Can Ketamine Treat Fibromyalgia Pain?

By Pat Anson

At a time when the medical and recreational use of ketamine is coming under more scrutiny from law enforcement, a new study highlights its potential value as a treatment for fibromyalgia pain.

Ketamine is an anesthetic drug that is only FDA-approved for depression and anesthesia. But in recent years ketamine infusions are increasingly being used “off-label” for severe chronic pain conditions such as Complex Regional Pain Syndrome (CRPS).

In a small systematic review (a study of studies), researchers in Brazil found that ketamine infusions were safe and effective in relieving fibromyalgia pain. The review was small – just 6 clinical trials involving 115 patients – because ketamine has rarely been considered as a treatment for fibromyalgia due to its potency. Ketamine infusions require constant medical supervision because they put patients into a temporary dream-like state that can lead to hallucinations and out-of-body experiences.

But the Brazilian researchers found the side effects from infusions were mild and short-term, with some fibromyalgia patients experiencing pain relief that lasted for days or weeks.

Fibromyalgia is a poorly understood condition that causes widespread body pain, fatigue, insomnia, brain fog and mood disorders. The FDA has approved only three medications for fibromyalgia, two antidepressants (Cymbalta and Savella) and a nerve drug (Lyrica), but many patients consider the drugs ineffective.

Could ketamine be another option?

“Ketamine infusions might be a reasonable therapeutic approach for short-term relief of symptoms but unsatisfactory at inducing long-term analgesia in FM (fibromyalgia) patients,” the Brazilian research team reported in Advances in Rheumatology. “Future studies that evaluate the safety and effectiveness of ketamine in FM are desired for long-term follow-up. In patients refractory to conventional therapy, ketamine infusions might be a reasonable therapeutic approach.”

A recent case study suggests ketamine does have potential as a long-term treatment. A 68-year-old woman with fibromyalgia experienced “significant, widespread pain relief” after receiving several ketamine infusions over a two-week period. She continued getting infusions twice a week for the next year.    

“Pain relief has persisted under this regimen, along with a demonstrable improvement in quality of life, a reduced use of morphine, and the cessation of anti-depressant medication. This case indicates that long-term ketamine infusions show promise for chronic pain management and that more longitudinal studies on this treatment are warranted,” researchers reported.

‘Targeting and Investigating Doctors’

The positive news about ketamine is being overshadowed by the investigation into the death of actor Matthew Perry, who drowned in a hot tub last year after getting three ketamine injections in one day – none of them while under medical supervision.  Five people, two of them doctors, were recently arrested in connection with Perry’s death, including an alleged drug dealer known as the “Ketamine Queen.”

Perry had long struggled with substance abuse issues, but federal prosecutors say the defendants “were more interested in profiting off Mr. Perry than caring about his well-being.”  The two doctors charged in the case both surrendered their DEA licenses and can no longer prescribe controlled substances.      

In a recent appearance on CBS’ Face the Nation, DEA Administrator Anne Milgram likened Perry’s death to the opioid crisis, claiming that his doctors were ultimately responsible.  

“It started with two unscrupulous doctors who were violating their oath, which is to take care of their patients, and instead supplying Matthew Perry with enormous quantities of ketamine in exchange for huge amounts of money. And then it switched to the street where Matthew Perry was buying the ketamine from two drug traffickers,” Milgram said.

“Every single day, (we) are targeting and investigating doctors, nurse practitioners, others who are violating this duty of trust to their patients by over prescribing medicine or prescribing medicine that isn't necessary.”

Milgram also claimed that ketamine “has a high potential” for addiction. While experts agree the drug can be abused, ketamine is not an opioid and does not suppress respiration, the leading cause of an overdose.  

Public Comments Sought on Marijuana Rescheduling

By Pat Anson, PNN Editor

The U.S. public is finally getting a chance to comment on the federal government’s historic decision to reclassify marijuana from a Schedule I substance with a “high potential for abuse” to a less restrictive Schedule III drug with “moderate to low potential for physical and psychological dependence.”

After months of foot dragging, the Justice Department published a notice in the Federal Register today giving the public 60 days to comment on the proposed rescheduling. Written comments must be submitted or postmarked on or before July 22. Online comments can be made here.

Every step in this process has been fraught with delays. And there may be more.

The Food and Drug Administration completed a review last August – nearly a year after it was requested by President Biden -- finding “credible scientific support” for marijuana’s rescheduling. But the FDA report was not made public until January, after a lawsuit was filed by two pro-cannabis lawyers seeking its release when the agency didn’t respond to requests under the Freedom of Information Act (FOIA).

Another four months passed before the Justice Department, which oversees the Drug Enforcement Administration, submitted to the Federal Register a notice about the proposed rescheduling. Since the DEA is charged with enforcing the Controlled Substances Act (CSA) and determines how drugs are scheduled, public notices involving the CSA are almost always signed by the DEA administrator.

This one, however, is signed by Attorney General Merrick Garland, not DEA Administrator Anne Milgram – a sign that her agency is not yet on board with marijuana’s rescheduling.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” Garland wrote. “The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs… The Attorney General has delegated that authority to the DEA Administrator, but also retains the authority to schedule drugs under the CSA in the first instance.”

According to an Associated Press report, Milgram told her staff in March that marijuana’s rescheduling “had been taken over” by Garland and the DOJ. The DEA wanted more time for studies to determine whether marijuana has an accepted medical use, a request that was rejected.

Former DEA Administrator Tim Shea believes the rescheduling process was hijacked by DOJ for political reasons.

“If she (Milgram) had supported it she would have signed it and sent it in,” Shea told the AP. “DEA was opposed to this and the politics entered and overruled them. It’s demoralizing. Everybody from the agents in the streets to the leadership in DEA knows the dangers this brings.”   

Asked recently during a congressional hearing what her views are on marijuana. Milgram ducked the question.

“Since DEA is ultimately the decider of scheduling and rescheduling, and the DEA administrator is in that role, it would be inappropriate for me to make comments about this process or parts of that process,” Milgram said.

‘Evidence Supports Marijuana for Pain’

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – may be historic, but it’s not the full “legalization” that many cannabis supporters have been calling for.  

Under the CSA, legal access to Schedule III substances requires a prescription from a licensed doctor that is filled at a licensed pharmacy. Any new medical marijuana products would also have to go through a lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would likely only be approved by FDA for certain conditions.  

Garland’s notice in the Federal Register is largely based on the FDA’s 2023 review, which states there is good evidence that marijuana is helpful in treating chronic pain and mixed evidence it could be useful in relieving nausea, anxiety, epilepsy and PTSD.

“FDA’s review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). Numerous systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for chronic pain,” Garland wrote.

As for marijuana’s potential for abuse, Garland cited findings that marijuana poses less of a health risk than illicit drugs and even some legal medications such as oxycodone and benzodiazepines.

“The rank order of the comparators in terms of greatest adverse consequences typically ranked heroin, benzodiazepines, and cocaine first or in immediately subsequent positions, with marijuana in a lower place in the ranking,” Garland wrote.

“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time. HHS thus concluded that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The opening of a public comment period does not mark the end of the rescheduling process. The DEA/DOJ will need time to review and evaluate thousands of comments, which will be followed by an administrative hearing and a final ruling that is subject to presidential review. Even then, the final rule has to be published in the Federal Register, followed by a 30 or 60-day wait period before the rule takes effect. 

During that process, and until a final rule is published, marijuana remains a schedule I controlled substance that is illegal under federal law. About three-quarters of states have already legalized marijuana for medical or recreational purposes.

DEA Report Downplays Role of Prescription Opioids in Drug Crisis

By Pat Anson, PNN Editor

After a three-year absence, the DEA’s National Drug Threat Assessment (NDTA) has returned, with a tacit admission by the agency that prescription opioids don’t play much of a role anymore in the nation’s drug crisis.

Prescription opioids are mentioned only a handful of times in the 57-page report, mainly within the context of their theft and diversion declining to levels not seen in over a decade.

“The DEA Theft/Loss Reporting Database reveals that the number of unaccounted-for narcotic prescription drugs (opioids) in 2022 was at its lowest level in 12 years and continued to decline into the first nine months of 2023,” the NDTA report states.

The DEA said the number of unaccounted-for opioids fell from 19.5 million pills/units in 2011 to just 4 million in 2023, an 80% decline.

Most of the focus in the 2024 NDTA is on illicit fentanyl, methamphetamine, and counterfeit medications that have become increasingly more toxic and deadly.

Nearly 108,000 fatal overdoses were reported in 2022, with fentanyl and other synthetic opioids – most of them illicit -- involved in 68% of drug deaths. The remaining overdoses were linked primarily to cocaine, methamphetamine and other synthetic stimulants.

“The shift from plant-based drugs, like heroin and cocaine, to synthetic, chemical-based drugs, like fentanyl and methamphetamine, has resulted in the most dangerous and deadly drug crisis the United States has ever faced,” DEA Administrator Anne Milgram said in a press release.

“At the heart of the synthetic drug crisis are the Sinaloa and Jalisco cartels and their associates, who DEA is tracking world-wide. The suppliers, manufacturers, distributors, and money launderers all play a role in the web of deliberate and calculated treachery orchestrated by these cartels.”

Most counterfeit medications in the U.S. are spiked with illicit fentanyl, a synthetic opioid 50 times more potent than heroin and 100 times stronger than morphine. In 2023, a DEA laboratory analysis found that about 70% of counterfeit pills contain at least 2 milligrams of fentanyl, a potentially deadly dose.

Fake pills are also increasingly being found with xylazine, a potent animal tranquilizer, and nitazenes, a synthetic opioid chemically unrelated to fentanyl. According to some estimates, nitazenes are 40 times more potent than fentanyl and 1,000 times more potent than morphine. Nitazenes have never been approved for medical use in the United States.  

Although Milgram called the NDTA “a critical tool for informing and educating the public about the current drug threats,” the DEA’s annual report literally disappeared from public view three years ago. The last NDTA was released in 2021.

The DEA did not respond to a request for comment from PNN on why a NDTA was not published for three straight years or why one was finally released this week.

The DEA has been under growing criticism for its failure to stop fentanyl trafficking and for imposing steep cuts in production quotas on drug manufacturers, which has contributed to record shortages of opioids, ADHD stimulants and other essential drugs.  

Sometimes, what is not disclosed in the DEA’s report can be just as revealing as what is. For example, while the DEA officially lists kratom as a “drug of concern” and even tried to ban the herbal supplement, the agency has never said a word about kratom in a NDTA report. Not in 2021. And not in 2024.

FDA and DEA Leaders Call for More ADHD Meds, But Ignore Rx Opioid Shortages

By Pat Anson, PNN Editor

Leaders of the Food and Drug Administration and the Drug Enforcement Administration say they’re working to end one of the worst drug shortages in decades.

“The lack of availability of certain medications in recent months has been understandably frustrating for patients and their families,” FDA commissioner Robert Califf, MD, and DEA Administrator Anne Milgram said in an unusual joint letter. “We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed.”

Those should be welcome words for pain patients across the U.S. who have trouble getting their prescriptions filled for opioid medication. Unfortunately, the letter has nothing to do with opioids. It’s only about shortages of Adderall and other prescription stimulants, which are used primarily to treat attention-deficit/hyperactivity disorder (ADHD).

The letter is the latest example of how the FDA and DEA have turned a blind eye to opioid shortages, which both agencies have played prominent roles in creating. Two widely used painkillers, oxycodone and hydrocodone, have been difficult to get for months, leaving thousands of patients in uncontrolled pain or going into withdrawal. Even big chain pharmacies like CVS are out of opioids or have a limited supply.   

“I had to once again follow up with CVS, just to be told they received absolutely nothing! Pain management provider in response sent another prescription to the outpatient pharmacy,” says Christine Kucera, a pain patient who recently wrote a column for PNN about her problems getting prescriptions filled for oxycodone.

“I'm currently sitting in the waiting area at the outpatient pharmacy, stressing, waiting for another bomb to drop.”

The American Society of Health-System Pharmacists (ASHP) first warned about a shortage of immediate release oxycodone in March. Over the next few months, hydrocodone/acetaminophen tablets (Vicodin) and oxycodone/acetaminophen tablets (Percocet) were added to the ASHP’s shortage list. Those shortages could soon grow even worse, because one of the largest generic drug makers in the world, Teva Pharmaceutical, is discontinuing production of immediate release oxycodone. 

Despite these warning signs, the FDA and DEA have yet to acknowledge shortages of either oxycodone or hydrocodone, and appear to be doing nothing about them. But they are moving to boost production of stimulants used to treat ADHD. The agencies say drug makers have sold only 70% of the stimulants they were authorized to produce.   

“We want to make sure those who need stimulant medications have access,” Califf and Milgram said in their letter. “We have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount.” 

“What this latest notice shows is that the FDA and DEA could get involved with the opioid shortage if they wanted to,” says Rick Martin, a retired pharmacist disabled by back pain. Martin recently had to switch to a weaker opioid for pain relief because he can’t find a pharmacy with hydrocodone in stock.

“Teva said they were going to stop making oxycodone. The DEA/FDA could be proactive and ask Teva to relinquish their remaining 2023 quota allotment, then redistribute to other manufacturers,” Martin told PNN. 

Lower Production Quotas

The DEA sets annual production quotas for opioids, stimulants and other controlled substances, working closely with the FDA in assessing demand. Last year, the FDA advised the DEA that demand for hydrocodone, oxycodone and other Schedule II opioids would fall by 5.3% in 2023, which resulted in another year of cuts by the DEA in opioid production. Since 2013, the supply of oxycodone has fallen by 65 percent and hydrocodone by 73 percent. 

The FDA also advised the DEA that domestic medical use of stimulants would fall by 0.1% in 2023, even while warning that shortages were developing. The DEA’s response last December was that amphetamine and other stimulants were overprescribed to patients who didn’t really need them, and that its proposed production quotas (APQ) for the drugs in 2023 would be adequate.

“The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs,” the DEA said in the Federal Register. “Based on this trend, DEA has not implemented an increase to the APQ for amphetamine at this time.”

That kind of background detail is missing from Califf’s and Milgram’s letter, which disingenuously claims that there is little that the DEA and FDA can do to ensure that there are adequate supplies of medication. 

“This is not a problem that the FDA and DEA can solve on our own,” Califf and Milgram wrote. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.” 

Only briefly do Califf and Milgram acknowledge that their own production quotas are part of the problem, saying they were “committed to reviewing and improving our quota process.” 

“These (stimulant) shortages were caused by the DEA, which limited the manufacture of these medications,” says Andrea Anderson, a pain sufferer and patient advocate. “This exact problem has affected patients who require opioid analgesics to manage their severe pain. It has been affecting them for over six years, yet we see no mention of the extraordinary difficulties these patients are experiencing trying to find pain medication.  

“The DEA has no reason to be involved in deciding how many prescriptions should be written for any medical condition. This is the purview of trained medical clinicians and quantities should not be dictated by law enforcement agencies.” 

Drug manufacturers are required to report shortages and supply interruptions to the FDA. Doctors, hospitals, pharmacies and consumers can also report supply problems by sending an email to drugshortages@fda.hhs.gov.

That’s where Christine Kucera recently sent an email addressed to the FDA commissioner.

“Three different medications used in my treatment are continuously unavailable, sometimes for weeks and months. CVS IS OUT, the system is not working, and all you do is NOTHING!” Kucera wrote to Califf. 

“When will you address the unethical treatment and harms being inflicted upon millions of US citizens directly caused by government practicing medicine, limiting and denying access to essential medicines based on biased and manipulated facts, reduced quotas, faulty CDC prescription guidelines that should never have been created; and the DEA who are making up their own rules, practicing medicine, and deciding what they think appropriate medical care is?”  

Second Patient Dies After DEA’s Suspension of Doctor’s License

By Pat Anson, PNN Editor

A second chronic pain patient has died as a result of the DEA’s suspension of a California doctor’s license to prescribe opioids and other controlled substances. 42-year Jessica Fujimaki died Saturday, December 10th at her home in Arizona, apparently due to complications caused by opioid withdrawal.

Jessica lived with Ehlers-Danlos Syndrome (EDS), arachnoiditis, stenosis and other chronic conditions that cause severe, intractable pain and left her bedridden. In the past year, she found relief through injections of the opioid hydromorphone every two hours, which allowed her to walk, have some quality of life, and take care of her husband and two children.   

That came crashing to an end in early November, when she learned from her pain specialist, Dr. David Bockoff, that his license to prescribe opioids and other controlled substances had been suspended by the Drug Enforcement Administration.

“She was frightened, because she knew what was going to happen to her if she didn’t have that medication,” said Tad Fujimaki. “There’s no way she could live without it.”

The Fujimakis were unable to find another doctor in Arizona willing to treat Jessica, and her health steadily deteriorated as opioid withdrawal set in. In desperation, they made two trips to Mexico to purchase oral opioids there, but were uncertain of the quality of medications they received.

JESSICA FUJIMAKI

A last-minute prescription for injectable hydromorphone from an out-of-state doctor failed to stop her cascading health problems. Her exact cause of death has yet to be determined, pending an autopsy.

Had the treatment that Jessica received from Dr. Bockoff continued, Tad believes his wife would still be alive today. He blames the DEA for her death.   

“Absolutely. DEA, government, all of them. If they didn’t stop the medication, if Jessica was still getting medication from Dr. Bockoff, this would have never happened,” he told PNN.

Like many patients with EDS, Jessica wasn’t diagnosed with the genetic connective tissue disease until well into adulthood. In 2020, when the Fujimakis lived in Hawaii, she had an epidural steroid injection for leg pain that made her condition far worse. Seeking better treatment, the family moved to the mainland.

“The one mistake we made was to move to Arizona,” said Tad, explaining they could find no doctors to treat Jessica near their Phoenix home.  

“Because she was too complicated a patient. They knew they can’t prescribe hydromorphone,” he said. “If we knew the state of Arizona was an anti-opioid state, then we probably wouldn’t have moved from Hawaii to Arizona. We’d have picked a different state.”

Like many other “opioid refugees” on high doses, Jessica searched for doctors out-of-state, eventually finding Bockoff, who has practiced medicine for over 50 years in California without any record of disciplinary action or complaints.

“I have no comment. A very unfortunate tragedy,” Bockoff replied in an email when asked about Jessica’s death.  

THE FUJIMAKI FAMILY

Another Bockoff patient who lived with intractable pain ran out of medication and died one week after the license suspension. Danny Elliott and his wife Gretchen were so distraught over his inability to find another doctor and get opioid treatment that they committed suicide in their Georgia home.

‘Imminent Danger to Public Health’

Why the DEA suspended Bockoff’s license is still not entirely clear. DEA agents searched his office in September, 2021 and confiscated the medical records of 240 patients, which they later returned.

Although a DEA notice of the suspension – signed by DEA administrator Anne Milgram -- states that Bockoff posed “an imminent danger to the public health,” his license was not suspended until 14 months after the initial search, when he was accused of violating the Controlled Substances Act when treating five patients.

Those allegations primarily deal with improper record-keeping and prescribing high doses of opioids that could potentially be diverted or abused. But there is no indication that any harm was caused to the five patients while under Dr. Bockoff’s care, or that they sold or abused the opioids he prescribed.

While Bockoff appeals his suspension, 11 of his patients have hired a lawyer and tried – unsuccessfully so far -- to sign on as intervenors, so they could participate in DEA hearings on the case. One of them was Jessica Fujimaki.

“With the suspension of Dr. Bockoffs license, I am left without care again. It took over a year to find the protocol that work for me and allowed me to have some quality of life,” Jessica wrote in a statement to the DEA.

“I was very fortunate to find Dr. David Bockoff, who accepted me as his patient and has been able to treat me in accordance with the treatment protocol that works for me. This treatment protocol changed my life and gave me hope,” she wrote. “I am able to walk most days unless I am in a huge flare. Without Dr. Bockoff's care and prescribed medication, I would be bedbound, unable to walk, unable to function, and certainly unable to care for my children.”

A DEA Administrative Law Judge declined to let Jessica and the other patients participate in a pretrial conference on November 28, but has not officially rejected or approved their motion to intervene in future hearings. The patients are considering other legal avenues.

Whatever happens, it’s not likely to happen in time to prevent future tragedies. Under DEA rules, doctors have 30 days to appeal their license suspensions. Legal experts say the process can then take months or years to resolve – too long for patients like Jessica and Danny Elliott, who suffered needlessly and didn’t have time to wait.