How closely does the CDC monitor HPV vaccine safety?

By Norma Erickson

SaneVax-FeaturedDecember 4, 2013, the Katie Couric Show aired several segments focusing on The HPV Vaccine Controversy. Her guests included Emily Tarsell, Rosemary and Lauren Mathis, Dr. Diane Harper and Dr. Mallika Marshall.

In response to the ensuing firestorm of criticism the show generated, Katie Couric invited Dr. Anne Schuchat, Assistant Surgeon General and Director of the CDC’s National Center for Immunization and Respiratory Diseases, to do a segment for Friday’s show in order to “make sure people understand the facts about this vaccine and human papillomavirus (HPV).”

Dr. Schuchat’s answers to Katie Couric’s questions can be viewed in the video above, or on HPV Vaccine Conversation Continued. During the interview Dr. Schuchat was asked about the safety of HPV vaccines, she stated:

“As the leader of the CDC Immunization Program, I am really committed to a very strong safety monitoring system. What I can say is more than 57 million doses have been used and with all the tests and systems that we track, we aren’t finding any concerning problems.”

Really, Dr. Schuchat – No concerning problems?

According to the CDC, VAERS data are monitored to:

  • Detect new, unusual, or rare vaccine adverse events
  • Monitor increases in known adverse events
  • Identify potential patient risk factors for particular types of adverse events
  • Identify vaccine lots with increased numbers or types of reported adverse events
  • Assess the safety of newly licensed vaccines

Ostensibly, the Vaccine Adverse Event Reporting System (VAERS) is the first line of defense when monitoring vaccine safety. Despite the obvious limitations of drawing concrete conclusions from VAERS data, it does provide an excellent tool for recognizing potential safety signals, red flags if you will, when looking at a specific vaccine’s safety profile.

This article will look at a few items which would raise red flags for the average medical consumer. Perhaps Dr. Schuchat can explain why they are not ‘concerning problems’ for the leader of the CDC Immunization Program.

According to the Rare Diseases Act of 2002, any disease or condition that affects less than 200,000 people in the United States is classified as a rare disease. There are currently more than 6,000 known rare diseases. One could safely assume that if one or more of these rare diseases began to show up in the VAERS database with any regularity it would certainly constitute a safety signal – a signal demanding further investigation.

Let’s take a look at a few examples of VAERS data that should at the very least raise a few eyebrows.

HPV Vaccines and ADEM

According to the NIH, National Institute of Health, acute disseminated encephalomyelitis (ADEM) is characterized by a brief but widespread attack of inflammation in the brain and spinal cord that damages myelin – the protective covering of nerve fibers.  ADEM often follows viral or bacterial infections, or less often, vaccination for measles, mumps, or rubella.

In other words, ADEM is a known side effect of some vaccines. It is listed as a rare disease in both the United States and Europe. Examine the following chart showing the VAERS reports of ADEM after all vaccines used in the United States each year from May 1997 through May 2013.

1-ADEM

One would think an 8,100% average per anum increase in reports of this rare condition after the introduction of HPV vaccines would be a huge red flag. Apparently, that is not the case for Dr. Schuchat despite the fact that ADEM is a known adverse effect of some vaccines.

HPV Vaccines and POTS

Postural orthostatic tachycardia syndrome (POTS) is one of a group of rare disorders that have orthostatic intolerance (OI) as their primary symptom (when an excessively reduced volume of blood returns to the heart after an individual stands up from a lying down position). In POTS, orthostatic intolerance causes lightheadedness or fainting, and there is also a rapid increase in heartbeat.

The following chart shows VAERS reports of POTS and related symptoms after HPV vaccines compared to the number of reports filed after all other FDA approved vaccines.

2-POTS-related-symptoms

There are over 80 vaccines FDA approved for use in the United States. If all vaccines were equally safe, HPV vaccines should account for around 3% of the total reports filed with VAERS. As you can clearly see, depending upon the symptom, HPV vaccines account for a disproportionate percentage of the reports filed pertaining to POTS and related symptoms. What is wrong with this picture?3-POTS-increase

Still – no ‘concerning problems’ Dr. Schuchat? Not with an average increase of 137% in reports filed per year?

HPV Vaccines and ITP

Idiopathic thrombocytopenic purpura (ITP) occurs when immune system cells produce antibodies that destroy platelets, which are necessary for normal blood clotting. The antibodies attach to the platelets. The spleen destroys the platelets that carry the antibodies.

The chart below illustrates the average number of reports of purpura on an annual basis for all vaccines listed in the VAERS database. There has been a 68% increase in the average number of purpura cases reported annually since the introduction of HPV vaccines in 2006.

4-ITP-increase

Seriously, Dr. Schuchat, wouldn’t this fall under the heading of potential unusual vaccine adverse events which the VAERS system is designed to alert the members of your staff to investigate?

HPV Vaccines and Infertility

Infertility in the United States is no small problem. The CDC estimates that 10.9% of women ages 15 to 44 experience fertility problems. This estimate was made from data collected from 2006-2010. Since this is not a rare disorder, one would think that any signal which indicated a tendency to exacerbate the problem would be of particular concern.

5-Infertility-increase

OK, the chart above shows a substantial increase of the reports of fertility problems, a 790% increase in the annual average to be exact beginning in 2007. What could have caused such an increase? Does it have anything to do with the introduction of HPV vaccines in mid-2006?

Let’s compare the percentage of infertility reports after HPV vaccines to infertility problems reported after all other vaccines in the VAERS database from May 2007 to November 2013.

6-Infertility-comparison

Dr. Schuchat, how can 2 vaccines, Gardasil and Cervarix, account for such a large percentage of infertility reports to VAERS for such an extended period of time without being a concern?

One Final Chart

7-Adverse-Event-comparison

Once again, Dr. Schuchat, how can two vaccines account for such a large percentage of the VAERS database? Why is this not a matter of concern?

Perhaps the mission statement for the National Center for Immunization and Respiratory Illness says it all:

“The mission of the National Center for Immunization and Respiratory Diseases (NCIRD) is the prevention of disease, disability, and death through immunization and by control of respiratory and related diseases.”

The amount of disease, disability, and death potentially caused by Gardasil and Cervarix are obviously not a ‘concerning problem’ for those who are supposed to be monitoring HPV vaccine safety at the CDC.

Thank you, Dr. Schuchat, for making that perfectly clear to medical consumers in the United States and around the world.

For more revealing graphs, click here.

Read this article in French here.

Comments

  1. Here’s the VAERS query to pull up all cases of acute disseminated encephalomyelitis in the US after HPV vaccinaton:

    http://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&SYMPTOMS%5B%5D=Acute+dissem
    inated+encephalomyelitis+%2810000709%29&VAX[]=HPV4&SERIOUS=ON&STATE[]=JUSTUS

    It only finds seven cases. Your graph must not have been specific to the HPV vaccine.

    ADEM is known to occur after infections. Three of those seven cases ( 338379, 339457, and 483416) were after or during infections, and one of those cases ( 495361 ) came three weeks after the patient attempted to pierce lip and tongue with fish hook and thumb tack. Those four cases are probably due to infections rather than the various vaccines.
    So that leaves three cases.

    Given that there have been about 60 million doses of HPV vaccine distributed in the US, the reporting rate would be about 3 in 60 million, or 1 in 20 million. And it’s not even clear which of the vaccines given caused the problem, if any.

    That seems like a pretty weak safety signal, even accounting for underreporting.

  2. For anyone following up on the POTS claims, http://pubmed.gov/24102827 is a recent study of six reported cases.

  3. When the CDC says “we aren’t finding any concerning problems” that means they are not finding any problems that exceeded their expectations. They new problems, including deaths, would occur but they had already made the determination (and continue to believe) that the cost in illness and deaths is worth it.

    Ironically, while we don’t have any idea how many deaths from cervical cancer may be prevented by these vaccines, we do know that the death rate from cervical cancer is less than 5,000 deaths per year. So, perhaps the CDC is guessing that a few hundred vaccine related deaths may be offset by saving 1,000 or so lives per year in decades to come. At least they hope so.

    Regarding the payout to pharmaceutical industry, doctors and the government, this goal of saving a 1,000 or so lives per year in future decades is also made more noble by the fact that they are pocketing three billion or more per year. Three billion divided by 5,000 is $600,000 in profits per cervical cancer death. Put another way, threatening young women and their families with the fear of cervical cancer is very, very profitable.

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