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Gardasil, the FDA, and VAERS: How Americans concerned about vaccines interact with government

Emily Tarsell thought she had enough information about Gardasil — a new vaccine marketed to young women to prevent certain types of cervical cancer — when she agreed to have her daughter receive the vaccine.  But after her third and last injection of Gardasil, in 2008, Christina Tarsell, a previously healthy 21-year old, was dead.

The depth of this family’s anguish at the death of their daughter can’t be conveyed.  But after some time, and after realizing the possible link between Gardasil and her daughter’s death, Emily Tarsell decided she must try to find out if the vaccine was responsible. Thus began a real-life, real-time case study of how the Food and Drug Administration responds to citizens’ inquiries about possibly dangerous vaccines.  Unfortunately, Tarsell would discover that the Food and Drug Administration’s system for monitoring adverse reactions to vaccines and informing the public about them was woefully inadequate.

The Tarsells are not the only family that has tried to navigate the FDA’s reporting system for vaccines, known as the Vaccine Adverse Event Reporting System or VAERS.  The FDA has called VAERS the “front line of defense” in vaccine safety, while admitting that the system has serious limitations.  First and foremost among these limitations is that VAERS is a “passive,” or voluntary, reporting system – which may explain why, according to FDA estimates, only 10% of adverse reactions to vaccines are reported.  In addition, anyone can file a report with VAERS, from patients to pharmacists to physicians to vaccine manufacturers.

Manufacturers can filter vaccine concerns

But perhaps the biggest problem with VAERS is that citizens who are concerned about vaccines are encouraged to interact not with the FDA or other government agencies, but instead with vaccine manufacturers.  According to at least one critic, that makes VAERS reports unreliable from the start.  Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), a vaccine watchdog group, says “there are no incentives for manufacturers to report [adverse events].”   A drug manufacturer that has spent years and vast sums of money to get a drug to market has little incentive to report information that could affect the vaccine’s reputation.  At the same time, once a vaccine has been approved for use, it can be “tested” on a larger and more diverse population than in pre-licensing clinical trials, which is why monitoring the safety of newly-approved vaccines is so important.

Manufacturers are required to file reports with the FDA when they receive comments and complaints, but there are no real consequences for failure to report adverse events to VAERS.  According to FDA spokesperson Shelly Burgess,  the agency has never brought an enforcement action against a vaccine manufacturer solely for failure to comply with VAERS reporting requirements.

Vaccine safety activist Loe Fisher wants doctors to file reports directly to VAERS, not through the manufacturer.  She says manufacturers’ reports are often incomplete, citing a  report in the Journal of the American Medical Association which says that while 68% of the adverse event reports on Gardasil came from manufacturers, nearly 90% of them could not be tracked or investigated because of they lacked the most basic contact information.

How – and whether – VAERS works inside government . . .

Dr. Andrea Sutherland, who works in the FDA office that oversees vaccination safety, credits VAERS with identifying problems and spurring further investigation of vaccines on the market, highlighting, for example, problems with the rotovirus vaccine Rotashield, which was eventually recalled.

The benefit of VAERS to consumers is its transparency, Sutherland argues.  “They can see what the FDA sees,” she says, and “get a general idea” about a vaccine’s safety.

Anyone can phone, fax, or e-mail in information about perceived reactions to vaccines, which might include fevers, rashes, convulsions or fainting.   This information from concerned citizens is entered into the FDA’s VAERS system by FDA-trained contract employees of SRA International, Inc., a Virginia-based company with 7,000 employees that has other large contracts with the FDA.  They assign medical codes to the events based on the Medical Dictionary for Regulatory Activities (MedDra). The VAERS reports are then read by nurses trained in coding and reading reports about potential problems with vaccines, according to Sutherland.  Serious adverse events, including death, are reviewed within 24 hours by FDA medical officers responsible for the particular vaccine.

“Our office works with the Immunization Safety Office of CDC to oversee SRA’s work,” Sutherland says.  CDC and FDA have helped SRA International, Inc. develop training and guidance manuals for employees entering data into the VAERS database, including correct coding for the complex and varied information people report about symptoms they see as related to vaccines they or their loved ones have been given.  In spite of the FDA/CDC training efforts, medical codes are not always entered correctly.  Sutherland attributes some coding discrepancies to the fact that several terms may describe the same condition.  And she adds that FDA medical officers can ask SRA to make any needed corrections.

The NVIC’s Loe Fisher says that in the 1980’s, record-keeping and analysis of adverse events were handled internally by the FDA.  “Subcontracting out VAERS has politicized it,” she complains.  NVIC believes an independent agency, similar to the National Transportation Safety Board, would do a better job overseeing the adverse effects reporting system.   Loe Fisher points out the “inherent conflict of interest” when the agency making policy recommendations for vaccine use is also responsible for monitoring vaccine safety.”

. . . and how VAERS works for people using it

Emily Tarsell has found out the hard way that medical codes aren’t the only incorrect information entered into VAERS.  The system listed the cause of her daughter Christina’s death following her third injection of Gardasil as heart failure.  Merck, the manufacturer of Gardasil, reported that Christina’s untimely death was due to a viral infection.  Yet the autopsy report labelled the cause of death as “undetermined.”  There were discrepancies in the vaccine lot numbers that the FDA or CDC have yet to explain.  And there was no follow up with the family to determine if Christine might have had a preexisting condition or medical history that might have contributed to her post-injection reactions or death.  This kind of experience with VAERS is reported by other families who have made inquiries about Gardasil through VAERS.

Tarsell believes that VAERS minimizes reporting of vaccine adverse events and keeps the public in the dark.  She conducted her own survey of adverse events from Gardasil and concluded that VAERS fails to track or evaluate symptoms that could relate to increasing vaccine doses and pre-existing health issues, and therefore it doesn’t allow consumers to compare cases.

Yet the FDA’s Sutherland contends that “VAERS worked” in the case of Gardasil, pointing out that VAERS identified fainting and convulsions following injections of the vaccine, which led to revisions on Gardasil’s product label.

Sutherland cites published papers, presentations, and communication with health care providers and others which show, in her view, that the FDA is getting the word out about VAERS.  She notes that the public can get data reported to VAERS about Gardasil or any other vaccines via the CDC’s website called “CDC Wonder,” But Sutherland admits that this system is also “subject to misinformation” due to incorrect coding.  The “Wonder” database can be searched using variables including the vaccine, symptoms and age and sex of patients.  However, to obtain records for individual patients, even parents of children who may have suffered adverse reactions must file Freedom of Information requests with the FDA.

So in the end, Tarsell and the FDA are talking past one another.  The FDA defends the VAERS process for gathering adverse event information about Gardasil and other vaccines and touts its efforts to make the information available to the public.  But Tarsell says she hasn’t received an adequate explanation of the discrepancies in her daughter’s records.  Nor does she believe that the government will revise VAERS to make it better.  And she wonders how many people contemplating vaccination even know about the CDC’s website.

“Why do we continue to use a system that we know cannot give us the data we need to evaluate safety?” Tarsell asks.  She doesn’t want other parents to be lulled into a false sense of security about Gardasil or any other new vaccine based on incorrect or incomplete VAERS reports.

Neither does NVIC’s Loe Fisher, who initially supported the creation of VAERS.  She says the system should be replaced by a mandatory reporting system including doctors as well as vaccine manufacturers.

“If you’re going to mandate vaccines, shouldn’t you mandate reporting?” she asks.

The FDA is looking to new systems that may provide more accurate information about a new vaccine’s performance, such as the Sentinel Initiative and the Vaccine Safety Data Link project, which links the FDA to managed care databases.   But for now, VAERS remains the only game in town — a voluntary reporting system few health professionals pay attention to, that few consumers know about, and that vaccine manufacturers can manipulate or even ignore.

Emily Tarsell, who is seeking compensation for her daughter’s death from the National Vaccine Injury Compensation Program, wants the government to change VAERS so that consumers get accurate information about the risks of newly approved vaccines — something she and many other families – who have to live with tragic consequences — have not had.

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More Resources

NVIC Reveals More Serious Reaction Reports After Gardasil, Feb. 9, 2009

Gardasil protects against cervical cancer, but the vaccine’s risks are a concern, Washington Post, March 9, 2010, originally published by Consumers Union of United States, Inc.

Webinar on FDA’s Safety Monitoring of Approved Vaccines, July 13, 2010, presented by Dr. Andrea Sutherland, Special Assistant to the Director of the Division of Epidemiology in the Office of Biostatistics and Epidemiology in FDA’s Center for Biologics Evaluation and Research

15 Responses to “Gardasil, the FDA, and VAERS: How Americans concerned about vaccines interact with government”

  1. Laurie Dean-Smith:

    Revising the product label for Gardasil was merely a baby step towards an endless journey for the true facts of the lack of accountability that is being lost in the proverbial smoke screen that Merck, the FDA and the CDC are not only allowing, but providing.
    When I asked my daughter’s doctor to report her adverse reaction, that happened within 20 minutes of a clean bill of health, she became defensive and combative. I also think that the Pharmaceutical companies should NOT be allowed to give kick backs to doctors or clinics who push these products on their patients.
    VAERS has my daughter’s records, that I had to report myself, wrong. It stated that at the age of 15, that my daughter was pregnant. When I called them to correct this, they told me that they weren’t allowed to take something off of her records?
    truthaboutgardasil.org has now created a survey for those injured for this very reason. To try to obtain an accurate record of injuries from those who were adversely effected globally, from this vaccine.
    My heart goes out to Emily Tarsell for, not only her loss, but her drive to continue on to fight for this wrong to be corrected.
    If there is anything that I can do to help in any way, please contact me at laurie.truthaboutgardasil@yahoo.com


    comment at 14. December 2010
  2. janet r:

    thanks for that informative article. My own daughter decided on her own not to take the treatment,


    comment at 15. December 2010
  3. UG Reader:

    I wrote the following comment to an article in http://www.sanevax.org about reporting of adverse events. I did not realise then that Emily Tarsell had investigated the reporting system in connection with the tragic case of her daughter Christina’s death following injection of Gardasil.

    Here are my thoughts:
    The package insert for Gardasil invites adverse events to be reported with this formulation:
    “To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or VAERS at 1-800-822-7967 or http://www.vaers.hhs.gov”

    Note that the vaccine manufacturer’ s name, Merck and contact information are stated first. The company is given ample opportunity to become involved in many cases and to manipulate reports.

    Obviously Merck, a company which is well known for its ingrained culture of corruption and criminality, will employ every possible means to avoid adverse events being reported to VAERS.
    Girls who have reported adverse events are known to have been contacted by Merck for further details and discussion. Many are undoubtedly lead to believe that their cases have been officially registered.

    It is not known how many girls, nor the number of doctors who have contacted Merck about adverse events, have been bribed to keep cases quiet.

    The company is known to threaten doctors who are negative towards their products and to liberally pay those who are positive.

    If Merck does forward a case to VAERS it may have been manipulated so that the information is insufficient or misleading. It is maintained that a large number of cases which are reported by manufacturers to VAERS are in this category and therefore not included in the statistics for adverse events.

    Regulations should be changed making it forbidden for manufacturers to be involved in reporting adverse events to VAERS.


    comment at 17. December 2010
  4. Sandy:

    I wrote the following comment to an article in http://www.sanevax.org about reporting of adverse events. I did not realise then that Emily Tarsell had investigated the reporting system in connection with the tragic case of her daughter Christina’s death following injection of Gardasil.

    Here are my thoughts:
    The package insert for Gardasil invites adverse events to be reported with this formulation:
    “To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or VAERS at 1-800-822-7967 or http://www.vaers.hhs.gov”

    Note that the vaccine manufacturer’ s name, Merck and contact information are stated first. The company is given ample opportunity to become involved in many cases and to manipulate reports.

    Obviously Merck, a company which is well known for its ingrained culture of corruption and criminality, will employ every possible means to avoid adverse events being reported to VAERS.
    Girls who have reported adverse events are known to have been contacted by Merck for further details and discussion. Many are undoubtedly lead to believe that their cases have been officially registered.

    It is not known how many girls, nor the number of doctors who have contacted Merck about adverse events, have been bribed to keep cases quiet.

    The company is known to threaten doctors who are negative towards their products and to liberally pay those who are positive.

    If Merck does forward a case to VAERS it may have been manipulated so that the information is insufficient or misleading. It is maintained that a large number of cases which are reported by manufacturers to VAERS are in this category and therefore not included in the statistics for adverse events.

    Regulations should be changed making it forbidden for manufacturers to be involved in reporting adverse events to VAERS.


    comment at 17. December 2010
  5. Barb:

    When you look and read between the lines we know all of these government agencies are intertwined and they are going to protect each other any way they can. Even covering up the deficiencies and inadequacies at the expense of our children. I am an RN and I know first hand of pharmaceuticals giving physicians “kick-backs” in many different forms. It absolutely happens all the time.
    My only child was gravely injured in 2008 after gardasil vaccines and continues to be handicapped to this day. We were told with a diagnosis of acquired ALS and fast progressive in children, that she may not live through 2010. That diagnosis was changed to an inflammatory demylinating form. I am blessed by God and truely grateful that she is here and will continue to recover. There are many families that have lost their children or that remain very ill. We can not forget, nor can we let them get away with what they’ve done or attempted to cover up. There are at least 3 agencies or corporations responsible for the lives of our children and what has happened to them; Merck pharmaceuticals, CDC and FDA. As I said, they are all intertwined. We need to prevent this tragedy from happening to someone else. I too, am now willing to help in any way. You may contact me bbolund@yahoo.com


    comment at 18. December 2010
  6. Barb:

    I would like to add to my earlier note: CDC and FDA personnel actually came cross-country to meet with my child’s neurologists after she was the 3rd child in this area stricken with a grave illness after gardasil vaccines. The neurologist filed a VAERS report and notified them that these sick girls were too coincidental that there could be a possible link between illnesses and gardasil. After the meeting they listed my child on VAERS as “it has been determined by FDA and CDC and neurologists this pt has ALS” this was a cover-up diagnosis so as not to incriminate themselves or reveal the possible link between Gardasil and her illness. The way I read it is—they want the public to think she either inherited this grave illness or just acquired it for no reason at all; that there could be no possible link. Of course, I have since attempted to file an addendum to the 2 VAERS reports but that addendum has never made it into the system. So my child is just one of the many girls that was going to get sick regardless of having the vaccine or not. I absolutely know differently. It’s all a big coverup and “who scratches whom’s back!”


    comment at 18. December 2010
  7. Rosemary Mathis:

    My daughter was injured by Gardasil at the age of 12. Her doctor did not report it to VAERS until I did and told him he was required by law to do so. I know VAERS is under reported.

    This team started a non profit to represent the victims of Gardasil and other vaccines and their members analyzed the VAERS data to prove the HPV Vaccine Gardasil is the worst offender in the VAERS database. Even more than the flu shot.

    Go to http://sanevax.org/ for more information. The CDC and FDA need to investigate the HPV Vaccines because they are causing injury and death all across the globe.


    comment at 19. December 2010
  8. GreenYourLife:

    Since we can no longer rely on the hippocratic oath of “do no harm”, we have to rely on what we know is happening. No liability, too many vaccines in the schedule, and no warnings about the risks spells cover-up! We need transparency about the risks involved and free choice!


    comment at 19. December 2010
  9. noflushot:

    I filed my own VAERs report. 2 hospitals and countless doctors, 24 days in the hospital from the flu vaccine and I filed my own. The system is broken.


    comment at 19. December 2010
  10. michele:

    the only safe vaccine is the one never given. the fda, the cdc, and big pHARMa cannot be trusted. please do your own research on vaccines (beyond the lies the fda, cdc, and big pHARMa tell you) before deciding to vaccinate so that you can make an informed decision. it breaks my heart to hear of all the children who have been injured or who have died because of vaccines. parents, please protect your children from the greedy monsters who create and promote the toxins they call vaccines.


    comment at 19. December 2010
  11. Barbie:

    The doctor’s clinic and hospital that treated my daugher after her shot of Gardasil mysteriously couldn’t find the records when we requested them. When they were able to locate them, they curiously said the very same thing. This is after she had the shot and convulsions in the clinic and was taken to the hospital. She remained in the hospital for two days, but the records said the same thing. Such a coincidence-or NOT!


    comment at 20. December 2010
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