In this post, I will be discussing a recent study of a newly developed drug that could possibly treat the most aggressive form of thyroid cancer.
Thyroid cancer refers to malignant tumors on the thyroid gland. The thyroid gland is an organ in the throat that helps control body temperature, heat rate, and blood pressure. Thyroid cancer is a public health issue because according to the National Cancer Institute (NCI), there are about 37,000 new cases of thyroid cancer each year in the US alone. Although thyroid cancer may affect people of all age groups, it is most prevalent amongst women and the elderly. The study I am about to talk about focuses on the most aggressive form of thyroid cancer, which according to the article, affects about five percent of all thyroid cancer patients. This form of thyroid cancer cannot be successfully treated by conventional means and patients must turn to chemotherapy, which is pretty unpopular and also not very effective.
In the study performed by Dr. Julian Molina at the Mayo Clinic, 37 patients with the most aggressive form of thyroid cancer took a new drug called pazopanib everyday. After a period of time (not specified by the article), results showed that tumor size decreased by at least 30 percent in almost half of the patients. Dr. Molina emphasized that pazopanib is not a cure for the most aggressive form of thyroid cancer, but rather a way to decrease the symptoms and growth of the tumor.
This study was a clinical trial in which there was only the intervention group and no control group. Due to the fact that there were only 37 patients in the study, there are clearly many weaknesses of this specific study. Even Dr. Molina said, "future research needs to be done on larger populations in order to confirm the findings." Also, the fact that there was no control group present in the study meant that there is no comparability. However, the reason for this small number of patients is that pazopanib is a new drug so people are wary of what side effects the drug may cause. In fact, 16 patients in the study had to reduce their pazopanib dosage because they were experiencing negative side effects. Also, the fact that many ethical issues arises when dealing with clinical trials discourages many patients from participating.
This study could be strengthened in many ways. There are many advantages of clinical trials such as randomizing patients into two groups, a treatment group and a control group. The purpose of randomizing patients into these two groups is to avoid bias and to increase comparablity of the groups to determine if intervention is associated with a better outcome. Therefore, increasing the number of patients being studied and randomizing them into a treatment group and control group would definitely better support the results. However, the disadvantage of clinical trials is the many ethical issues involved when conducting experiments on actual human beings. In the past, these ethical dilemmas have even sometimes made it to the Supreme Court.
Link: http://www.msnbc.msn.com/id/39239797/ns/health-cancer/
You are right that this is a randomized clinical trial, however this study isn't really a public health issue, but rather a medical issue. Generally you can look at all randomized controlled trials that are looking at the risks/benefits of a specific drug or treatment as medical issues; public health issues would be looking more at prevention aspects, social issues surrounding it, or exposures that could cause an illness.
ReplyDeleteSorry, it looks like I forgot to paste my second paragraph of my comments. So this was a phase II trial which is part of a series of tests that drug companies must do to get approval to sell a drug from the FDA. It most likely did have a control, although this article didn't state what the control group was and also didn't have a link to the actual study (so I couldn't check it directly), as phase II trials are designed to see if the drug appears to be effective in a small group of people before plunging ahead with a large-scale trial (which is much more expensive). Those larger trials (phase III) are required as the final step before the FDA will give approval for a drug, so this is just a preliminary report on a drug that is going through the approval process. Safety issues are also monitored during phase II trials, and many drugs do not make it through the entire approval process (due to safety issues or lack of real efficacy), so phase II results generally aren't of major interest except to the manufacturer.
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