When it comes to fighting cancer, medical researchers are always looking to create new vaccines. This is especially true of cervical cancer, which takes thousands of women’s lives annually. As a result, drug manufacturer Merck has been conducting clinical trials of an experimental vaccine to fight the human papillomavirus, better known as HPV. A sexually-transmitted disease, it generally causes no harm in most people. However, others develop genital warts, and in some instances cervical cancer. Because of this, Merck began clinical trials of a vaccine named Gardasil on people who were considered at high risk of developing cervical cancer. However, the results of the trials have been mixed at best.
While many participants in the trials experienced no problems, others developed chronic fatigue syndrome due to abnormal immune responses. While the clinical trials involved more than 25,000 participants, both male and female, Merck and other researchers pointed to the vast majority of participants experiencing no adverse side effects. Stating it was confident in Gardasil’s safety profile, Merck also noted the National Institute of Health stated that of tens of thousands of people tested in the United States, the vaccine has not produced any serious side effects.
Despite the results provided by Merck, many researchers believe the Gardasil trials may have been flawed from the beginning. By regulators allowing unreliable data to be used during the vaccine’s testing, a flawed study design could lead to numerous issues regarding the validity of the clinical trials. With many people who got sick during the clinical trials, also known as the pre-licensure study, their symptoms were never registered in the study as potential side effects.
For a clinical trial’s results to be accurate and reliable, objective evaluation needs to occur. With the Gardasil testing, some aspects were thought to not include the proper evaluation techniques, which could have resulted in flawed data. Rather than relying on factual data, investigators may have instead used their personal judgement to determine what constituted adverse side effects. By doing so, patient data and physical symptoms may not have been tracked the same way, allowing for human discretion to be used instead of facts.
When it came to study protocol, there were numerous indications Merck may have committed a variety of errors that led to inaccurate data. For example, safety assessments such as medical history metrics of participants were not given enough room for accurate measurement. Since the worksheets used by researchers allowed only one line for the medical history as well as symptom severity, duration, or outcome, an in-depth analysis of each patient was deemed to be too difficult, due to a lack of information.
Regulations and Guidelines
Despite claims by other agencies and participants, Merck maintains that the clinical trials for Gardasil met all required guidelines and regulations. According to trial investigators, much data may not have been correctly reported, leading to flaws that put participants at risk. However, much of this is still unclear regarding how the reporting or lack thereof with key data may or may not have impacted the trial’s results. However, many doctors and researchers familiar with HPV and cervical cancer believe it’s not far-fetched to think a link could exist between the vaccine and problems experienced by patients.
With so many questions surrounding the clinical trials of Gardasil, attorneys and medical researchers believe it will be difficult going forward to obtain the answers patients need. However, by continuing to analyze test results and speak with those who participated in the trials, it’s believed eventually the answers sought by many will be obtained.
Learn more about the HPV Vaccine.