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Article continues below Safe and Unsafe Sources of Omega-3 Fatty Acids For Mothers
World Breastfeeding Week August 1-7, 2002
Will Three Unlicensed Smallpox Vaccines Be Used to Immunize 500,000 Americans?
This is an interesting announcement, because to my knowledge there exist no FDA-licensed smallpox vaccines. There are three vaccine candidates whose safety and efficacy are uncertain at this time. The first vaccine made available was named Dryvax, which was pulled out of storage after approximately thirty years. Initial reports indicated that a 1:5 dilution yielded 70% efficacy. However, recent reports indicated that this diluted old vaccine was nearly 100% effective. Which is it? Furthermore, a 1999 report in Science noted that the rubber seals on the vials were deteriorating, and that 1/4 of the vials "were suspect." Are the suspect vials being diluted to make new vaccine also? The second vaccine comes from the Aventis stockpile, allegedly "lost" for decades. Millions of doses of vaccine do not get lost. Vaccine lots are required to have a documented testing history, and both the manufacturer and FDA should have records on file of the dates the lots were released and their specifications at the time. For both these ancient vaccine stockpiles, there exists no approved method by which FDA can legally "relicense" them for current use based on test results generated today. There is no way long-expired product can be "regenerated" for licensure within current FDA regulations. The third vaccine candidate is the Acambis (previously Oravax, using Baxter as subcontractor) smallpox vaccine. This is a new vaccine whose makeup, as well as its safety and efficacy profile, have not been publicly discussed. The FDA finalized a rule May 30, 2002 for accepting animal tests in lieu of human tests for efficacy of bioterrorism drugs and vaccines. This opens the door for the new vaccine to receive a full FDA license. An article in this month's Emerging Infectious Diseases (CDC) by James LeDuc and Peter Jahrling et al indicates that the Acambis vaccine is in Phase I trials and licensure is not expected until sometime in 2003. When will the public and medical professionals learn all the details needed to make an informed decision about using this new product? This information is not releasable by FDA until after licensure. One hopes that the vaccine will not be used until adequate safety testing has taken place: Phase I trials do not provide thorough information on drug and vaccine safety. It thus appears that three unlicensed vaccines may soon be available for use in 500,000 Americans. Potentially severe consequences are anticipated in those with eczema, HIV infection, other forms of immune deficiency, and cancers (who are receiving radiation or chemotherapy). There may be other, unknown risk factors that predispose to serious vaccine complications. The anticipated extent of spread of the varicella virus to contacts of the 500,000 has not been publicly discussed, nor have measures to minimize such spread, although taking such steps is a very important part of protecting the health of contacts. Recall that most of the 500,000 are involved in direct patient care: their contacts are the very people most at risk of varicella's spread. Are the 500,000 expected to acquiesce to receiving an experimental vaccine(s)? Will they be asked to sign an informed consent, and will the consent ask them to give up any rights to compensation for injuries sustained as a result of vaccination? Will they be placed into clinical trials comparing the three vaccine candidates? Who will pay for deaths and injuries to these vaccine recipients that occur as a result of vaccination? Who will pay for deaths and injuries in their contacts? Does it make good sense to perform this experiment with all our nation's first responders and a sizable chunk of our lab techs and physicians? Or does it make more sense to start vaccinations slowly and observe closely for problems, so they can be mitigated prior to vaccinating large numbers of critical personnel?
I am a primary care physician with a hospital practice, and I may be one of the designated half million. I daresay that if offered the vaccine, I will not be a "taker". How many of the 500,000 intend to comply with this DHHS directive?
Smallpox Outbreak Myths
What will happen next? Pandemonium. The press has done its job over the last few months reinforcing the belief that an epidemic is about to occur, potentially causing millions of deaths. Americans thousands of miles from Washington will demand the smallpox vaccine, a vaccine with the highest risk of complications of any vaccine ever manufactured and with a dubious track record for success. However, because you are informed, you will have a different response. You will not panic. You will turn off the TV. You won't listen to your hysterical neighbors. And more importantly, you won't rush to be vaccinated. Here's why: On June 20, 2002, I attended the Center for Disease Control's (CDC) meeting of the Advisory Committee for Immunization Practices (ACIP) and listened to one and a half days of testimony prior to posting the recommendations for smallpox vaccination that are currently being considered by the CDC and the Department of Health and Human Services (DHHS.) Various physicians and researchers associated with the CDC presented by public participants and many testimonies and comments. Noting that two weeks have past since the June 20th meeting and the media has still not reported on this historic event, I decided it was imperative to report the content and outcome of this meeting to the general public. After reading this report you will gain a new perspective on smallpox and, hopefully, in the event of an outbreak, you will understand that you have nothing to fear.
Generally Accepted Facts
A very similar media campaign was developed prior to the release of the Salk polio vaccine in 1955. The polio vaccine had been in development for more than a year prior to its release and was an untested "investigational new drug," just as the smallpox vaccine will be. The difference is that the potential side effects and complications of the smallpox vaccine are already known, and they are extensive.
Generally accepted facts about smallpox include:
As it turns out, these "accepted facts" are not the "real facts."
Myth 1: Smallpox Is Highly Contagious
This statement is a direct contradiction to nearly everything we have ever heard or read about smallpox. However, keep in mind that this comes "straight from the horse's mouth" and should be considered the "real story" regarding how smallpox is spread. Even if a person is exposed to a known bioterrorist attack with smallpox, it doesn't mean that he will contract smallpox. The signs and symptoms of the disease will not occur immediately, and there is time to plan. The infection has an incubation period of 3 to 17 days,[1] and the first symptom will be the development of a high fever (>101º F), accompanied by nausea, vomiting, headache, severe abdominal cramping and low back pain. The person will be ill and most likely bed-ridden; not out mixing with the general public. Even with a fever, it is critically important to realize that at this point the person is still not contagious. In fact, the fever may be caused by something else, such as the flu. However, if a smallpox infection is developing, the characteristic rash will begin to develop within two to four days after the onset of the fever. The person becomes contagious and has the ability to spread the infection only after the development of the rash. "The characteristic rash of variola major is difficult to misdiagnose," stated Walter A. Orenstein, M.D., Director of the National Immunization Program (NIP) at the CDC. The classic smallpox rash is a round, firm pustule that can spread and become confluent. The lesions are all in the same stage of development over the entire body and appear to be distributed more on the palms, soles and face than on the trunk or extremities.
Action Item:
Myth 2: Smallpox Is Easily Spread By Casual Contact With An Infected Person
"Smallpox will not spread like wildfire," said Orenstein. He stated that the spread of smallpox to casual contacts is the "exception to the rule." Only 8% of cases in Africa were contracted by accidental contact. Transmission of smallpox occurs only after intense contact, defined as "constant exposure of a person that is within 6-7 feet for a minimum of 6-7 days."[5] Dr. Orenstein reported that in Africa, 92% of all cases came from close associations and in India, all cases came from prolonged personal contact. Dr. Tom Mack from the University of Southern California stated that in Pakistan, 27% of cases demonstrated no transmission to close associates. Nearly 37% had a transmission of only one generation, meaning that the second person to contract smallpox did not pass it onto the third person. These statistics directly contradict models that predict an exponential spread to millions. Even without medical care, isolation was the best way to stop the spread of smallpox in Third World, population dense areas. With a slow transmission rate and an informed public, Mack estimated that the total number of smallpox cases in America would be less than 10, a far cry from the millions postulated by the press. Dr. Kuritsky said at the CDC Public Forum on Smallpox on June 8 in St. Louis, "Given the slow transmission rate and that people need to be in close contact for nearly a week to spread the infection, the scenario in which a terrorist could infect himself with smallpox and contaminate an entire city by walking through the streets touching people is purely fiction."
Point to ponder:
The CDC and the WHO organization attribute the eradication of smallpox to the ring vaccination of close contacts. However, since the infection runs its course in 3-6 weeks, perhaps ISOLATION ALONE would have effectively accomplished the same thing.
Myth #3: The Death Rate From Smallpox Is 30%
Villages would apparently have "an importation" every 5-10 years, regardless of vaccination status, and the outbreak could always be predicated by living conditions and social arrangements. There were many small outbreaks and individual cases that never came to the attention of the local authorities. Mack stated that even with poor medical care, the case fatality rate in adults was "much lower than is generally advertised" and thought to be 10-15%. He said that the statistics were "loaded with children that had a much higher fatality," making the average death rate reported to be much higher. Amazingly, he revealed his opinion that even without mass vaccination, "smallpox would have died out anyway. It just would have taken longer." Even so, people died. Why? After all, smallpox is a skin disease and "other organs are seldom involved."[6] I posed this question to the committee on two separate occasions. Kathi Williams of the National Vaccine Information Center asked this question at the Institute of Medicine meeting on June 15th. On June 20, an answer was finally forthcoming when a member of the ACIP committee said, "That is a good question. Does anyone know the actual cause of death from smallpox?" At that point, Dr. D.A. Henderson, from the John Hopkins University Department of Epidemiology volunteered a comment. Dr. Henderson directed the World Health Organization's global smallpox eradication campaign (1966-1977) and helped initiate WHO's global program of immunization in 1974. He approached the microphone and stated, "Well, it appears that the cause of death of smallpox is a 'mystery.'" He stated that a medical resident had been asked to do a complete review of the literature and "not much information" was found. It is postulated that the people died from a "generalized toxemia" and that those with the most severe forms of smallpox -- the hemorrhagic or confluent malignant types -- died of complications of skin sloughing, similar to a burn. However, he concluded by saying, "it's frustrating, because we don't really know." Comment: I find this to be extremely frightening. If we knew why people died when they contracted smallpox, perhaps current medical technology could treat the complications, making the death rate much lower. Considering that the last known case of smallpox in the U.S. was in Texas in 1949, continuing to report that smallpox has a 30% death rate is similar to saying that all heart attacks are fatal. Based on 1949 technology, that would be accurate reporting. But in 2002, all heart attacks are NOT fatal. Neither would smallpox have a mortality rate of 30%.
Myth #4: There Is No Treatment For Smallpox
One such drug is called hexadecylosypropyl-cidofovir (HDP-CDV). Not yet available for human use, it has been found to be 100 times more potent than its cousin, cidofovir, a drug used to treat retinal infections in HIV patients. If studies pan out, HDP-CDV will be offered in a pill or capsule form over 5-14 days for the prevention and treatment of people exposed to smallpox.[8] Unfortunately, this drug is being developed in Europe and will most likely be kept out of the US market until long after the general public has been subjected to mass vaccination. It is important to note that there are several different presentations of a smallpox infection. The most common is called "ordinary discrete" smallpox, occurring in more than 40% of the cases. The outbreak is seen as a small scattering of pustules distributed across the body. The person with this type of smallpox needs minimal medical care and the reported death rate is 10%.[9] For mild cases of smallpox, adequate hydration and anti-fever products are essential for comfort and maintaining a temperature below 102ºF. Keeping the skin clean to prevent secondary bacterial infections is also important. A 1927 Textbook of Medicine recommends applying gauzed soaked in carbolic acid to "decrease itching and prevent extensive scarring."[10] Carbolic acid is used acutely for burns that tend to ulcerate and other skin conditions that cause burning or prickling pain. Homeopathic forms of carbolic acid are also available. For the severe complications of smallpox, modern day treatment options are available. The hemorrhagic type of smallpox, occurring in approximately 3% of cases, presents as hypotensive shock and can be treated accordingly. In another 3% of serious cases, the confluent-type has extensive skin involvement. These patients can be treated the same as a burn patient. All severe cases need to be treated for dehydration and watched for signs of bacterial suprainfection. Research done by Dr. Peter Havens, MS, MD from the Medical College of Wisconsin postulated that death from smallpox was due to multisystem organ failure, a complication of an untreated acute cytokine (inflammatory) response. Massive oxidative stress occurs, leading to free-radical damage in the kidneys and other internal organs. However, Dr. Havens estimates that modern medical technology would indeed decrease the death rate, to possibly as low as 2-3%. Comment: The treatment of choice for severe free-radical stress is high dose intravenous Vitamin C. If conventional medicine would recognize the value of this treatment, they would also be forced to realize mass vaccination is simply not necessary. Treating severely ill patients would require hospitalization and unfortunately, smallpox spreads the most quickly in the hospital setting due to poor isolation techniques. In addition, most patients in hospitals are ill and immunosuppressed by disease or medication, making them more susceptible to infection. Dr. Mike Lane, former director of the CDC's smallpox eradication program in the 1970s, said severely ill smallpox patients could be treated in a suburban motel or remote government building. "You can bring care to the patient if you elect to use the Motel 6 on the edge of town" rather than put smallpox victims in a hospital where the disease could spread to patients with weakened immune systems.
Side Bar With Dr. Mike Lane:
"I would rather vaccinate them and take my chances treating the potential complications. In India, we vaccinated everyone. The only medical contraindication was leprosy, and we sometimes vaccinated them. I'm sure that we killed a few people, but we did the best that we could." I pressed the issue further by saying, "if the death rate really is 30% (which I doubt), doesn't that mean the survival rate is 70%? Shouldn't that person have the right to play the odds with his health if he chose to?" His answer was the same: "If the person is exposed, there will be NO exceptions, medical or otherwise. Those people in the first ring -- regardless of health status MUST be vaccinated." That means that all people with medical contraindictions -- organ transplants, cancer, HIV, eczema and other skin conditions -- would be vaccinated, even it was against their will and with the use of force, if necessary. He was quite the zealot about it; hopefully, in the event of a smallpox exposure, more reasonable minds will prevail.
Myth #5: The Vaccine Will Keep Me From Getting The Infection
This little known fact is not only true for all vaccines, it is also true for the smallpox vaccine. Here are a few examples:
Chickenpox vaccine:
Pertussis vaccine:
Smallpox vaccine:
Dr. Harold Margolis, Senior Advisor to the Director for Smallpox Planning and Response, stated in Atlanta that "the vaccine decreased the death rate among those vaccinated by 'modifying the disease', not by preventing infection."
Take Home Points:
Addendum:
Preparations are also underway for rapid mass vaccination of the general public. The more extensive vaccination plan is possible because supplies are increasing. As I have stated before, the government spent more than $780 million to develop its arsenal. Now that we have it, we will use it. In addition to medical first responders, a presentation at the June 20th meeting suggested that first responders should also include a class to be defined as "economic first responders," those who would be necessary in keeping the economy moving in the event of a nationwide "lock down" caused by an outbreak. This group would include pilots, truck drivers, food handlers, etc. It is the "etc." that is of concern. Where do you draw the line? Obviously, the line will be drawn after Tommy Thompson's vision of a "vaccine for every man, woman and child" has been fulfilled. One of the major problems is the lack of vaccinia immune globulin (VIG), the "antidote" that is needed for those who experience a severe reaction to the vaccine. The Times article reports that there are only 700 doses currently available. Dr. Tom Mack, among others at the CDC warned that, "in the absence of VIG, extensive vaccination would be extremely dangerous." With the continued rhetoric about the US plans to go to war with Iraq, we are essentially taunting Saddam into launching a biological weapons attack on our own people. We are not given an exact knowledge as to Saddam's capability but are given euphemisms such as "reasonably high" or "quite high." But we don't know for sure. And if the government knows, it is not telling. And if Saddam does have biological smallpox, what is the chance he has other weapons of biological destruction, those for which we do not have a vaccine? We are developing "grounds" for a war with Iraq in spite of the rest of the world telling us to stay out of there. I encourage all to spend some time on this site: www.globalpolicy.org for some eye-opening information on policy that you won't see in the popular press. We are setting the stage for a health disaster unlike anything we have seen before in America, and it will be our own doing. World health records (England, Germany, Italy, the Philippines, British India, etc.) document that devastating epidemics followed mass vaccination. The worst smallpox disaster occurred in the Philippines after a 10 year compulsory US program administered 25 million vaccinations to its population of 10 million resulting in 170,000 cases and more than 75,000 deaths from 'smallpox', in a country having only scattered cases in rural villages prior to the onslaught of vaccines.[15] I received an excellent bulletin from Larken Rose www.Theft-By-Deception.com who is an activist regarding taxes. So much of what he said applies to the vaccine movement, that I got his permission to include part of his letter here. It is time to stand against forced vaccination. Stop the hysteria! Information is power. However, after gaining power, you must ACT.
Here is something to inspire you:
The Declaration was not a threat to take King George to court; it was not a petition, or a request for fairness, or even a demand. It was a statement -- a declaration -- that the people of America refused to tolerate the oppression, and were going to openly resist it, and didn't give a damn what the King thought about it. Though it may be politically incorrect to describe it this way, the Declaration of Independence was a bunch of people openly stating that they were going to ignore the law (not debate it or litigate it), and overthrow their present government. (King George was not a foreign invader; he was "the government.") Again, in the words of the Declaration, "when a long train of abuses and usurpations, pursuing invariably the same object, evidences a design to reduce them under absolute despotism, it is the people's right, it is their duty, to throw off such government."
Where are the Americans who still have that attitude?
"Power concedes nothing without a demand. It never did, and it never will. Find out just what people will submit to, and you have found out the exact amount of injustice and wrong that will be imposed upon them, and these will continue till they have resisted with either words or blows, or with both. The limits of tyrants are prescribed by the endurance of those whom they suppress."
This is a very different country today from what it was 226 years ago. We have become a country of sheep. We occasionally "baaa" at government injustice, but we do not ACT. For the most part, our "rebelliousness" now consists of pushing buttons in voting booths, to hopefully elect the less scummy of two lying scumbags (after a debate about which one is scummier). For most people that is the extent of their resistance to government-imposed injustice. Each of us cowers in a corner for fear that we will be the next one that government makes an "example" of. While self-preservation is no sin, at some point a country of "self-preservers" will "preserve" itself into total submission to tyrants. We are one step away from that now. Once upon a time, a group of individuals declared to the world that they would fight and risk death, rather than tolerate the oppressions of an abusive government. Now, we are too comfortable for that. We are spoiled. We are cowards. For today's battle, we need only the smallest fraction of the courage our forefathers demonstrated. We do not need to lie in the mud, squinting in the cold to see the rifle sites, waiting for the glimpse of British Troops that we know are headed our way just over the next ridge. We do not need to run into the open field, in heavy enemy fire, to retrieve our buddy who just had his leg blown off by a cannonball. We do not need to leave our families and friends to fight, and possibly to die. No, today the price for our freedom (at least a huge chunk of it) is a pittance compared to what others have paid, but I have my doubts about whether we are willing to pay even that. What is that price? What do we need to do?
We need to just say NO by affirming the following:
One of the major problems is the lack of vaccinia immune globulin (VIG), the "antidote" that is needed for those who experience a severe reaction to the vaccine. The Times article reports that there are only 700 doses currently available. Dr. Tom Mack, among others at the CDC warned that, "in the absence of VIG, extensive vaccination would be extremely dangerous."
References:
The Scoop on Sun Screen
Autistic are A-OK
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