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Merck is the developer of the HPV vaccine Gardasil. The company has an independent website, www.gardasil.com, devoted to explaining the product, complete with social marketing tools to “help spread the word about cervical cancer and HPV.” It features responses to “Questions about what you are hearing,” as well as a vertical labeled “More for parents.”
Throughout the site, certain information appears with regularity. Merck states that their product is “the only cervical cancer vaccine that helps protect against four types of human papilloma virus (HPV). Two types that cause 70% of cervical cancer cases; two types that cause 90% of genital warts cases.”
The vaccine is targeted at girls and women from 9 – 26. It is administered in three injections over a six-month period. It is acknowledged that the vaccine does not provide full protection for everyone, or for all types of cervical cancer. Merck endorses continued pap smears.
Regarding adverse reactions, Merck stresses that those who are severely allergic to yeast or women who are pregnant should not receive the vaccine. It also warns of potential reaction for those who may be sensitive to the “other” ingredients found in the vaccine.
Possible side effects listed include “swelling, itching, bruising, redness at injection site, headaches, fever, nausea, dizziness, vomiting and fainting.” It is noted that fainting can be accompanied by falling, shaking, stiffening, or other seizure-like activity. Patients are advised to remain in the doctor’s office for fifteen minutes after receiving the shot, for observation.
I spoke with Media Relations spokesperson, Pam Eisele, about the vaccine. I submitted a series of questions for the company to answer via e-mail, referencing red flags that had come up in my research. All my queries were responded to, and Eisele offered to put me in touch with a clinical researcher if I required further explanations.
Eisele also forwarded me a comment on how parents should respond to side effects from the Gardasil vaccine. She wrote, “We would encourage parents to report any adverse experience associated with any Merck medication or vaccine to their healthcare provider, Merck or the FDA. Patients can report adverse events through their healthcare provider, the Merck National Service Center (1-800-444-2080), or FDA MEDWatch or call 1-900-FDA-1088. Consumers should speak with their doctor if they have any concerns or questions.”
Based on my findings, I would suggest that anyone experiencing a problem report it directly via the Vaccine Adverse Event Reporting System (VAERS).
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HOW LONG IS THE VACCINE EFFECTIVE?
Gardasil has demonstrated duration of protection for five years with no disease breakthrough against all four of the targeted HPV types. We also have data from a follow-up study of the HPV 16 component of Gardasil, which demonstrated an average 8.5 years of protection. We also are conducting several studies to assess long-term safety and duration of efficacy, including a post-licensure evaluation of 44,000 people to evaluate general safety and pregnancy outcomes and a pregnancy registry to further monitor pregnancy outcomes in women who received Gardasil inadvertently. In addition, 5,500 people from one of our Phase III studies will be evaluated for long-term safety and efficacy for a minimum of 10 years through the Nordic Cancer Registry Program, a population-based evaluation of Gardasil in Nordic countries that have a mandatory HPV vaccine registry. We also are following participants (girls and boys) in one of our adolescent studies for 10 years to evaluate long-term safety and effectiveness in the adolescent population.
WHAT ARE THE LONG TERM SIDE EFFECTS?
Known side effects with Gardasil include pain, swelling, itching, bruising and redness at the injection site; headache, fever, nausea, dizziness, vomiting and fainting. Currently, no signal for long-term side effects has been identified in the evaluation of reports of adverse events in the post-licensure time period. [I]Would refer you to the recent CDC and FDA statement released on August 20, 2009 reaffirming that, "based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks."
ARE BOOSTERS NECESSARY? HOW OFTEN?
No boosters are currently required. Long-term studies are ongoing. We cannot speculate on whether or not a booster will be recommended in the future.
WHY IS THE VACCINE A BETTER SOLUTION TO PREVENTING CERVICAL CANCER THAN A REGULAR PAP SMEAR?
Vaccination with Gardasil is not a replacement for routine Pap or other cervical screening and women who receive Gardasil should continue to undergo screening. Screening has shown great benefit to women and is an important part of cervical cancer prevention; however, screening can sometimes miss cell abnormalities that might progress. In addition, not all women get screened or screened regularly. We believe vaccine prevention along with routine cervical cancer screenings is the best way to help reduce the significant health burden associated with HPV diseases.
WAS A FIVE-YEAR CLINICAL TRIAL AMPLE TIME TO DO THE NECESSARY FOLLOW UP ON THE SAFETY OF THE VACCINE?
Yes. The clinical trials for Gardasil were robust with ~ 25,000 subjects in the database submitted to the FDA as well as broadly internationally-based (33 countries on 5 continents).
WHAT ARE THE OTHER INGREDIENTS BESIDES YEAST THAT PEOPLE CAN BE ALLERGIC TO IN THE VACCINE?
Individuals should not get Gardasil if they have or have had an allergic reaction after getting a dose of Gardasil or a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate or polysorbate 80. Signs of an allergic reaction may include difficulty breathing, wheezing (bronchospasm), hives or rash.
IF THE VACCINE DOES NOT LAST 15 YEARS, WHY GIVE IT AS SUCH AN EARLY AGE (9 years old)?
The best time to administer any preventative vaccine is before individuals are exposed to the virus in question. Gardasil works when given before there is any contact with HPV types 6, 11, 16 and 18. Because it is not feasible to conduct HPV vaccine studies in younger adolescents who have not yet possibly been exposed to the HPV virus and who are not yet sexually active, Merck and the FDA agreed that efficacy findings in 16- to 26-year-olds can be applied to younger adolescents using immunogenicity data. The immune response in younger adolescents was higher than in older adolescents and adults, which supports this approach. Immunogenicity "bridging data" is an accepted surrogate for efficacy for most childhood vaccines.
MERCK REPORTED 68% OF THE ADVERSE EFFECTS. HOWEVER, 90% OF THOSE REPORTS HAD TO BE THROWN OUT BY THE CDC FOR INADEQUATE INFORMATION? WHAT IS MERCK'S PLAN IN THE FUTURE TO IMPROVE THIS PROTOCOL?
The reports were not thrown out by CDC. They were included in CDC's quantitative analysis. Merck has a robust process for seeking follow-up information on every case but this is a voluntary system and cannot control whether health care providers will take the time to provide all of the requested follow-up information. It is important to remember that spontaneous reports are one element of the post-marketing safety system and are complemented by information from clinical trials and observational studies. The FDAAA-mandated Sentinel Network is being developed in part out of recognition of the well known limitations of spontaneous reporting.
WHAT IS MERCK DOING TO ADDRESS THE REPORTED SIDE EFFECTS TO GARDASIL?
Nothing is more important to Merck than the safety of our products. We carefully monitor the safety of Gardasil on a routine basis. Merck monitors vaccine safety by conducting comprehensive analyses of adverse events reported to Merck, and we share these adverse event analyses with the CDC, the U.S. Food and Drug Administration (FDA) and regulatory and medical authorities around the world to support their efforts. After carefully reviewing all of the information available to us about reported adverse events, Merck continues to be confident in the safety profile of Gardasil. While no vaccine or medicine is completely without risk, leading health organizations throughout the world including the US Centers for Disease Control and Prevention (CDC) and the European Medicines Agency (EMEA) have reviewed all of the safety information available to them about Gardasil and continue to recommend its use. Please see our statement on the safety of Gardasil. Also, this is our statement specific to the recent JAMA publication:
HOW DO YOU RESPOND TO THE CHARGES OF AN OVERLY AGGRESSIVE MARKETING CAMPAIGN FOR GARDASIL, AND THE ARTICLE IN The Journal of the American Medical Association, “Marketing HPV Vaccine – Implications for Adolescent Health and Medical Professionalism”?
The article in JAMA is a mischaracterization of our efforts. We are committed to the prevention of HPV diseases including cervical, vaginal and vulvar cancers as well as genital warts caused by the HPV types included in Gardasil. Education is a critical component toward achieving that goal. As such, Merck will continue to provide independent grant support to professional medical associations that develop and distribute their own educational information about HPV and cervical cancer to broad audiences, including underserved communities.
We value our relationships with these groups and conduct our interactions with strict adherence to the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals. Merck closely follows the standards for commercial support of Continuing Medical Education established by the Accreditation Council for Continuing Medical Education. Merck also discloses grants over $500 provided by the company's Global Health Division to U.S. organizations in support of independent accredited educational programs for health care professionals. Disclosure is to respond to public interest and to broaden the visibility of Merck's support of key stakeholders to advance health, science, community welfare and the economy.
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My final inquiry to Merck involved looking for a clarification about the relationship between Women In Government, an organization of women state legislators, and Merck. I had repeatedly read articles questioning the connection, including in The Washington Post(2/21/07), Medical News Today (12/31/07), and SourceWatch (1/31/07). In addition to the qualification from Merck, the following is a statement via e-mail from Mary Brooks Beatty, the President of Women In Government. She responded to my phone call asking if her organization had been promoting state legislation of mandatory vaccination for girls. On October 21, 2009 she wrote:
“Women In Government is a non-profit, bi-partisan organization that provides educational resources to female state legislators on diverse topics, including energy and the environment, the economy, transportation, healthcare, and education. Our goal is to provide information for legislators to make sound policy decisions.
Women In Government's policy and conference programming is guided by our Board of Directors, a group of 13 female state legislators that represent various geographical segments of our country and the two major political parties. The Board of Directors has never taken a position on how states should deal with HPV/Cervical Cancer issues. Further, the organization has never promoted any commercial product. All information provided to legislators originates from the medical community, or from government agencies such as the Centers for Disease Control (CDC) or the Food and Drug Administration (FDA).
Women In Government's Board of Directors decided that the organization should educate female legislators on HPV and cervical cancer because of the strong interest female legislators have in preventing cancer and saving lives. Every two and half hours a woman dies from cervical cancer in the United States, a cancer that is 100% preventable. The organization's interest in this policy topic is based on saving the lives of women.”
Question to Merck:
CAN YOU ADDRESS THE RELATIONSHIP BETWEEN MERCK AND THE WASHINGTON D.C. ORGANIZATION WOMEN IN GOVERNMENT? ON THE SITE, MERCK IS LISTED AS A CONTRIBUTOR. HOW MUCH HAS MERCK CONTRIBUTED TO THE ORGANIZATION IN THE LAST FIVE YEARS? IN THE PAST, DID MERCK LOBBY THIS GROUP OF FEMALE STATE LEGISLATORS TO MAKE THE HPV VACCINE MANDATORY FOR SCHOOLGIRLS? WILL MERCK HAVE A PRESENCE AT THE WOMEN IN GOVERNMENT 5TH ANNUAL HPV & CERVICAL CANCER SUMMIT BEING HELD IN NOVEMBER IN WASHINGTON D.C?
Merck supports organizations that support policies that can expand access to important medical advances, so that the greatest number of individuals can benefit from them. One example is our support of Women in Government, a group that through its education efforts has successfully advanced numerous health issues for many years. We did not lobby this group. The fight against cervical cancer and other HPV related diseases is just one of the current initiatives led by Women in Government and we too support that fight. We support Women in Government and other organizations by providing resources that these groups independently direct toward programs to provide education regarding the importance of fighting cervical cancer, the second leading cancer among women around the world.
Our financial support of Women in Government is in line with Merck and industry guidelines on grants. Starting in October 2008, Merck began disclosing grants provided to U.S. organizations on a quarterly basis. As noted within those disclosures, we have provided a non-continuing education grant of $200,000 in June of this year to Women in Government for HPV education outreach meetings, which includes support for the upcoming November event.
This is the first in a series of articles exploring HPV and vaccines In the next article: Doctors speak out.
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