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HPV Vaccine – Should It Be Required?Tue, 03/27/2007 - 2:36pm
By: Letters to the ...
Before making a decision about whether or not Merck’s HPV vaccine Gardasil should be required for 9- to 12-year-old girls and teens, let’s look at some information from Merck, the CDC, and the American Cancer Society (ACS). Cost: Since “the retail price of the vaccine is $120 per dose ($360 for full series),” not including the doctor’s fee or the cost of giving the injection (CDC and ACS), we might want to question the financial incentive that Merck has to get the vaccine mandated and, therefore, eligible for government (i.e., taxpayer) funding. Merck stands to make billions of dollars from this venture, dollars that will offset its losses from Vioxx. Long-term effects: No one knows the long-term health results for women since there was only a 3.9-year follow-up to the clinical trial. Gardasil “has not been evaluated for the potential to cause carcinogenicity or genotoxicity (damage to cellular DNA, resulting in mutations or cancer)” (Merck). One long-term effect is the potential for an autoimmune disorder such as arthritis or lupus (Merck). A few vaccine recipients did develop these diseases within the 4-year time span of the clinical trials. Merck states that it does not know “whether Gardasil can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity” since the only studies were done on rats (although rats cannot even be infected with HPV). Forty pregnant women who received the vaccine did have “a serious adverse experience during pregnancy,” and “congenital anomalies” occurred when the vaccine was administered within 30 days of conception. Merck is maintaining a pregnancy registry to monitor adverse effects. Although the vaccine recipients of the study were given “urine pregnancy testing prior to administration of each dose of Gardasil,” there are no plans for this minimal precaution (and extra expense) by legislators who are working to have Gardasil required. Merck will not be financially responsible for adverse effects or even deaths (part of the 2002 Homeland Security bill). Once Gardasil is deemed a “compensable” vaccine, all compensation will be paid through the National Vaccine Injury Compensation Program (VICP), a federal program established to protect drug companies and health care personnel from liability. VICP paid out $70 million or greater for four of the five years between 1996 and 2000; however, VICP awarded only $1.9 million in 2004, and the number of awards has steadily declined from 278 in 1996 to only three in 2004. (There are no figures listed for 2005 and 2006.) This does not mean that there have been fewer adverse reactions, just fewer compensable injuries awarded compensation. The stresses of dealing with federal bureaucracy should be considered before making Gardasil mandatory. Remember other “safe” medicines, such as Vioxx, that proved to have disastrous results? Merck withheld culpable information from the FDA, doctors, and patients, and numerous lawsuits have been brought against Merck. Emails revealed that there were scientists who had “great concern” about Vioxx, yet Merck told physicians that there were very few adverse effects (0.5 percent) in one of its trials when actually 14.6 percent of the recipients had had adverse effects. A video revealed that Merck’s sales reps were trained to avoid answering physicians’ questions about cardiovascular risks and were told that Vioxx did not increase the risk of heart attacks. Merck even used intimidation tactics to silence medical researchers who spoke out about the risks. By the time the FDA approved Vioxx as “safe and effective,” Merck had completed approximately 60 studies in thousands of patients. Gardasil has not been tested as thoroughly, yet Merck has launched a national advertising campaign and extensive lobbying efforts to make its vaccine a household word. The vaccine of Merck’s primary competitor will not be available for another 6 months. Effectiveness: Will the HPV vaccine promote a false sense of security since many have the common misconception that vaccines are 100 percent effective for all recipients? Merck admits, “Gardasil may not fully protect everyone and does not prevent all types of cervical cancer.” Because the four clinical studies conducted by Merck evaluated the vaccine’s efficacy in women 16 to 26 years of age, not 11-year-old girls, will the vaccine’s effectiveness be the same with younger girls? Is there a greater possibility for side effects in younger recipients? The vaccine has no preventative effects if the virus is already present, a likely scenario with many teens since “at least 50 percent of sexually active men and women (other medical sources say at least 70 percent) acquire genital HPV infection at some point in their lives” (CDC), many within four years (ACS) of sexual activity. This vaccine “does not treat existing HPV infections, genital warts, precancers, or cancers” (CDC). The CDC warns, “The vaccine will NOT protect against all types of HPV that cause cervical cancer, so vaccinated women will still be at risk for some cancers”; and Merck states in its product insert, “About 30 percent of cervical cancers will NOT be prevented by the vaccine.” Just how effective will Gardasil be when vaccine recipients are older and most likely to develop cancer? Again no one knows the long-term effectiveness of this drug since Merck admits that “the duration of immunity ... has not been established.” Cost-versus-risk benefit: According to the CDC, “All types of HPV can cause mild Pap test abnormalities which do not have serious consequences. Approximately 10 of the 30 identified genital HPV types can lead, in rare cases, to development of cervical cancer. Research has shown that for most women (90 percent), cervical HPV infection becomes undetectable within two years.” The CDC encourages personal responsibility: “A Pap test can detect pre-cancerous and cancerous cells on the cervix. Regular Pap testing and careful medical follow-up, with treatment if necessary, can help ensure that pre-cancerous changes in the cervix caused by HPV infection do not develop into life threatening cervical cancer. The Pap test used in U.S. cervical cancer screening programs is responsible for greatly reducing deaths from cervical cancer ... Most women who develop invasive cervical cancer have not had regular cervical cancer screening.” The ACS gives this encouraging news: “For most women, pre-cancerous cells will remain unchanged and go away without any treatment. But if these precancers are treated, almost all true cancers can be prevented ... Treatment of precancers can stop cervical cancer before it is fully developed.” The survival rate for the cancer caught in its earliest forms is above 95 percent, and “the death rate from cervical cancer continues to decline by nearly 4 percent a year.” Since “most HPV types cause no symptoms and go away on their own” (CDC) and cervical cancer does not form suddenly but tends to occur in midlife (35-55), rarely occurring in women younger than 20 (ACS), why is there such a rush to force this vaccine on children? Today most cases of cervical cancer arise in the developing world, not in the U.S. (The Lancet). Prevention: Since the vaccine is effective for only four of the 40 genital HPV types, “a long-term, mutually monogamous relationship with an uninfected partner is the strategy most likely to prevent future genital HPV infections” (CDC). Delaying having sexual relations as long as possible is healthier since adolescents are biologically more susceptible to infections. Limiting the number of sexual partners and avoiding those who have had multiple partners are two other ways to reduce infection risks. HPV cannot be spread through bodily fluids, nor does it live in blood or any organs (CDC). “By far, women bear the greatest burden of STDs, suffering more frequent and more serious complications than men” (CDC); therefore, greater emphasis needs to be put on prevention of ALL sexually transmitted diseases and on making teens and parents aware of the growing problem of STDs – a “hidden epidemic” with “severe and sometimes deadly consequences” (CDC). As of 2005, there were an estimated 19 million new cases of STDs in the U.S. each year (up from 15 million in 1999), almost 50% of them among young people ages 15 to 24 (in 1999 only 25 percent of the new cases were in this age group – CDC). The incidence of STDs is rising mainly because people are becoming sexually active at earlier and earlier ages and with multiple partners. “Safe” sex isn’t so safe! “Just say no” is the mindset toward drugs, smoking, and excessive drinking. Couldn’t abstinence also be emphasized with a media campaign to prevent the emotional and physical impact of unhealthy sexual relationships? Classes covering self-control, decision-making, goal-setting, character development, communication skills, as well as the very real health consequences from the more than 25 STDs, will give teens the tools that they need to realize that they can control their sexual behavior and make wise choices that will have long-term consequences. Gayla Conley Peachtree City, Ga. login to post comments
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