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

VAERS2Emily 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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