Many people believe that just because medication was prescribed by a doctor, it’s perfectly safe to use. Unfortunately, the staggering number of people who die from opioid overdoses every year – 155 per day in the United States alone – is enough to dispel that idea, since many of them became addicted after first having a valid prescription. How is it that doctors can recommend these medications if they’re so dangerous? Part of it has to do with the fact that the opioid industry seriously misled everyone about the actual dangers of their products – which is why many of them are in the process of being sued right now – but another factor has to do with the way the Food and Drug Administration approves new drugs.
For one thing, clinical trials leading up to a drug’s approval to be placed on the market are often quite small. The majority of trials for drug approvals involve less than 1,000 patients and only last six months or less. These trials don’t last long enough to predict any long-term effects. For example, antidepressants may only undergo a few weeks of clinical trials, but then patients end up staying on them for decades. It might take ten years for a serious problem to develop, and no one would have known it was even a concern.
According to researchers at the Yale School of Medicine, seventy-one of the 222 drugs approved from 2000 to 2010 were either withdrawn, needed a “black box” warning (a warning that the medication has side effects that might cause serious injury or death), or required a safety announcement about new risks.
Another problem is that researchers only test drugs on people with whatever specific condition they’re looking to treat. That might sound like the obvious thing to do, but consider medication for Alzheimer’s disease. This is mostly a disease that affects older people, who are likely to have all manner of other conditions they’re dealing with and possibly taking medication for. Heart problems, high cholesterol, diabetes, arthritis, blood clots – anything that the target group is likely to suffer from should be taken into consideration. What if that new Alzheimer’s drug turns out to interact poorly with blood thinners, for example?
The FDA issues approvals faster than its counterpart in Europe, the European Medicines Agency (EMA). Between 2011 and 2015, the FDA approved more new drugs than EMA — 170 compared to 144. The median review time for FDA-approved drugs was 306 days, compared to 383 days for approval by EMA. The FDA’s times are also faster when compared to the similar agency in Canada. Unfortunately, the United States government is currently pushing for even faster approval of new medications.
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