Merck’s Gardasil

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people – it created a sense of panic that says you have to have this vaccine now.” – Dr. Diane Harper, professor of medicine at Dartmouth Medical School and a principal investigator on the clinical trial of Gardasil, to The New York Times.

An editorial accompanying a study published online yesterday by The New England Journal of Medicine (“Human Papillomavirus Vaccination – Reasons for Caution”) by Charlotte J. Haug, M.D., Ph.D, questioned the “lack of sufficient evidence of an effective vaccine against cervical cancer.” An article on the marketing of Merck’s (MRK) Gardasil vaccine in The New York Times describes how the company managed to get “an obscure killer confined mostly to poor nations to the West’s disease of the moment.” Merck is forecasting sales could top $2 billion this year.

According to the government’s Centers For Disease Control and Prevention (CDC) website, “11,892 women in the U.S. were told that they had cervical cancer in 2004, and 3,850 women died from the disease. It is estimated that more than $2 billion is spent on the treatment of cervical cancer per year in the U.S.” Scrolling further down the CDC’s web page shows statistical trends that “suggest that cervical cancer incidence and mortality continue to decrease significantly overall." These statistics are from 2004 – two years before the FDA approved Merck’s Gardasil vaccine.

Cervical cancer is caused by the human papillomavirus (HPV) virus. As Merck’s Gardasil Patient Information sheet states: “There are more than 100 HPV types; Gardasil helps protect against 4 types (6, 11, 16, and 18). These 4 types have been selected for Gardasil because they cause approximately 70% of cervical cancers and 90% of genital warts.”

Most of the population has contracted the HPV virus but their immune system has been able to combat it on its own. The sure way for women to avoid HPV erupting into genital warts or cervical cancer is to live a life of celibacy. Since this is not acceptable way of life for most of the population, the next best thing is to keep your sexual partners to a minimum and know their sexual health history. The more partners a woman has been with, the more important it becomes to have regular gynecological exams and Pap tests. Cervical cancer can be treated if detected early enough.

Considering that genital warts and cervical cancer rates are decreasing in the West because it can be prevented/treated by women taking charge of their health through appropriate behavior and preventative health care, why should the US government be spending over $1 billion on administering the Gardasil vaccine to girls? What’s even worse than that is 24 states are proposing to mandate that middle school girls get the Gardasil vaccine.

How Merck got politicians and parents to put Gardasil up there in importance with vaccines for such deadly diseases as polio and smallpox, explains why Gardasil was named “Brand of the Year” by Pharma Executive Magazine, and won the 2008 Pharmaceutical Advertising and Marketing Excellence awards. According to The New York Times, Merck paid hundreds of doctors and nurses $4,500 for each 50 minute talk performed on Gardasil over Merck-sponsored meals. Many even got paid just to attend “advisory board” meetings on the vaccine. Despite the vaccine’s questionable effectiveness for young women in their late teens and early twenties, Gardasil has got promoted from college campuses to ads airing before “Sex and the City” at movie theaters. Merck pays Cornerstone Government Affairs to lobby Congress and the CDC for more federal money for vaccines.

Virginia will become the only state requiring girls get Gardasil to go to school, unless parents opt out. Governor Kaine signed the legislation after Merck said it would spend $57 million to expand its Elkton plant that makes the vaccine. $193 million more was pledged by Merck after the governor signed the bill, with the state providing a $1.5 million grant (on top of a $700,000 grant from an agency that is part of the executive branch). Lieutenant governor Bolling is an active participant in the “Ending Cervical Cancer in Our Lifetime” campaign" of the NLGA, financed by Merck and GlaxoSmithKline (GSK), who has a competing vaccine awaiting FDA approval. Mandatory Gardasil for school girls in Texas was signed by the governor and overturned by the legislature after the governor’s former chief of staff was hired by Merck and contributed $6,000 to Governor Perry and $38,000 to other state legislators.

Gardasil retails between $400 to $1,000 for the series of three shots. Gardasil was studied in clinical trials for five years, and as The New England Journal of Medicine states, “the overall effect of the vaccines on cervical cancer remains unknown.” There are more questions than answers available about Gardasil’s long term effectiveness. To quote a Gardasil ad: “The duration of protection has not been established.” Clinical trials were conducted on 16-24 year old women, not the 11-12 year old girls who the CDC and FDA view as the ideal target, so how it will affect them is still unknown. In some girls in the trials, the vaccine’s immunity was gone after three years. According to the medical journal, “published reports of trials show an increasing trend of precancerous cervical lesions caused by HPV serotypes other than HPV-16 and HPV-18.” More time and more trials will be needed to confirm this. The other concern is if other more virulent HPV strains emerge after heavy use of vaccination.

The CDC’s voluntary Vaccine Adverse Events Reporting System has logged 6,667 US reports on Gardasil from its June 8, 2006 FDA approval to June 30, 2008. Reports ranging from pain and soreness at the injection site, to nausea and fainting were most commonly reported. Cases of paralysis and 17 US deaths were reported, but the CDC and FDA could not determine if Gardasil was the cause. Gardasil is being given to many girls who are not even menstruating yet; no one knows if these girls’ future fertility/babies will be adversely affected.

The purpose of vaccines prior to Gardasil has been to protect the person receiving the shot from the disease and to protect the community from a contagion spreading. HPV doesn’t spread through airborne or casual contact, and is treatable through early detection. Policymakers should not be wasting money on a vaccine with little to possibly even a detrimental return when there are so many serious health needs that go unmet in America. I urge parents and young women to look beyond the slick ads and do some serious research on this. When medical providers and politicians tout Gardasil, investigate their vested interest.

Merck has already applied to the FDA to market Gardasil to women 26 to 45, and boys are next. Merck and its shareholders are desperately depending on it.

Previous Merck Posts: “Merck’s Lower Numbers”, “Merck’s Ghost Story”, and “Merck & Schering-Plough: More Nails in Vytorin’s Coffin”