Just something to Think About...Hepatitis B vaccine

2004-03-05T13:16:00.000-08:00

Silence responds:

Julie:

You made the following statement:
"If we learn of problems after a product is on the market, we do a
thorough evaluation and decide what action to take. I want to emphasize to
you that FDA would not be aware of a safety issue under its jurisdiction,
and stand by and do nothing about it."

Well I am here telling you now there is a serious medical issue facing us, and the FDA is doing nothing! We see VAERS reports added on a daily basis describing serious adverse reactions to the Hep B, and the FDA is doing nothing. I have a child that was healthy, and now is chronically sick after receiving this so called vaccine, but the FDA is doing nothing. There has been report after report, hearing after hearing presenting serious medical data regarding what can go wrong with the Hep B vaccine, but the FDA does nothing. My list can continue, but the fact is:

The FDA is doing nothing...its about time someone steps up to the plate and does something. In the meantime child after child after child is paying the price--but the FDA does nothing. If possible I would like to discuss this matter on the phone with you to see how I can get this serious medical problem turned around---we must do it for the children.

2004-03-05T13:14:00.000-08:00

Another FDA employee writes:

Silence:

Diane Bartell forwarded your e-mail to me, asking whether I might have any
additional information for you. I am sorry that Diane's reply angered
you--I know that was not her intent. Diane and all of us in my office take
our responsibilities at FDA very seriously and try to be as responsive to
the public as we can. Often, FDA employees cannot provide all the
information that a consumer or health professional or concerned parent might
want. Sometimes FDA laws and regulations forbid us from discussing an
issue. Other times, we simply do not have the information the public seeks.
Or we lack jurisdiction or legal authority over an issue. This can be
frustrating for the public and also frustrating for us because we want to
help.

In your e-mail, you said, "If the FDA knows that children may suffer adverse
effects, why aren't
parents warned in advance and given the chance to opt out?" I think you may
be responding to something Diane said, which was "We are aware that children
vaccinated with the hepatitis B vaccine may experience adverse effects."
Please allow me to explain what Diane meant. FDA recognizes that the
possibility exists for hepatitis B vaccines, as well as all drugs or medical
products, to cause adverse effects in some people, including children,
because no drug or medical product is risk free. FDA's job is to evaluate
whether a vaccine, or any other regulated product, is safe and effective,
and whether the benefits outweighs the risks. If so, we approve the
product. If we learn of problems after a product is on the market, we do a
thorough evaluation and decide what action to take. I want to emphasize to
you that FDA would not be aware of a safety issue under its jurisdiction,
and stand by and do nothing about it.

I'm afraid that I can't help with your questions about NVICP because this
program is not under FDA's jurisdiction. NVICP is managed by the Health
Resources and Services Administration. You might want to talk with someone
at HRSA. Here is their web site: http://www.hrsa.gov/osp/vicp/.

Also, FDA does not set immunization policy and does not require any
individuals to receive vaccinations. If a parent wanted to opt out, and not
have his child vaccinated, it would be a good idea to first discuss any
concerns with a personal physician and weigh the risks and benefits of
receiving vs. not receiving a vaccination. This is a serious decision that
is best made after consultation with a medical professional.

With regard to court cases, FDA does not comment on proposed or pending
litigation, so we would have no comments on the Merck subpoena.

Sincerely,

Julie Zawisza
Chief, Consumer Affairs Branch
Center for Biologics Evaluation and Research
Food & Drug Administration
(t) 301.827.1348
(f) 301.827.3843
(e-mail) zawisza@cber.fda.gov

2004-03-05T13:13:00.000-08:00

Another letter from Silence to the FDA:

Diane---

No this information has not satisfied me.

If the FDA knows that children may suffer adverse effects, why aren't parents warned in advance and given the chance to opt out? If the FDA knows that children may suffer adverse effects why has the National Vaccine Injury Compensation Program never awarded a claim for Hep B injuries? If the FDA knows that children may suffer adverse effects, why do we now have to prolong the misery of children and prove a case in the NVICP that the Hep B can cause injuries. If we know that Hep B can cause injuries, why has the FDA not submitted discovery information to the vaccine court and why is Merck fighting the subpoena?

No your answers are not adequate; in fact I am so angry I can barely respond.

Silence

2004-03-05T13:12:00.000-08:00

Read carefully...see what they admit to in the body of the letter

Dear Silence:

Thank you for your inquiry to Mark B. McClellan, MD, PhD, Commissioner of
Food and Drugs, Food and Drug Administration (FDA), regarding your concerns
over the hepatitis B vaccine. Your email was forwarded to FDA's Center for
Biologics Research and Evaluation (CBER) for review and response. CBER, one
of six centers within FDA, is responsible for the regulation of
biologically-derived products, including blood intended for transfusion,
blood components and derivatives, vaccines and allergenic extracts, and
cell, tissue and gene therapy products. We appreciate your concern
regarding the hepatitis B vaccine and we are sorry to learn of your child's
diagnosis.

CBER regulates vaccine products. A manufacturer submits a request to FDA to
market a product typically because it is anticipated there is a demand or
need for such a product. We assess the data submitted by the manufacturer
and license a product based on the ability of the manufacturer to
demonstrate both safety and efficacy. Many of these childhood vaccines have
contributed to a significant reduction of vaccine-preventable diseases.
According to the Centers for Disease Control and Prevention (CDC), vaccines
have reduced preventable infectious diseases to an all-time low and now few
people experience the devastating effects of measles, pertussis and other
illnesses.

Vaccines, as with all products regulated by FDA, undergo a rigorous review
of laboratory and clinical data to ensure the safety, efficacy, purity and
potency of these products. Vaccines approved for marketing may also be
required to undergo additional studies to further evaluate the vaccine and
often to address specific questions about the vaccine's safety,
effectiveness, or possible side effects.

We are aware that children vaccinated with the hepatitis B vaccine may
experience adverse effects. Currently the two manufacturers of hepatitis B
vaccine are Merck and Co., Inc. which makes Recombivax HB® and
GlaxoSmithKline which makes Engerix-B®. Information on their vaccines,
including adverse events, are outlined in the product's package insert and a
copy of the insert can be found at their respective websites listed below.
http://www.merckfrosst.ca/e/products/recombivax_hb/home.html
http://gskvaccines.com/vaccines/pages/engerix_product.jsp?product=ENGERIXB_P
ED

As a regulatory agency, FDA does not give medical advice or make
recommendations concerning immunization requirements. Immunization
recommendations are made by individual state health departments, the Centers
for Disease Control and Prevention (CDC), the CDC's Advisory Committee on
Immunization Practices (ACIP), and the American Association of Pediatrics
(AAP). CDC's childhood recommended immunization schedule can be found at:
http://www.cdc.gov/nip/recs/child-schedule.htm#Printable

In closing, I hope that this information has been responsive to some of your
concerns. We take such concerns raised by you and other parents very
seriously. You can be assured that the FDA continues to work to ensure that
vaccines are as safe as possible. More information on vaccines can be found
on CDC's website at: http://www.cdc.gov/nip/default.htm.

Sincerely,
Diane Bartell
Consumer Safety Officer
FDA/CBER
Office of Communications, Training & Manufacturers Assistance
301-827-2000

2004-03-05T13:09:00.000-08:00

I have been in touch with Rep Tom Delay's office regarding the
NVICP. After multiple commuciations with the FDA, Delay's office
aksed me for my recommendation.. My suggestion for an amendment
follows. I don't know if anything will come up with it, but if you
agree with my suggestion please send a note to your representative.

A proposal to add a new section to H.R.1349

To amend the Public Health Service Act with respect to the National
Vaccine Injury Compensation Program.

Section 13 Forced Alternative Dispute Resolution

In the event that a petitioner's case has not been fully processed
within two years of the original filing date, The Special Master will
require, upon agreement of the petitioner, to move the case into a
ADR process. An award is available for any vaccine listed in the
approved table regardless of nature or type of adverse event. If a
settlement is not reached within 45 days, the case can be moved back
to the Special Master for a determination of award. If the petitioner
does not accept the award and or decision of the Special Master, the
petitioner may then select alternatives as currently stated in the
NVICP.

All petitions that have been filed and waiting for processing longer
than two years will be moved into ADR, upon the agreement of the
petitioner, within six months of the approval of this amendment.

Silence

2004-02-08T05:13:00.000-08:00

2004-01-26T13:12:00.000-08:00

Dear Dr. McClellan (FDA Director)

This weekend I read an article about you in the Houston Chronicle written by Gina Kolata of the New York Times. The theme of article focused on your willingness to buck the system. I am imploring you to take on one more cause. This new cause effects many, many more young US citizens. What I am speaking about is the terrible pain and suffering we are putting our children through because of the Hepatitis B vaccine that is mandated by most states in our county. As a doctor I am sure you know how folks get infected with Hep B. If a child is not at risk at birth there is practically no way they will ever get the disease. More children in Texas are sent to the hospital annually from the vaccine then incur the disease. I am convinced that the Hep B vaccine is the major cause behind the increase in autism, ADD, and other childhood neurological diseases. It is interesting to note that the increase in these diseases corresponds exactly to the introduction of the mandated recombinant genetically re-engineered vaccine in the early 90's. In the computer business we always ask when a problem occurs: "What has changed". Well, in the case of childhood neurological diseases--the Hep B is what changed. Worldwide experts including our own Dr. Bonnie Dunbar of the Baylor College of Medicine have testified to the damage this vaccine has causes, but no one listens or even cares to look into this.

And yes, my 12 year old son has been profoundly harmed by the shot...and no one cares; plus we are stuck in the adversarial system of the NVICP.

Please help...we need a strong spokesperson to stop what we are doing to our children.

2004-01-25T09:29:00.000-08:00

On Jan. 23, 2004, I had to take my son to a medical clicnic to have a doctor look at his throat. He frequently breaks out in cold sores on the back of his throat. This started when he was on a variety of meds to help lessen the pain from reative arthritis in his ankles. I gave the doc the quick story; and mentioned that it all started from the hep b vaccine. He said this is an bad vaccine--basically a vaccine that is just not is needed. He has heard other stories of reactions; plus he said there is talk in the medical community regarding the inherent problems with this drug. He said the his school dristrict is forcing him to vaccinate his 12 year old daughter. Since his daughter has already had a localized reaction to a previous vaccine he is worried about the possibility or an adverse reaction to hep b. I suggested filing an objection to the shot and led him to www.vaccineinfo.net for the paperwork.

He said multiple times: Since there is no need for the vaccine, why are we being forced to vaccinate our children. He answered his own question: "It must be about money".

Mandated vaccines are big money!!!

2004-01-25T09:14:00.000-08:00

On Jan 15, 2004 I had to go to Walgreens, to pick up supplies for a homemade skin cream for my son. The pharmacist asked why I needed the ingredieints. I quickly said he has been faced with a few problems since experiencing a reaction to the Hep b vaccine two years ago. The pharmacist said she understood the issue; she has a friend in Hong Kong whose new born baby died after receiving the hep b vaccination.

The effects of this evil vaccine has no boundaries.....

2004-01-15T08:23:00.000-08:00

I spoke today with Special Master Sweeny's law clerk. She informed me that there soon will be a conference call between all parties to discuss the establishment for the hearing date for Hep B Neurological injuries. The clerk thought the actual date of the hearing would be within the next six months. Location of the hearing is uncertain. It could be in Washington State, Washington D.C. or anyplace in between. The hearing would be open to the public. Once the hearing occurrs a ruling would come down from the SM that would specify if neurological cases can be compensated, and which type of injuries would qualify. It would be safe to assume that another year will pass us by before any hep b cases are settled....this madness must stop. I sugest we all call our representatives to get this damn law changed!. If a vaccine injury cases can not be processed within 18 months of filing, and if the vaccine is in the table ( and regardless of type of injury) the parties must be forced to settle. Nothing less is acceptable.

2004-01-15T08:14:00.000-08:00

The National Vaccine Injury Compesation Program must be changed! If the the Court can not determine if a case should be compensated within 18 months of filing, the parties must then be forced to settle. Cases for approved vaccines are lingering much too long--as cases linger, the injured continue to suffer. Most of the cases in question involve children---as parents we watch our children suffer, we watch our financial resources dwindle, and we watch the government wait. Help stop this madness now.

2004-01-03T07:34:00.000-08:00

What’s Merck trying to hide?

An Associated Press article regarding mercury content in fish appeared in the Dec. 28, 2003 issue of the Houston Chronicle. The first paragraph read: “Fish are heart-healthy and most Americans should eat more. But fish also contain mercury, and too much can harm brain cells, especially in the very young”. Countless numbers of research studies have documented this fact over the years.

If it is wrong for pregnant women or young children to eat too much fish due to mercury, why is it that childhood vaccine manufacturers have been allowed to manufacture and distribute vaccines with a mercury laced preservative called Thimerosal?

Yes, if administered properly, the amount of mercury in each shot is below the CDC/FDA recommended limits. However, if multiple vaccines are simultaneously administered either following birth or later in life, the overall amount is well above the recommended amount.

In 1986 Congress enacted a law called the National Vaccine Injury
Compensation Program. This little known program had two very important aspects. First, it shielded all vaccine manufacturers from lawsuits due to vaccine injury; and secondly, it created the so-called “Vaccine Court”. The vaccine court is managed under the US Court of Federal Claims. It was intended to be a quick, non-adversarial way to compensate the victims of vaccine injuries. It is funded by a 75 cent tax on every vaccine. The court has hundreds of millions dollars in its fund. It has paid out millions of dollars since its founding.

The Vaccine Court has a set number of vaccines it will consider for compensation. Even if a vaccine not on the list causes an injury, the claimant must still file in the court. The Court will add vaccines to the list; in fact, a genetically re-engineered form of the hepatitis b vaccine by Merck and a few other manufacturers was added in 1998. No claims for injury due to the Hepatitis B vaccines have been awarded. Hundreds of claims for injury due to the Hepatitis vaccines are now held up in Vaccine court. Many of the claims have been held up for years.

Many of you may remember the federally sponsored fund for 9/11 victims. This fund is very similar to the vaccine court. The only difference is that 9/11claimants only have to present a death certificate. In the vaccine court an injured party has to hire a lawyer and suffer through an adversarial process against the respondents including lawyers from both the Department of Justice and the Department of HHS.

The vaccine court is currently in the discovery phase on two major issues. First, could Autism be caused by vaccines; and secondly, which type of injuries will the court consider for compensation due to a Hepatitis B vaccine. The court has identified five different types of possible Hepatitis B injuries. The first two under review are neurological and arthritic conditions. There have been over 3000 Autism cases filed.

There has been much publicity (including inconclusive federally sponsored studies) during the last two years regarding both autism and its cause and injuries due to the hepatitis vaccine. The increase in childhood neurological conditions such as ADD, MS, and autism is alarming and well documented. Many parents feel the increase in mandated childhood vaccines is the cause. Just think, what has changed in the health care of children? Since the early nineties, the number of, and combinations of mandated vaccines have increased dramatically, and until recently, many of the vaccines contained mercury.

In Houston, we have Dr. Bonnie Dunbar, a world famous microbiologist that has written and testified multiple times regarding the damaging effects that the genetically re-engineered Hepatitis B vaccine can cause. Additional Congressional testimony has been presented by doctors from the Baylor College of Medicine regarding the effect of mercury in vaccines.

Even though the Hepatitis B and Autism proceedings are being reviewed independently, they both have one thing in common, and that is Merck &Co.

The Autism Omnibus Proceedings has collected a huge amount of information that is now under review by the court, the lawyers and Federal agencies. However, one set of information is still missing.
The Special Master in charge of the Autism hearing has issued a subpoena to collect the final information; the Product Licensing Application (PLA) and all of the supporting documentation from Merck regarding its Hepatitis B vaccine called, Recombivax HB. Merck is vigorously fighting the subpoena.

Even though Merck is protected from vaccine lawsuits by Federal statutes, it has vigorously refused to hand over the requested information. As I often tell my friends, the vaccine manufacturers could put sewage water in vaccines and still be exempt from legal action. So, what are they hiding? Much of the requested data is already in the hands of the FDA; however, due to federal privacy laws, the FDA is not allowed to give the Federal courts the information. Therefore, the Court must be forced to get the information from Merck. The proceedings from the court can be found at:
http://www.uscfc.uscourts.gov/OSM/OSMAutism.htm

Just read the insert from the Merck Hepatitis vaccine; it states that in its clinical studies a variety of neurological, immune system, and digestive reactions were either observed or reported in less than 1% of the time. One percent does not seem like a lot, but if millions of shots are administered annually in the U.S. alone, the number of adverse reactions is huge. Furthermore, cases of adverse reactions were only monitored for five days. No long term adverse reaction studies were ever undertaken.

Most states require that all students have three doses of the hepatitis b vaccine before reaching twelve years old. If the vaccine series is not taken, the schools will not allow your child to attend public school. Exemptions are possible, but not advertised or offered as an alternative. We were sent a letter from our school system threatening expulsion if we did not get our child vaccinated. We did, and it has been a horror story ever since.

The Vaccine Adverse Reporting System is a federally sponsored reporting system that documents vaccine injuries. It is well documented that the hepatitis b vaccine injures more children than contract the disease. VAERS information can be found at:
http://www.vaers.org/info.htm

So, if Merck and the other vaccine makers are protected from lawsuits, what do they have to loose? Vaccines are big business, and mandated vaccinations are huge profit maker. If parents can not afford to pay for the government mandated vaccines, the States will. The drug companies reap huge profits from mandated vaccines. I am sure they do not want these income streams interrupted.

It is unclear whether the mercury in the hepatitis b vaccines causes problems, or it is the hepatitis b vaccine alone, or if hepatitis b in combination with other vaccines that are harmful; but it is obvious that Merck is hiding something and this should not be allowed to continue. I even submitted a Freedom of Information request in October 2002, and have not received the requested PLA information from the FDA for both Merck and Smithkline hepatitis b vaccines. We owe it to our children to make Merck come clean. In fact we need a Howard Baker to ask, “what do they know, and when did they know it”.