Tag Archives: FDA

MedWatch Voluntary Reporting Form

MedWatch Voluntary Reporting Form – the official FDA site for complaints

Another patient described on Pharmacist Steve’s blog how to word complaints about sudden, medically unjustified, reduction in opioid medication:

Here’s the blurb I came up with:

Withdrawal symptoms, and other adverse reactions, are considered a serious safety problem with medication, especially when this is happening as a result of a doctor abruptly discontinuing or inappropriately tapering your drug treatment in a way directed against in the medicine’s US FDA approved prescribing information.   Continue reading

How the Fed Used Opioids as Scapegoat

Games without Frontiers: How the Fed Used Opioids as Scapegoat & Diversion for the Nation’s True Crises – by Matthew Giarmo, Ph.D. – Sept 2018

Here’s a guy who lays it out as he sees it, remarkably similar to the view of pain patients. This could be because he took time off to take care of a family member with cancer – he saw firsthand the full destructive force of their pain.


  • The problem is not opioids. It’s heroin.
  • The problem is not painkillers. It’s pain.
  • The problem is not prescription. It’s diversion.

To all those sanctimonious crusaders, self-aggrandizing careerists, and shameless opportunists looking for a piece of the opioid pie, I say that you are more addicted to the opioid crisis than we are to opioids.  Continue reading

Report adverse or no medication effects to the FDA

MedWatch Voluntary Reporting Form – for reporting adverse drug effects to the FDA

Perhaps the FDA doesn’t know how ineffective “alternative” non-opioid drugs are for pain because no one has told them. You can download a form from this site (link above) to report your experiences.

Use the MedWatch form to report adverse events that you observe or suspect for human medical products,including

  • serious drug side effects,
  • product use/medication error,
  • product quality problems, and
  • therapeutic failures

It’s this last category that presents our opportunity for action. We could report the “therapeutic failures” and awful side-effects of non-opioid medicaitons like Lyrica, gabapentin, or antidepressants for pain. Continue reading

Addiction crisis shifts to the next drugs

The previous post and these three articles, all from this year (2018), highlight the absurdity of our drug-war against prescription opioids. Each article finds that drugs other than prescription opioids are becoming increasingly available and more often abused.

As the mushrooming crisis of addiction moves on, the CDC is still busy counting pain patients’ pills and meddling in medical practice.

While America wages war on opioids, meth makes its comeback – CNN – By Drew Kann, CNN – September 28, 2018

For Capt. Mark Wollmershauser Jr. and the Tulsa Police Department, the late-2000s and early 2010s were an extremely dangerous time. In Oklahoma, a state that is no stranger to the scourge of methamphetamine addiction, those years were the heyday of the “shake and bake” method — a rudimentary way of making meth using just cold medicine, some toxic chemicals and an empty two-liter bottle.  Continue reading

FDA seeking ‘right balance’ for opioid regulations

FDA seeking ‘right balance’ in regulating opioid prescriptions | BioPharma Dive By Rebecca Pifer Published July 10, 2018

Food and Drug Administration chief Scott Gottlieb reaffirmed in a statement Monday the agency’s commitment to finding the “right balance” between reducing the U.S. rate of opioid addiction and providing access to legitimate patients, for whom these medications can be lifesaving.

He had strong words for practitioners regarding their role in helping spur the opioid epidemic. “The roots of this crisis are embedded in the practice of medicine, and prescribing practices that were at times too cavalier,” Gottlieb said.

No, they are not. The “roots” of this crisis are the skyrocketing rates of addiction. And the problem is expanding much farther than just opioids, with use of and overdoses from drugs like meth and cocaine rising.  Continue reading

DEA Revises Opioid-Quota Rules Unchanged

DEA Revises Opioid-Quota Rules, Leaving Out Requested Change by Kerry Dooley Young – July 13, 2018

The Drug Enforcement Administration (DEA) will update its established procedures for setting production quotas for addictive drugs without heeding a recommendation from medical groups regarding shortages of injectable opioids.

The DEA on July 11 announced its final decision on changes to its regulations regarding aggregate production quotas (APQs), which it said were initially issued in 1971.

When a policy is close to 50 years old, it shouldn’t be revised or changed as much as thrown out entirely. So much more is known about medications and drugs in general than 50 years ago, it’s ludicrous that such old policies are still used at all.   Continue reading

FDA Finds Errors in Opioid Data, calls for quality review

FDA finds errors in its opioid sales data, calls for quality review – by Meg Tirrell | @megtirrell – May 16, 2018

The Food and Drug Administration says it’s found mistakes in opioid sales data provided by industry researcher Iqvia that led to an overestimation of the amount of prescription fentanyl being used in the U.S

This means that they assumed more of the fentanyl found on the streets and involved in overdoses was from prescriptions when instead it was illicit.

Because the larger number fed into the prevailing narrative that prescription opioids are fueling the “opioid crisis”, these numbers weren’t questioned closely.  Continue reading

FDA Acknowledges Suffering from Opioid Crackdown

FDA Head Acknowledges Suffering Caused by Opioid Crackdown – By Jacob Sullum|May. 15, 2018

Yesterday Scott Gottlieb, head of the Food and Drug Administration,acknowledged that the crackdown on pain pills, aimed at preventing nonmedical use, is hurting legitimate patients, some of whom have contacted his agency.

He announced a July 9 public meeting focusing on the concerns of people who use opioids to relieve chronic pain. The FDA is accepting public comments on the subject through September 10.   Continue reading

Patient-Focused Drug Development meeting with FDA

Patient-Focused Drug Development meeting with FDA – Twitter Conversation sent by Scott Gottlieb, the FDA Commissioner from:

Scott Gottlieb, M.D. @SGottliebFDA   
#FDA will be hosting a Patient-Focused Drug Development meeting July 9 to obtain patients’ perspectives on the impacts of chronic pain, views on treatment approaches and challenges or barriers to accessing treatments.

This sounds promising to me. It seems like big step forward for pain patients, for the FDA Commissioner to publicly acknowledge that we exist and that opioids are necessary for some of us… quite a daring move in today’s opiophobic political atmosphere. Continue reading

FDA, AAPM on Evidence-Based Opioid Prescribing

FDA, AAPM Open Talks on Evidence-Based Opioid Prescribing & Increased Naloxone Availability – April 13, 2018 – By Angie Drakulich

In a follow-up statement to an announcement by FDA Commissioner Scott Gottlieb, MD, the American Academy of Pain Medicine (AAPM) has issued its support for the development of evidence-based opioid prescribing guidelines.

The federal agency’s announcement seemed to mark a shift in approach from the 2017 declared opioid public health emergency and the administration’s “avoid opioids at all costs” mentality, not to mention its alleged temporary retreat from “evidence-based” medicine.

This implies a retreat from the CDC guidelines, thank goodness!   Continue reading