I am 57 years old and live in Hemet, California.  I have suffered from chronic intractable pain for over twenty-five years.  The primary causes of my pain are diagnosed as early severe degenerative cervical spine disease, Chiari malformation, spondylosis and subsequent nerve damage, and spinal cord impingement by bone spurs.  I have worked with two pain management doctors through all available step therapies without success.  Managed pain medication is the only treatment that has afforded me a reasonable quality of life; allowing me to work and volunteer part time.

In 2017, my pain management doctor began reducing my dosages of pain medication and intentionally under-treating my intractable pain.  He has admitted that this was medically contraindicated, since my condition is worsening.  But pressures from the DEA to comply with CDC dosing “guidelines” are making him taper all his patients regardless of condition or impact on their quality of life.

He fears DEA actions that would lead to prosecution if he treats under prevailing best practices. 

In addition, he has shared that scrutiny from the Medical Board of California under the Death Certificate Project has further restricted his ability to provide safe, adequate medical treatment to relieve suffering.  His attorney has advised him that deviating from forced tapering of patients could lead to closure of his practice, leaving hundreds of patients with no treatment.  He has shared that several of his colleagues have expressed to him a similar concern and many have closed their pain management practices as a result of draconian government regulation.

For me, this unwarranted reduction in pain medication dosing is forcing me into an unbearable quality of life (unrelenting pain, lack of sleep, limited activity, poor appetite, depression).  Due to my worsening condition, I have been accepted in a palliative care program with the Visiting Nurses Association.  Unfortunately, after eight months I have yet to find a pain management physician who will adequately treat my pain under the palliative care exemption frequently stated in the 2016 CDC guidelines.  All of the doctors I have consulted with declared concerns with DEA and Medical Board sanctions as reasons for not providing treatment.  Without adequate pain treatment, I will not be able to make the monthly 140 mile round trip to my pain management physician.  I will have to quit my part-time job and volunteering and will end up bed-ridden.

Additionally, the pharmacy I have used for over fifteen years has declined to fill my legitimate controlled medication prescriptions, stating that they fear scrutiny from the DEA.  Even the administrators for our insurance carrier are interpreting the CDC prescribing guidelines as strict regulations, causing my physician to spend an inordinate amount of time securing medication pre-authorizations and justifying medical diagnosis to people with no medical training.  The CDC dosing guidelines state they do not necessarily apply to patients being treated for long-term, chronic pain, and cancer/palliative/hospice patients yet innocent doctors are being bullied and threatened.  The broad brush of government regulations and miss-applied guidelines is causing unnecessary suffering for countless, law-abiding intractable pain sufferers.  Even cancer patients who only have a short time to live are dying or have died in agony.  Intractable pain is very individualized and should be controlled by pain management physicians.

I have stated before and this letter from a pt seems to validate my conclusions.  I have always suspected that the CDC was doing some of the “dirty work” for the DEA… because the DEA could never get by with publishing things like the opiate dosing guidelines and many believe that the CDC does not have the statutory authority to do it either… but… so far they have gotten by with this ILLEGAL ACTIVITY…

The end goal – IMO – was to get >50% of the health care community to adopt these guidelines, and once that happened then they could be considered to be the “standard of care” and “best practices” for ALL HEALTHCARE PROVIDERS and it would then be EASY for the DEA to get one of their “experts” to testify against prescribers that the DEA wanted to TAKE DOWN … that they were providing opiates greater than standard of care and best practices suggests is not appropriate… and thus could come to the conclusion that the prescriber was treating/maintaining a person who suffers from opiate use disorder, substance abuse or opiate addict.  Seems very easy for the DEA to FABRICATE a story line for a jury to find a prescriber GUILTY.

There is a lot  in the news media that is accusing President Trump with the MANUFACTURED CRISIS AT THE BORDER… but they can’t see how the war on drugs seems to be equally MANUFACTURED/FABRICATED since it began in 1970 with the passage of the Controlled Substance Act.

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$375,000 price leads disabled mom to ration meds

https://www.krdo.com/health/375000-price-leads-disabled-mom-to-ration-meds/1031640099

Bhanu Patel couldn’t believe the news. The cost of the medication that allows her to move — the one that enabled her to walk stairs again — shot up to $375,000.

Fear gripped her: What would this mean for her independence? Would she become a financial burden on her family? How is this possible in the country that’s given her so much?

The past three years, she said, the medication had been completely free as part of a specialty program. Until recently, the drug was known as 3,4-DAP made by Jacobus Pharmaceutical. But late last year, Catalyst Pharmaceuticals won FDA approval for a slightly modified version of the drug after two small clinical trials and announced an annual list price of $375,000 for the new drug, called Firdapse.

For Patel, the drug has been a game-changer. She was diagnosed in 2015 with a rare neuromuscular disease called Lambert-Eaton myasthenic syndrome, a condition known as LEMS that affects about 400 people in the United States, according to the National Organization for Rare Disorders.

The disease attacked her hip muscles and abdominal muscles first, then her back muscles she said. Just trying to stand up to walk was agonizing. She dragged herself across rooms and up and down stairs to get around her home. For two years, she wore three back braces on top of each other to allow her to stand.

The disease even attacked her tongue, making it difficult to eat. She lost a lot of weight, and her muscles atrophied. Every aspect of her life was impacted.

When she was introduced to the drug, her doctor told her it would make her feel more alert and allow her to regain basic functions. Her eyes opened wide when she first took the pills. “I said, ‘Wow, you’re right about that,’ ” Patel, 67, recalled. “You feel you want to live and have a life.

“Without this medication, you just can’t even move. It’s like your body is totally like a sweet potato.”

So imagine the predicament a skyrocketing price hike puts a patient like her, she said.

Fearful of burdening her family with exorbitant bills, Patel said, she’s begun rationing her meds — taking two pills a day, instead of four. She said she’s trying to stretch her three-month supply for as long as possible.

“The words that I can use is I can’t believe this is happening, to be honest,” she said.

Her son, Krishan Patel, said his mother has been rejected by Medicare for coverage of the medication, raising concerns the family could get stuck with a massive bill. He said she is appealing for coverage as an exception. His mother has also applied with the Assistance Fund, a nonprofit organization that helps pay for patients’ co-pays. He said she has yet to hear back.

Between he and his sister, Krishan Patel said, they will do everything they can to help their mother. He’s already begun writing and calling lawmakers, AARP, the drugmaker and anyone else who will listen.

He said he’s not just speaking up for his mom, but for those less fortunate. “If we’re not shining a light on these things,” he said, “then really what the hell are we doing?”

“My mother’s livelihood is fundamentally at the hands of a small outfit with full capability to do whatever they want,” he said. “You’re leveraging human suffering to make money — and that is a heartbreaking idea.”

Bernie Sanders demands action

Sen. Bernie Sanders, who earlier this month demanded answers from Catalyst Pharmaceuticals about the drug’s $375,000 price, blasted the company for not responding, and he ripped Catalyst for endangering patients’ lives.

“Instead of answering my questions or lowering the price of this drug, they’ve hired a lobbying firm,” Sanders told CNN in a written statement Wednesday. “It is now clear that some patients are rationing their supply of Firdapse because they cannot afford to cover the outrageous cost of the drug, which they used to receive at no cost.

“If Catalyst does not immediately lower the price of the drug, I will ask FDA to allow pharmacies and manufacturers who were previously making this drug to be permitted to resume providing it, so that all patients can get the medication they need.”

CNN has contacted the US Food and Drug Administration for comment.

Two weeks ago, Sanders sent a blistering letter to Catalyst for its decision to raise the price of Firdapse — “and forcing production and distribution of the older, inexpensive version to cease.” Patients had been able to get the previous version of the drug for free through a compassionate use program through the FDA.

“Catalyst’s decision to set the annual list price at $375,000 is not only a blatant fleecing of American taxpayers, but is also an immoral exploitation of patients who need this medication,” said Sanders, who on Tuesday announced his latest Democratic presidential bid. “I am profoundly concerned that Catalyst’s actions will cause patients to suffer or die.”

Assuming his mother gets approved for the drug, Krishan Patel said Firdapse is listed as a Tier 4 medication on his mother’s Medicare with a 40% co-insurance. Even after rebates, he said, the family fears the possibility of spending more than $100,000 a year on the medication.

Catalyst maintains patients will be left with little to no cost, despite the fears within the LEMS community. CNN asked Catalyst about the possibility of patients getting stuck with a $100,000 tab as the Patel family has expressed.

“All Medicare patients are being directed to foundations that support the LEMS community. These foundations are reducing the co-pay for all patients to $0,” Catalyst spokesman David Schull said in an email. “No out-of-pocket costs for Medicare patients with this set-up.

“Your facts are wrong.”

Asked how Catalyst is informing patients about the co-pay program, Schull shot back: “Everyone is well informed. We do not have any additional information. I suggest you look for what will be a launch update when the company provides its year-financial results and corporate update in March.”

Krishan Patel said patients like his mother don’t have until March to wait when they need answers now. He blasted what he called Catalyst’s “inconceivable behavior to create anxiety in some of the most vulnerable patients with this disease.”

“That sounds like the most insane statement I’ve ever heard,” he said of Catalyst’s response. “At the end of the day, it’s like: ‘Really?’ “

The Patels aren’t the only ones filled with anxiety over this issue.

Dr. S. Vincent Rajkumar, a hematologist oncologist with the Mayo Clinic, said he was giving a lecture to Mayo doctors on the rising costs of prescription drugs and what can be done about the issue. Unbeknownst to Rajkumar, one of the doctors brought along a patient who suffers with LEMS. The patient told him she’d been getting the drug from Jacobus for free since 2004 and that she had just been told she would have to pay $3,800 a month in co-pay.

That patient was Lore Wilkinson. She was outraged by the price hike she’s decided she’s not going to take the medicine — even if it means a rapid decline in her health. She’s already begun looking into getting a wheelchair “because my quality of life is going to tank.”

“I’m going to do without. I’m not going to be a party of enriching the pockets of this predatory pharmaceutical. Unconscionable!” she told CNN. “I don’t think it’s right to be a party to this highway robbery.”

“I would probably choke on it if I took it,” she said. “That’s because I think it’s such an outrage.”

Wilkinson said she was in the process of writing a “thank you” note to Jacobus for providing the medication for free for so many years. “You just wish every pharmaceutical was like theirs,” she said.

Jeane Arlowe leads a private Facebook group for the LEMS community. She said members of her group “have been reeling from the news and trying to wade through the insurance quagmire and Catalyst’s enrollment forms.” Beyond the price hike, Arlowe said, are other complaints.

“Most in my support group were on Jacobus DAP,” Arlowe said. “Many are reporting side effects since being on Firdapse such as racing heart, severe headache, dizziness, exacerbated weakness and gastrointestinal issues. A common complaint is that the Firdapse kicks in too fast and wears off too fast or doesn’t work at all.”

Many of these side effects are identified as possibilities in the drug’s packaging and product information.

A mother weeps

For Patel, the entire ordeal is overwhelming.

She grew up in South Africa during apartheid, often hiding from violence. Her father traveled the world to try to find a better place for his family to live — Europe, South Asia and South America. Her family eventually settled in Canada, before moving to the United States decades ago.

She remembers being taught about America as a girl — a shining beacon of hope that stood for justice.

But her experience with this price hike has soured her. “This is the America we live in,” she said.

An America where one drug can break a person. “What does the future hold for my children — and the children of this country?”

She sobbed as she described not wanting to be a financial burden on her family.

“It’s just a lot of fear. I have to be honest,” she wept. “It just doesn’t feel good.”

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Chronic Pain, Medical Research, Standards of Care, Government Policy, Guidelines and Regulations, Ethics in Medicine and Government

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YouTube’s Doctor Mike learns from his mistakes

Mikhail Varshavski, DO, (better known on social media as “Doctor Mike”) is a board-certified family medicine physician at the Atlantic Health System’s Overlook Medical Center in Summit, New Jersey. His YouTube channel educates over 3 million subscribers with two weekly shows covering everything from trending medical stories, to health myths, to reaction videos critiquing popular medical TV dramas. His goal is to expose medical misinformation and increase the health literacy of young adults.

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www.nationalpainreport.com/a-new-documentary-chronicling-the-scary-truth-about-our-pain-problem-8838786.html

There are no marathon runs for chronic pain, no walks for its cure. Yet chronic pain disables some 25% of the population in developed countries such as Canada and the U.S.A. This is no small disease. In Canada, chronic pain costs the economy an estimated 60 billion annually in treatment, lost wages & productivity; in the U.S.A. a staggering 634 billion.

Those who suffer with intractable pain in North America now outnumber heart disease, cancer & diabetes patients combined. The current media focus on “The Opioid Crisis,” a dramatic but not necessarily more serious issue – has unfortunately resulted in a profound loss of care for chronic pain sufferers who in many cases are being undertreated- with dire consequences. This burgeoning epidemic is largely ignored &underfunded.

Pain Warriors by award winning filmmakers Tina Petrova and Eugene Weis, examines with unflinching truth “the forgotten ones.” Long time pain patients denied life giving medications by government policies can be driven to suicide while some doctors who bravely fight to uphold their Hippocratic oath are threatened with loss of license, livelihood and even criminal charges that can lead to incarceration. Would we take away someone’s insulin, beta blocker or Warfarin because a small percentile of the population found a way to monetize those drugs and get high off them? Are the human rights of pain patients being sacrificed for politically expedient policies, and extreme cuts to patient care costs?

Pain Warriors serves up a plate of disturbing truth: chronic pain patients face a lifelong battle with no cure in sight. They build their lives around managing pain and struggle to perform simple every day functions like walking or shopping for food. Their demographic is invisible, shunned and disbelieved. And yet “they” “could be “us” in a flash. We are all a car accident, a surgery, or a degenerative condition away from this tragic outcome. This brave documentary shines a light on patients fighting for the right to manage severe pain, including an eleven-year old who draws his pain as long toothed monsters, as well as specialists prevented from helping their patients achieve a small degree of comfort and dignity through pain control. Tragically, when opioids and other medications are suddenly withdrawn because of a blanket “one-size-fits-all” legislation, doctors and patients alike are being left with nowhere to turn. From the somber spreading of ashes at Newport Beach Ca. to H.H. The Dalai Lama’s hospital in Zanskar India, viewers are swept up in a stunning cinematic journey featuring gripping stories from the trenches.

Pain Warriors~ enters into the desperate lives of pain patients fighting for their very survival, families torn apart by suicide, and the troubled worlds of compassionate doctors who stand up for them, risking reputations and licenses in doing so. Tina and Eugene bring a balanced view, to a timely issue. painwarriorsmovie@gmail.com/ www.painwarriorsmovie.com

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Twin Lakes police captain accused of illegally removing prescription medication from department

https://fox6now.com/2019/02/18/twin-lakes-police-captain-accused-of-illegally-removing-prescription-medication-from-department/

TWIN LAKES — Captain Dennis Linn, the second in command at the Twin Lakes Police Department, was placed on administrative leave amid an investigation into allegations he illegally removed prescription medication from the department.

In 2016, Captain Linn was awarded for 20 years of service, and on Monday, Feb. 18, FOX6 confirmed the Twin Lakes Police Department, along with the Wisconsin Department of Justice’s Division of Criminal Investigation (DCI) launched an investigation into allegations against him.

According to an affidavit, comments Linn made to a fellow detective in the evidence room raised “red flags.” Captain Linn told the fellow detective his wife was in “a lot of pain” and was recently cut off from her prescriptions by her doctor. This, as Linn and the detective processed medication collected through the “Drug Take Back Program.” The affidavit said the detective was about to leave to get supplies when Linn said “I wouldn’t leave me down here. I don’t want to be suspected of anything, especially after I just told you about my wife.”

The detective stayed in the room and soon alerted the police chief when she noticed a bottle of oxycodone hidden inside a small garbage can.

According to the affidavit, a body camera was placed in the evidence room, which recorded Linn picking out an item from the garbage can at the end of his shift. The camera picked up sounds of “pills rattling.”

A search warrant executed at Linn’s home revealed three empty Walgreens prescription bottles, one for oxycodone and two for hydrocodone. The names on the bottles did not match Linn’s name or that of his spouse.

Marijuana concentrates and six twisted tissues with black material were taken — found in garbage cans at his home, according to the affidavit.

FOX6 News knocked on the door at Linn’s home Monday. No one answered. He has not been charged with a crime at this point, but the police chief said the investigation is ongoing — including a separate, internal investigation into whether Linn violated any department policies or procedures.

Linn has been a full-time member of the Twin Lakes Police Department since 2002.

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Attorneys for ex-DEA agent Chad Scott say prosecutors retaliated against defense witness

https://www.theadvocate.com/new_orleans/news/courts/article_191e2f6a-354b-11e9-83da-cba26c0974a5.html

In a sharply worded new court filing, attorneys for indicted former federal drug agent Chad Scott are accusing federal prosecutors of improperly retaliating against a defense witness. They are asking the judge to dismiss the charges against Scott as a result.

The broadside, filed Tuesday in federal court, is the latest in a series of blistering motions filed by Scott’s attorneys, Matt Coman and Stephen Garcia. It comes less than three weeks after jurors were unable to reach a verdict on any of the seven counts Scott faced, forcing U.S. District Judge Jane Triche Milazzo to declare a mistrial.

In another motion, Coman and Garcia urge Milazzo to postpone the March 18 scheduled date for Scott’s retrial, arguing that they have crowded trial schedules and that it will be difficult to subpoena witnesses and experts for the second trial. 

Coman and Garcia reserved their strongest language for their motion to dismiss. 

Prosecutors ran afoul of the law when they “intimidated and retaliated against James ‘Skip’ Sewell after that witness testified and the first trial ended in mistrial,” Scott’s attorneys wrote. Their actions “must not be sanctioned by allowing this prosecution to continue.”

Sewell, one of three witnesses who testified for Scott, was a longtime, highly decorated DEA agent who had been Scott’s supervisor before Scott was suspended in 2016 as part of the investigation into the task force he led.

Sewell was also caught up in the probe. Although there were no allegations against him, he was put on light duty for more than a year while the investigation proceeded. He then retired — in good standing — from the DEA and went to work for 22nd Judicial District Attorney Warren Montgomery as an investigator.

During his time with Montgomery’s office, he was placed on a violent crime task force and was sworn in as a DEA task force officer in late 2018. But soon after his Jan. 30 trial testimony, he was notified by DEA brass that he was no longer on the task force. The government’s actions were ” ‘intentional and in bad faith,’ warranting the dismissal of the indictment with prejudice,” the defense filing says.

This is at least the second time that Scott’s legal team has accused prosecutors of misconduct. In June, they accused prosecutors of “framing” Scott and hiding evidence that supported his innocence. They asked Milazzo to toss out the indictment, but she refused.

In a separate filing, Coman and Garcia say that both of them have trial commitments in different parts of the country during late March and April, and that forcing them to reconvene to retry Scott at that time would place an undue burden on the defense. They also say they are trying to secure the testimony of an additional expert, which would be difficult given the quick turnaround of the trials. They suggest a trial date in September.

Scott faces 11 total charges, but last year, Milazzo split the counts into two trials. The first, on seven counts of obstruction, perjury and falsification of government forms, ended Feb. 4 in a mistrial. The trial on the remaining four counts is currently set for Oct. 1, though that date has been thrown into question by the status of the retrial on the first seven counts. 

Scott and some members of the Metairie-based task force he led have been the targets of an investigation that began more than three years ago. Two task force members, former Tangipahoa Parish Sheriff’s Office deputies Johnny Domingue and Karl Newman, have already pleaded guilty to federal crimes. Both testified for the prosecution in Scott’s trial.  

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Trump Administration Is No Friend to Pharmacy Benefit Managers Like CVS

https://realmoney.thestreet.com/investing/trump-administration-is-no-friend-to-pharmacy-benefit-managers-like-cvs-14872546

Pharmacy Benefit Managers (PBMs) are in for some problems if proposed regulation is given approval.

The usually business friendly Trump administration is not as amicably positioned for pharmacy benefit managers (PBMs) like CVS Health Corp.  (CVS) .

Shares of the pharmacy, retail, and healthcare giant are slumping after its pre-market earnings report provided much weaker guidance than was expected.

A large degree of deceleration was noted in both PBM and long term care in the company’s report.

“In Retail/LTC and PBM, we expect our greatest level of year-over-year deterioration in Q1,” the company reported, while still holding out hope for pick-up in the latter half of the year.

The pressure on PBM specifically could intensify if proposals from the Department of Health and Human Services (HHS) are enacted.

Reading the Regulation

According to the department’s “American Patients First” proposal, released shortly after the State of the Union address earlier this month, it argues for a new “safe harbor” for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs would be created.

Under the proposed rule, prescription drug rebates, that are estimated to constitute up to 30% of the list price of drugs, may be passed on directly to patients in order to make transactions more transparent and streamlined.

“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” HHS Secretary Alex Azar said in a statement announcing the proposal.

The rule would offer prescription drug discounts directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs.

If enacted, the deal would crush the preferred drug status offered to drug manufacturers in exchange for kickbacks to PBMs. The “kickback” rebates offered to PBMs provide a significant revenue stream to these providers, like CVS, especially for higher end drugs.

The rule could promote some bipartisan support as well.

Drug pricing has been a major platform for leading  Democrats like Representative Elijah Cummings of Maryland and recently announced Democratic presidential candidate Bernie Sanders, though the aforementioned senators have narrowed their focus far more to manufacturers than the Trump administration has.

Erin Taylor, a health economist at the RAND Corporation, told the Pew Trusts that the largest PBMs – [UnitedHealth Group’s (UNH) ] OptumRx, [Cigna (CIG)  owned] Express Scripts and CVS Caremark, are “practically oligopolists” with power that rivals that of the drug companies.

“They are the elephants going up against the gorillas, because they have so many covered lives,” Taylor said in the research report. “The concern has arisen that the PBMs are getting too big a piece of the pie and contributing to high prices.”

Considering a PBM like CVS has $47 billion up for renewal in 2019 in its PBM business, a clamp on this income is a key issue to follow in 2019 as the proposal is considered.

Rebuke of Regulation

The proposed rule provoked a strong reaction from CVS CEO Larry Merlo on Wednesday morning.

“We see the rebate rule taking us backwards, not forwards,” Merlo told analysts. “A small percentage of seniors may net out favorably…but as many as 70 percent of beneficiaries are going to be worse off.”

“We’re certainly weighing in during the comment period with our concerns with the rebate rule, but more importantly what we believe the appropriate solutions are to address the root cause,” he added.

Still, CFO Eva Boratto said that the company is well positioned to deal with the shifting regulatory environment.

“It is clear that the PBM industry is in the middle of an environmental change given the dialogue around rebate,” she acknowledged. “However, it is also clear that the PBM brings tremendous savings and value to the clients we serve. The importance of size, scale and customer relationship will continue to be paramount, and we remain focused on delivering the value our clients expect.”

The company has also worked to increase transparency independently, anticipating governmental requirements for the company.

This begins with the creation of a a new PBM contracting model that will maintain guaranteed costs and offer 100% of rebates to customers and seek to reduce costs overall.

Further, executive VP of pharmacy services and supply chain Kevin Hourican was bullish on the Aetna integration’s ability to mitigate regulatory and pricing impacts with the scale that Boratto cited.

“By owning a large insurer and owning the largest PBM, we can lead that change by structuring a contracting relationship that if we can lower overall health care costs, we can take some of the burden off the annual reimbursement reform,” he noted. “Where that will come from is the last thing I’ll say is we can prove through technology and clinical care programs that we can improve medication adherence.”

The rule, which would go into effect in 2020 if approved, was not optimistically observed by Merlo in terms of voter acceptance either.

He estimated the total cost of the legislation to the taxpayer at $200 billion over 10 years and would likely lead to many seniors leaving Medicare Part D coverage. He noted that this high cost signifies the proposal is not likely the best solution to bring forward.

As the presidential campaign season picks up and healthcare costs and drug pricing remains the number one issue in the mind of voters according to the Henry J. Kaiser Family Foundation, the progress of the proposal and the pushback from PBMs will be a pivotal issue to follow.

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