Electronic Cigarettes vs Swine Flu Vaccines, Two DIfferent Responses to a Similar Public Health Threat

My report on an article claiming E Cigarettes May Be More Effective Than Swine Flu Vaccine got me to thinking about how the FDA has responded to the public health threat of the swine flu in comparison to the public health threat of smoking. The differences are astounding.

The H1N1 Swine Flu Pandemic has now been declared a "National Emergency" and as the article pointed out

According to President Obama's Council of Advisers on Science and Technology on H1N1, "A plausible scenario is that the epidemic could cause between 30,000 and 90,000 deaths in the United States."  

Many doctors questioned the validity of these numbers and in October CBS News pointed out in a scathing report that the CDC had absolutely no idea how many actual swine flu cases there were because they had simply stopped testing people for the virus months ago.

In late July, the CDC abruptly advised states to stop testing for H1N1 flu, and stopped counting individual cases. The rationale given for the CDC guidance to forego testing and tracking individual cases was: why waste resources testing for H1N1 flu when the government has already confirmed there's an epidemic?

They went on to further report, that after the CDC ignored their repeated requests for data, they went ahead and asked all 50 states to provide their data on lab confirmed cases of H1N1. They found the vast majority of these cases tested negative for the swine flu as well as seasonal flu. For example:

• Florida - 8,853 specimens 83% negative, 17% H1N1
• California - 13,704 specimens 86% negative, 12% other flu, 2% H1N1
• Georgia - 3,117 specimens 97% negative 2% H1N1
• Alaska - 722 specimens 92% negative 5% seasonal flu, 1% H1N1

Perhaps the most interesting part of the report, which explains why they only reported 2%, was what California's Chief of Emergency Preparedness and Response, Dr. Bela Malyas had to say:

"What we are doing is much more detailed and expensive than what CDC wants, We're gathering data better to answer how severe is the illness. With CDC's fallback position, there are so many uncertainties with who's being counted, it's hard to know how much we're seeing is due to H1N1 flu rather than a mix of influenza diseases generally. We can tell that apart but they can't."

But despite these numbers and the laboratory evidence provided by the states, the CDC went ahead and declared a national public health emergency so that the FDA could lower its standards and set aside the usual testing requirements for new drug approval so they could speed up the delivery of new and as yet unproven H1N1 vaccines. Clinical trials began in August and based on preliminary data only, in mid September four drug companies were authorized to begin producing and distributing millions of vaccines while the clinical trials to test their effectiveness continue.

The FDA assures us they are "working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program."

But they feel that these "adverse events" are really just all in your head because these untested vaccines are "precisely the same technology as the annual seasonal flu vaccine", the ingredients of which they know are safe. Reuters reported in an often misquoted article in Sept that:

One million heart attacks, 700,000 strokes and 900,000 miscarriages -- U.S. public health officials want Americans to know these will happen every single year with or without a swine flu vaccine campaign. 

Yet this year, they know a significant number will be blamed on the H1N1 vaccine, which will roll out within weeks, and they are struggling to be ready.

They expect an avalanche of so-called adverse event reports, which are reports of death, illness or other health trauma that occur within two weeks after receiving treatment -- in this case, the swine flu vaccine. 

"We are going to be overwhelmed with potential events," said Mike Osterholm, a public health expert at the University of Minnesota.

 

"Anything that happens to anybody in the period of seven to 14 days after vaccination will be reported."

Memories linger of the 1976 swine flu debacle, when 43 million Americans were vaccinated against a virus that never spread, and newspapers filled with reports of a rare and crippling neurological disease called Guillain-Barre syndrome.

 

Guillain-Barre was never definitively linked with the vaccine, but many Americans have viewed immunizations with suspicion ever since.

So, even if there are reports of adverse effects of the new untested H1N1 vaccines, medical professionals are more than likely to discount them as patients over reacting and unfairly blaming the vaccine for problems they would have had anyway. It's all just coincidence, like in 1976.

The fact is, when it came to the Swine Flu and an estimated potential of 30,000 to 90,000 deaths, we gave drug companies the OK to rush untested experimental vaccines to the market that will be used on millions of people without knowing exactly what the long term effects or potential dangers might be.

But not everyone getting these untested drugs is doing so voluntarily, unlike users of the electronic cigarette. The Washington Post reported in September:

New York this year became the first state to require all health-care workers with direct patient contact at hospitals, health centers, hospices and private homes to get flu shots -- both the seasonal flu vaccine, which is already available, and the swine flu vaccine, which will start to arrive next month.

In that story one frightened worker was quoted as saying:

"I'm scared," said Sandra Webb, 45, of the District, who has a clerical job at Washington Hospital Center and blames a flu shot she had several years ago for making her sick. "It's really freaking me out. I don't know what to do."

But the company she works for says she has to take the vaccine or find another job:

MedStar is requiring vaccination of all 25,000 of its workers -- including nurses, orderlies, janitors and food-services employees -- as well as 5,000 affiliated doctors, every volunteer, and employees of suppliers who step inside any of its facilities, regardless of whether they routinely have direct patient contact.

and another health-care worker concerned for her own health said:

"I don't want to be a guinea pig," said One Banks-Hopkins, 55, a clerical worker at Washington Hospital Center. "I don't think I should be forced to take something I don't want to take."

But the government's attitude when it comes to protecting us from Swine Flu is that there is no time to wait for studies and clinical trials to prove these vaccines are safe and effective in the long run. The time to act is now. People's lives are at stake. We'll go ahead and sell them now and test them as we go.

John Banzhaf, head of the anti smoking group ASH, has argued many times while leading the charge in the campaign to have the electronic cigarette banned from the market that

Smokers desperate to quit should not serve as guinea pigs to test a new product which may be neither safe nor effective

However, every user of an electronic cigarette does so voluntarily. Most, if not all, are completely aware the products have not been FDA approved. They know there are limited studies showing the safety of these devices in the long term. They understand the ingredients and have decided that the benefits of being smoke free, in the jargon of pharmaceutical ads "far outweigh the risks".

The electronic cigarettes have been on the market for years, without any "avalanche of adverse event reports", real or imagined. Hundreds of thousands of vehemently loyal users, or "vapers" as they like to be called, claim they have experienced no side effects using this product while anti smoking groups, and even the FDA seem hard pressed to find anyone claiming to have had any adverse reactions. In July the FDA set up a hotline to solicit consumer complaints, but as of yet have failed to report any. It should be noted they did not ask vapers to call in with any success stories.

Despite continued warnings of the "potential dangers these untested products may pose" there doesn't seem to be any complaints or reports of injuries or deaths related to electronic cigarettes or even one single lawsuit against an e-cig manufacturer that wasn't brought on by the government or an anti-smoking activist group trying to get them banned.

This is in stark contrast to some of the FDA approved smoking related drugs like Chantix, which lawyers around the country are reviewing for a potential class action lawsuit due to the hundreds of documented deaths related to it's use and the avalanche of adverse event reports it's users have claimed. Even Zyban has come under fire and is facing lawsuits by consumers claiming it induces suicidal thoughts and is responsible for a number of deaths.

Then we have the hundreds of billions of dollars tobacco companies have paid out in lawsuits and settlements to it's customers claiming damages or as compensation for the millions of deaths attributed to it's products each and every year. But cigarettes are still legally sold in corner stores across the nation and our latest tobacco legislation actually prohibits the FDA from banning them while at the same time calling for the FDA to encourage development of "less harmful alternatives".

These approved drugs and cigarettes are the very products ecigarette users are trying to get away from and it seems to me vapers found their own "less harmful alternative" all on their own without any encouragement or help from the government, big pharma or big tobacco.

Cigarette smoking is called "the leading cause of preventable death" and has been proven time and time again to kill millions each year. So where is the "National Emergency" and the lowering of FDA standards for the electronic cigarette? Where is the fast action and the attitude of "the time is now, there is no time to wait. People's lives are at stake?"

Instead, we threaten to ban all electronic cigarettes because "we just don't know what the long term effects or potential dangers might be" even though the product has been used by hundreds of thousands of people for years and all the available research, including the FDA's own studies, indicate ecigarettes are far safer than the real ones?

While I still don't agree you should say "E Cigarettes May Be More Effective Than Swine Flu Vaccines" I may have to agree with that article that "a disproportional effort in preventative measures are currently being channeled to defend against a lower risk health issue."

Like the rush to get the vaccines to the market, there is no time to wait. The National Public Health Emergency is now and requires innovative new measures to combat. After all, if we stick with the products we have available now, we are looking at nearly half a million dead smokers in the US this year alone and some estimate as many as five million worldwide.

If that's not a pandemic that demands extraordinary new and perhaps as yet unproven solutions, I don't know what is.

Authors Note: After writing this I learned the FDA did give fast track status to an Anti-Smoking Vaccine It will be years before it's ready and I still say electronic cigarettes should be allowed as an alternative, especially in the interim. But at least the FDA is fast tracking something!