When you see about a medical office practice, pharmacy and/or any other entity that has the legal right to handle, prescribe or dispense controlled substances …being raided and shut down… Who is conducting the raid… NOT THE FDA… NOT THE CDC…

Typically, the raiding of the office practice or others is done by the DOJ/DEA/FBI/local law enforcement.

Who has the statutory authority to permit a medication to be prescribed and dispensed in the USA — How about the FDA. ?

Who has the authority to establish and approve the appropriate medical use for a particular substance/medication, the appropriate dosage range, the potential lethal dose and all the other related items as to the safe use of a particular substance/medication.

Who was the entity who “jumped on” the CDC guidelines in 2016 and attempted to get  the guidelines recognized as standard of care and best practices ?  When >50% of the prescribers in a given area, state, region follow these guidelines… the becomes a de-facto law.

Does the FDA utilize these de-facto laws/rules and search the various states’ PDMP databases to find prescriber who is “exceeding” these opiate dosing guidelines and fabricate a “probable cause case” that a particular prescriber is routinely prescribing an excessive amounts of opiates and controlled substances and labeled as operating a “pill mill” ?

Has anyone noticed that when the states are unhappy with what the FEDS do… what do they do… THEY SUE…  they don’t sign petitions, they don’t send letters, texts, faxes, emails to members of Congress.

Human Psychology strongly suggests that people will continue to do something that they consider illegal, immoral or unethical until they suffer some bad personal consequences.  No matter if you are talking about the Insurance/PBM industry, large hospital systems, chain pharmacies…etc…etc…  they can – and have – denied care, abused pts – intentionally throwing pts into cold turkey withdrawals – directly – indirectly causing chronic pain pts to commit suicide… and have any of these entities had to deal with any consequences — personally, financially ?

They have NO REASONS for changing what they have been doing… in fact… it would seem that many have increased the number of chronic pain pts that have been adversely impacted.

Just think “Lucy” as the various bureaucracy, the “football” as some proposed change in rules/regulations and “Charlie Brown” the chronic pain community…

How many times is “Lucy” going to put the “football” in place with the theoretical promise to hold it in place .. and then just as “Charlie Brown” gets ready to kick the football… Lucy pulls it way – once again..  How many times is the chronic pain community going to live thru this “Groundhog Day” scene ?

Pain patients beg FDA for more options, easier access to opioids

https://www.nbcnews.com/storyline/americas-heroin-epidemic/pain-patients-beg-fda-more-options-easier-access-opioids-n890081

People with chronic conditions cope with prescription restrictions and limited alternative therapies amid the nation’s opioid crackdown.

SILVER SPRING, Md. — One pain patient lay on the floor. Another leaned against the wall, easing her back. A third paced to and fro.

At this week’s Food and Drug Administration hearing on chronic pain, accommodations were at the forefront.

And the agency says it wants to be accommodating in other ways as it tackles the opioid crisis. Thus, a meeting was called simply to listen to people’s stories about their pain and how they may, or may not, handle it.

It was a room full of some very unhappy people.

“Suicide is always an option for us,” said Mariann Farrell of Pittsburgh, who says she has multiple conditions, including fibromyalgia and the post-herpetic pain that can linger after shingles. Farrell was one of several dozen people who traveled to the FDA’s headquarters outside Washington to ask the agency to ease restrictions that they say has made it harder for them to get opioids.

Sandra Flores, a former emergency room nurse from Tucson, Arizona, roused rounds of applause as she told of her repeated efforts to get opioid prescriptions for her pain. Flores said she was diagnosed with adhesive arachnoiditis, an inflammation of the membranes protecting the brain, spine and nerve endings.

“I am seeing the true face of medicine,” Flores said. “Now they are throwing me in the trash.”

The FDA said it wants to consider the needs of patients with chronic, intractable pain as it considers the problem of opioids, and as it encourages drug companies to come up with safer alternatives.

“We don’t want to perpetuate practices that led to the misuse of these drugs, and the addiction crisis. At the same time, we don’t want to act in ways that are poorly targeted, and end up disadvantaging legitimate patients,” FDA Commissioner Dr. Scott Gottlieb said in a statement.

“In most circumstances, opioids should only be used for the treatment of acute pain and prescribed for short durations of time,” he added.

“However, the FDA is aware that there are certain circumstances — such as in the treatment of metastatic cancer pain and the episodic treatment of migraine pain — where the drugs are administered over longer periods. In select patients and for certain medical conditions, opioids may be the only drugs that provide relief from devastating pain.”

The FDA, Centers for Disease Control and Prevention and other medical groups agree not only that there’s an opioid crisis, but that it has been driven in no small part by overprescribing.

The CDC reported last year that the number of prescriptions for the painkillers tripled between 1999 and 2015. “A generation of providers dispensed these medicines too liberally, and were slow to address the signs of misuse and addiction,” Gottlieb said.

The CDC says more than 42,000 people died from opioid-related overdoses in 2016, a 30 percent increase from the year before. Synthetic opioid overdoses killed 20,000 of them. Opioid overdose deaths are so numerous they have helped drive down U.S. life expectancy.

So the CDC has issued guidelines recommending that doctors cut back on opioid prescriptions, and advising patients to try anything else they can before asking for the powerful and addictive drugs.

They recommend first trying Tylenol or drugs such as ibuprofen or naproxen, which are in a class called non-steroidal anti-inflammatory drugs, or NSAIDs. They also recommend trying low-tech options such as ice, physical therapy and massage. And, the CDC says, patients may have to change their expectations about living with pain.

But the CDC and FDA do not regulate physicians. States do.

At least 28 states have some limits on opioid prescriptions, according to the National Conference of State Legislatures. Seventeen limit prescriptions to three to 14 days.

Others have prescription drug monitoring programs to keep watch for providers who might be writing prescriptions too freely.

The pain patients who traveled from across the country to testify to the FDA say they are feeling the effects.

Flores, who said she was diagnosed with her painful condition two years ago, said she can no longer find a doctor to prescribe her opioids.

“I have yet to have a doctor accept me as a patient,” Flores told NBC News.

“No doctors will fight. They just don’t want to get into trouble. They have forgotten the people these drugs were made for.”

Flores said she worried she was failing as a mother, her teenaged son unwilling to put her down as an emergency contact. “He knows I often don’t answer the phone because I am in bed,” she said.

“When can I have medicine so I can just be comfortable in my body?” she asked.

It’s clear who they blame for their reduced ability to get opioids.

“To the FDA — we are begging you. Correct the CDC’s egregious mistakes,” said Rose Bigham of Seattle, who spoke on behalf of the Alliance for the Treatment of Intractable Pain.

“The CDC recommendations have done irreparable harm to people in pain.”

Fears of being denied pain relief

More than 90 percent of the patients at the FDA meeting and watching online said they had used NSAIDs and more than 80 percent said they had used opioids to control their pain. And 77 percent said they had used gabapentin (Neurontin) or pregabalin (Lyrica), both anticonvulsant drugs also approved to treat pain.

As for non-prescription treatments, 68 percent said they had used dietary supplements or herbal remedies to treat pain, 47 percent said they had tried medical marijuana or other cannabis-based products, 68 percent had tried acupuncture, massage or other complementary therapy and 47 percent had tried counseling or other psychological treatment.

“None of them are covered by insurance,” Bigham noted, to applause and loud cheers.

Bigham said she has ankylosing spondylitis, a form of arthritis affecting the spine.

She said she has tried NSAIDs, muscle relaxants, antidepressants, injectable drugs, cortisone and an electric current therapy called transcutaneous electrical nerve stimulation. “I remain on opioids to this day,” she said.

“My new worst nightmare is being admitted to the hospital, being in agony, and being denied pain relief,” Bigham said to more applause.

Charlotte Diggs of Atlanta said it’s not easy to get alternatives to opioids, either. Her physician was not forthcoming about possibilities when he was treating her for complex regional pain syndrome. “He didn’t offer it,” she said. “I had to hear about it and then ask him,” Diggs told NBC News.

Filed under: General Problems