The Trump Administration says it wants to get medications to consumers faster by pushing for less regulation and faster approvals. However, a move like that could have dire consequences for public health, says Dr. Joseph Ross, an Associate Professor of Medicine at Yale School of Medicine. Dr. Ross and colleagues published a study in the Journal of the America Medical Association (JAMA) that found one-third of medications approved by the Food and Drug Administration (FDA) from 2001 to 2010 had major safety issues years later. That is very significant and also quite troubling. Instead of weakening regulation, the government should be doing a better job.
It should be noted that 71 of the 222 drugs approved during that period of time were either withdrawn from the market, required to add a “black box warning” regarding side effects, or were the subject of a safety announcement about new risks. Again this information is apparently being ignored by the Trump Administration.
For example, Zelnorm was one of the 222 drugs approved by the FDA from 2001 to 2010, and one of three during that time period to be pulled from the market due to safety concerns. The others include the anti-inflammatory drug Bextra, which was also linked to cardiovascular risks, and the psoriasis drug Raptiva, which was linked to a rare and fatal infection that causes brain damage. Another 68 drugs approved during that decade required a black box warning regarding side effects or a safety announcement about new risks, according to Dr. Ross’s study.
Admittedly, this is a difficult spot to be in. Medications can improve or even save lives. But it takes years for thorough testing of these drugs to flesh out potential side effects. Longer-term studies and those involving larger pools of people are better indicators. Often, the FDA has approved drugs based on studies involving 1,000 people or less and lasting just six months or less. That is totally inadequate and there should be no dispute over that assessment.
It took a median of 4.2 years after approval for most safety concerns to come to light. Most often, “concerning side effects” appear among psychiatric drugs, biologic drugs, and drugs that were pushed through the approval process in an accelerated programs. These programs are designed to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The drug industry has abused this system quite often, to the detriment of public health.
Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, who did not participate in the study, said that the research should give patients a more realistic view of the medication they are taking. He said:
All too often, patients and clinicians mistakenly view FDA approval as (an) indication that a product is fully safe and effective. Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s been on the market and only after use among a broad population.
The Trump Administration is playing politics with drug regulation and that’s very dangerous. Poor regulation will result in consumers being put at risk.
Sources: Law360.com and NPR
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