Controversial HPV Vaccine Stirs Up Yet More Trouble

Controversial HPV Vaccine Stirs Up Yet More Trouble

Last year when I wrote about the HPV vaccine, developed to fight the human papillomavirus, a sexually transmitted virus that can cause cervical cancer, I voiced concern about its safety and efficacy given that it was new and had been approved very quickly by the FDA (see Daily Health News, January 23, 2006). Many of these concerns remain, while new politically based controversies have arisen. Led by Texas (which since changed course), numerous states jumped to propose making the vaccination mandatory for all girls entering the sixth-grade. Given, however, that HPV is normally transmitted sexually, not through casual contact as is the case with other viruses (such as measles, mumps and rubella, for instance) in which childhood vaccines are mandated, this enthusiastic legislative response appears to be driven by politics and corporate greed rather than public health concerns, some speculate.

BIG PHARMA STRIKES AGAIN

Consumer advocacy groups and the news media are quick to blame Merck, manufacturer of the vaccine, for the tactics it employed in promoting the vaccine's use. First and foremost, the vaccine was tested in only a small sample of girls under 16 (fewer than 1,200) and as a new vaccine it has no track record for safety, I was told by Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC), a national, non-profit, educational organization dedicated to the prevention of vaccine injuries and deaths. Secondarily, she adds, the majority of Americans do not want state governments forcing this kind of decision upon their families. There was clearly a groundswell of opposition to the mandated vaccine from all sides, hence the bill for it being overturned in the state of Texas. Some oppose it due to safety concerns... others because it tramples on parents' rights. A recent survey confirmed this opposition. In a University of Michigan Health System poll, only 44% of parents supported the mandatory HPV vaccine. The rest were neutral or opposed. Nonetheless, the manufacturers have succeeded in promoting their extraordinarily profitable materials as "necessary for the public's safety."

QUESTIONABLE MARKETING TACTICS

There's no doubt that vaccines mean big money for big business. In June 2006, pharmaceutical giant Merck received approval for its vaccine, sold under the name "Gardasil," from the US Food and Drug Administration (FDA) after clinical trials showed very positive results, leading the FDA to speed its approval under its "priority review process." Shortly thereafter, the Centers for Disease Control and Prevention (CDC) issued a recommendation for its use in girls ages 11 and 12, followed within a few months by a huge advertising campaign from Merck, featuring young girls jumping rope and chanting "I want to be one less, one less" on TV and in magazines. Simultaneously, the company launched an aggressive behind-closed-doors lobbying effort in state after state to require the vaccination for all girls entering sixth grade or of middle-school age. The projected revenue for Gardasil should the mandates pass is hundreds of millions of dollars per year.

Serious questions about a conflict of interest arose in Texas earlier this year. Literally the same day Governor Rick Perry's chief of staff met with Merck execs, the drug company made a significant contribution to Perry's campaign (as well as those of eight other Texas legislators). One of the Merck lobbyists in Texas is the governor's former chief of staff, and the governor is also closely aligned with Women in Government, a non-profit bi-partisan advocacy group of women legislators that receives money from Merck. Similar concerns have arisen in other states, including Florida, Virginia and Maryland, suggesting that Merck is more or less buying its way into the mandates.

Then there is the fact of Merck's recent poor track record for drug safety. Multi-million dollar lawsuits continue against the company for its osteoarthritis medication rofecoxib (Vioxx), abruptly pulled from the market in 2004 after causing heart attacks and stroke. It turned out that Merck had been aware of these cardiovascular risks for years, but covered them up. (Interestingly, Vioxx received a six-month priority review just as Gardasil did.) Now there are safety questions about another Merck drug, alendronate (Fosamax), which is used to treat osteoporosis. (For more on the dangers of Fosamax, see the January 18, 2007 issue of Daily Health News.)

SERIOUS HEALTH CONCERNS PERSIST

Politics aside, Fisher continues to have health concerns about the HPV vaccine, including...

• Insufficient study. In Fisher's opinion, Merck and the FDA have not been completely honest with the American people about the pre-licensure clinical trials. The HPV vaccine has been studied in fewer than 1,200 girls under age 16, yet is being recommended for all girls 11 and 12.
• Safety. There were 385 Gardasil adverse events reported to the federal Vaccine Adverse Event Reporting System (VAERS) during the last six months of 2006. These included collapse into unconsciousness and seizures in the doctor's office after vaccination or in the next 24 hours. Two-thirds of those affected required additional medical care, and nearly one-third of all reports (where age was reported) were for girls 16 or younger. One out of four of these reactions occurred when Gardasil was administered along with other vaccines. As a result, NVIC is calling on the FDA and CDC to issue warnings that Gardasil should not be combined with other vaccines, and that girls be monitored for fainting, seizures, tingling, numbness and loss of sensation in the fingers and limbs for 24 hours after vaccination.
• Long-term effectiveness. At Merck's urging, the FDA agreed to fast-track the HPV vaccine in February 2006, and it was approved that June. Although testing was limited -- particularly in the age group for which the mandate is proposed -- some speculate it was in Merck's best financial interests to roll out the vaccine as soon as possible so that it could achieve market domination before GlaxoSmithKline introduced its own version. Rarely has a vaccine this new been granted such a rapid and sweeping mandate after FDA approval, observes Fisher. The process typically takes five to six years -- as it should, to verify there are no long-term health risks.
• Necessity. Fisher notes that cervical cancer causes less than one percent of all cancers and cancer deaths (between 3,000 and 4,000 US deaths annually). In contrast, tobacco is implicated in an estimated 438,000 American deaths each year.

So, I ask, if the government is going to legislate health, why not ban tobacco? Why instead mandate a controversial vaccine that impacts only a very narrow portion of the population, putting them at risk for side effects?

• Cost. At $360 for a three-shot regimen, Gardasil is unusually expensive and not all insurance plans may cover it. However, if the vaccine is mandated, insurance coverage is far more likely. Clearly that will make the people at Merck very happy. Fisher points out that because a competing HPV vaccine is in the pipeline, Merck is highly motivated to seize and dominate the market before a rival pharmaceutical firm steps in.
• Public health impact. There is no evidence that the HPV vaccines will eliminate all HPV strains or cervical cancer. The vaccine targets two high-risk HPV strains that are known to cause cervical cancer and two low-risk types that are know to cause genital warts. However, FDA and CDC officials have questioned whether other high-risk HPV strains will eventually replace those controlled by widespread use of the vaccine and continue to cause disease. It is not knownn if boosters will be needed and long-term safety is also unknown.

A PERSONAL DECISION

To find out whether legislation is under consideration in your state to mandate the HPV vaccine for young girls, visit the Web site of the National Conference of State Legislatures at www.ncsl.org/programs/health/HPVvaccine.htm. If you learn that a mandate may be instituted, most states allow exemption to vaccination for medical reasons and for sincerely held religious beliefs. Only about 17 states allow exemptions for personal or philosophical beliefs. This may mean that your daughter would be excluded from attending public school if you cannot obtain one of these exemptions.

In the long run, the HPV vaccine may or may not prove to be safe and effective. Only time will tell -- and I'd argue, we need to let more time pass before making such a big decision. In the meantime, meet with your physician, review its pros and cons from unbiased sources, and come to an independent decision about what's best for your family. Be careful though, since all sides have strong opinions. Most physicians are influenced by their specialty and state medical societies, while consumer organizations questioning the safety of vaccines are often influenced by personal experience with vaccine reactions. The complexities of this issue may make it difficult to get a clear answer from any single source. Ideally, this is a personal decision that you should be able to make without inappropriate government, social or medical interference.

Source(s):

Barbara Loe Fisher, President, National Vaccine Information Center, www.909shot.com

Centers for Disease Control and Prevention, www.cdc.gov

US Food and Drug Administration, www.fda.gov