Gardasil. It is a first of its kind vaccine designed to prevent cervical cancer and approved by the Food and Drug Administration on June 8, 2006 for use in females aged 9 to 26. Within weeks the vaccine was unanimously approved by the CDC's Advisory Committee on Immunization Practices for 11 and 12- year old girls. What followed was a cascade of calls by legislators around the country, including in Florida, pushing for this new to the market vaccine to be mandated for scores of young girls.

"This is a real danger zone, " says Dr. Diane Harper.

Why might you care about what she says? Dr. Harper is one of the world's top experts on the Human Papilloma virus, HPV, which can lead to cervical cancer. In fact, she's one of the leading scientists the pharmaceutical industries turned to for help to conduct clinical trials - including those that led to approval by the US Food and Drug Administration of Gardasil - and the recommendations that followed.

Speaking out in her first such television interview with WFOR-TV Chief Investigative Reporter Michele Gillen, Dr. Harper expresses concerns over what she considers a rush to recommend and mandate the vaccination of very young girls with the vaccine. "It went too fast, it went too fast without any breaks," says Harper, who devoted nearly two decades of her career to research on HPV.

Dr. Harper says she believes the vaccine is safe but cautions that time is needed to study potential side effects in larger numbers of young girls before any consideration should be given to mandating such a vaccine.

According to Dr. Harper, "the vaccine has not been out long enough for us to have post marketing surveillance to really understand what all the potential side effects are going to be. We feel it is very safe." However, she adds, "We don't know yet what's going to happen when millions of doses of the vaccine have been given and to put in process a place that says you must have this vaccine, it means you must be part of a big public experiment. So we can't do that until we have more data."

Barbara Low Fisher agrees. She took to the streets a grass roots fight credited with derailing many efforts around the country to mandate the vaccine. "It was the quickest effort I have ever seen in 25 years for a vaccine to be mandated," says Fisher. A mother of a son who she say was left with learning disabilities following a routine vaccination in the 1980's, Fisher is President and Co Founder of the National Vaccine Information Center. It is a non-profit independent clearinghouse for information on vaccines and disease.

Fisher says her organization has been contacted by nearly 100 parents claiming their daughters have suffered some type of adverse reaction following a Gardasil shot - at times given in combination with other vaccines. She says many parents are frustrated in their search for answers and that they don't know where to turn. She tells Gillen "the National Vaccine Information Center is getting reports every week, mostly mothers, of what is happening to their 11-year old girls after receiving Gardasil."

Fisher says she has heard from parents upset that their doctors are refusing to report reactions potentially tied to this vaccine they recommended, if not aggressively pushed.

"I think that this has caused a real crisis of trust in the hearts and minds of parents who are being more educated about vaccines and all types of products they give their children," says Fisher.

Harper says parents need to be armed with as much information as possible. She believes the vaccine should be an educated choice. She explained that many parents do not realize or are not being told by physicians, that their daughters might end up needing a booster shot. She says what can be considered key study trials lasted at most 5 years and that there is no way to know exactly how long the vaccine will be effective.

"I think the thought is that there probably will be efficacy for longer than 5 years but its probably not going to be lifetime efficacy. There probably will be some need for a booster. There will be some need for understanding when we going to need to be able to revaccinate those women. Those are all open questions," says Dr.Harper.

Given that it is unknown for how long the vaccine will be effective, Dr. Harper says she can't stress enough the need for pap tests throughout a woman's lifetime, even if she has received an HPV vaccine.

Dr. Harper understands why some parents are left wondering how young might be too young?

Gillen asked Dr. Harper what she thought the optimum age of a girl should be to receive the shot.

"I would have started at 15, and not at 12," explained they physican.

Fisher says she applauds Dr. Harper for being willing to address controversial questions regarding HPV vaccines and concerns by parents who say they want more information before deciding if the shot is right for their daughters.

"I think that Dr. Harper has done a tremendous public service to stand up," says Fisher.

Dr. Harper says she is convinced HPV vaccines can help prevent cancers in the long run. But that parents and women should have a choice. Dr. Harper has also served as a consulting researcher for study trials for another HPV vaccine named Cervarix, being developed by GlacoSmith Kline, GSK. "I am the first author on two of the GSK papers," she noted.

But again she expressed her disapproval for any potential effort to mandate a Cervex vaccine for young girls. As Dr. Harper explains " It's still like-wise with Gardasil. They haven't been out long enough , there isn't enough information to have a mandate that you can't go to school until you have this vaccine. It does not make any sense."

Dr. Harper served as a researcher on study trials for Gardasil and Cervarix while employed as a professor at Dartmouth College. The University was contracted by both Merck and Co.. and Glaxo Smith Kline for the HPV studies who paid for the studies. Dr. Harper has disclosed receiving speaking fees from both Merck and from GSK for speaking about the HPV vaccines, and has received consultation fees from both Merck and GSK for consulting about trial development and data interpretation, in addition to the monies paid to Dartmouth to conduct the trials.

In asking a representative from Merck. for a response to the WFOR-TV interview with Dr. Harper and the types of concerns she raised a Merck representative provided WFOR-TV with the following statement:

Merck's research program for GARDASIL® [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] spans more than 10 years of rigorous study of more than 25,000 individuals around the world and the labeling for GARDASIL reflects the extensive data available from our clinical trials.

In addition, the data from our clinical trials have been discussed in public settings by leading medical and policy experts, including an FDA Advisory Committee meeting in May 2006, publications in The New England Journal of Medicine and The Lancet and meetings of the CDC's Advisory Committee on Immunization Practices (ACIP).

In February of 2006 the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for GARDASIL and designated the file for priority review. A priority designation is intended for products that address unmet medical needs and under the prescription Drug User Fee Act (PDUFA), the FDA's goal is to review and act on BLAs designated as priority review within six months of receipt.

GARDASIL received its U.S. FDA approval on June 8, 2006 and on June 29, 2006 received a universal ACIP recommendation for use in 9-26 year old girls and young women.

We began discussions of data from the clinical trials with the ACIP's HPV Working Group as early as 2004. It is important to note that the three week time period between FDA licensure and the ACIP recommendation in June of 2006 does not represent the total amount of time the ACIP Working Group and full ACIP membership actually discussed the data and potential recommendation for GARDASIL - this time period was more than two years.

Since FDA licensure in June 2006 GARDASIL has been approved in 101 countries around the world and through March 31, 2008 more than 26 million doses have been distributed globally.

We are very confident in GARDASIL, and look forward to continuing to lead in the fight against cervical cancer. Here are some additional milestones you may be interested in as you complete your story.

· By 1996, Merck started production of the HPV-16 targeted prototype of GARDASIL.
· Merck filed an Investigational New Drug Application and started Phase I clinical trials of the HPV-16 prototype in 1997.
· Phase II trials of the prototype began in 1998.
· In 2000, Merck conducted the first dose-ranging trial of a vaccine to protect against HPV types 6, 11, 16 and 18.
· The first pivotal Phase III trial of GARDASIL, FUTURE 1, started in 2001.
· November 2001: An FDA Advisory Committee agreed on clinical trial design.
· The results from the first phase II trials of the HPV-16 prototype were published in NEJM in 2002.
· Merck presented results from the pivotal Phase III trials of GARDASIL at the Infectious Diseases Society of America (IDSA) meeting in October 2005.
· In December, 2005, Merck submitted its first license application for GARDASIL to the FDA. FDA later grants priority review. Merck also begins to file regulatory applications worldwide.
· May 2006: An U.S. FDA Advisory Committee unanimously agrees that the clinical data support the efficacy and safety of GARDASIL.
· June 8: U.S. FDA approves GARDASIL.
· June 29, 2006: In the U.S., the Center's for Disease Control (CDC's) Advisory Committee on Immunization Practices (ACIP) unanimously recommended broad vaccination with GARDASIL - routine for girls and women ages 11-26, with 9- and 10-year-old girls vaccinated at their physicians' discretion.
· Since July 2006: GARDASIL receives approval in more than 70 countries worldwide, including Canada, those in the European Union, Australia, New Zealand, Brazil, Peru, Taiwan and two countries in Africa.
· Nov. 1, 2006 - GARDASIL is added to the CDC's Vaccines for Children (VFC) Program
· In January 2007, GARDASIL was added to 2007 U.S. Childhood and Adolescent Immunization Schedules released jointly by the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).
· Recommendations have since been made by health agencies in other countries (i.e. Canada's National Advisory Committee on Immunization (NACI) on Jan. 30, 2007 and by the Australian Government in November 2006) and funding and reimbursement for GARDASIL is also becoming available in additional countries as well (i.e. Austria, Germany).
· In March 2007 the CDC finalized the provisional recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL. These vaccination guidelines were published in the March 23, 2007, issue of the CDC's Morbidity and Mortality Weekly Report (MMWR).