Should pregnant women get H1N1 vaccine?

By LANDON HALL

Dr. Bob Sears has tried to avoid controversy during the swine flu outbreak. But his recommendation that pregnant women not get the H1N1 vaccine departs from the rest of the medical community.

The federal government and most physicians have spoken in unison on the issue, and they advise pregnant women to receive the injected form of the vaccine because of the virulence of the H1N1 strain and the vulnerability of a pregnant woman's immune system. Two Orange County pregnant women are among 28 who have died nationally since the pandemic began in April. But Sears says the vaccine has never been sufficiently tested for safety on this demographic.

"As a doctor, we swear an oath to 'First, do no harm.' So I have a hard time recommending a treatment that doesn't show it causes no harm," he said. "It's not just the H1N1 vaccine that's not been tested. The regular flu vaccine has not been tested in pregnant women, either, to show that it's safe in babies. That kind of boggles my mind, because the regular flu vaccine has been around for years, and there have been plenty of opportunities for the companies to do some safety testing on them so pregnant women can feel more comfortable about them."

Dr. Felice L. Gersh, an OB/GYN at Women's Medical Group of Irvine who has been practicing for 28 years, echoes the assessment of governmental health agencies, who say the vaccine is safe and are mounting a campaign to urge pregnant women to get the H1N1 and seasonal-flu vaccines. Gersh said Sears and other doctors skeptical of the H1N1 vaccine are "going against the weight of scientific evidence."

"Sometimes in medicine, as in life, you have to go with your best guess using available data," she said. "Everything can't be signed, sealed and guaranteed. This is a judgment call. And all the data is in favor of getting the vaccine."

Christina Chambers, an epidemiologist and associate professor in the Department of Pediatrics at UC San Diego, said Sears' views "don't hold water." She added that history has shown that pregnant women are at greater risk of hospitalization and death during flu pandemics.

"One day you could be feeling fatigued and achy, the next day you could be in a coma," she said.

Because he's part of a nationally trusted brand, Sears' opinions carry great influence. His pediatrician father, Bill, and registered-nurse mother, Ruth, wrote a series of books ("The Birth Book," "The Baby Book") that have become indispensible references for expectant and new parents. Sears, his parents and his brother Jim operate out of their seaside practice in Capistrano Beach.

"Dr. Bob," as patients and staffers call him, published his first solo book, "The Vaccine Book: Making the Right Decision for Your Child," in 2007. His inclusion of an "alternate vaccination schedule" brought him criticism from some fellow doctors who see his views as anti-vaccine, an accusation he hotly denies. But in recent postings about H1N1 on the family Web site, AskDrSears.com, his neutrality might have brought more questions than reassurance.

On July 30, he was undecided about the upcoming mass-vaccination effort. But he told readers that "what you can fret about is whether or not the government will make the vaccine mandatory." The first commenter wrote: "Way to fan the hysteria fire there Dr. Bob."

The Centers for Disease Control and Prevention has stated that the H1N1 vaccine is made the same way as the seasonal-flu vaccine, which "millions of Americans have received" over the years. Sears says that's a "completely unscientific statement." He points out, correctly, that no widespread clinical trial of either vaccine has been conducted on pregnant women. The 19-page product insert issued by Sanofi Pasteur, the largest of the five companies that supply the U.S. with H1N1 vaccines, acknowledges that it's "not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity." It adds that the vaccine "should be given to a pregnant woman only if clearly needed."

Chambers, who runs a support center out of UCSD to answer questions about H1N1 (in California, 1-800-532-3749), is gathering information for a future vaccine study. She said symptoms of H1N1 include fever, fatigue, muscle aches, headaches, runny nose, cough and sometimes vomiting and diarrhea. She urges women to get vaccinated, and if they feel symptoms to seek medical attention. Antiviral medications like Tamiflu can be prescribed within 48 hours of the symptoms arising.

"We don't know of any risk from the vaccine, but we do know the risks from getting the virus," Chambers said.

Contact the writer: lhall@ocregister.com

CDC Admits Thousands May Be Harmed By Swine Flu Vaccine

The Center for Disease Control and Prevention (CDC) has admitted as many as 30,000 Americans may suffer serious, potentially lethal adverse reactions to the swine flur or H1N1 vaccine, and the FDA guidelines for the vaccine only require that it work in 3 out of every 10 people. This is alarming, and even worse, the vast majority of people are unaware of this. Instead, political leaders are encouraging people to get the vaccines when they can. The public is being deliberately left in the dark about the dangers of the swine flu vaccine!

Back in 1976 during a mass vaccination campaign, 1 in every 100,000 recipients ended up with Guillain Barré syndrome (GBS), a disorder in which the body’s immune system attacks the peripheral nervous system. The result can be paralysis and death, and there is no cure for this horrible disease. At that time about 40 million Americans received the vaccine and some 4,000 ended up suffering with GBS as a result. The CDC is setting up a new intensive surveillance system so they can monitor and track GBS cases that occur from the swine flu vaccine. Guillain Barre syndrome is a debilitating and possibly fatal side effect and anyone subjecting themselves to the vaccine should be made fully aware of the risk they are taking.

As shocking as that is, it’s not even the whole story about the swine flu vaccine. According to the FDA: " a vaccine will be accepted if it creates antibodies in 4 out of 10 recipients (40%), with at least 70 percent of those 4 achieving an antibody level believed to provide benefit. This means that an acceptable vaccine candidate would provide “protection” for 28% of vaccine recipients (70% of the 40%), or less than 3 in 10 recipients. The requirement drops to 18% efficacy for those over 65 years of age (60% of 30%)."

This is outrageous!

According to the CDC:

As many as 30,000 Americans will be harmed by the H1N1 vaccine.

And according to the FDA:

The vaccine may be ineffective for at least 7 out of 10 people that receive it.

Meanwhile, dont’ expect the FDA or any government officials to suggest the public be pro active and take supplements which have antiviral properties which could prevent people from getting sick in the first place. Supplements like Vitamin D, liquid zeolte (see the link for the zeolte ebook to the right here) healthy diet and exercise, and doing all we can to maintain good health.

Sources

www.noshot.org/

www.naturalhealthnews.com

http://www.swinefluissues.com/cdc-admits-thousands-may-be-harmed-by-swine-flu-vaccine/

Beware - H1N1 FluMist

Regardless of where you stand on the vaccination issue, please be aware that both the seasonal flu and H1N1 have a nasal FluMist that is being administered to children and adults. Sometimes at schools and local grocery stores. The repercussions of this is scary!

FluMist - The Vaccine that Keeps Giving


September 23, 2009 by Sherry Tomfeld

Please Be a Responsible User!
Everyone has to be responsible for their own decisions. If you are afraid of catching the H1N1 flu this year. You may be pondering whether to get a flu shot or using the H1N1 FluMist. The FluMist is administered into your nostrils. Before making your final decision, you may want to ask some questions and think of some consequences to taking the H1N1 FluMist nasal spray.

The H1N1 FluMist is made with "live" virus. This means that the H1N1 flu will be a part of the nasal spray formula. It's supposed to be just enough to start your immunity to build defenses to it. The shot is supposed to be a killed virus.

If you take the H1N1 FluMist, you will in fact become a carrier of the H1N1 flu. Information on this drug states that you can and will shed the virus for up to 21 days. That means as you are visiting with your elderly family members, or shopping in the isles of your grocery store or sitting in church with young children and people with immune problems, YOU are going to be shedding the virus H1N1 germs.

If you are a person that cannot tolerate the shot or the FluMist for the H1N1 flu, you are a sitting duck when it comes to being around people who have taken the FluMist. The use of FluMist is for people ages 2 - 49. How many people do you come into contact each day that don't fit the age range?

Drugs.com says that you should be careful when coming into contact with "FluMist with anyone who has a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by certain medicines such as steroids, cancer chemotherapy, or radiation treatment. A person with a weak immune system can become ill if they have close contact with you after you have recently received a an influenza vaccine." Pregnant women are also on this list of people who should NOT use FluMist.

What happens when anything gets in your nose? You sneeze! Please be a responsible user of the FluMist and cover your face when you sneeze and cough. Remember, you are passing the H1N1 flu germs. The flu is passed from person to person with the sneezing, the coughing and germs from your hands. So if you take FluMist for the H1N1 flu, please practice good hygiene for the rest of us and wash, wash, wash your hands!

If you take the H1N1 FluMist nasal spray, please read up on it. Please ask questions about it. And please be a responsible user of the FluMist. We're all counting on you out here!

H1N1 Vaccination

Gardasil Researcher Speaks Out

"Public Should Receive More Complete Warnings"

By Sharyl Attkisson

(CBS) Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.

Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.

Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last... we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”

Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.

According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. "The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program."

"The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from Merck's warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information," said Harper.

Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks - “small but real” - could occur more often than the cervical cancer itself would.

"Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade's work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil."

She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. "The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers - something never stated, but often inferred by many in the population-- a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably."

CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine’s benefits outweigh its risks and that it is an important tool in fighting a serious cancer.

Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. “Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”

Why the Chickenpox Vaccine is Nuts

Another great article on a common vaccine that many of us give our babies without thinking twice.

Like I have said before - I am in no ways anti-vaccine. I am pro-know what you are injecting in your child, what the potential side effects are, and what is the success rate of that particular vaccine.

An Alternative View of Whooping Cough

Check out this great article on whooping cough and the vaccine used against it.

Our family dealt with whooping cough in the fall of '03. My fully vaccinated daughter came down with it and then passed it on to her siblings, the youngest of which was just under 4 mos old and 10 lbs. The baby spent one week in the PICU (she was never left alone) at my request for monitoring, but recovered completely.

Infant Death Due to Hep B Vaccine

Such a sad tragedy for this family. Baby Ian died at 47 days old after having an allergic reaction to the Hep B vaccine.

All 50 states have some sort of vaccine exemption. Here in Utah, it is as simple as going to the health department, paying them $25 and signing a form saying you understand the risks you are taking by not vaccinating. You do have options to selectively vaccinate - or not at all.

Think Twice
Vaccine Links

I also recommend the books The Vaccine Book, by Dr. Sears and What Your Doctor May Not Tell You About Children's Vaccinations, by Stephanie Cave, MD. Both share the history of the disease, history of the vaccination, statistics of the disease, how effective the vaccination is and an alternate schedule for those that choose to vaccinate.

I am not anti-vaccine by any stretch. As with all things, I hope that everyone does their research and are making an informed choice. Know what you are injecting into your children. Once it is given, it cannot be taken back.

Children Who Get Flu Vaccine Have Three Times Risk Of Hospitalization For Flu, Study Suggests

So, the flu vaccine doesn't work for kids and then raises their risk of hospitalization by 3 times! Why are we continuing to encourage it? I am sure a majority of the parents who choose to get this vaccine for their child does not know about this.

ScienceDaily (May 20, 2009) — The inactivated flu vaccine does not appear to be effective in preventing influenza-related hospitalizations in children, especially the ones with asthma. In fact, children who get the flu vaccine are more at risk for hospitalization than their peers who do not get the vaccine, according to new research that will be presented on May 19, at the 105th International Conference of the American Thoracic Society in San Diego.

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Flu vaccine (trivalent inactivated flu vaccine—TIV) has unknown effects on asthmatics.

"The concerns that vaccination maybe associated with asthma exacerbations have been disproved with multiple studies in the past, but the vaccine's effectiveness has not been well-established," said Avni Joshi, M.D., of the Mayo Clinic in Rochester, MN. "This study was aimed at evaluating the effectiveness of the TIV in children overall, as well as the children with asthma, to prevent influenza-related hospitalization."

The CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend annual influenza vaccination for all children aged six months to 18 years. The National Asthma Education and Prevention Program (3rd revision) also recommends annual flu vaccination of asthmatic children older than six months.

In order to determine whether the vaccine was effective in reducing the number of hospitalizations that all children, and especially the ones with asthma, faced over eight consecutive flu seasons, the researchers conducted a cohort study of 263 children who were evaluated at the Mayo Clinic in Minnesota from six months to 18 years of age, each of whom had had laboratory-confirmed influenza between 1996 to 2006. The investigators determined who had and had not received the flu vaccine, their asthma status and who did and did not require hospitalization. Records were reviewed for each subject with influenza-related illness for flu vaccination preceding the illness and hospitalization during that illness.

They found that children who had received the flu vaccine had three times the risk of hospitalization, as compared to children who had not received the vaccine. In asthmatic children, there was a significantly higher risk of hospitalization in subjects who received the TIV, as compared to those who did not (p= 0.006). But no other measured factors—such as insurance plans or severity of asthma—appeared to affect risk of hospitalization.

"While these findings do raise questions about the efficacy of the vaccine, they do not in fact implicate it as a cause of hospitalizations," said Dr. Joshi. "More studies are needed to assess not only the immunogenicity, but also the efficacy of different influenza vaccines in asthmatic subjects."

FDA ties pneumonia deaths to infant vaccine

FDA ties pneumonia deaths to infant vaccine
Agency panel considering approval of oral medicine for diarrhea virus

MSNBC - updated 9:20 a.m. MT, Fri., Feb. 15, 2008

WASHINGTON - GlaxoSmithKline Plc's rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.
The review comes ahead of a Food and Drug Administration advisory meeting next Wednesday to consider approval of the oral vaccine to prevent the most common cause of severe diarrhea and dehydration among infants and young children in the world.
FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo, documents posted on the FDA's Web site said.
That study, which enrolled about 63,000 children, also found an increase in convulsions in children given the drug, named Rotarix. Another study found an increased rate of bronchitis, compared with placebo.
In a conclusion section, the FDA documents noted the pneumonia-related deaths and convulsions, but did not appear to make a recommendation to the advisory panel.
That expert panel will weigh the staff review, but makes its own recommendation, which is typically followed by the FDA.