Posts Tagged ‘FDA’
Why Does It Take So Long to Find a Cure for COVID-19?
Currently, there is no cure or vaccine proven to be effective against COVID-19. There simply hasn’t been enough time to conduct the required research. However, as the above figure illustrates, there is a gallant worldwide effort to find effective treatments and vaccines.
Read MoreFlushing Out the Truth About Disposing of Pain Medications
The FDA believes that the risk of harm from overdose is greater than the danger the drugs present to the environment. That is why the FDA recommends flushing them down the toilet—which puts the drugs in contact with our water supply.
Read MoreIs Your Medication Effective or Was It Placebo Effect?
This article, in a slightly edited form, first appeared on Pain News Network on April 31, 2019. Most of us have been prescribed a medicine at some time in our lives, and if we got better, we probably assumed it was because the medication was effective. However, this may not have been completely true. A…
Read MoreDon’t Lose Sleep Over It
Black box warnings may be alarming. However, they are not meant to scare you into panicking and discontinuing medication that you need. Their primary purpose is to inform prescribers and patients about dangers they may pose.
Read MoreIs Fentanyl a Weapon of Mass Destruction?
However, before we classify the chemical fentanyl as a WMD, we need to know what that would mean for its legitimate use during surgery, or for cancer and chronic pain patients. Access to the medication for the treatment of pain must be part of the calculus in assessing if a relatively safe and effective drug should be classified as a WMD.
Read MoreWhen Will Forced Tapering of Opioids End?
Will the DEA stop pursuing doctors who treat pain patients with levels of opioids that exceed the guideline’s recommendations? For Larry and other pain patients who have been forcibly tapered, the answer may be a matter of life and death.
Read MoreOregon’s Proposed Tapering Policy Is Still Undecided
Forced Tapering Proposal On March 14, 2019, the Oregon Health Authority Health Evidence Review Commission (HERC) had planned to vote on a proposal that could affect thousands of Medicaid patients in Oregon. The proposal would limit Medicaid coverage of opioids to 90 days for chronic pain patients. Those who have been using opioids for more…
Read MoreMy Testimony Before the ADCOM for AcelRex’s DSUVIA
On Friday, Oct. 12, 2018, AcelRex Pharmaceuticals, Inc. presented its case to the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (ADCOM) to discuss the approval of the new drug application (NDA) 209128 for DSUVIA™. DSUVIA is a small sufentanil pill deposited below the tongue with an applicator. It is…
Read MoreBreaking Bad 2018
TV’s Hit Show “Breaking Bad” Glamorized Meth Abuse The television hit show, Breaking Bad, lionized the idea of making and selling meth. A high school teacher who was dying of lung cancer wanted to leave his family enough funds to live, and he chose drug dealing as a way to achieve his goal. The show…
Read MoreBlack 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…
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