# Treading on the Hamster Wheel



## Alex (27/5/15)

*Treading on the Hamster Wheel*
*Wednesday, May 27, 2015 6:15:51 AM America/Los_Angeles*
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TREADING ON THE HAMSTER WHEEL







How often do we hear “I don’t know”? In general, how often does it lapse into our jargon? Quite often, except, generally _I don’t know_ is an invite for an explanation, indentation and/or opinion._ I don’t know_ means nothing. There is no faith in_ I don’t know_. There is no science in _I don’t know_. There is no validity in _I don’t know_; the simple point is “I don’t know” equals nothing. _When do we hear “I don’t know?”_

In class perhaps. “Johnny, what is the answer to question seven?”
Johnny: “I don’t know.”
The teacher will then explain the question’s answer. Now, if the teacher were to respond to Johnny by saying “I don’t know either.” Unless the question is about philosophy or theory, that teacher will look like an idiot. The class might question the teacher’s ability to teach. The class wouldn’t trust that teacher’s expertise. After all, a teacher is supposed to have surpassed the intellectual content discussed in the class. But then again, little Johnny is just a kid in class. 

*A QUESTION OF TRUST*






When does we _don’t know_ become okay in terms of stigmatizing an innovation? The FDA has stated that it requires generational research before deeming electronic cigarettes safe. When considering the mortality rate, a breach of waiting becomes a question of trust: how far have we come, both technologically and medically, and are we at a point where we can make fast and vital decisions? Can we trust our scientists and doctors? Ebola is a primary example of where swift medical decisions have been made, as the virus claimed 4,877 lives in 2014. While Ebola continues to grow and kill, 443,000 people died in 2014 from _smoking cigarettes_. Ebola and smoking-related illness are nothing alike though the attention and the need for a swift solution is paramount, and the comparison of these two figures has been utilized to contrast the desensitized nature of cigarette-related death. 

In the past, the FDA was quick to provide assistance during an epidemic. Right now though, the FDA and dozens of other non-smoking, anti-vape health authorities continue to rage against the electronic cigarette technology with little to no dependable research indicating that these devices are ineffective. In fact, many journalists declare defenders of electronic cigarettes to be at war with anti-vaping authorities. These published raves contain no conclusive evidence and generally end with a cringe-worthy, “We don’t know”. 

Let’s keep this simple. According to a popular job interview site, (How should I respond to interview questions when I don't know the answer?) “It is perfectly acceptable to say "I don't know the answer to that, and I'm not familiar enough to hazard a guess." It is also perfectly acceptable to say "I'm not entirely sure of an answer, but given my limited understanding of the topic, here are a few thoughts."

While we _don’t know_ the long-term effects of vaping, publishing redundant articles (many by highly credited websites) presenting twisted commentary are misleading, at best. This boring and redundant journalism is lazy and counterintuitive to the advancement of public health and science. Because _we don’t know_, there exists _probability_. Therefore, the overwhelming lack of honest journalism (_actually researching topics, interviewing users, utilizing critical thinking skills_) is halting what could lead to even more advancements. 

*BEING FAIR ABOUT NOT KNOWING*






(National Review) …Of the highest-profile precautionists in the U.S. is Thomas Frieden, director of the Centers for Disease Control, which oversees the nation’s anti-smoking efforts. “There is much we don’t know about e-cigarettes,” he often laments. But we do know quite a bit: foremost, that they don’t combust tobacco and so do not produce carcinogenic tars and disease-producing gasses, including carbon monoxide, which increases the risk of cardiovascular disease. This advantage makes vaping at least 95 percent safer than smoking tobacco, according to toxicologists.”

“So these e-cigarettes — are they better than the patch? Because, certainly, they’re more popular than buying patches at the drug store,” Bricker said. “The story is: We don’t know yet.”

The War on E-Cigarettes (The National Reviews): “I don’t know how you go to sleep at night. I don’t know what gets you to work in the morning except the color green of dollars. You are what is wrong with this country.”

Regardless of _not knowing_, laws and legislatures are passing that affect the entire vaping community, as well as future smokers who may be seeking an alternative to the proven cancers and disease associated with tobacco combustion. The real question is this: if so much pro-vape content is being published (arguably more genuine), then why is the FDA (and health advocates, many who have never smoked and do not understand the technology) quick to propel anti-vape propaganda by using the _I just don’t know_ cliche. It isn’t acceptable, and the public (mostly non-smokers), is lead to believe that the cons precede the pros (even though they “don’t know”). But our trusted FDA has released plenty of substances that were recalled as a result of death, psychosis, permanent injury… So ask yourself, how many commercials you’ve seen for compensation as a consequence of FDA-approved medications? Apparently, those medications did not undergo rigorous generational tests. The fact is, the FDA will release drugs without generational research, just not e-cigs-

(R.A.P.S.) In 2014, 836 drugs were recalled by the FDA: “But with 2014 already on pace for a record-breaking year for recalls, perhaps it's worth asking if this is an anomalous, one-time surge in recalls, or if the rise is the new normal for the foreseeable future.”

*INCONSISTENCIES*

*BAYCOL* (3 Years until FDA recall): Ed to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization
*BEXTRA* (3.3 Years until FDA recall): Serious cardiovascular adverse events (like death, MI, stroke); increased risk of serious skin reactions (like toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme); gastrointestinal bleeding
_“The FDA determined that Bextra showed no advantage over other NSAID pain relievers on the market.”_
*LONTRONEX* (0.8 Years until FDA recall): 49 Cases of ischemic colitis (inflammation and injury of the large intestine); 21 cases of severe constipation (10 requiring surgery); 5 deaths; mesenteric ischemia (inflammation and injury of the small intestine) 
*RAPLON* (2 Years until FDA recall): Bronchospasms and unexplained deaths





And, ironically enough, we have programs like the FDA Fast-Track Programs for Drugs and Medical Devices…

(Drug Watch) “The U.S. Food and Drug Administration’s (FDA) expedited approval programs – also referred to as fast-track programs ¬¬– give doctors and patients quicker access to new drugs and devices that are sorely needed to treat a number of health issues. The FDA created these programs for new drugs in 1992 under the Prescription Drug User Fee Act (PDUFA) with the aim of meeting treatment needs for serious or life-threatening medical conditions more quickly.

PDUFA changed the way drugs can be approved and sped up the process by giving the FDA more money to increase staff. Prior to this law, FDA funding came only from the U.S. government, which did not provide enough resources to push new drugs through the approval process fast enough to meet patient demands. In fact, the process often took so long that drug companies complained that FDA delays cost them money. For the first time, the agency began taking fees from the very companies whose drugs they are tasked to review. While this provided the struggling agency with funding to get more work done, some experts call it a conflict of interest.

Another type of expedited program created in 1976, the 510(k) Premarket Notification program, allows medical device companies to gain clearance for a new product if its design and functionality are based on a device that already exists on the market. The clearance comes despite the lack of full testing on the new device. While not considered a fast-track option, the 510(k) does shorten the time it takes for devices to hit the market. Device companies pay an application fee when they want to have their new near-identical products evaluated by the FDA.

Fast-track programs and the 510(k) program draw criticism because they put speed before safety. Some experts think that in its rush to approve or clear drugs and devices, the FDA actually allows more dangerous products on the market.

The FDA states that it “has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious conditions.”

*SPEAKING OUT*

Dr. Mercola, Former FDA Reviewer Ronald Kavanagh (1988-2008) had this to say in regards to the FDA’s processing and approval strategies: 

“… While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. 
In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which of course was our job as drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.

…”After FDA management learned I had gone to Congress about certain issues, I found my office had been entered and my computer physically tampered with," Kavanagh tells Rosenberg.
"... After I gave Representative Waxman's (D-CA) office a USB drive with evidence, FDA staff was admonished that it was prohibited to download information to USB drives. Then, after I openly reported irregularities in an antipsychotic drug review and FDA financial collusion with outsiders to Senator Grassley's office and the House Committee on Oversight and Government Reform, I was threatened with prison if I should release trade secret information to Congress... The Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley's staff to destroy the evidence I provided them. 

The threats, however, can be much worse than prison. One manager threatened my children - who had just turned 4 and 7 years old - and in one large staff meeting, I was referred to as a 'saboteur.' Based on other things that happened and were said, I was afraid that I could be killed for talking to Congress and criminal investigators.’"

And it wasn’t just one former employee speaking out:

“As Dr. David Graham—another prominent FDA whistleblower who blew the lid on the Vioxx scandal—stated in a 2005 interview:

"As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured.
Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about 5 percent. The 'gorilla in the living room' is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug.’"

And he concludes:

“The FDA's responsibilities for protecting the health of Americans are far-reaching. The FDA protects our nation's food supply through regulatory activities designed to cover 80 percent of the food consumed in this country. The FDA also regulates all drugs, human vaccines, and medical devices, and hence plays a critical role in ensuring the appropriate safety and efficacy of rapidly emerging medical products.
... The FDA is also central to the economic health of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually.. Thus, the nation is at risk if FDA science is at risk. The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.’"

*TREADING ON THE HAMSTER WHEEL *






As usual, the FDA continues to change policies. Interestingly enough, a few more changes have occurred…

An ongoing argument (one of the largest) concerning e-liquid is that nicotine intake is inconsistent, and, therefore, dangerous. It is also frowned upon to _dual vape_, or vape and smoke cigarettes. Some vapers significantly cut back their cigarette intake while also vaping. In the vaping community, the concept of nicotine is simple and understood. Vapers know that pure nicotine is not smoking and that its effects are similar to caffeine. So, this whole hoopla of varying and inconsistent nicotine consumption is a point of hypocrisy: 
(Consumer Updates/ FDA): “Now, the Food and Drug Administration—after reviewing scientific research on the safety of NRT products sold over the counter (OTC)—has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.
The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence.

The changes being recommended by FDA include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT.”

Nicorette Gum’s website now states: “The FDA has determined that there are no significant concerns with using NRT products like Nicorette at the same time as another nicotine-containing product like a cigarette.”

According to The Partnership for Drug-Free Kids, Nearly 1 Billion dollars in sales (FDA-approved over-the-counter smoking cessation devices as well as medications like Chantix) were sold in 2013. Pair this with Big Tobacco (which is rich enough to be suing actual countries), and there is MASSIVE monetary competition. If e-cigs are deemed safe in a non-monopolized sector, HUGE industries/companies stand to lose billions if not trillions of dollars. If people _were_ to benefit from e-cig technology (again, "we don’t know"…), thousands of other ailments would also dissipate (i.e. heart disease, diabetes…).

Right now, e-cig technology is promising. Vapers are bending over backward to keep e-cigarettes on the shelves, not only for themselves, but for future smokers seeking an alternative to death and crooked Big Tobacco. In a perfect world, nobody would be dependent on nicotine, but sadly that is just not the case. So, as more people keep dying, why isn’t this testing speeding up? And when _will we know_ what our options are? Does the FDA really need generations of research when other drugs, drugs which are literally killing people (Chantix, for example) are available to the public? _I guess we just don’t know._

Source: http://www.clearette.com/blog/Treading-on-the-hamster-wheel/#sthash.tHGowpSB.dpuf

Reactions: Like 1 | Winner 2 | Informative 2


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## Andre (27/5/15)

Right on target! Thanks @Alex.

Reactions: Like 1


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## Nooby (27/5/15)

Brilliant read. Thank you @Alex

Reactions: Like 1


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