drugs Archives - The Painful Truth

Black Box Warnings

How Drugs Receive FDA Approval

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is the watchdog agency that’s responsible for testing new medications before they are approved. Drug manufacturers seek approval from the FDA after they have conducted numerous clinical trials and submitted all of their data to the FDA for review. Drugs are approved only if the FDA believes the data supports the efficacy for the targeted indication and that the drugs’ risks are reasonable and manageable.

How Do You Know If You Are Addicted?

Babies Can’t Be Addicted

“Babies Born Addicted,” “Addicted Babies,” “Babies with Addiction,” and similar headlines appear nearly daily in the media. This is because babies exhibit horrible withdrawal symptoms if they are born physically dependent on opioids, and it pulls at our heartstrings to see them suffer. But it misleads media consumers, policymakers, and family members into believing the newborns are addicted. They confuse signs of withdrawal with opioid addiction.

Salt Lake City Tribune Op-Ed Supports Utah House Health Bill 266

Salt Lake City Tribune Publishes an Op-Ed Supporting Utah House Health Bill 266

On June 20, 2017, the Salt Lake City Tribune published an op-ed that I co-authored with some of my colleagues. The commentary is called “Patients should not be stuck with ‘fail first’ medicine,” and we wrote it in response to Utah House Health Bill 266.

What Is Utah House Health Bill 266?

Those who live outside of Utah may not have been following this bill. So let me explain that Utah House Health Bill 266 asks that insurers stop mandating “fail-first,” or step therapy, for patients. There are similar bills throughout the country.

When to Say No

An article called “7 Words That Could Have Biotech and Big Pharma Very Worried,” written by Sean Williams and recently posted on The Motley Fool, tells both sides of the story.

Pressure on price for pharmaceuticals is a real concern. Affordability is important. A drug can only work if patients can afford to pay for it.

So, on the one hand, the price of drugs must be kept in check.

Biotech and pharma can’t just raise the price of a lifesaving drug by 5,500% overnight. That isn’t reasonable, and that isn’t a good decision for anybody.