Tag: cancer

Is the HPV Vaccine a Savior or the Most Dangerous Vaccine Ever Made?

I’m still surprised at the responses some parents have when I mention that it is time for their kids to get their HPV vaccine.

Despite what you might read on the Internet, the HPV vaccines are safe and necessary.
Despite what you might read on the Internet, the HPV vaccines are safe and necessary.

While most say things like, “good, I was wondering when they would start it,” a minority still use arguments that could come straight off of any anti-vaccine website or forum.

Is the HPV Vaccine Dangerous?

The HPV isn’t dangerous, but it is easy to see why some parents still think that it is.

How many myths about the HPV vaccine have you heard?

“I don’t like this vaccine… Heaven help us if we have a generation of kids who get a hepatitis B vaccine and a HPV vaccine and they think that now unprotected sex is okay…

I don’t think it is really clear that this vaccine is really as safe as they say it is and it is certainly not as dangerous as they say it is, but I recommend against it in my practice.”

Dr. Jay Gordon discussing the HPV vaccine on the Ricki Lake Show

You can rest assured that they aren’t true.

Deciding to Get an HPV Vaccine

The HPV vaccines are well studied and in continuing studies have only been found to cause mild side effects, just like most other vaccines.

Still undecided?

“The manufacturers of Cervarix and Gardasil are following patients in Scandinavia for at least 15 years to verify that protection from both vaccines lasts at least that long.”

National Cancer Institute on HPV Vaccines

Parents who are still hesitant should know that:

  • Gardasil, the first HPV vaccine, was approved by the FDA in 2006. The first phase 1 and phase 2 trials began in 1997. It has been given to over 200,000,000 children, teens, and young adults for over 10 years now all over the world.
  • while fainting might occur after vaccination, it is also not uncommon after other vaccinations and medical procedures, especially in teens. It is not a specific issue caused by the HPV vaccine or any vaccine, for that matter.
  • the HPV vaccine does not cause primary ovarian failure, venous blood clots, behavior problems, multiple sclerosis, autoimmune disorders, or any of the other serious side effects you read on the Internet
  • while the HPV vaccine won’t protect against all forms of HPV, it protects against the forms that are most likely to cause cervical cancer. Just two types of HPV, types 16 and 18, cause 70% of cervical cancers, and another two types, types 6 and 11, cause 90% of genital warts. All are included in the Gardasil vaccine and Cervarix includes the types most likely to cause cervical cancer.
  • HPV is not rare – in fact, it is the most common sexually transmitted infection in the United States. While many infections do go away on their own, spontaneously, others linger and can cause cervical cancer.
  • HPV doesn’t just cause cervical cancer though, it can also cause vaginal, vulvar, penile, and anal, and oropharyngeal cancer, and genital warts
  • the HPV vaccines seem to provide long lasting protection, although, as with any new vaccine, we won’t know just how long the true duration of protection is until the vaccines have been out even longer. So far, Gardasil and Cervarix are providing protection that lasts at least 8 and 9 years.
  • boys need the HPV vaccine too, as there are around 11,000 cases of HPV induced cancer in men each year, including anal cancer and cancers of the mouth/throat and penis.
  • you want your child to get the HPV vaccine before they are having sex, to prevent them from ever getting infected with HPV, which is why it is routinely recommended when kids are 11 to 12 years old. That they are not sexually active yet is the whole point! As with other vaccines, if you continue to wait, you might eventually wait too long, although you can still get the vaccine if they are already sexually active, even if they are already infected with HPV, as it might protect them against another strain that they don’t have yet.
  • getting the HPV vaccine does not make it more likely that a teen will have sex
  • using condoms will not prevent all HPV infections. HPV can also spread through nonpenetrative sexual contact.
  • cervical cancer is serious, with about 4,200 women dying of cervical cancer each year, even in this age of routine pap tests
  • although you may hear that the HPV vaccine has been banned in some places, it is still offered in Japan, Utah, and other places where they talk about these bans, and since 2014, at least 64 countries have added the HPV vaccine to their immunization schedule

Get educated about vaccines and get your kids their HPV vaccine series. Remember that if you start the series before your kids are 15 years old, they only need two doses of the vaccine. After 15 years, they need 3 doses.

What To Know About Deciding to Get an HPV Vaccine

The HPV vaccines are safe, they work, and are necessary, which are beliefs shared by experts and most parents who decide to get their kids vaccinated and protected against HPV.

More Information on Deciding to Get an HPV Vaccine

 

Save

How to Read a Package Insert for a Vaccine

The highlights of prescribing information of the package insert offers a nice summary of each section, with more details in the full prescribing information section that follows.
The Highlights of Prescribing Information of the package insert offers a nice summary of each section, with more details in the Full Prescribing Information section that follows.

Show me the package insert!

If you are going to ask for a package insert, you should know what’s in it and how it should be read.

Otherwise, it is easy to get misled by antivaccine propaganda, like when Mike Adams claimed he discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”

He really just found the widely available vaccine package insert that said no such thing.

How to Read a Package Insert for a Vaccine

What goes into a package insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines.

Much like the package inserts for other medicines, a vaccine package insert includes up to 17 major sections, including:

  1. Indications and Usage – what the vaccine is used for
  2. Dosage and Administration – the recommended dose of vaccine, when and where it should be given, and how to mix it
  3. Dosage Forms and Strengths – available dosage forms
  4. Contraindications – all situations when the vaccine should not be given
  5. Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
  6. Adverse Reactions – this section includes clinical trials experience, postmarketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine.
  7. Drug Interactions – any reactions you might expect between the vaccine and other drugs
  8. Use in Specific Populations – can include recommendations for use in pregnancy, nursing mothers, pediatric use, and geriatric use
  9.  Drug abuse and dependence – usually blank
  10.  Overdosage – usually blank
  11. Description – general information about the vaccine, including how it was made and all vaccine ingredients.
  12. Clinical Pharmacology – how the vaccine works, including how long you might expect protection to last
  13. Nonclinical Toxicology – must include a section on carcinogenesis, mutagenesis, impairment of fertility, even if it is to say that the vaccine “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
  14. Clinical Studies – a discussion of the clinical studies that help us understand how to use the drug safely and effectively
  15. References – when necessary, a list of references that are important to decisions about the use of the vaccine
  16. How Supplied/Storage and Handling
  17. Patient Counseling Information – information necessary for patients to use the drug safely and effectively

In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.

Myths About Package Inserts

Just as important as what’s listed in a vaccine package insert, is what the package insert doesn’t say.

Or what you might be led to believe it says.

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

When reading a package insert, don’t be misled into thinking that:

  • you should be worried if a package insert states that a vaccine has not been evaluated for carcinogenic (being known or suspected of being able to cause cancer) or mutagenic (being known or suspected of causing mutations in our DNA, which can lead to cancer) potential or impairment of male fertility. Vaccines don’t cause cancer or impair male fertility, or female fertility for that matter. And as you probably know, many vaccines actually prevent cancer. Formaldehyde is the only vaccine ingredient on the list of known carcinogens, but it is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is carcinogenic, not the residual amounts you might get in a vaccine over short amounts of time.
  • any vaccine actually causes SIDS or autism
  • pediatricians are trying to keep parents from reading package inserts. Your pediatrician is probably just confused as to why you want it, as the VIS is designed for parents, not the package insert. But if even if your pediatrician doesn’t hand you a package insert for each and every vaccine your child is going to get, they are readily available from the FDA and many other websites.

Better yet, just don’t be misled by anti-vaccine misinformation.

“Based on previous experience, carcinogenicity studies are generally not needed for adjuvants or adjuvanted vaccines.”

WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines

Vaccines are thoroughly tested for both efficacy and safety before they are approved.

It is also important to understand that the WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines and the European Medicines Evaluation Agency both state that mutagenicity and carcincogenicity studies are typically not required for vaccines.

Why not?

It is because vaccines have a low risk of inducing tumors.

There are also very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

So, as expected, there are no surprises in vaccine package inserts. You can be sure that everything that needs to be tested to show that a vaccine is safe has been done. If it has “not been evaluated,” it is simply because it was not necessary.

Get educated about vaccines and get your family vaccinated and protected against vaccine preventable diseases.

What to Know About Reading Vaccine Package Inserts

Learn how to read vaccine package inserts so that you aren’t misled by many of the myths about what they do and don’t say, including why they are likely missing information on the vaccine’s potential to cause carcinogenicity, mutagenicity, or impairment of fertility.

More on How to Read a Package Insert for a Vaccine:

Cancer Vaccines Can Prevent and Treat Many Cancers

The CDC recommends HPV vaccination for 11 and 12 year olds.
The CDC recommends HPV vaccination for 11 and 12 year olds.

When you think about a cancer vaccine, what do you imagine?

Hopefully it isn’t the anti-vaccine myth that the polio vaccine causes cancer – it doesn’t.

Is it a vaccine that prevents all cancer, a so-called universal cancer vaccine? Or vaccines that target specific types of cancer?

Or do you get thoughts of a cancer vaccine that targets and kills cancer cells, treating patients once they already have cancer?

Sound too futuristic?

While a universal cancer vaccine is likely for than a few years away, many people are surprised that some of the vaccines in the current childhood and adolescent immunization schedule can actually prevent cancer.

Another vaccine is approved to treat cancer.

And that’s good news, as cancer is now the leading cause of death in the United States.

Current Cancer Vaccines

When cancer is caused by an infection, it makes sense that you can prevent the cancer by preventing the infection in the first place. That is the rationale for the current preventive cancer vaccines for the human papillomavirus (HPV) and hepatitis B:

  • Gardasil – an HPV vaccine that can be given to preteen boys and girls to protect against most genital warts and anal cancer. Gardasil also protects women against most cervical cancers.
  • Hepatitis B – the hepatitis B vaccine prevents hepatitis B infections, which when they become chronic, can develop into liver cancer.

For these vaccines to be effective, they have to be given before you are exposed to the virus. That is why it is critical for preteens to get the HPV vaccine before they become sexually active teens and young adults.

Since babies can get hepatitis B if their mother is infected and they are more likely to develop chronic hepatitis B infections, it is also important that all infants be vaccinated with the hepatitis B vaccine. Vaccination programs that instead try to target just those newborns of mothers already known to be infected with hepatitis B are much less successful than universal vaccination programs.

In addition to a preventive cancer vaccine, another type of cancer vaccine is the therapeutic or cancer treatment vaccine. This type of cancer vaccine actually helps your body fight the cancer.

So far, only one cancer treatment vaccine has been approved by the FDA.

Provenge is approved for some men with metastatic prostate cancer, increasing their survival by about 4 months. Provenge works by stimulating T lymphocytes, a part of our immune system, to kill prostate cancer cells.

Cancer Vaccines in Development

Although there are just four approved cancer vaccines in use today, there are many more in development, including:

  • DCVax(R)-L – in phase III trials to treat certain patients with glioblastoma multiforme, a type of brain tumor.
  • NeuVax – in multiple phase II trails, including one for certain patients with breast cancer to help prevent breast cancer recurrence.
  • Rindopepimut – in phase III trial to treat certain patients with glioblastoma.
  • Tecemotide – in phase III clinical trials for certain patients with non-small cell lung cancer.

Even more cancer vaccines are in phase I and phase II trials, such as WDVAX, which is in phase I clinical trials to treat certain patients with melanoma.

Although perhaps not as far along and still in early exploratory or pre-clinical research stages, there are other preventive cancer vaccines being developed too. These new vaccines would provide protection against hepatitis C (liver cancer), Epstein-Barr virus (Burkitt lymphoma, non-Hodgkin lymphoma, and Hodgkin lymphoma, etc.), Helicobacter pylori (stomach cancer), schistosomes (bladder cancer), and liver flukes (liver cancer).

What To Know About Cancer Vaccines

In addition to the hepatitis B and HPV vaccines that can prevent cancer, multiple vaccines are being developed to actually treat cancer.

For More Information On Cancer Vaccines

 

Formaldehyde in Vaccines

While formaldehyde is an ingredient in many vaccines and other products, it is also naturally found in all of our bodies and in some foods.

“Formaldehyde also occurs naturally in the environment. It is produced in small amounts by most living organisms as part of normal metabolic processes.”

National Cancer Institute

Doctors get to be familiar with formaldehyde in medical school. It is the preservative that is used in mortuaries and in gross anatomy lab and students often leave the lab with the “pungent, suffocating odor” of formaldehyde on their clothes.

Formaldehyde in Vaccines

So why is formaldehyde in the vaccines that we give our children?

Formaldehyde is present in some of the vaccines on the childhood immunization schedule, including the flu shot, polio vaccine, and DTaP vaccine, because it works to eliminate any possible harmful effects of these bacterial toxins (like diphtheria toxin) and makes the viruses unable to replicate or reproduce themselves.

The very small amount of formaldehyde that is left over in the vaccines that are given to kids is less than the amount naturally found in children and much less than that amount safely given to animals in research studies.

And that formaldehyde is quickly broken down by our bodies and then excreted in urine.

The residual amount (most is removed) of formaldehyde in vaccines is safe.

Formaldehyde vs Formaldehyde

But even if your body makes formaldehyde, is that the same thing as the formaldehyde that is in a vaccine?

“When the body breaks down formaldehyde, it does not distinguish between formaldehyde from vaccines and that which is naturally produced or environmental.”

FDA Common Ingredients in U.S. Licensed Vaccines

While you may be shaking your head wondering why this is even being questioned, some folks are debating the differences between synthetic copies of natural chemicals and the original chemicals. Are they really the same?

If they are a true copy, with the same exact chemical structure, then yes.

For some chiral compounds or stereoisomers, like d-α-tocopherol and dl-α -tocopherol, which are both vitamin E, they might have different effects. One is natural, while the other is synthetic. They have the same molecular formula, but they are different, much like your right and left hands are different.

Formaldehyde is not a chiral compound though, so formaldehyde is formaldehyde.

Does Formaldehyde Cause Cancer?

Exposure to formaldehyde is known to cause cancer in rats and it is now classified as a known human carcinogen.

“Carcinogens do not cause cancer at all times, under all circumstances.”

American Cancer Society

It is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is the big concern though. Those most at risk would be workers, who are hopefully protected with the latest OSHA standards that limit exposure to formaldehyde.

What To Know About Formaldehyde in Vaccines

The small amount of formaldehyde in vaccines is safe and is not toxic.

More Information About Formaldehyde in Vaccines: