The fast-track approach to getting the cervical cancer protection drug Gardasil® through the approval process may be on its way to haunting both the drug maker Merck & Co., and the approving agency, the U.S. Food and Drug Administration (FDA). It was recently revealed that at least 18 women have died in the past 2 years after receiving injections of the drug.
Gardasil is aimed at preventing the cancer-causing risks of the Genital Human Papillomavirus (HPV), which is considered to be the most common sexually transmitted disease in the world. Of the 30-some known strains of the virus, many are not harmful and go away on their own. Fifteen known strands of the virus can lead to cancer, with two of them causing the most cases. The drug Gardasil is aimed at protecting woman from only four of these known viruses.
The FDA approved Gardasil in June of 2006 after only 6 months of review. Typically, new drugs are reviewed for at least 10 months, but cancer drugs are often put on this fast-track approval process. Gardasil received unanimous approval from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and full FDA approval followed soon after.
Since then, it is reported that some 8 million young women between the ages of 9 and 26 have been injected. Three separate doses of the drug are given over a 6 month period at $120 each for a total of $360.
Now it has been learned by the watchdog group Judicial Watch that there have been 8,864 adverse reaction reports to the FDA since Gardasil was approved. These include the 18 deaths, 140 “serious” complications (27 considered life threatening), as well as 45 spontaneous abortions or miscarriages, plus cases of neurological disorders and blood clots.
As these issues come to light, parents and young women will have decisions to make regarding the advertised benefits of the drug versus a growing number of adverse reaction reports. “Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” said Tom Fitton, president of Judicial Watch.
This seems sage advice given the fact that Merck is advertising this drug by alleging to protect women from cancer, and while it does not even know if Gardasil itself might cause cancer! A report to the FDA on Merck’s testing protocol said this: “Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity.” In plain language this means, that they don’t know if Gardasil causes cancer or genetic damage to the cells that can cause cancer.
Merck also doesn’t know for sure how Gardasil will react when given in conjunction with any one of the common teenage vaccines. One in particular is the Menactra® vaccine for meningitis. Some very severe reactions to this vaccine alone are part of the 8,864 reports.
DR. CRAIG’S COMMENTS: Think twice, do your own research, and then think twice again before putting substances like Gardasil into your body. Your doctor may be doing what they “think is right”, but that does not mean that it is your best, or healthiest option! Clearly, the pharmaceutical industry’s influence on the American Medical Association is strong, and warrants a little skepticism on your part. We must take responsibility for our own health. Be proactive and educated - there is no better way than this!
Speak up and educate others,
Dr. Craig
Tuesday, October 21, 2008
RISE IN C-SECTION DELIVERIES REACHES NEAR ONE-THIRD OF ALL U.S. BIRTHS… BUT, WHY?
The number of Caesarean Sections performed in United States hospitals has soared over those performed just a decade ago. Charges by U.S. hospitals for the procedure have netted over $17.4 billion annually for these operations alone.
According to the most recently available numbers provided the Agency for Healthcare Research and Quality, the number of women who now have the C-section procedure is nearing 1/3 of all births. About 1.3 million women in 2005 gave birth through a C-section. This figure represents a 38 percent increase over 1995. That year, about 800,000 C-sections were performed in the U.S.
C-sections have their rightful place in deliveries when complications would be thought to put either the mother or the child at risk. An umbilical cord wrapped around the child’s neck or a breech delivery would be two common reasons for a C-section delivery. More recently, C-sections are being performed for many other reasons including convenience, a feeling by attending physicians that the procedure reduces lawsuit risk and even the idea that this type of delivery is better for the mom and child than a normal vaginal delivery.
The area of sharpest decline in vaginal deliveries occurred in the case of those mothers who had previously given birth via C-section. Vaginal deliveries of subsequent children dropped 60 percent from 157,200 in 1995 to just 63,300 in 2005. Apparently some doctors and hospitals are not allowing a woman to consider and attempt vaginal delivery following a C-section delivery.
Another major contributing factor to the increase in C-sections would logically be financial. In 2005, hospitals charged a total of $17.4 billion for about 1/3 of the deliveries through C-section. Hospitals took in just $21.3 billion for the remaining 2/3 of the deliveries. Clearly, the profit lies in C-section deliveries!
Consider the difference in costs based on 2003 figures as provided by the U.S. Agency for Healthcare Research and Quality.
- Vaginal birth with no complications: $6,239
- Vaginal birth with complications: $8,177
- C-section with no complications: $11,524
- C-section with complications: $15,519
At about $5,000 more for an uncomplicated C-section and over $7,000 more for a complicated procedure above vaginal delivery, is it really any wonder that the medical profession, as well as hospitals, might like to see the number of C-sections rise even higher in the years to come?
DR. CRAIG’S COMMENTS: There is a time and place for the C-section procedure. However, the child’s health and future well being should supersede all other variables. Natural child birth has too many benefits to be dictated by hospital protocols. Benefits of a natural birth: less stress to the baby’s spine, muscles and nerves, better lung function, improved immune system, reduced chance of asthma and allergies… to name but a few. Is it just a coincidence that we are seeing a decline in the health of infants and children, or is it more a matter of our meddling with God’s design and the natural order of life?
Speak up and educate others,
Dr. Craig
According to the most recently available numbers provided the Agency for Healthcare Research and Quality, the number of women who now have the C-section procedure is nearing 1/3 of all births. About 1.3 million women in 2005 gave birth through a C-section. This figure represents a 38 percent increase over 1995. That year, about 800,000 C-sections were performed in the U.S.
C-sections have their rightful place in deliveries when complications would be thought to put either the mother or the child at risk. An umbilical cord wrapped around the child’s neck or a breech delivery would be two common reasons for a C-section delivery. More recently, C-sections are being performed for many other reasons including convenience, a feeling by attending physicians that the procedure reduces lawsuit risk and even the idea that this type of delivery is better for the mom and child than a normal vaginal delivery.
The area of sharpest decline in vaginal deliveries occurred in the case of those mothers who had previously given birth via C-section. Vaginal deliveries of subsequent children dropped 60 percent from 157,200 in 1995 to just 63,300 in 2005. Apparently some doctors and hospitals are not allowing a woman to consider and attempt vaginal delivery following a C-section delivery.
Another major contributing factor to the increase in C-sections would logically be financial. In 2005, hospitals charged a total of $17.4 billion for about 1/3 of the deliveries through C-section. Hospitals took in just $21.3 billion for the remaining 2/3 of the deliveries. Clearly, the profit lies in C-section deliveries!
Consider the difference in costs based on 2003 figures as provided by the U.S. Agency for Healthcare Research and Quality.
- Vaginal birth with no complications: $6,239
- Vaginal birth with complications: $8,177
- C-section with no complications: $11,524
- C-section with complications: $15,519
At about $5,000 more for an uncomplicated C-section and over $7,000 more for a complicated procedure above vaginal delivery, is it really any wonder that the medical profession, as well as hospitals, might like to see the number of C-sections rise even higher in the years to come?
DR. CRAIG’S COMMENTS: There is a time and place for the C-section procedure. However, the child’s health and future well being should supersede all other variables. Natural child birth has too many benefits to be dictated by hospital protocols. Benefits of a natural birth: less stress to the baby’s spine, muscles and nerves, better lung function, improved immune system, reduced chance of asthma and allergies… to name but a few. Is it just a coincidence that we are seeing a decline in the health of infants and children, or is it more a matter of our meddling with God’s design and the natural order of life?
Speak up and educate others,
Dr. Craig
Monday, October 6, 2008
What you need to know about this year’s Flu Shot controversy
News reports have been flooding us with articles warning that the impending flu season may be the worst in years. Even though it is difficult to separate the facts from the hype, a close evaluation of the flu vaccine will reveal that serious questions must be raised about the recommendations that are routinely touted, namely high efficacy with little risk. Anyone considering a flu shot should become informed about the substances coming through that needle, and should be determined to investigate the safety and efficacy issues that are still unresolved.
The vaccine virus
Each year, a new vaccine is developed that contains three different viruses (one influenza B and two influenza A strains). CDC officials select the new viruses based on which viruses were prevalent during the flu season in China and Australia the previous year. The CDC admits that the viruses selected for the new vaccine are chosen on the basis of an "educated guess."
What's in a flu shot?
The influenza virus is grown in "specific pathogen-free" (SPF) eggs. Eggs are tested for a variety of agents-usually between 23 and 31-to confirm the absence of those specific pathogens. Laboratories limit the number of agents that are screened due to the shear abundance of potential viruses and/or bacteria to choose from. In addition, screening for every potential agent would be cost prohibitive. If none of the tested agents are detected, the vaccine is reported as "pathogen free."
However, it should be understood that there is a distinct difference between "pathogen free" and "specific pathogen-free." In its July 1996 report, the Institute of Medicine acknowledged that "although it is not possible to produce a completely uncontaminated animal, it is possible to produce an animal [or egg] certified to be free of specific pathogens." Viruses that are harmless to their animal host, however, may be potentially harmful to humans.
During the manufacturing process, antibiotics (neomycin, polymyxin B and gentamicin) are added to eliminate stray bacteria found in the mixture. The final solution can contain the following additives in any combination: Triton X-100 (a detergent); polysorbate 80 (a potential carcinogen); gelatin; formaldehyde; and residual egg proteins. In addition, many of the influenza vaccines still contain thimerosal as a preservative. Thimerosal (mercury) is being investigated for its link to brain injury and autoimmune disease.
Does the flu shot protect?
There are no guarantees that the influenza viruses selected for the vaccine will be the identical strains circulating during a given flu season. In fact, it has recently been announced that this year's flu vaccine does not include the strain that is being reported by doctors in the community called the "A Fujian" strain. Outbreaks have been reported in Texas, Colorado and elsewhere that involve strains that do not match the current flu vaccine. CDC tests have confirmed that more than 80 per cent of the 55 strains of influenza virus isolated thus far are the A Fujian strain. Even so, the CDC still maintains that the current vaccine could provide cross-protection against the new variant, but the fact is, no one knows for sure.
Moreover, the majority of illnesses characterized by fever, fatigue, cough and aching muscles are not caused by the influenza virus. Non-influenza viruses (e.g., rhinoviruses respiratory syncytial virus [RSV], adenoviruses, and parainfluenza viruses) can cause symptoms referred to influenza-like illnesses (ILI). Certain bacteria, such as Legionella spp., Chlamydia pneumoniae, Mycoplasma pneumoniae, and Streptococcus pneumoniae, have been documented as the causes of ILI.
Notably, these microbes are not part of the flu vaccine. Unless an organism's antigen is contained within the vaccine, there is no protection conferred by the vaccine. It is estimated that most adults will average 1-3 episodes of ILI, and most children will average 3-6 episodes. The CDC also admits that "many persons who have been vaccinated against influenza can still get the flu".
A serious concern: Alzheimer's Disesase
Hugh Fudenberg, MD, an immunogeneticist and biologist with nearly 850 papers published in peer review journals, has reported that if an individual had five consecutive flu shots between 1970 and 1980 (the years studied), his/her chances of getting Alzheimer's Disease is ten times higher than if they had zero, one, or two shots.
Dr. Boyd Haley, Professor and Chair of the Department of Chemistry at the University of Kentucky, Lexington has done extensive research in the area of mercury toxicity and the brain. Haley's research has established a likely connection between mercury toxicity and Alzheimer's disease. In a paper published in collaboration with researchers at University of Calgary, Haley stated that "seven of the characteristic markers that we look for to distinguish Alzheimer's disease can be produced in normal brain tissues, or cultures of neurons, by the addition of extremely low levels of mercury."
Does this prove that the mercury contained in the influenza shot can be directly linked to Alzheimer's? No, absolutely not. But further research in this area is critically needed because the absence of proof is not the "proof of absence."
Flu vaccine now for children
The Advisory Committee on Immunization Practices (ACIP) adopted a resolution effective March 1, 2003 that expanded the use of the influenza vaccine to include children aged 6-23 months. The recommendations also included vaccinating those aged 2 to 18 years who live in households containing children younger than 2 years of age.
The flu vaccine most commonly given to children is Fluzone, a trivalent vaccine grown in chicken eggs. Harvested with formaldehyde and containing the recommended ratio of 15 ug of each of the three prototype viral strains, each dose of Fluzone also contains 25 ug of mercury. The new CDC recommendations include giving the influenza vaccine to children beginning at six months of age and then annually, for the rest of their lives. Children less than age 9 receiving their first flu shot, two doses of vaccine are recommended, with a minimum interval of one month between the two doses. However, the CDC does not provide a direct reference to substantiate this recommendation.
On June 17, 2003, the FDA approved an intranasal influenza vaccine for use in healthy persons aged 5-49 years. Flumist is a live-virus vaccine that can cause a litany of problems. Please, do your research before using this drug!
Alternatives?
If you choose not to receive the flu shot, have a discussion with your doctor regarding other options. However, some simple and possibly quite effective things you can do for yourself to prevent the flu include: 1) avoid white sugar; 2) exercise regularly; 3) get adequate sleep; 4) eat a healthy diet, omitting trans-fats; 5) drink plenty of purified water daily and 6) wash your hands. A common way people contract viral illnesses is by rubbing their nose or their eyes after their hands have been contaminated with a virus. The CDC states, "the most important thing you can do to keep from getting sick is to wash your hands."We are so used to taking medications-for prevention and treatment-that it is difficult to comprehend that these modest recommendations are really the most powerful ways to minimize the likelihood of getting the flu.
Making the decision
You may decide to consult a physician who is schooled in alternative medicine to assess a variety of options for you and your family. What is most important, in the end, is to become as informed as possible regarding your options for keeping healthy and avoiding the flu.
Speak up and educate others,
Dr. Craig
The vaccine virus
Each year, a new vaccine is developed that contains three different viruses (one influenza B and two influenza A strains). CDC officials select the new viruses based on which viruses were prevalent during the flu season in China and Australia the previous year. The CDC admits that the viruses selected for the new vaccine are chosen on the basis of an "educated guess."
What's in a flu shot?
The influenza virus is grown in "specific pathogen-free" (SPF) eggs. Eggs are tested for a variety of agents-usually between 23 and 31-to confirm the absence of those specific pathogens. Laboratories limit the number of agents that are screened due to the shear abundance of potential viruses and/or bacteria to choose from. In addition, screening for every potential agent would be cost prohibitive. If none of the tested agents are detected, the vaccine is reported as "pathogen free."
However, it should be understood that there is a distinct difference between "pathogen free" and "specific pathogen-free." In its July 1996 report, the Institute of Medicine acknowledged that "although it is not possible to produce a completely uncontaminated animal, it is possible to produce an animal [or egg] certified to be free of specific pathogens." Viruses that are harmless to their animal host, however, may be potentially harmful to humans.
During the manufacturing process, antibiotics (neomycin, polymyxin B and gentamicin) are added to eliminate stray bacteria found in the mixture. The final solution can contain the following additives in any combination: Triton X-100 (a detergent); polysorbate 80 (a potential carcinogen); gelatin; formaldehyde; and residual egg proteins. In addition, many of the influenza vaccines still contain thimerosal as a preservative. Thimerosal (mercury) is being investigated for its link to brain injury and autoimmune disease.
Does the flu shot protect?
There are no guarantees that the influenza viruses selected for the vaccine will be the identical strains circulating during a given flu season. In fact, it has recently been announced that this year's flu vaccine does not include the strain that is being reported by doctors in the community called the "A Fujian" strain. Outbreaks have been reported in Texas, Colorado and elsewhere that involve strains that do not match the current flu vaccine. CDC tests have confirmed that more than 80 per cent of the 55 strains of influenza virus isolated thus far are the A Fujian strain. Even so, the CDC still maintains that the current vaccine could provide cross-protection against the new variant, but the fact is, no one knows for sure.
Moreover, the majority of illnesses characterized by fever, fatigue, cough and aching muscles are not caused by the influenza virus. Non-influenza viruses (e.g., rhinoviruses respiratory syncytial virus [RSV], adenoviruses, and parainfluenza viruses) can cause symptoms referred to influenza-like illnesses (ILI). Certain bacteria, such as Legionella spp., Chlamydia pneumoniae, Mycoplasma pneumoniae, and Streptococcus pneumoniae, have been documented as the causes of ILI.
Notably, these microbes are not part of the flu vaccine. Unless an organism's antigen is contained within the vaccine, there is no protection conferred by the vaccine. It is estimated that most adults will average 1-3 episodes of ILI, and most children will average 3-6 episodes. The CDC also admits that "many persons who have been vaccinated against influenza can still get the flu".
A serious concern: Alzheimer's Disesase
Hugh Fudenberg, MD, an immunogeneticist and biologist with nearly 850 papers published in peer review journals, has reported that if an individual had five consecutive flu shots between 1970 and 1980 (the years studied), his/her chances of getting Alzheimer's Disease is ten times higher than if they had zero, one, or two shots.
Dr. Boyd Haley, Professor and Chair of the Department of Chemistry at the University of Kentucky, Lexington has done extensive research in the area of mercury toxicity and the brain. Haley's research has established a likely connection between mercury toxicity and Alzheimer's disease. In a paper published in collaboration with researchers at University of Calgary, Haley stated that "seven of the characteristic markers that we look for to distinguish Alzheimer's disease can be produced in normal brain tissues, or cultures of neurons, by the addition of extremely low levels of mercury."
Does this prove that the mercury contained in the influenza shot can be directly linked to Alzheimer's? No, absolutely not. But further research in this area is critically needed because the absence of proof is not the "proof of absence."
Flu vaccine now for children
The Advisory Committee on Immunization Practices (ACIP) adopted a resolution effective March 1, 2003 that expanded the use of the influenza vaccine to include children aged 6-23 months. The recommendations also included vaccinating those aged 2 to 18 years who live in households containing children younger than 2 years of age.
The flu vaccine most commonly given to children is Fluzone, a trivalent vaccine grown in chicken eggs. Harvested with formaldehyde and containing the recommended ratio of 15 ug of each of the three prototype viral strains, each dose of Fluzone also contains 25 ug of mercury. The new CDC recommendations include giving the influenza vaccine to children beginning at six months of age and then annually, for the rest of their lives. Children less than age 9 receiving their first flu shot, two doses of vaccine are recommended, with a minimum interval of one month between the two doses. However, the CDC does not provide a direct reference to substantiate this recommendation.
On June 17, 2003, the FDA approved an intranasal influenza vaccine for use in healthy persons aged 5-49 years. Flumist is a live-virus vaccine that can cause a litany of problems. Please, do your research before using this drug!
Alternatives?
If you choose not to receive the flu shot, have a discussion with your doctor regarding other options. However, some simple and possibly quite effective things you can do for yourself to prevent the flu include: 1) avoid white sugar; 2) exercise regularly; 3) get adequate sleep; 4) eat a healthy diet, omitting trans-fats; 5) drink plenty of purified water daily and 6) wash your hands. A common way people contract viral illnesses is by rubbing their nose or their eyes after their hands have been contaminated with a virus. The CDC states, "the most important thing you can do to keep from getting sick is to wash your hands."We are so used to taking medications-for prevention and treatment-that it is difficult to comprehend that these modest recommendations are really the most powerful ways to minimize the likelihood of getting the flu.
Making the decision
You may decide to consult a physician who is schooled in alternative medicine to assess a variety of options for you and your family. What is most important, in the end, is to become as informed as possible regarding your options for keeping healthy and avoiding the flu.
Speak up and educate others,
Dr. Craig
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