May 9, 2016
People Often Clinically Excluded From Type 2 Drug Trials
People are under intense scrutiny for selection for type 2 diabetes drug trials. This is often done to help obtain the results desired and Big Pharma does this to obtain positive results for drug approval from the FDA.
Young women of childbearing age are usually excluded. Exclusion criteria for clinical trials of type 2 medications that affect women of childbearing potential are frequently disproportionate to risk to the participant and fetus. This data is shown from a study published in Diabetes Care.
Clinical trials often exclude women of childbearing potential due to concerns about adverse fetal effects of treatment. Because of the high prevalence of diabetes among pregnant women, researchers examined the prevalence of fertility-related exclusion criteria in clinical trials for type 2 diabetes medications. They sought to determine whether these criteria are an accurate representation of type 2 diabetes drug risk.
This is why many of the women who develop diabetes while pregnant are put on insulin rather that any oral medications.
The next group is young people under the age of 18 to 20 years of age. This is mainly because of the legal process of obtaining permission for testing. The other problem is parents that pull the young from trials for capricious reasons. Most researchers avoid this by excluding them from trials.
The elderly are also excluded from trials because of other comorbid conditions that researchers do not want to deal with. Most of the time, the age excluded is 65 and older. However, people under the age of 65 are also excluded if they have other comorbid conditions or diseases.
Read my blog here about elderly discrimination and why it harms the elderly. Occasionally, a study will use limited comorbid conditions for the elderly up to the age of 74. These trials are very limited and the comorbid conditions are also limited.
This makes many clinical trials very discriminatory and possibly harmful to the classes of people mentioned above. Yet, when people in these classes are diagnosed with type 2 diabetes, the doctors prescribe the medications to people not in the clinical trials. They do this normally on the advice of drug reps of the companies making the drugs. The doctors are often unaware that these classes have been excluded from the drug trials and may be causing harm to the very patients they want to help.