Gardasil controversy pits real moms vs. actor moms

The loudest, most heavily backed and widely distributed message on Gardasil is the one now saturating TV markets from coast to coast.

Gardasil, the human papillomavirus (HPV) vaccine marketed by Merck & Co., is aimed at virgins, so who better to sell the vaccine to the health care decision maker in most every household than an actor portraying a caring, modern mother?

Gardasil ads have increased during August to coincide with the national shift toward back to school shopping. The timing of the ads is not a coincidence.

As AdAge reporter Rich Thomaselli pointed out recently, Merck has launched major ad buys to increase visibility during the key back-to-school shopping period that began this month.

"As we move into the third quarter, we expect sequential growth as we leverage the back-to-school season," said Ken Frazier, Merck executive vice president of global human health, when speaking to analysts.

With sales down 28 percent this quarter compared with the second quarter last year, according to AdAge, Merck needs to beef up sales of the controversial drug aimed at girls age nine though young women in their 20s.

The TV ads are just one piece of a broad campaign to sell the vaccine to the parents of young girls. Merck is also sponsoring vaccination-day events at physicians' offices and clinics and vaccine workshops for doctors and public health officials. Merck has offered free “Make the Connection” bead bracelet making kits for girls,  and continues to lobby Congress and state legislatures to make the vaccine mandatory for public school attendance.

Merck and other pharmaceutical manufacturers also worked to gain greater influence on the agencies regulating drug manufacturers. They serve as advisors, ad hoc members and participate in the review process. Always an area of concern, the influence was allowed to flourish over the past eight years, and so far there are few signs of abatement.

Despite alarming reports about side effects and deaths attributed to the vaccine, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) enthusiastically promote Gardasil vaccinations for all American females age 11 and up. The goal is to inoculate girls against HPV before they become sexually active. The FDA has approved the drug for girls as young as nine years old.

All of these orchestrated and aggressive tactics have helped drown out the growing controversy surrounding the drug.

So far, individual reporting (whether done by a parent or clinician) through the voluntary VAERS reporting system, has been dismissed as anecdotal. Officials in both the United States and the United Kingdom (which also officially promotes nationwide vaccination of girls 11 and up) have stuck to the mantra that there is no “causal relationship” between the deaths and the vaccine. Parents are left with a major unanswered question: why are healthy children and young women falling sick or in some cases dying after receiving the vaccine? Industry outsiders are left with the impression that these adverse events are inconsequential because they aren’t part of a massive pharma-sponsored study.

Aside from the side effects, researchers involved with the initial clinical trials for Gardasil suggest vaccine promoters are giving women a false sense of security.

Diane Harper, a professor at Dartmouth Medical School, has been studying HPV for nearly 20 years. She was also a lead investigator with Merck’s Gardasil drug trials. Harper has stated that those receiving the vaccine might feel they are protected from HPV and forego pap smears or other screening tests.

She also said new evidence suggests Gardasil’s protective effects may wear off after five years. "We also have some evidence now that Gardasil is losing efficacy after five years. So if you need a booster shot later, are we really providing the best protection by vaccinating at an early age?"

It’s far too soon to tell since the drug has only been on the market since 2006.  

Having sex exposes girls to the HPV virus, a precursor to some but not all, cervical cancers. Gardasil was found in Merck sponsored clinical trials to prevent some, up to 70 percent, of the 18 types of cervical cancer that attack women.

But some experts believe the vaccines’ benefit is over exaggerated. "If it were a perfect vaccine you would never have to think about cervical cancer again,” Charlotte Haug, MD, PhD, editor-in-chief of the Journal of the Norwegian Medical Association, told WebMd.

“But it is effective against two of the strains of the virus, and there are at least 20 cancer-causing strains out there."

Obviously, having sex exposes women to the possibility of a lot of things: STDs, AIDs, motherhood. This isn’t an issue of promiscuity. It’s an issue of health and whether we should be exposing young people to risky therapies that may not be in their best interests.

The message Merck, the FDA and CDC are sending the nation flies in the face of real life experiences of mothers, many of whom are convinced the vaccine ruined their daughters’ health or in rare cases, killed them.

The FDA needs to take a step back and start listening to them.

Reports of ill effects believed associated with Gardasil are widespread throughout the United States and Europe but are isolated within communities.

The National Vaccine Information Center, a watchdog group, has published some reports, but many more mothers’ stories are found in local news reports, on personal blogs, and on other citizen advocacy sites.

Moms are clearly the underdogs in this matchup.

As of today, the FDA has ignored the growing maternal clamor to halt or slow the aggressive promotion of Gardasil.

Many experts, including Harper, the drug's lead investigator, believe the drug was pushed too rapidly on the public. A process that normally takes three years from application to approval was reduced to six months.

Regulatory and public safety authorities should halt the promotion and lobbying of the drug while it completes a comprehensive and independent (of the pharma company) analysis of the side effects and deaths reported after Gardasil vaccination.

Instead, the FDA appears poised to grant Merck clearance to market the vaccine to boys and older women.

And it’s helping Merck build the case through its blind support of the virgin vaccination program.

Will we see a decline in cervical cancer rates as a result of the tens of millions of Gardasil vaccinations that have already taken place? Since cervical cancer generally appears around age 30, we’ll have to wait another 20 years to find out.

Sources:

Is HPV Vaccine Benefit Exaggerated?

Experts Debate Whether Gardasil Marketing Clouds Risk/Benefit Decision, WebMD, Aug. 18, 2009

As Sales Drop, Fall Brings Big Push for Gardasil Vaccine, AdAge, Aug. 10, 2009

Merck's Gardasil Push Ignored Important Questions, Aug. 20, 2008, Parker Waichman Alonso LLP

The Politics and PR of Cervical Cancer, A 4-part series published by Center for Media and Democracy, PR Watch, Sept. 16, 2008

Drug Makers’ Push Leads to Cancer Vaccines’ Rise, New York Times, Aug. 19, 2008