“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
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)
Medicare Advantage plans took the top spot in this year’s Shkreli Awardsopens in a new tab or window, the annual list from the Lown Institute that calls attention to some of healthcare’s most greedy and unethical behavior.
The plans’ penchant for defrauding or overbilling Medicare by an estimated $25 billion in 2020 alone by saying beneficiaries were much sicker than they actually were earned them their top marks, according to the Lown Institute.
Others who made the 2022 list included Texas hospice leaders who tried to hasten patients’ deaths to avoid losing federal funds; a Wisconsin dentist who broke patients’ teeth so they would need crowns; and a Virginia hospital that diverted federal discounts from its poorer hospital to its wealthier ones.
The annual ranking is named after pharma executive Martin Shkreliopens in a new tab or window, who raised the price of a life-saving drug for AIDS patients from $13.50 to $750 per pill, and who was sentenced in 2018 to seven years in prison for securities fraud. Patient activists, health policy experts, and journalists were among the judges.
Lown Institute president Vikas Saini, MD, told MedPage Today that this year’s list reads like “a tragic comedy of grift and profiteering.”
If the actions of these companies and individuals seem to be worse than in past years, Saini said that’s because governmental agencies and media organizations appear to be “more vigilant in calling out bad actors.”
Medicare Advantage companies were selected as the worst offenders because the prevalence of fraud was so overwhelming, Saini said: “It struck a chord with our judges.”
“It was pretty prevalent in that nine of 10 insurers in terms of market share were among those named, so it’s not just one or two bad actors,” Saini said. “If anything, it is their business model. A pervasive and systemic problem with immense costs that in my view really represent foregone opportunities to make us all healthier.”
MedPage Today, in a series of stories on the downsides of Medicare Advantage plans, focused on enrollees’ problems getting access to specialistsopens in a new tab or window, deceptive and fraudulent MA plan marketingopens in a new tab or window, and federal attempts to approve all TV adsopens in a new tab or window before they can air. The series also pointed to a federally approved commission structure that results in brokers receiving two or three times as much in commission for selling MA plans than Medicare supplemental plans.
The winners are:
1. Most large Medicare Advantage insurers now face federal accusations that they have been defrauding the Medicare program by mining patients’ charts for diagnoses that have resolved or which they never had, or exaggerating their severity. The amount of overpayment is estimated at $25 billion in 2020 alone, according to a New York Timesopens in a new tab or window investigation and numerous other investigations by the Office of Inspector General, as reported by MedPage Todayopens in a new tab or window. The huge amount of overpayments has raised questions about continued federal payment policies to these companies and the health of the Medicare Trust Fund.
2. Private equity-backed startup Noble Healthopens in a new tab or window bought two rural Missouri hospitals, then left employees with drug and supply shortages that led to unsafe conditions for patients. Noble also stopped paying for employees’ health insurance, despite deducting premium funds from their paychecks. Then Noble closed the two hospitals after taking $20 million in COVID relief funds.
3. Safety net hospitals that have a disproportionate share of low-income patients benefit from the federal 340B program, which provides hefty discounts on medications. But Richmond Community Hospital, in the Bon Secours Health Systemopens in a new tab or window, profited from this program even though it lacks an ICU, maternity ward, or even a consistently working MRI machine. It diverted profits incurred by Richmond to its other hospitals in wealthier, whiter neighborhoods, “basically laundering money through this poor hospital to its wealthy outposts,” according to a former Richmond ER doctor.
4. Leaders of Novus Hospiceopens in a new tab or window in Frisco, Texas provided their employees with pre-signed prescription pads with directions to give patients morphine and hydrocodone without guidance or oversight from physicians. CEO Bradley Harris instructed employees to give higher doses of the painkillers to hasten patient death. The goal was to avoid longer lengths of stay that would result in a cap on government reimbursement to the hospice.
According to the Federal Bureau of Investigation, Harris sent an employee a text message saying, “You need to make this patient go bye-bye.” The Lown Institute said it was unclear whether any patients were actually overdosed or died because of Harris’ instructions.
5. Johnson & Johnsonopens in a new tab or window sold talc baby powder products for years knowing that they contained asbestos, a deadly carcinogen. Now faced with lawsuits from 40,000 cancer patients, many of them Black women to whom J&J marketed its powder products, the company created a subsidiary with all the baby powder-related liabilities. Then, it declared this company bankrupt. It ranked in the top 50 of Fortune’s largest companies last year.
6. Tobacco company Philip Morris has spent 175 years selling cigarettes known to cause heart disease, chronic obstructive pulmonary disease, and other health problems. According to STAT Newsopens in a new tab or window, it now is reaping profits by acquiring companies that make inhaled therapeutics that treat the conditions cigarettes cause. The Lown Institute said that experts have concerns the company could use research on these inhalation therapies “to hook even more people” on their products.
7. Rather than counsel low-income patients on financial assistance programs they might be entitled to, Washington state-based Providenceopens in a new tab or window healthcare system instead “hounded them to pay and sent debt collectors after them when they didn’t.” The “Rev-Up” campaign, developed with help from corporate consultant McKinsey, directed employees to inform patients about financial assistance programs only as a last resort.
More than 55,000 patients were pursued by debt collectors when they should have been offered a discount. Providence told New York Times reporters that they stopped the practice and will issue refunds to about 760 patients.
8. Three North Texas laboratoriesopens in a new tab or window got $300 million more from Medicare by bribing physicians to order unnecessary drug tests and blood work. The founders of the three labs pleaded guilty to fraud in April 2022.
9. Catholic Medical Centeropens in a new tab or window in Manchester, New Hampshire, continued to let cardiac surgeon Yvon Baribeau, MD, operate on patients despite knowing his high number of malpractice case settlements, including some involving 14 patient deaths. Yet the hospital system continued to support him and promote him in ads. His malpractice record was said to be among the worst in the country.
10. Wisconsin dentist Scott Charmoliopens in a new tab or window went from fixing 434 crowns a year to 1,000 by breaking patients teeth starting in 2015. He “intentionally broke their teeth with his drill in order to convince the insurance companies to pay for the crowns. In March 2022, a jury found him guilty of five counts of healthcare fraud and two counts of making false statements to insurance companies.” He was sentenced to 54 months in prison and ordered to pay more than $1 million in fines.
Probably some definitions and explanations are needed here…. “Private Equity” is “businessmen”, for profit corporations that are acquiring office practices to MAKE MONEY out of owning there practices and often applying “common business practices” to lower overhead expenses and increasing profitability.
advanced practice providers (APPs) are also commonly known as mid-level practitioners ( NP, PA, ARNP, PharmD). Generally speaking, services/care/procedures provided by a mid-level, the entity they work for is reimbursed at abt 85% of what they would have been paid if it was provided by MD.
So, it would appear from this article, that these private equity firms that are buying these practice – in an effort to increase their bottom line – they are increasing the number of mid-levels to every MD on staff.
There’s More Clinician Replacement at Practices Acquired By Private Equity
These practices also saw increases in advanced practice providers versus those not acquired
When it comes to workforce composition at physician practices, differences abound between those that had recently been acquired by private equity (PE) firms and those that had not, according to a study that used longitudinal clinician-level data linked to PE acquisitions.
Among dermatology, ophthalmology, and gastroenterology practice sites from 2014 to 2019, PE-acquired practices had higher clinician replacement ratios compared with their non-PE-acquired counterparts (1.75 vs 1.37), as well as significant annual increases in the number of advanced practice providers (APPs), reported Jane Zhu, MD, MPP, of Oregon Health & Science University in Portland, and colleagues in Health Affairsopens in a new tab or window.
This was also the case for each specialty on its own:
Dermatology: 1.71 versus 1.28
Gastroenterology: 2.18 versus 1.93
Ophthalmology: 1.40 versus 0.98
Furthermore, entering physicians replaced exiting physicians at ratios of 1.50 and 1.14 in PE-acquired versus non-PE-acquired practices, respectively, and the replacement ratio for APPs was 2.51 in PE-acquired practices compared with 1.66 in non-PE-acquired practices, Zhu and team noted. This held true for both physicians and APPs across the specialties studied.
“Although these findings should be considered preliminary in nature, they raise important questions about the implications of PE ownership on the clinical workforce, particularly as PE investment accelerates across medical specialties,” the authors concluded.
Zhu told MedPage Today that “there may be both positives and negatives” when it comes to PE in the healthcare sector.
For instance, it is possible that hiring more APPs — such as physician assistants and nurse practitioners — might aid in expanding access to care to more patients, such as in cases when and where physicians are not readily available, she noted. But at the same time, it is possible that larger shifts in entrances and exits, and less longitudinal staffing may affect quality or continuity of care.
Overall, the topic “really does deserve further study,” Zhu said.
In addition, although the authors noted that they did not observe statistically significant changes for total physician counts, total counts of APPs per year increased at PE-acquired practices relative to non-PE-acquired practices (0.15, 95% CI 0.05-0.25, P=0.004).
At the individual clinician level, Zhu and colleagues found that the probability of both entering and exiting a practice was higher for physicians at PE-acquired practices compared with physicians at their non-PE-acquired counterparts. The estimated difference of entry for physicians was 15.74 percentage points (95% CI 10.79-20.69, P<0.001), and the estimated difference of exit was 6.0 percentage points (95% CI 1.91-10.07, P=0.004).
For APPs, the probability of entering was higher at PE-acquired practices compared with non-PE-acquired practices, but the difference was not statistically significant, the authors said. They further noted that they did not find evidence of differential probabilities of APPs exiting in PE-acquired practices compared with non-PE-acquired practices.
Replacement ratios were higher for younger physicians than for older physicians in both PE-acquired and non-PE-acquired practices: 1.70 vs 1.29 for physicians ages 40 to 60 and 0.50 vs 0.38 for those older than 60.
For this study, Zhu and colleagues examined a sample of 1,208 practice sites — including 691 in dermatology (1,735 clinicians), 166 in gastroenterology (741 clinicians), and 351 in ophthalmology (748 clinicians) — across the U.S. The PE sample included 422 dermatology clinicians at 112 practice sites, 259 gastroenterology clinicians at 45 practice sites, and 211 ophthalmology clinicians at 56 practice sites.
The authors combined several data sources to identify providers affiliated with PE-acquired versus non-PE-acquired practices, including Pitchbook (for mergers and acquisitions data), the IQVIA OneKey dataset (for individual provider-level and practice-level information), and the Medicare Physician and Other Practitioners dataset (to evaluate practice workforce turnover and composition over time.)
They then examined workforce change in three different ways. First they calculated clinician replacement ratios for PE-acquired versus non-PE-acquired practices. They also estimated whether practice-level entrants and exits differentially changed the total number of clinicians at PE-acquired practices versus non-PE-acquired practices. Finally they examined the probability of a clinician entering and exiting a PE-acquired practice versus a non-PE-acquired practice.
Zhu and colleagues noted that they may have missed some PE acquisitions, adding that it is also possible that there were some inaccuracies in how affiliations or clinicians were identified. Furthermore, the study did not estimate a causal effect of PE acquisition on workforce composition.
Anne Fuqua keeps a list of suicide deaths. She’s chronicled hundreds of cases of chronic pain sufferers who have killed themselves after losing access to opioid medication since 2014. Recently, she almost became an entry.
Ms. Fuqua, a former nurse, has an incurable genetic disorder that causes agonizing spasms and shaking. She can only function when she takes opioids. She’s one of the estimated five million to eight million Americans with chronic pain who regularly rely on them. But in November, her doctor’s license to prescribe controlled substances was suspended by the Drug Enforcement Administration — marking the second time she’s been left to fend for herself to avoid pain and withdrawal because of law enforcement action against a pain clinic.
Between the mid-1990s and the early 2010s, the number of opioid prescriptions written for Americans roughly doubled, driven by dishonest pharmaceutical marketing campaigns and unscrupulous entrepreneurs who opened so-called pill mills to sell drugs. Medical guidelines, legislation, law enforcement and other measures have since returned painkiller prescribing to pre-crisis levels. But because people who lose access to medical opioids are rarely provided with immediate treatment (whether they are experiencing pain or addiction or both), the result has been more overdose and suicide deaths, not fewer.
Despite these dismal facts, American medicine and law enforcement continue to fight the last war. Policymakers still operate under the assumption that too many opioids are being prescribed. Overdose deaths — including those among adolescents — are now overwhelmingly caused by street fentanyl, not prescription medications. And fatalities have nearly doubled since 2012, in concert with the decline of the medical supply.
To make matters worse, the D.E.A. has just reduced the permitted quota that opioid manufacturers can produce for next year by 5 percent — even though Kaiser Permanente, a major health insurer, recently told its patients that it may slash their doses because there is already a shortage. This scarcity, too, is linked to the last war:
Distributors and pharmacies promised to minimize availability as part of opioid litigation settlements. But this course correction can create difficulties for people who need opioids to function amid chronic pain.
Earlier efforts intended to help patients like Ms. Fuqua — and the millions of Americans like her — have failed. Both the Food and Drug Administration and the Centers for Disease Control and Prevention have issued warnings about the life-threatening dangers of cutting or ending opioid prescribing involuntarily. The C.D.C. even published revised prescribing guidelines in 2022, which emphasize that its recommendations are not mandates and that patient consent is important when determining whether to reduce or eliminate opioids.
Moreover, the Supreme Court ruledunanimously in June that only doctors who show provable criminal intent should be prosecuted for overprescribing. Nonetheless, the D.E.A. continues to target physicians who have large numbers of patients on high opioid doses or on combinations of opioids and other drugs that it considers “red flags.”
Ms. Fuqua estimates that she knows dozens of people who have lost more than one doctor to law enforcement action. When her most recent doctor’s license was suspended, she said, “there were no provisions for ongoing care for patients,” and added that the only thing she was given was a list of emergency rooms and a flier with the numbers for two addiction treatment hotlines.
“I am barely able to get by on my own,” she said, noting that the condition she suffers from, dystonia, “went from well controlled to not controlled at all.”
“Entire body is shaking and jerking 24/7,” she said.
Ms. Fuqua said she has contacted dozens of doctors trying to find care. She also called the C.D.C.’s Opioid Rapid Response Program, which is intended to help when pain clinics are shut down or large numbers of opioid patients lose doctors for any reason. “It was almost like they thought I was out of line, even ridiculous, for calling them,” she said. The program’s management admits it has difficulty finding physicians to help such patients, and is in the preliminary stages of considering proposals to study why they get rejected.
Patient advocates say the answer is simple: Doctors who agree to take significant numbers of chronic pain patients who need opioids rightly fear law enforcement scrutiny. Physicians with more than a few high-dose patients will immediately stand out in prescription monitoring databases, even if they are pain specialists.
So what can be done to help people with intractable pain that only responds to opioids? First, the surgeon general needs to send another letter to health care professionals, as Dr. Vivek Murthy did when he announced the publication of the 2016 C.D.C. guidelines for opioid prescribing. The new letter must inform providers about the 2022 update and, this time, strongly warn against involuntary dose cuts for existing patients as a way to reduce overdose risk. The initial guideline warranted this high level of national attention, and it hurt people in pain — surely an update intended to improve their treatment would deserve equivalent publicity.
Second, the U.S. attorney general needs to send a similar letter to the D.E.A. and to its prosecutors, instructing them to stop pursuing doctors simply because they prescribe high doses of opioids or potentially risky drug combinations. If there are no other signals of criminal intent, this is a matter of medical judgment and possible malpractice, not an issue that should be handled by federal law enforcement. And when agents find physicians who actually are dealing drugs, they and agencies like the C.D.C. need to ensure that there is no disruption in pain or addiction care for patients, before busting doctors.
Patients who are abandoned to withdrawal and untreated pain have an increased overdose death risk of nearly 300 percent, and their risk of suicide is also significantly elevated. If thousands of them hadn’t been cut off in the first place, the enormous street fentanyl market that now exists might have been minimized rather than given rocket fuel. It is both cruel and nonsensical to increase patients’ risk of overdose death and suicide in an attempt to reduce these harms.
To permanently solve this problem, Congress needs to pass legislation to provide a safe harbor for patients with intractable pain and their doctors. People like Ms. Fuqua who have a clear, documented need for opioids should not have to live as though each time they successfully pick up a prescription it’s a “stay of execution,” as she put it.
It is not the fault of people who suffer pain that America has an addiction problem. Denying them access to needed medication helps no one. At least one man and his wife have already died by suicide following the closure of the clinic Ms. Fuqua attended.
Her list now contains 932 suicide deaths, 235 of which are documented with materials like news articles, suicide notes, family accounts and medical records and include the patients’ full names; the rest are culled from sources that do not include names, such as medical case reports. She should never have to add another entry.
A Medscape report that explores how physicians prioritize substance abuse among leading American social issues also reveals their divergent views about a proper role in pain management through opioids.
The Centers for Disease Control and Prevention last month updated its guidelines for prescribing opioids to adults with acute and chronic pain. In part, the new guidelines 1) urge clinicians to maximize use of nonopioid therapies, 2) support lowest effective dosages and immediate-release drugs when physicians do turn to opioids, and 3) ask doctors to prescribe no greater quantity of opioids than needed for the expected duration of the patient’s pain.
Some survey respondents in the “Substance and Opioid Abuse Report 2022: Drugs and Alcohol Are Challenging Problems for Physicians and Their Patients” believe doctors still overfocus on pain management and 0-to-10 pain scales, even during the nation’s opioid crisis.
“It’s easy to become addicted to opioids when [physicians are] using a pain scale in the hospital and stating that post-op patients should be encouraged to use meds when they are at a 3,” an ob/gyn said. “If patients were told to expect significant post-op pain going into surgery, then they would have appropriate expectations post-op.”
“Our MIPS forms tell us that we need to present a plan if a patient complains of pain greater than zero,” a rheumatologist respondent added. “Primary care people feel compelled to treat pain. This has resulted in a far more cavalier use of opiates, because other medications have failed.”
And a toxicologist felt continuing “pressure on doctors for their overprescribing during the opioid crisis” would be a positive for society.
Beware Unintended Consequences
But some physicians in the Medscape survey felt the pendulum needs to swing back to more aggressive pain management, including prescribing opioids when appropriate. “Chronic pain and cancer pain patients are often undertreated by MDs, pharmacists, nurses, and support staff,” one internist argued. “These caregivers are not educated properly on pain control, and that is so unfortunate.”
A number of other doctors pointed to unintended consequences for which they said champions of stricter oversight of opioid prescribing cannot avoid responsibility.
“I think the government’s crackdown on physicians…has actually worsened” the opioid crisis, a gastroenterologist said. “Now, people are more often going to the streets and are getting fentanyl-laced drugs, resulting in accidental deaths. It’s a big problem.”
That viewpoint was backed by an orthopedic surgeon.
“Discouraging legal prescriptions doesn’t cure opioid use disorder,” he argued. “Other doctors and I are afraid to prescribe opioids, which is a boon to the illegal drug trade. Opioid prescriptions have been nearly cut in half in 10 years due to the new guidelines and rules, but overdoses and illegal opioids have nearly doubled.”
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. If the practitioner pushes the needle “a tad too far’ and accidentally injects the corticosteroid into the spinal fluid and the pt ends up with a VERY PAINFUL and IRREVERSIBLE MEDICAL ISSUE. Outcomes – such as Jessica Fujimaki – is potentially what happens when these pts lose any/all pain management. Likewise for Danny & Gretchen Elliott, As long as our law/judicial system is entitled to qualified immunity https://leb.fbi.gov/articles/legal-digest/legal-digest-qualified-immunity-how-it-protects-law-enforcement-officers it would seem that they will do as they damn please and they have no consequences.
The DEA Shut Down a Pain Doctor. Now 3 People Are Dead
After a California doctor was labeled an “imminent danger” to the public, the consequences were devastating for his patients and their families.
Jessica Fujimaki, 42, died in December, shortly after the DEA shut down her pain doctor. Image via GoFundMe campaign.
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.
Jessica began seeing Bockoff in late 2021. After years of the DEA cracking down on 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 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.”
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.
“No human being, already going through such a difficult life of pain, should have their only relief and hope pulled out from underneath them in a moment, with absolutely no advance notice to prepare, at a time and environment when the vast majority of pain doctors aren’t even taking new patients,” the patient wrote.
Another Bockoff patient, 61-year-old Danny Elliott died by suicide on Nov. 7, 2022, along with his wife Gretchen. Danny left a post on Twitter saying Bockoff was his third pain doctor to be shut down by the DEA since 2018. They tried to find another doctor with no avail, and although Gretchen was not a pain patient she chose to end her life at the same time as her husband.
An undated image of Danny and Gretchen Elliott. Provided photo.
Danny’s brother, Jim Elliott, shared an excerpt from a note Danny left behind after his suicide: “I just can’t live with this severe pain anymore, and I don’t have any options left,” he wrote. “There are millions of chronic pain patients suffering just like me because of the DEA. Nobody cares.”
Experts have warned for years that abruptly cutting off opioid users increases the risk of overdose and death, and authorities responded by forming the Opioid Rapid Response Program, “an interagency, coordinated federal effort to mitigate drug overdose risk among patients impacted by law enforcement.”
According to statements from the DEA and Centers for Disease Control and Prevention issued previously to VICE News, the Opioid Rapid Response Program was called into action when Bockoff’s license was suspended. But the CDC said that while it can notify local public health agencies and other stakeholders, it does not receive lists of affected patients or offer any direct outreach or resources to those affected, such as connecting them with another pain specialist.
In effect, patients like the Elliotts and Fujimakis—who have done nothing beyond taking medications prescribed by their doctor—are abandoned and forced to navigate the system with no support from the authorities that upended their lives in the name of public health and safety.
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A former CDC staffer who helped develop the Opioid Rapid Response Program, Jennifer Carroll, described an effort with good intentions that has struggled to gain traction amid bureaucracy. Carroll, now a professor at North Carolina State University, blamed the DEA for much of the dysfunction.
“These clinic closures are outrageously disruptive—I’m surprised more people aren’t dead,” Carroll said. “The DEA operates this culture of control and fear, justified by control of drugs, that prevents us from keeping people from dying. It not only causes the problem, it prevents the solution to the problem.”
Jessica Fujimaki, 42, with her husband Tad.
While the judge in Los Angeles declined to reinstate Bockoff’s license this week, he still has an opportunity to plead his case in the DEA’s administrative law courts, which adjudicate licensing disputes between doctors and the agency. Those proceedings are sealed from the public, but scheduled to start on January 19. Court filings reviewed by VICE News indicate both sides plan to call witnesses, with the DEA focused on Bockoff’s allegedly inadequate record keeping practices and the fact that he prescribed “several million dosage units for mainly opioids.” Federal authorities have also seized money from Bockoff, including over $140,000 cash (much of it Euros) from his home and nearly $1 million from his business bank accounts.
The money was seized through civil asset forfeiture (a process that will require the government to show it was acquired illegally in order to confiscate it permanently), and when asked about it Bockoff said he was unfamiliar with the legal process. He noted that he’s been paying out of pocket to keep his office open to help with patient referrals. He called the deaths of his patients who lost access to medication “recurring tragedies.”
“It apparently doesn’t matter to the DEA that they’re abruptly stopping patients’ medications,” Bockoff said.
The doctor, according to court filings, plans to testify in defense of his medical practices as he petitions the DEA’s administrative law judge to reinstate his license. Independently, a group of Bockoff patients has filed a rare attempt to intervene in the DEA administrative court, according to records obtained by VICE News.
John Flannery, a lawyer representing the patients, told VICE News in early December that they had so far received “no reaction from the administrative court” regarding their petition.
“The chronic pain patients continue to suffer without their medication,” Flannery said. “As far as we can tell, Dr. Bockoff was a healing physician and thus DEA’s false charges and the suspension of his authority to prescribe for his patients has created an ‘imminent danger’ to every one of 240 suffering pain patients.”
Another ex-Bockoff patient, Anne Fuqua, told VICE News that after the DEA action she was forced to start visiting a methadone clinic near her home in Alabama because she could not immediately find another chronic pain specialist who would treat her for a condition she described as similar to Parksinson’s disease, causing muscle spasms. While the methadone helped prevent withdrawals, Fuqua said, her pain has returned.
An activist in the chronic pain community, Fuqua has been tracking suicides since 2014 in cases where patients abruptly lost access to their medical provider. So far, according to a database she shared with VICE News, she’s tallied more than 1,000 deaths using obituaries and other public records. That staggering total, she said, is likely only the tip of the iceberg as many deaths go unreported as suicides.
Fuqua said she’s heard from other ex-Bockoff patients who are considering suicide because they can’t find another doctor. An informal support network has popped up, she said, but facing a medical system that seems indifferent to their plight makes it difficult to endure.
“I don’t want to die,” Fuqua said. “There are so many others. I have all these people calling saying ‘How are you doing?’ We’re all doing that to each other. It’s basically code for, ‘Are you alive?’”
Could this mean that as the number of prescribers who have completed the new obligatory requirement of taking the 8-hour training on managing patients with opioid and other substance use disorders that all pts that these practitioner who treat for chronic pain could be required to have at least a secondary diagnosis of “opiate use disorder” ? Could the feds make the requirement to take this 8-hour training retroactive for all prescribers when they renew their DEA license – which is every THREE YEARS. In theory, every chronic pain pt could be diagnosed with opiate use disorder if the feds decided to go down this path.
But now, doctors will have to take substance use disorder training to get their DEA license
The Biden administration’s recent spending billopens in a new tab or window contained under-the-radar changes for addiction medicine, including eliminating the X waiver requirement for clinicians who treat opioid use disorder with medication-assisted treatment (MAT).
The X waiver, a special Drug Enforcement Administration (DEA) certification that allowed clinicians to prescribe buprenorphine (Suboxone), a partial opioid agonist that curbs opioid cravings, has long been considered a bureaucratic hurdle to improving treatment access for patients who struggle with opioid addiction.
“Treatment for opioid use disorder is limited by there not being enough people that offer medications for opioid use disorder,” said Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine (ASAM). “Removal of the X waiver opens up the capability of prescribing to a much broader group of clinicians.”
Previously, obtaining an X waiver required 8 hours of training on prescribing MAT to patients with opioid use disorder. But in April 2021, the Biden administration nixed the training requirementopens in a new tab or window for doctors, nurse practitioners, and other providers who wanted to prescribe buprenorphine. Providers simply had to register for the waiver to prescribe.
This law requires all providers who apply for a DEA license to prescribe controlled substances to undergo a one-time, non-repetitive, 8-hour training on managing patients with opioid and other substance use disorders.
“That training is for you to get your DEA license, so that means, obviously, your controlled substance license,” said Rahul Gupta, MD, MPH, MBA, director of the Office of National Drug Control Policy, in an interview with MedPage Today. “That’s different from what used to be the X waiver training, which was primarily focused on prescribing of buprenorphine and opioid [abuse treatments].”
Hurley said ASAM is a “strong supporter of education for clinicians that have controlled substances prescribing authority, really to help preserve the safety of the patients that we treat.” As all controlled substances do carry a risk, it is critical for clinicians to understand how to prescribe them, and buprenorphine should not be singled out, he said.
Removing the X waiver does more than just make it easier to prescribe buprenorphine, Hurley said, adding that this action could pave the way for further de-stigmitization of MAT for opioid use disorder.
“When you put buprenorphine behind the X waiver, it creates the impression that the medication is complex or dangerous,” Hurley said. Clinicians routinely prescribe other medications that are more dangerous than buprenorphine — such as other opioids — which have not previously required additional training, Hurley said.
“So not only does the elimination of the X waiver create the regulatory pathway” for clinicians to prescribe buprenorphine without a separate certification, Hurley said. “It also removes the impression that the treatment of opioid use disorder with buprenorphine is a highly specialized, complex, or dangerous activity.”
While removing the X waiver is a positive change for addiction medicine, more action is needed to encourage providers to actually treat patients with addiction, said Allister Martin, MD, an emergency medicine doctor in Boston and CEO of the non-profit A Healthier Democracy.
“There are some parts of the population that could have been prescribing buprenorphine but simply because of the X waiver, they did not,” Martin said in an interview. “That’s the group that we now need to mobilize.”
Weather “red flags” are guidelines created by DEA in which the agency “lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine and further lacks authority to promulgated new regulations regarding the treatment of pain?
We further ask this Court to determine whether a Pharmacists refusal to fill a prescription for a “legitimate medical purpose” under the Pharmacists “corresponding responsibility,” provision, constitute and violates the Eight Amendment prohibition against cruel and usual punishment?
Whether it was the intent Congress for DEA to regulate the field and practice of medicine and pharmacy auger deference awarded to administrative agencies ?
RETIRED DETROIT POLICE SARGENT SUFFERED UNDER TREATMENT OF PAIN FROM ALS
MOVING THE GOAL POST BACKWARD AND FORWARD
Those pharmacists who merely question these DEA policies risk loss of employment and/or administrative sanctions. The DEA can impose these errant actions because they possess unchecked authority and weapons the ability to intimidate by seizings property and assets. Under this interpretation, a golf ball can become a football and baseball bat can enforced as a hockey stick. The DEA Administrator need not determine the underlying legitimacy of the prescriptions a pharmacy filled, but rather, may use “red flags” as a proxy to presume a prescription was illegitimate.
GERALD KILEY FLORIDA UMBILICAL HERNIA 2019, TAMPA FL, HOWVER LISTED BY DEA AS DRUG SEEKER (SEE LINK)
The question we seek out as pharmacist here in is when does a golf ball become a football, at what point in the game does a baseball bat become a hockey stick and at what point does the umpire call a strike across the plate third down?
When does the referee call a prescription written for a “legitimate medical purpose” illegal so that a pharmacy violates its corresponding responsibility whether or not there is evidence of a prescription’s illegitimacy? At what point on the mile marker does a prescription written by a licensed authorized provider to treat a medical disease of a disease state become illegal or can the Umpire convert the rules of the game into scienter as an financial incentive to issue more fines and expand his/her authority?
DEA’S CAMPAIGN OF DIS-INFORMATION
The DEA has been waging a campaign of disinformation to sway the public to a point prescribed narcotic analgesic medications are indeed drugs, dangerous drugs who dosages are red flags indicating abuse and trafficking contributing to the so-called Opioid crisis around America. Notably, DEA’s evidences always realize upon execration on numbers of “pills” and street language such as “pill mills,” “Holy Grails,” and “Cocktails,” not on medical disease states or clinical conditions.
August 29, 2019 DEA’s raid Pronto Pharmacy LLC, Tampa Florida
Prosecutors, have found these forms of distortion, redefinition of medical procedures effectively sells juries. Further Judges often instruct the juries to ignore any clinical presentation or will not allow such testimony on the record. By 2006, federal regulatory agencies perceived what they called an “opioid crisis” and mistakenly attributed it to doctors “overprescribing” opioids and generating a growing population of opioid addicts.
This formed the basis for an even more massive intrusion of federal and state power into the privacy of medical records, patient-doctor confidentiality, and the very way in which doctors are allowed to use scientific and professional knowledge to practice medicine. Medical decision making came increasingly under the purview of law enforcement, spark- ing a new wave of arrests and prosecutions.
Patients who had their pain controlled with long-term opioid treatment are being denied treatment or involuntarily tapered off their pain control, as doctors fear arrest and an end to their medical careers. A growing population of “pain refugees” has emerged, with some patients turning in desperation to the black market for opioids and some even turning to suicide.
As prescribing rates continue to plunge, overdoses from the non-medical use of opioids are skyrocket- ing, now largely caused by illicit fentanyl. These guidelines were disastrous for chronic pain patients. Many were driven to buy illegal drugs on the street, which were laced with poisonous fentanyl. In 2021 this led to 100,000 deaths in the United States.
Unfortunately prosecutors and the DEA has learned when facts don’t support the charges one just fabricates the facts. Thus the phrase garbage in is garbage out or the legal term false en uno false en omnibus is applicable.
It would have been expected a higher level of scientific accuracy and integrity from an agency such as the DEA entrusted to protect citizens’ health and welfare.
“…Without the discipline of good science, nontransparent implementation produces poor public outcomes. These outcomes are pressed into service in the field, offer no benefit, and harm physicians, pharmacies, patients, and public policy at large…”
URGENT!!! HELP AND SUPPORT NORMAN CLEMENT vs. DEA IN US SUPREME COURT CASE NO: 22-6000
“Let me add another friend to my list of folks who had a long life ahead of him and died because of chronic pain! Travis Reyes an athlete, a friend!
Travis and I had a-lot in common, we both were stand out athletes who were hurt in the hights of our glory! We were good at anything with a ball (big or small) running, jumping, lifting weights, and both of us cared for the pain community because we both knew what torture was caused by chronic pain.
Travis had his dad’s undying love and support! His dad and I went to his defense and talked to his doctor and his dad then would drove way out of his way to find a damn pharmacy that would filled his prescription medication once we got the doctor to call it in elsewhere.
Today an Arizona doctor called me and said, he would take Travis! I was so excited I left him a message that said, hey Travis that doctor will see you… How are you brother! Only to find out my friend is now gone 12-11-2022 at such a young age!
This is such a common theme in this frigging community that I have grown personally tired of. It makes me wonder how the hell am I still here when Travis was so damn young and strong!
That kid was the age of my own son and his only mistake in life was being a chronic pain patient living in a country who hates chronic pain patients!
Another common theme I’m way to tired of is saying, Travis you will be missed my friend and thank you for the fight you gave to this community! Love ya Brother! RIP and maybe tell the big guy we could use some help down here! And to his beloved father I’m so damn sorry.”
CONCLUSION
Wherefore, For the foregoing reasons, we respectfully request this Petition for rehearing in Case number 22-6000 submitted in a timely manner be granted and the revocation and the Court should further grant this Petitioner’s writ of certiorari as the decision in this case by this Court will have far-reaching effects on the professions of Medicine, and Pharmacy. The Petitioner is a Pharmacist Not a Street Drug Dealer.
