Drugmaker sent data to FDA through 'improper channels'

Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug's manufacturer, submitted years of data through "improper channels."

Some 150 suicides - more than doubling those previously known - were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.

"We've had a major breakdown in safety surveillance," said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems - including reports of completed suicides, suicide attempts, aggression and hostility and depression - had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved.

They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts.

"It's really chilling," said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the Journal of Pharmacotherapy. "This seems to unleash something in people. It can be violence to anything around."

Truth was an early victim in the battle against tobacco. The big lie, repeated ad nauseam in anti-tobacco circles, is that smoking causes more than 400,000 premature deaths each year in the United States. That mantra is the principal justification for all manner of tobacco regulations and legislation, not to mention lawsuits by dozens of states for Medicaid recovery, class actions by seventy-five to eighty union health funds, similar litigation by thirty-five Blue Cross plans, twenty-four class suits by smokers who are not yet ill, sixty class actions by allegedly ill smokers, five hundred suits for damages from secondhand smoke, and health-related litigation by twelve cities and counties - an explosion of adjudication never before experienced in this country or elsewhere.

The war on smoking started with a kernel of truth - that cigarettes are a high risk factor for lung cancer - but has grown into a monster of deceit and greed, eroding the credibility of government and subverting the rule of law. Junk science has replaced honest science and propaganda parades as fact. Our legislators and judges, in need of dispassionate analysis, are instead smothered by an avalanche of statistics - tendentious, inadequately documented, and unchecked by even rudimentary notions of objectivity. Meanwhile, Americans are indoctrinated by health "professionals" bent on imposing their lifestyle choices on the rest of us and brainwashed by politicians eager to tap the deep pockets of a pariah industry.

The aim of this paper is to dissect the granddaddy of all tobacco lies - that smoking causes 400,000 deaths each year. To set the stage, let's look at two of the many exaggerations, misstatements, and outright fabrications that have dominated the tobacco debate from the outset.

There's been a call to license smoking, and to have a system similar to the one proposed for gamblers, to limit the number of cigarettes people can smoke in a set time.

The Sunday Age reports this morning Professor Simon Chapman, an anti-smoking campaigner from the University of Sydney says a smoking ban could be a reality within 10 to 15 years, and he believes a licensing scheme, using a swipe card for authorised smokers, would pave the way.

Valentina Echeverria, a researcher at Bay Pines VA Healthcare System and the University of South Florida, was lead author of the cotinine study.

Cotinine, a compound derived from tobacco, reduced plaques associated with dementia and prevented memory loss in a mouse model of Alzheimer's disease, a study led by researchers at Bay Pines VA Healthcare System and the University of South Florida found.

The findings are reported online in the Journal of Alzheimer's Disease in advance of print publication.

"We found a compound that protects neurons, prevents the progression of Alzheimer's disease pathology, enhances memory and has been shown to be safe," said Valentina Echeverria, PhD, a scientist at Bay Pines VA Healthcare System and an assistant professor of Molecular Medicine at USF Health. "It looks like cotinine acts on several aspects of Alzheimer's pathology in the mouse model. That, combined with the drug's good safety profile in humans, makes it a very attractive potential therapy for Alzheimer's disease."

Clinic's patients include Western smokers

Claims to cure cancer, autism, emphysema

Smokers grow six-fold in 40 years in Indonesia

An Indonesian woman exhales cigarette smoke into the mouth of a gaunt, naked patient at a Jakarta clinic, where tobacco is openly touted as a cancer cure.

The Western patient is suffering from emphysema, a condition she developed from decades of smoking. Along with cancer and autism, it's just one of the ailments the Griya Balur clinic claims it can cure with cigarettes.

"I missed this," says the woman, a regular customer, with an American accent, as Phil Collins's I Can Feel It blares in the background.

Griya Balur would be shut down in many parts of the world, but not in Indonesia, one of the developing-country new frontiers for big tobacco as it seeks to replace its dwindling profits in the health-conscious West.

Long traditions of tobacco use combined with poor regulation and the billions of dollars that flow into government coffers from the tobacco industry mean places like Griya Balur go unchallenged.

About 30 percent of lung cancer patients who never smoked had the same uncommon variant, or allele, residing in a gene known as GPC5.

A five-center collaborative study that scanned the genomes of thousands of "never smokers" diagnosed with lung cancer, as well as healthy never smokers, has found a gene they say could be responsible for a significant number of those cancers.

"This is the first gene that has been found that is specifically associated with lung cancer in people who have never smoked," study lead investigator, Ping Yang, M.D., Ph.D., Mayo Clinic genetic epidemiologist, was quoted as saying.

The research was co-led by scientists at the Mayo Clinic in Minnesota, Harvard University, University of California at Los Angeles (UCLA) and MD Anderson Cancer Center. Researchers found that this allele leads to greatly reduced GPC5 expression, compared to normal lung tissue. The finding suggests that the GPC5 gene has an important tumor suppressor-like function and that insufficient function can promote lung cancer development.

The following excerpt is taken from Lauren A. Colby's book In Defense of Smokers.

Chapter 9: Smoking Animals

Remember the smoking beagles? Movietone News, the old newsreel company, featured a piece on these cute little dogs, shot some time in the 1950's or 60's. It's sometimes re-run on late night TV, even today.

Actually, the experiment was rather cruel (although not nearly so much so as later ones). The beagles were strapped side-by-side to a long bench, in a rather unnatural upright position. They were fitted with face masks, which forced them to inhale and exhale smoke from lighted cigarettes. A mechanical device lit a new cigarette and dropped it into the air line, as soon as an old one was used up. Although the Surgeon General later claimed that the smoking machines did not force animals to inhale and exhale deeply, the newsreel footage sure made it look as if the dogs were inhaling and exhaling very deeply.

It was, perhaps, the smoking Beagles that were referred to in the 1964 SG's Report, when the Committee made the observation that with the "possible exception of dogs", the animal experiments had all failed to induce lung cancers. Whatever the case, in the 1971 Report, the Surgeon General conceded that the experiments with dogs, using smoking machines, had failed. However, also in the 1971 Report, the SG described a new experiment, conducted by a government physician, Oscar Auerbach, and others, in which the Beagles were forced to smoke in what the SG described as a "more natural" manner.

Every year, thousands of medical doctors and other members of the "Anti-Smoking Inquisition" spend billions of dollars perpetuating what has unquestionably become the most misleading though successful social engineering scam in history. With the encouragement of most western governments, these Orwellian lobbyists pursue smokers with a fanatical zeal that completely overshadows the ridiculous American alcohol prohibition debacle, which started in 1919 and lasted until 1933.

Nowadays we look back on American prohibition with justifiable astonishment. Is it really true that an entire nation allowed itself to be denied a beer or scotch by a tiny group of tambourine-bashing fanatics? Sadly, yes it is, despite a total lack of evidence that alcohol causes any harm to humans, unless consumed in truly astronomical quantities.

Being exposed to highway pollution can cause brain damage in mice akin to memory loss and Alzheimer's disease, US researchers said Thursday.

Scientists recreated the airborne pollutants that come from the burning of fossil fuels and the weathering of car parts and pavement, and exposed mice to the harsh air for 15 hours per week over 10 weeks.

The tiny air particles were "roughly one-thousandth the width of a human hair, and too small for car filtration systems to trap," but exerted massive damage on the brains of the exposed mice, said the study.

"You can't see them, but they are inhaled and have an effect on brain neurons that raises the possibility of long-term brain health consequences of freeway air," said senior author Caleb Finch of the University of Southern California.

Scientists found that the exposure resulted in "significant damage" to neurons involved in learning and memory, and they detected "signs of inflammation associated with premature aging and Alzheimer's disease."

A flight attendant for U.S. Airways claims toxic airplane cabin air is making flight crews sick. The toxic airplane cabin air, which some say can lead to an illness known as Aerotoxic Syndrome, has been linked to problems with the bleed air systems used on most aircraft to recirculate cabin air during flight.

Most commercial planes are designed to make cabin air by drawing in a compressed supply of it from plane engines. Typically, this "bleed air" is mixed with existing cabin air and recirculated throughout the flight. Unfortunately, this system does not always remove fumes or vapors from the engine. If it malfunctions, these chemical contaminants - including fumes from the oil that lubricates the engine - can result in toxic airplane cabin air.