We all hear it. The new drug on the market with all the side effect warnings. They are more scary than what the drug supposedly treats sometimes. Those warnings can be based on multiple incidents in a trial, or just one. So that can be very unclear just how serious the side effects are based on you, not the person who suffered those effects. Its a very complex thing to balance the benefits of a future medicine with the risks of each individual taking it.
"On August 11, the drug division of the FDA held a public hearing to discuss this issue [of cardiac events], and the diaTribe and Close Concerns teams presented on behalf of patients.
The day featured public presentations and discussion from a range of experts, including the ADA’s Dr. Robert Ratner, who spoke most compellingly on behalf of patients, in our view (he was a very respected long-time researcher before taking the reigns at the ADA running the science side). Some talks, including ours as well as Dr. Ratner’s, centered on ways the FDA should balance innovation with the need to gather long-term safety data on new drugs. diaTribe editor-in-chief Kelly Close presented on the challenges of revealing early results from CVOTs [cardiovascular outcomes trials], as well as the consequences of the CVOT requirement on innovation (e.g., multi-year delays on Novo Nordisk’s insulin degludec and potentially transformational combo insulin/GLP-1 Xultophy, fewer funds going into the field, etc.)."
Read the full article (and all the sub articles) here: http://diatribe.org/issues/68/new-now-next/7
I know I personally want to know if a drug may kill me so I can weigh the benefits versus the risks. The additional study of cardio events in a study may slow things down, but is it worth it? That is a hard question. The hearing held had many prominent people saying that drugs should not be held up for the extensive (and more expensive) cardio event trials. And I do get their point. What it could do to save lives could be monumental. It could also be devastating.
What do you think?
Would you rather have a potentially life saving drug on the market earlier?
Or would you rather know as much about the risks of the medicine before it comes to the market?
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