JAMA research itself should be used to call into question the FDA's motives on "safety."

Anyone happy to let known-to-be-false research be published should be called on the carpet.

3) All vaping research must be reproducible.  If its not (though not that anyone in authority at a large government agency would care) then we are just as guilty and evil as "big pharma" and "big government."

From what I have see much of what's done in the "pro vaping" area looks reasonable - though without full disclosure no one can really tell.

Tuesday, February 10, 2015

Now to Defeat a Stingray...

Find Tower - By Giacomo Balli
I've been following discussions of "stringrays" for years (for example this).

The idea is that you create a mini cell phone tower that you can put in a car or van that's controlled by law enforcement.

You drive around until it picks up a phone you have a warrant for.

Your phone picks up the "fake" tower and uses it for your calls.  (Since its in a van or car they can drive around after you.) After collecting data they you use it to dump out the actual call audio, text, or other data that the device.

Criminals cannot detect this kind of device is being used because their phones don't disclose what tower is being used.  So when the law sets up a new one you don't know.

Your phone uses it automatically because A) they can prioritize its use over your regular tower (conjecture) and B) because, as they say, they've got your number).

So you go down...

So I am searching around for apps and I find a site (and app) like opensignal.com or apps like Find Tower (iOS) and Signal Finder (Android) and link up their data so that when new towers appear you get a notification...

Hmmm...

While I understand the need for law enforcement its troubling that you don't have knowledge or control over what a device you buy does on your behalf.


Ove Fernö - Father of Nicotine Replacement Therapy (NRT)

The history of aerosol nicotine goes back quite some time.

Here is an article on Ove Fernö (a PDF link) - a Swiss inventor of Nicotine Replacement Therapy (NRT).  From treatobacco.net:

"Ove Fernö (1916-2007), the inventor of nicotine replacement therapy (NRT), died at the age of 91 years in October 2007 in Helsingborg, Sweden. He was born in Gothenburg in 1916 and was trained as an organic chemist at the University of Lund, Sweden. During the late 1960s and 70s he was responsible for the development of the first NRT product – a chewing gum."

There is a lot of insightful information in the linked PDF.  Among others a brief discussion of a plan to "investigate the absorption of nicotine through the nasal mucosa in 1979..."

There is a trove of articles by Fernö here including research on a Nasal Nicotine Solution (text available) and a discussion of a nasal nicotine spray (no text available).  This seems to mostly date from the late 1980's and early 1990's.

This all links back to the Society for Research on Nicotine and Tobacco where there are a lot of public abstracts on research related to electronic cigarettes, general tobacco addiction, discussions of racial profiles for addiction, etc. (look in the "Abstract Book" links).  

Lots of links to associated grants as well...