As parents contemplate whether or not they should have the Gardasil vaccine administered to their daughters, one of the first people that they turn is to their doctors. In this segment, I posed questions to two doctors supporting the vaccine.
Dr. Margaret Lewin, M.D., F.A.C.P., is the Medical Director of Cinergy Health, an insurance benefits provider. She advises the board on patient related issues and public health concerns. Lewin is board-certified in Internal Medicine, Hematology, and Medical Oncology. Lewin is affiliated with New York Presbyterian Hospital and the Hospital for Special Surgery.
Dr. Alan Gibstein, M.D., F.A.C.S., F.A.C.O.G., is a Clinical Assistant Professor of Obstetrics and Gynecology at NYU School of Medicine. He is board-certified in Obstetrics and Gynecology, and is affiliated with North Shore University Hospital. He was president of the Long Island Jewish Medical Center medical staff from 1982-1983. In addition to his work as an attending gynecologist, he has been actively involved in medical and residency teaching.
On why they supported the vaccine:
Dr. Lewin wrote:
“The evidence clearly shows that the quadrivalent HPV vaccine prevents cervical intraepithelial neoplasia caused by 70% of known HPV subtypes as well as preventing genital warts – both of which are highly contagious (even without sexual penetration), cause significant distress, substantial cost, and cannot reliably be permanently eliminated. There are published reports of oral cancer caused by the HPV virus. Oral cancers and their treatment are devastating, and the ability to avoid HPV-related oral cancers strongly increases my support from the vaccine.”
Dr. Gibstein wrote:
“Gardasil produces lasting immunity against the four most common types of HPV that we see in the vast majority of men and women. Types 6 and 11 are a benign virus that causes warts. Types 16 and 18 – most common associated types – causes pre-cancer or a cancerous cervix. Published results have shown that Gardasil blocks these four types of HPV, and therefore women will not get genital warts or dysplasia of cervix. If a series of injections are completed, this gives complete immunity against the four majority types and it can eradicate cervical cancer.
The most important aspect of the need for and value of the Gardasil vaccine is not just cervical cancer prevention, (which is extremely important), but the prevention of invasion by HPV in the first place. Only someone in a busy clinical practice could begin to describe and understand the enormous emotional impact that the first abnormal Pap smear has on any woman, but especially a young one. Women are well aware, by Internet, etc., about HPV and STDs. Unfortunately not all practioners, or even gynecologists, are aware of the natural pathogenesis of most HPV infections to "cure” themselves. This ignorance or greed leads to the beginning of a cycle of repeat examinations, repeat biopsies, colposcopies, conizations, LEEPs, etc. In other words, fear, anxiety, social upheaval and accusations, time, enormous expense and risk of real damage. This can be prevented with Gardasil in the vast majority.
Gardasil will also protect against HPV infections of the vulva, vagina and cervix, as well as tongue, throat and floor of the mouth where cancers also occur linked to HPV. In my practice, I examined every male consort of my patients with HPV and found evidence of warts in virtually 100% of them. Since abstinence is a proven failed social condition, and because HPV literally coats the earth, eventually the majority of sexually active adolescents and young adults will be exposed. The amount of expense, time, and emotion expended to treat HPV amounts to scores of millions of dollars per year, nearly all of which would be prevented by vaccination.”
On the reports of young girls who have suffered adverse side effects to the vaccine:
Dr. Lewin wrote:
“The adverse effects of the vaccine are grossly overstated in the lay media. The post licensure safety surveillance for this vaccine (via VAERS: the Vaccine Adverse Event Reporting System) has reported 12,424 adverse events (53.9 per 100,000 doses distributed). 772 of these have been serious. The rates of most of the serious adverse events are not greater than the background rates for other vaccines, except for the following:
• Syncope (passing out) – in 0.2 per 100,000 doses, leading to the recommendation that the recipient receive the vaccine while lying down and be observed in the physician’s office for 15 minutes after it has been administered
• Venous thromboembolism (abnormal blood clots). 90% of those who had blood clots had a known risk factor for such clots, such as the use of oral contraceptives – a pre-condition well-known to cause such clotting. The possibility of a causative relation to the vaccine is being closely investigated.
• 32 reported deaths, of which 12 could not be verified by review of the medical records. There was no common pattern to the remaining deaths that would suggest they were caused by the vaccine, and the cause of the deaths can be explained by factors other than the vaccine. For example, 2 were from vaccine-unrelated diabetic ketoacidosis, 6 were cardiac related, and 1 was associated with prescription drug abuse.”
Dr Gibstein wrote:
“Critics seem to forget the uproar in the past to reactions to the polio vaccine, the varicella vaccine (including neurologic reactions) and the triple vaccines. Gardasil can and does cause local reaction, pain and redness in many, some syncope in a small number, and perhaps can trigger serious neurologic disorders such as Guillane-Barre or ALS in a few. Girasol is composed of DNA (protein) gotten from the envelope (capsule) of the human papilloma virus. As such, it is not a live virus and cannot directly cause infection or disease. But it contains several metals and minerals, and is made in yeast. Therefore it can, like many other vaccines, trigger hypersensitivity reactions in susceptible individuals. Except for people known to be allergic to yeast, most of these reactions would not be predictable.” Gibstein acknowledged that the vaccine has a fair amount of local reaction with soreness/redness 48-72 hours, and that a small percentage of recipients have a bit of mild flu reaction.”
Gibstein referenced Dr. Martin M. Fisher, Director of Adolescent Medicine at Schneider’s Children’s Hospital at North Shore/Long Island Jewish Hospital, who is advising that Gardasil be recommended to all women from age 12 to 26. Both Dr. Gibstein and Dr. Fisher agree that adverse reactions are 97% local and transient, and the severe reactions as reported by the www.cdc.gov CDC are occurring at no greater frequency than occur spontaneously in the general population of the same age.
Dr. Lewin maintained that a 5-year clinical trial was ample time to do the necessary follow-up, with the “understanding that close post licensure studies continued.” Responding to my query on the point of giving the vaccine as early as 9 years old if the vaccine does not last fifteen years she wrote:
“It is not yet clear how long the vaccine lasts and it might be necessary to give a booster after ten years or so as is the case with mumps and polio, for example. Since it takes several months for the vaccine to be fully effective, starting at a young age is necessary to protect young girls from this highly contagious virus, which can be transmitted by any skin-to-skin contact. In addition to the unfortunate early beginning of consensual sexual activity (whether oral, vaginal or simply intimate ‘petting’), it cannot be ignored that many young girls are victims of non-consensual contact.”
Gibstein suggested that time would tell if the protection is durable, and if complications can be directly attributable to the vaccine.
Both doctors had strong words about the marketing tactics of all pharmaceutical companies. They had read the JAMA article, “Marketing HPV Vaccine.” Dr. Lewin responded, “I am outraged by all Pharma advertising to the lay public.” Dr. Gibstein stated, “Drug companies like Merck and others often behave both unethically and disgracefully in both their limited reporting of adverse reactions and their abhorrent advertising on TV, radio, etc. The advertising for Gardasil is, in my opinion, inexcusable. The high cost of the vaccine is another example of price gouging by Pharma, but is worth it to offset the cost of treating HPV infections.”
In reaching out for this piece, a sidebar of interest arose. Adina Nack, Ph.D., author of Damaged Goods? Women Living with Incurable STDs and professor of medical sociology and sexuality studies at California Lutheran University, contacted me to emphasize her concern for the advocacy of “comprehensive HPV education, and for allocating resources to improve the development and provision of testing and treatment options for those who contract the variety of HPV infections and HPV-related cancers.” Her work has focused on these concerns, in addition to her support of the development of Gardasil.
In the next article: A conversation with Dr. Diane Harper