Safety and Bioethical Concerns - Essay Example

1. Gardasil may alter sexual behavior in adolescent girls, they become sexually more active.
2. Gardasil does not impart 100% immunity against cervical cancer as it is directed against only 4 serotypes of HPV.
3. There are serious doubts about the short-term and long-term safety of Gardasil.

Gardasil, a vaccine against human papillomavirus (HPV) has been approved by FDA, to be administered to girls between 9-26 years, in order to prevent cervical carcinoma. Amongst more than 80 different types of HPV, serotypes 16, 18, 45, and 56 are associated with a high risk of developing cancer, while serotypes 31, 33, 35, 51, and 52 are of intermediate risk of causing cervical carcinoma (Ackland 70). 

One of the major ethical concerns is that the vaccine may change adolescent sex behavior, because of the perception of reduced risk of transmission of HPV through sexual intercourse. This behavior of ‘disinhibition’ is similar to that which occurs after taking oral contraceptives that reduce the fear of pregnancy, and lead to more sex, especially in young people. Moreover, it may also send confusing messages to girls that premarital sex is acceptable. Consequent high-risk behavior in young girls may ultimately lead to fatal carelessness by acquiring HIV infection.

Another concern that remains is that Gardasil is only protective against HPV strains 16, 18, 6, and 11, which account for 70% of all cervical cancers. As there are more than 80 serotypes, with several serotypes associated with high and intermediate risk of developing cervical cancer, protection against all of them remains elusive. Moreover, different HPV serotypes may be linked with cervical cancer in different regions of the world, resulting in marked differences in the protective efficacy of the vaccine. The highest risk relates to the safety of the vaccine, which has not been proven yet. The majority of the subjects who received Gardasil had side effects within 15 days, which included fatigue, muscle pain, and inflammation at the injection site (Merck’s Gardasil vaccine has not proven safe).

Part B

Is Gardasil safe?

The current vaccines containing synthetic/ recombinant antigens are less immunogenic than the older versions of vaccines derived from live attenuated or killed organisms. As a result, adjuvants are added to them to make them more immunogenic and effective. Gardasil contains 225 mcg of aluminum as an adjuvant, and during clinical trials, a base containing aluminum was used as a placebo in the control group of trial participants. All aluminum in the vaccine is absorbed, with distribution to all tissues, including the brain. The uptake by the brain may involve complexes formed with transferring and citrate (Yokel and McNamara 159) with an elimination half-life in years. Aluminum can cause various serious side effects which include myofascitis and abscesses and has also been linked to the neurodegenerative disorder, Alzheimer’s disease (Petrovsky and Aguilar 488). Aluminum adjuvants can cause the death of brain cells and are neurotoxic. About 90% of Gardasil recipients and 85% of aluminum placebo recipients in the clinical trial had side effects which included fever, myalgia, nausea, vomiting, and diarrhea. Also, recipients of Gardasil had bronchospasm, pelvic inflammatory disease, appendicitis, and arthritis (Merck’s Gardasil Vaccine Not Proven Safe).

The issue of Gardasil has rekindled the earlier debates about the long-term safety of vaccines, in which thimerosal (containing 50% ethyl mercury) was used as a preservative. Thimerosal has been associated with autism and speech difficulties in children, only appreciated by the afflicted families passing through the catastrophe. Another example was the approval by the FDA of the anti-inflammatory drug Vioxx (Rofecoxib), incidentally also manufactured by Merck and which played havoc by causing an increased risk of serious cardiovascular events (including heart attack and stroke) in patients suffering from arthritis, ultimately leading to its withdrawal from the market. The long-term impact of Gardasil in the form of the development of juvenile arthritis, autoimmune disease, or neurological degenerative disorder is not known. Any catastrophe in store for the next generation, by Gardasil can only be prevented by thorough safety trials, and not fast-tracking the vaccine into the market.