The final authorization for a drug named Aduhelm has now become a great controversy. A recent study now adds up to it. It found out that most of the patients who took part in the clinical trial that resulted in its green signal could not have been qualified for it.
The US Food and Drug Administration, in June, gave accelerated approval for a drug called Aduhelm. It is intended as a treatment for mild forms of dementia and mild cognitive impairments.
Alzheimer’s Patients Would Not Qualify For The Controversial Drug Trial
Critics were quick to question the approval. According to them, the drug is too expensive for the average person to avail. They also doubt a nexus between the regulators and the drug manufacturers. This new research mentions its other issues.
The drug’s phase 3 trials excluded the elderly. Still, it caused certain serious vascular side effects. The group most at risk, according to the study, is those using blood thinners and those suffering from chronic ailments. FDA, however, authorized the drug without indicating any risk.
According to scientists, the relaxed labeling of the FDA is a cause of concern.
The debate among the general public today is its high cost. Such a huge amount for these limited benefits is not worth it, they feel. They should also evaluate the possibility of serious complications. The drug may pose more risk to patients who were excluded from the trial.
Researchers took 27000000 Medicare claims of those suffering from cognitive impairments, Alzheimer’s disease, and related issues. The team discovered that most of them had one or the other condition that may have barred them from participating in the trials for Aduhelm. Most of them were elderly, were suffering from cardiac ailments, or were using blood thinners.
For instance, the study showed that one among nine among those suffering from Alzheimer’s had at least one factor that would have forbidden them from taking part in such trials. In the same way, 85% of those suffering from Alzheimer’s had at least one factor that disqualified them from the drug trials. And over two-thirds of those suffering from diseases like dementia had numerous factors that may disqualify them from the trials.
The drug trial of aducanumab included only averagely healthy patients. They don’t represent the majority of dementia patients of the country; the elderly.
Researchers thus want Medicare to confine its protection to those who may actually benefit from the treatment. They also requested that authorities should conduct another trial for the drug involving those previously excluded from it. They should also be mindful of the serious side effects the drug may carry. They published their report on September 14 in the American Medical Association’s journal.
In July, there was a report that two congressional committees were evaluating the process that resulted in the approval of the drug.
FDA had said earlier that there is no sufficient evidence to suggest that the drug aducanumab is effective in treating cognitive impairments. Even then, the agency authorized the drug. Three among its advisers stepped down afterward.
Dementia, in the meantime, still remains an unpreventable disease. Its reason still remains unknown to scientists even today. But doing the following, according to them, slows its onslaught.
- Stay active
- Exercise your brain
- Sleep well
- Follow a healthy diet
- Minimize the intake of alcohol
- Quit smoking
- Read as much as you can
- Learn stress management techniques and use them.
- Learn to play a musical instrument
As you age, you become more prone to cognitive impairment. Even then, keeping your blood sugar in check, maintaining the standard bodyweight, practicing safe sex, managing depression-anxiety, and minimizing the possibility of strokes will do wonders.