“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
There is a term in pharmacology – LD50 – it is the dose that 50% of the animal/human taking such a dose – 50% would die ! https://go.drugbank.com/drugs/DB00813
Fentanyl has an intravenous LD50 of 2.91mg/kg in rats1, an oral LD50 of 18mg/kg in rats and 368mg/kg in mice.MSDSThe LD50 in humans is not known.
This is all I could find regarding LD50 for Fentanyl, but according to Wikipedia there is some 400 known different analogs of fentanyl… and the FDA approved analog – citrate – is claimed to be about twice the potency of the analog (acetate) that is typically used in illegal fentanyl tabs from the Mexican cartels.
“back in the day” we kids had “connect the dots” graphic that would display some sort of image when all the dots were connected. Over the last few weeks, I have seen where numerous federal entities or members of Congress are publicly sharing “dots” of information about the war on drugs. Such things as the attached video where the “expert” testifying on a trial, showing the cartels and the routes of distributions used by the various cartels and that the DEA has been fully aware of all of this for maybe TWO DECADES.
Recently on a national new program it was stated that 379 MILLION illegal fentanyl tabs were confiscated in the USA in the last calendar year and/or last federal fiscal year and just this week a member of Congress from Arizona on national TV program and the millions of illegal fentanyl tablets that are being released to the media only represents 8% to 15% of what actually comes across the border.
So this would mean that anywhere from 2.52 BILLION to 4.7 BILLION is coming across our boarders every year. This means that 2.15 BILLION to 4.32 BILLION illegal fentanyl tablets actually gets to our streets.
I am not sure what this means, it is around the change of practitioners treating pts who are addicted or diagnosed with Opiate Use Disorder. What interpretations that the DEA generates in the future – one can only guess –
From March 8, 2022, to March 18, 2022, a U.S. Food and Drug Administration investigator inspected your facility, Optum Infusion Services 308 LLC, located at 2555 West Fairview Street Suite 104 Building D, Chandler, Arizona 85224. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.
FDA issued a Form FDA 483 to your firm on March 18, 2022. FDA acknowledges receipt of your facility’s response, dated April 8, 2022. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Compounded Drug Products Under the FDCA
Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].
B. Violations of the FDCA
Adulterated Drug Products
The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:
1. You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area. Vermin are a source of microbial contamination. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.
2. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.
3. An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.
It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.
C. Corrective Actions
We have reviewed your firm’s responses to the Form FDA 483. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:
1. In response to Observation 5 of the Form FDA 483, you stated that you changed pest control providers, installed insect light traps, and that you will be installing air curtains on exterior doors and plastic flap curtains inside of the warehouse door. It is unclear where the insect light traps, air curtains, or vortex curtains will be installed in relation to the classified areas. Additionally, it is unclear when these corrective actions will be fully implemented.
2. Regarding your response to Observation 1 of the FDA 483, we acknowledge your response indicating that you will update the way you assess and document the risk associated with every “patient compound” potentially affected by an excursion and train staff on the new policy. Also, you stated that you have conducted a retrospective review of “compounds” referenced in the observation and found there to be no product or patient impact. However, your response lacked supporting evidence, for example, you did not provide the retrospective review referenced. Furthermore, we acknowledge your response states, in SOP Compounded Sterile Product Impact Assessment Process, that a low risk level would be determined by the pharmacist in charge (PIC) based on the actionable microbial growth. Please note, any microbial contamination in the ISO 5 area is considered an insanitary condition.
Additionally, your response states, in SOP Compounded Sterile Product Impact Assessment Process, that “(b)(4).” Please note, any microbial contamination within the ISO 5 area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.
3. In response to Observation 2 of the Form FDA 483, you stated that you provided on-site training to staff. However, you did not provide the attachment Aseptic Technique Evaluation Update 04072022 referenced in your response.
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.
D. Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time in which you will do so.
Send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV U.S. Food & Drug Administration 19701 Fairchild Road Irvine, California 92612-2506
Please identify your response with unique identifier 647842.
If you have any further questions, please contact Nayan Patel, compliance officer, by email at Nayan.Patel1@fda.hhs.gov or by phone at (303) 236-3010.
Sincerely, /S/ Steven E. Porter, Jr. Program Division Director Division of Pharmaceutical Quality Operations IV
CC: Keith McFalls, Regional Vice President (via e-mail k.mcfalls@optum.com) 3428 Wild Oaks Court Burleson, TX 76028 (817) 676-8760
A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.
On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Texas, prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.
Instead, the injection ended up increasing her pain.
“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)
Jessie remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department (ED), staff ordered a “STAT MRI” in preparation for an emergency laminectomy.
For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself it wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)
During the wait, Adams continued to experience excruciating pain. “I kept screaming, ‘Help me,’ ” she recalls today. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.
The hospital disagreed. In court, it maintained that Adams was already paralyzed when she arrived at the ED and that there was no delay in care.
The jury saw things differently, however. Siding with the plaintiffs, it awarded Adams and her husband $10.1 million, including $500,000 for Richard Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.
Their music career now effectively over, Richard spends most of his time taking care of Jessie.
BRATTLEBORO — Eye all the photos, postcards and news clippings that paper Mary Giamartino’s office, and you’ll see how the Hotel Pharmacy opened at downtown’s Brooks House in 1940, then kept its name when it moved to the old fire station in 1978 and to the former Methodist church in 1993.
But just past the store shelves lit by century-and-a-half-old stained-glass windows is a stack of bills that illuminates an even bigger contrast.
Take the prescription for the pain reliever hydromorphone. The pharmacy bought it for a patient at $189.12. Yet, after the customer’s $10 copay, insurance reimbursed only another $15.21.
“I lost $163.91,” Giamartino said. “But do you not fill it? No, this woman was dying.”
And so, as a result, is the local independent drugstore — a shooting star outside a larger galaxy of corporate insurers, big-box pharmacies and generic manufacturers.
“Loss, loss, loss, loss, loss, loss, loss …” Giamartino said as she ran her finger down record after record calculating what’s charged versus what’s collected. “It just kept getting worse and worse and worse and worse and worse and worse. Like beyond worse.”
That’s why the Brattleboro mom-and-pop will close for good Tuesday after 83 years, dispersing customers to one of the town’s four chain drugstores while dropping the number of Vermont independents from upward of 50 a decade ago to 16 today.
“Insurance company reimbursements to us are so low, we can’t make any money,” Giamartino said. “It just got to the point where there was nothing else I could do.”
The 67-year-old didn’t envision her current predicament when she and her fellow pharmacist husband, Frank, bought the business in 1982. Working more collaboratively than competitively, the drugstore was one of three downtown seemingly founded by Mr. Gower in the film “It’s a Wonderful Life.”
Moving to the former Methodist church, the metropolitan New York family hung Mets baseball banners under the vaulted ceiling, rock-riffing stereo speakers where the choir once sang, and snapshots everywhere else of sons Vincent and Nicholas — the latter pictured on a school bus alongside classmate (and current state treasurer) Mike Pieciak.
Then came tragedy. In 2001, Nicholas died in his sleep from an infection at age 17. Five years later, in 2006, Frank was killed in a car crash at age 53.
“The only good thing about this,” the wife and mother told the local paper upon her husband’s death, “is that every day he won’t have to wake up and say, ‘I love you, Nick. I miss you.’”
Brattleboro’s Hotel Pharmacy has operated out of the town’s former Methodist church since 1993. Photo by Kevin O’Connor/VTDigger
Giamartino has run the business ever since, heading a team of 20 employees who offer 24-hour emergency service, local delivery and the ability to compound medication in-house.
“They go out of their way to support the clientele,” said Karen Peterson, outgoing executive director of the AIDS Project of Southern Vermont. “It doesn’t matter who you are or what your status is in the community. You feel cared for there. You are an individual, not a number.”
Hotel Pharmacy has stood alone after the closure of Brattleboro’s three other mom-and-pop drugstores. Statewide, it has seen counterparts recently shuttered or sold to larger outfits in Bennington and Manchester; Bristol, Middlebury and Vergennes; Rutland; and Woodstock.
Independent drugstores hope a new Vermont law boosting state regulation of pharmacy benefit management will start to stem the losses.
“Pharmacies are not in control of their financials — we don’t control the cost of the medications, nor do we control the reimbursement,” said Jeff Hochberg, president of the Vermont Retail Druggists Association. “Every state in the country is feeling this, rural ones in particular. I think that pharmacy is a great bellwether for true reform of the health care system.”
The Vermont Department of Financial Regulation is set to release a report on the issue this month. But it’s too little too late for Hotel Pharmacy, which has waded too many years in red ink.
Giamartino tried to cut costs by dropping advertising, then donations to community causes, then staff raises and bonuses. This past year she looked for someone to buy the business.
No one made an offer.
“A friend said, ‘Mary, it’s going to break your heart. Get ready.’ And I said, ‘I bet everything I have that it won’t.’ I was wrong.”
And so Giamartino reached out to Brattleboro’s two chains, Rite Aid and Walgreens, before deciding to pass on her customer files to the latter upon the close of business Tuesday.
No one is happy with the ending, as seen on social media or heard through talk about town.
“We made sure our patients would be OK,” said Jodi Harrison, a pharmacy technician for three decades. “Now we’re not sure who’s going to make sure.”
Giamartino is set to sell the building, but not before gathering the photos, postcards and clippings that hold so many memories.
“I am going to remember working with a wonderful group of people that gave the best possible pharmacy care that anybody could,” she said. “There’s nothing like helping somebody, making them feel better, letting them die the way they want to die.”
Even if, as she understands firsthand, they ultimately don’t want to.
A sign reports the coming closure of Brattleboro’s Hotel Pharmacy after 83 years. Photo by Kevin O’Connor/VTDigger
Starting Jan. 17, veterans in acute suicidal crisis will be able to go to any VA or non-VA health care facility for emergency health care at no cost – including inpatient or crisis residential care for up to 30 days and outpatient care for up to 90 days. Veterans do not need to be enrolled in the VA system to use this benefit.
This expansion of care will help prevent veteran suicide by guaranteeing no cost, world-class care to veterans in times of crisis. It will also increase access to acute suicide care for up to 9 million veterans who are not currently enrolled in VA.
“Veterans in suicidal crisis can now receive the free, world-class emergency health care they deserve – no matter where they need it, when they need it, or whether they’re enrolled in VA care,” said VA Secretary for Veterans Affairs Denis McDonough. “This expansion of care will save veterans’ lives, and there’s nothing more important than that.”
VA has submitted an interim final rule to the federal register to establish this authority
· Provide, pay for, or reimburse for treatment of eligible individuals’ emergency suicide care, transportation costs, and follow-up care at a VA or non-VA facility for up to 30 days of inpatient care and 90 days of outpatient care.
· Make appropriate referrals for care following the period of emergency suicide care.
· Determine eligibility for other VA services and benefits.
· Refer eligible individuals for appropriate VA programs and benefits following the period of emergency suicide care.
Eligible individuals, regardless of VA enrollment status, are:
· Veterans who were discharged or released from active duty after more than 24 months of active service under conditions other than dishonorable.
· Former members of the armed forces, including reserve service members, who served more than 100 days under a combat exclusion or in support of a contingency operation either directly or by operating an unmanned aerial vehicle from another location who were discharged under conditions other than dishonorable.
· Former members of the armed forces who were the victim of a physical assault of a sexual nature, a battery of a sexual nature, or sexual harassment while serving in the armed forces.
If you’re a Veteran in crisis or concerned about one, contact the Veterans Crisis Line to receive 24/7 confidential support. You don’t have to be enrolled in VA benefits or health care to connect. To reach responders, Dial 988 then Press 1, chat online at VeteransCrisisLine.net/Chat, or text 838255.
Two years ago, I summarized all of the RCTs for PRP used to treat knee arthritis. It’s now time for an update, especially with the recent craziness around fake PRP studies. Let’s dig in.
What Is an RCT?
The top level of research quality is called an RCT or Randomized Controlled Trial. Usually, two treatments are compared and the study participants are randomly assigned to one group or the other. The type of patients admitted and how they’re treated is rigorously controlled.
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If you click on the image above, you get taken to a PDF and each circle is a link out to a study. The studies are listed by their category, for example, “Vs HA” means that the study compared the efficacy of PRP versus HA for the treatment of knee OA.
The Fake PRP Study Issue
I’ve blogged already on new studies that purported to use PRP but really used something much less concentrated (i.e. Bennell et al) that didn’t meet the definition. These fake PRP studies showed that what they used didn’t work. However, even if a footnote is needed, those studies have to be added into the total body of PRP literature, hence it was time for an update.
Here’s my latest PDF summarizing everything I found in the US National Library of Medicine as of yesterday:
There are now 39 RCTs (there were 32 in 2020) with 37 showing that PRP is effective in the treatment of knee OA (blue circles) and 2 showing that it didn’t work (red circles). One of those is a small study comparing PRP to plasma and saline. The other is the Bennell et al study I have already reviewed on the blog.
Here is the total number of patients (n) represented above that were part of studies where PRP worked (Pro) versus PRP was ineffective (Con):
If we just include larger studies of 150 patients or more in the same league as Bennell et al, this is that comparison:
If we increase that to 200 patients, then it’s 4 to 1.
The upshot? PRP RCTs continue to show overwhelming evidence that the treatment is safe and effective for the treatment of knee osteoarthritis. There’s so much published to date that’s it’s hard to draw any other conclusion. However, even if the Bennell et al study didn’t use PRP, given that it claimed to, it needs to be included in the body of literature, even if it needs a major footnote.
Radiofrequency is a technology I’ve covered many times on this blog. It’s basically a way for doctors to burn away the nerves causing pain. It’s becoming increasingly popular in the knee, so let’s review that today. In addition, we’ll review combing RF of the knee nerves with orthobiologics and whether that makes sense.
What is RFA or RFN?
RFA stands for Radiofrequency Ablation, and RFN for Radiofrequency Neurotomy. In the context of pain medicine, these are both the same procedure where the doctor guides a needle called a “probe” to a nerve that transmits pain and uses radiofrequency energy to heat the tip of the probe to destroy the nerve. How does that help? The nerve is cooked and ablated, so its cells cannot carry pain signals. That generally means that the body part innervated by those nerves is no longer painful, but that only lasts until the nerve grows back.
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The knee has geniculate nerves that take most of the pain signals, as shown below:
Credit: Shutterstock
These nerves can be “cooked” using RF, and this can reduce knee pain. In general, the research shows that this procedure works but is of low quality (1).
How well does this work? There is only one randomized trial with a small number of 19 patients who received either RF or a sham, and only 59% of those patients reported more than 50% relief at three months (2). Other studies were of lesser quality, including one that compared RF to knee steroid injections which showed that it worked better at six months, but half of the patients were lost to follow-up because they had other procedures like knee replacement by 12 months (3). Other studies have been sponsored by industry or have lacked blinding (4-8).
It’s well known that if you denervate a joint that the structure deteriorates more rapidly. In medicine, this is called a Charcot joint (9). In the third world, we know that this can be caused by venereal disease that destroys the knee nerves, and in the first world, diabetes does the same thing. In fact, you can create diabetes in a rat by feeding it a high-fat diet and running it on a treadmill, which destroys the nerves in the leg through diabetic peripheral neuropathy, which ultimately destroys the joints in the legs (10).
In summary, we know that the destruction of the nerves in the knee leads to a mess of a knee joint. So rather than increasing the time before the patient needs a knee replacement, we’re likely accelerating the need for that surgery by using RFA/RFN.
RFN+Orthobiologics?
It recently came on my radar that several Florida clinics are offering knee RFN and then combining that with a PRP shot. So putting those concepts together, the RFN likely accelerates arthritis while the PRP may help arthritis? That’s like buying better tires for your car and then driving them over a bed of nails. As a physician-patient, I would never sign up for that treatment.
The Divide in Pain Medicine: What Insurance Will Cover vs. What’s Good for the Joint
I’ve blogged many times on the problem with high-dose knee steroid shots. We know they destroy the knee joint and make that patient more likely to get an infection once the joint gets replaced. However, steroid shots are still very common because they’re widely covered by insurance. So physicians are choosing to destroy the joint rather than using something like PRP, which could help the joint.
It’s the same game with RFN of the knee; only the reimbursement is much better. For example, for a knee steroid shot, the doctor is typically paid about $70 in the office. For a knee RFA/RFN, if you own the surgery center where the procedure is done, the total reimbursement between professional and facility fees can be several thousand dollars.
In both cases, the physician is choosing to do something that physicians have been taught will wreck the joint in exchange for a 6 in 10 chance of helping the knee pain. Why? The answer will be the same old adage, “because it’s covered by insurance.”
The upshot? As I get older and my knees need treatment, I won’t be signing up to have anyone destroy my geniculate nerves. I’ll stick with PRP, which has much better evidence supporting it works, and because, more likely than not, it will decelerate the progression of arthritis rather than accelerate it like RFA/RFN!
CASE 22-6000: U.S. SUPREME COURT FAILURE TO GRANT CERT PETITION “CLEMENT vs. DEA,” INADVERTENTLY SANCTIONS DEA’s MIS-BEHAVIORS, ABUSES AND PAIN PATIENT’S DEATHS
Leo Beletsky of Northeastern calls the government crackdown on prescribers getting indicted low-hanging fruit. “The DEA measures success based on the number of arrests and prosecutions. Doctors are minor players. The DEA convicted two hundred sixty-three physicians on charges between 2003-2017, and over 3000 were forced to surrender their licenses.
The flags created during the pill mill era are now self-perpetuating. If you mine data enough, you might find something, and law enforcement can access data without individualized suspicion, probable cause, or any judicial review.
“Numbers alone can’t determine whether a crime has been committed: The ‘normal’ amount of opioid prescribing for a physician treating pain or addiction will inevitably be much higher than the average for all doctors or the typical amount in most other specialties.”
THEY CREATE THEIR TARGETS: POMPY PAIN AND PROSECUTION
WEST VIRGINIA vs. EPA
“The Supreme Court’s recent decision in West Virginia v. EPA reminds us that oftentimes an agency must point to “clear congressional authorization” for the authority it claims. No. 20-1530 (2022) (slip op. at 17-19).
In “extraordinary cases”, those in which “history and the breadth of the authority that [the agency] has asserted, and the economic and political significance of that assertion, provide a reason to hesitate before concluding that Congress meant to confer such authority”, prec- edent advises that an agency must point to “clear con- gressional authorization” for the authority it claims. Id. at 17 (quotations and citation omitted). The DEA’s interpretation of § 1306.04(a) is clearly an “extraordinary case” given the Court’s findings in Gonzales, 546 U.S. at 265-66.”
FROM THE PHARMACIST STREVE FILES
DOJ-DEA HELL BENT ON GETTING AROUND RUAN
“Jessica Fujimaki suffered from a rare disorder called arachnoiditis. A common cause of this very painful and irreversible health issues is a error or “sloppy technique” of a practitioner doing a ESI procedure ( Epidural Spinal Injection). Anything that is injected into the spinal fluid must not only be sterile but must be preservative free and only a SOLUTION – NOT A SUSPENSION. ESI involve the injecting of a corticosteroid in the EPIDURAL SPACE – NOT IN THE SPINAL FLUID.
Jessica Fujimaki, 42, died in December, shortly after the DEA shut down her pain doctor. Image via GoFundMe campaign.
If the practitioner pushes the needle “a tad too far’ and accidentally injects the corticosteroid into the spinal fluid and the patients ends up with a VERY PAINFUL and IRREVERSIBLE MEDICAL ISSUE. Outcomes – such as Jessica Fujimaki – is potentially what happens when these patients lose any/all pain management. Likewise for Danny & Gretchen Elliott,
COURT IGNORING THE PHARMACY BENEFIT MANAGER SCRIPT SCAMS
The DEA ShutS Down a Pain Doctor. Now three People Are Dead
Dr. Bockoff has shown compassion beyond any doctor I have ever worked with, he is well versed in medicine and is cutting edge. my doctor for life, just try him once and you’ll never go back! the staff has become family to me.
“After a California doctor was labeled an “imminent danger” to the public, the consequences were devastating for his patients and their families.
First, there was the double suicide—a husband and wife from Georgia who took their lives one week after the Drug Enforcement Administration (DEA) suspended the license of their doctor, David Bockoff, a pain specialist in Beverly Hills. After Bockoff lost his ability to prescribe fentanyl and other powerful painkillers on Nov. 1, dozens of his patients became “opioid refugees” with nowhere to turn. The third death came barely a month later.
Another ex-Bockoff patient, 42-year-old Jessica Fujimaki, died Dec. 10 at her home near Phoenix. Autopsy results are pending, but her husband told VICE News he believes the cause of death was complications related to opioid withdrawal and medical conditions that caused severe chronic pain. She left behind two daughters, ages 13 and 11.
The DEA alleges Bockoff prescribed “alarmingly high dosages” of opioids to multiple patients, posing an “imminent danger” to the public. The doctor—who does not currently face any criminal charges—is attempting to fight back in civil court, denying any misconduct and alleging that DEA agents are the ones responsible for harming the public by effectively shutting down his practice with no consideration for people who relied on medications he prescribed.
“Much like a diabetic is dependent on insulin,” Bockoff’s attorney wrote in one court filing, “taking away the controlled substances allowed only by prescription from a DEA registered physician can be life threatening.”
On Tuesday afternoon, a federal judge in Los Angeles denied Bockoff’s request to override the DEA and restore his authority to prescribe, citing “serious concerns about the improper dispensing of highly addictive and frequently abused substances that can have devastating consequences.”
But exclusive interviews with Bockoff patients and court documents reviewed by VICE News make it appear as though the devastation came only after the DEA intervened against Bockoff, sending his patients into desperate spirals to stave off withdrawals and manage their pain.
Jessica Fujimaki’s husband Tad said his wife was a gymnast and ballroom dancer when she was younger, but she suffered from a rare disorder called arachnoiditis, which in recent years combined with other health problems to leave her unable to function without pain medications.
FROM OKLAHOMA TRIAL 2019 MORE THAN DEMONSTRATES DEA WAS WELL AWARE OF ILLICIT FENTANYL MARKET AND KNEW DRUG MANUFACTURERS, PHYSICIANS AND PHARMACIST DID NOT CONTRIBUTE TO THE SO-CALLED OPIOID CRISIS
Jessica began seeing Bockoff in late 2021. After years of the DEA cracking down on “so called,” over-prescribing and billions of dollars worth of settlements against the pharmaceutical industry for helping to create an overdose crisis, finding a pain doctor was no easy feat. While illicit fentanyl smuggled across the border by Mexican cartels is fueling record overdoses, prescription medications have become more tightly controlled, with doctors, pharmacists, and insurers becoming highly restrictive with opioids under the threat of DEA raids and civil litigation.”
THE CLAW BACK: WHY IT’S BETTER TO PAY CASH AS THE US SUPREME COURT IGNORES GAG CLAUSES AND REBATES
The 80-year-old Bockoff had been a specialist in the field for over two decades and was one of the few physicians willing to treat Fujimaki and others with complex conditions and dependencies on high levels of opioids. In court filings, his lawyers called him “the last option for many patients with severe chronic pain.” Records show a medical expert consulted by the DEA raised concerns about five patients on unusually large doses of fentanyl and other drugs.
In a phone call with VICE News, Bockoff said of those five cases flagged by the DEA: “They typify my patients—I try to give absolutely the best quality of care possible.” Court records show those five patients disagree with the DEA expert’s assessment and are willing to testify on behalf of Bockoff in his efforts to get his DEA license renewed.
Bockoff said he fell into pain management as a speciality 30 years into his medical career, taking satisfaction in improving the quality of life for people with excruciating conditions.
“There have been ups and downs through the decades with regard to the governmental view of opioids,” Bockoff said. “Hopefully we’re in a climate now where we’re a little more supportive of intractable pain patients, but I’m not sure.”
DEA TAKES ISSUE WITH BOCKOFF, HOWEVER LACKS ANY AUTHORITY TO DICTATE THE PRACTICE OF MEDICINE
“The DEA has also taken issue with Bockoff’s record keeping and patient intake process, but Tad Fujimaki said Bockoff was always professional with his wife’s treatment, requiring a thorough screening and regular check-ups to get prescriptions renewed. Her last visit was Oct. 31, a day before the DEA visited Bockoff’s office and suspended his license. Their pharmacy declined to fill the prescription, leaving her with a limited supply.
“It’s not like my wife could see a primary care provider and have him prescribe Percocet or something,” Fujimaki said. “No, it doesn’t work that way. We tried so many pain management doctors and nobody would take her because she’s so complicated.”
The Fujimakis ultimately resorted to taking a trip across the border from Arizona into Mexico, where they purchased opioid pills at a pharmacy to help Jessica manage withdrawals. “But the day before Thanksgiving shit hit the fan, basically,” he said.
It seemed like she was having a heart attack and couldn’t move, he recalled. She went to the emergency room and received some opioids, but not her normal prescription. She died two weeks later. Tad believes her death was caused by stress on her organs and high blood pressure linked to the withdrawals. She was stable until the upheaval caused by the DEA action against Bockoff.
“Whoever signed off on the decision to suspend Dr. Bockoff’s license must’ve had a healthy family to go back to,” Fujimaki said. “They just don’t understand why we need these medications. They don’t even think about it. But there are patients who need this medicine to have a decent quality of life.”
In court filings, lawyers for the DEA said Bockoff’s patients needed treatment because of “his unsafe practices contributing to their opioid dependency and addiction,” adding that, “while it would be regrettable that Dr. Bockoff’s patients may face hardships,” there are other resources available, such as detox and rehab programs.
The patients who arrived at Bockoff’s office after the DEA suspension received a list of emergency rooms in the LA area where they could be treated—not for their pain issues, but for their severe withdrawal symptoms from losing their prescriptions.
For the patients and their advocates, the notion that they were addicts or victims is absurd. One wrote a letter to the court in Los Angeles saying the doctor’s care had given them a new lease on life.
“This pain medication allows me to practice law and serve as a prominent traumatic brain injury litigator for the largest personal injury firm in California,” wrote the patient, identified by the initials E.C., in a letter reviewed by VICE News. “Dr. Bockoff counsels me on how to manage my pain and prescribes medication for me that allows me to manage my pain so I can be a contributing member of society.”
Another patient, identified by the initials D.L., wrote to the court that they and other Bockoff patients were “in unbearable pain and many contemplating suicide” since the DEA action.”
DEA STATED IN Scotus CASE 22-6000, “agency lacks authority to issue guidelines“
However, according to the DEA it lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine. The DEA DEA has not promulgated new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that may be prescribed on a single prescription on the duration of treatment intended with the prescribed controlled substance.
The DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards.
This is outlined in the DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain, 71 FR 52716.
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: Richard A. Lawhern, Ph.D. DATED FEBRUARY 12, 2021
1. (See exhibit 5-6F, Letter dated February 12, 2021, from Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, to Richard A. Lawhern, Ph.D. 3691 Nestling Lane Fort Mill, South Carolina 29708 lawhern@hotmail.com )
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: KEVIN NICHOLSON, RPH. DATED NOVEMBER 04, 2019
2. (See exhibit 5-4D, letter dated November 04, 2019, from Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control Division, to Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and Regulatory Affairs National Association of Chain Drug Stores1776 Wilson Boulevard Suite 200 Arlington, Virginia 22209)
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: Walter F. Wrenn MD DATED April 16, 2022
3. See letter dated April 16, 2022, from Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control Division, to Walter F. Wrenn, MD.
Further;
DEA’s Letter To Congresswoman Grace Meng, Member of Congress Sixty District of New York, DATED DECEMBER 18, 2021
“As a Law Enforcement agency, DEA is not in a position to authorize or dictate what a doctor prescribes to a patient. DEA cannot grant waivers of any kind when it comes to the practice of medicine because no such waiver exists as the United States’ component body charged with the management of controlled substances and chemicals for scientific, medical research, and industrial applications; the DEA regulates the flow of control substances, not the practice of medicine. The changing prescribing practices of practitioners are derived by a shift to prescribe medicine consistent with guidance issued by the Center for Disease Control and Prevention, along with guidance and recommendations of state boards of medicine.”
_________________________
CONGRESSWOMAN GRACE MENG
EXHIBIT 5-3C Norman Clement vs. DEA
MENG LETTER
3. (See exhibit 5-3c Congresswoman Grace Meng, Member of Congress Sixty District of New York, December 18, 2019). However, Pharmacists and pharmacies also get contradictory guidance from federal health agencies and even the DEA, which often disagrees with the plaintiffs’ theory that pharmacists should interfere with a doctor’s individualized medical judgment.(ibid 4)(5)
An undated image of Danny and Gretchen Elliott. Provided photo.
ANALYSIS
Therefore, Congress did not even leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances— without health care agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before initiating proceedings . . . [to schedule or reschedule a drug] . . . request from the [HHS] Secretary a scientific and medical evaluation, . . . The recommendations of the Secretary to the Attorney General shall be binding . . . as to such scientific and medical matters.”).
Jessica Fujimaki, 42, with her husband Tad.
Rev. Dr. Martin Luther King 1968
“Yes the hour is dark, evil comes forth in the guise of good. It is a time of double talk when men in high places have a high blood pressure of deceptive rhetoric and an anemia of concrete performance.”
Then how is it that, DEA through comes forth in the guise of good and in this time of double talk when both men and women sitting in high places (Supreme Court of the United States) have a high blood pressure of deceptive rhetoric of “except as authorize, knowing and intentionally,” which they have failed to enforce within an anemia of concrete performance???
In which David Bockoff MD., faces life in prison, Norman Clement a Pharmacist/Dentist and are both classified along with countless other medical professionals whom have been authorized as a street drug dealers and their properties stolen without due process under forfeiture laws while Jessica Fujimaki, Danny & Gretchen Elliott along WITH thousands of other are needlessly dead through United States Drug Enforcement Administration Unauthorized Authority.
FOR NOW, YOU ARE WITHIN
YOUAREWITHINTHENORMS.COM,(WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)
There is a term in pharmacology – LD50 – it is the dose that 50% of the animal/human taking such a dose – 50% would die !
Moving to the former Methodist church, the metropolitan New York family hung Mets baseball banners under the vaulted ceiling, rock-riffing stereo speakers where the choir once sang, and snapshots everywhere else of sons Vincent and Nicholas — the latter pictured on a school bus alongside classmate (and current state treasurer) Mike Pieciak.
