Senators Grill Califf On Role in Opioid Crisis, Abortion Pill Restrictions

https://www.medpagetoday.com/publichealthpolicy/fdageneral/96199

Biden’s nominee for FDA commissioner also asked about his close pharma industry ties

President Biden’s nominee for FDA commissioner, Robert Califf, MD, fielded pointed questions about a variety of controversial topics during a hearing of the Senate Committee on Health, Education, Labor and Pensions on Tuesday.

Questions ranged from the agency’s approval of Oxycontin to risk mitigation protocols for mifepristone (Mifeprex), as well as his close ties to the pharmaceutical industry.

In his opening statement, Califf said that his top priority, should he be confirmed, is to focus on emergency preparedness and response — learning from what the pandemic has taught the country so far and applying those lessons.

Other priorities include ensuring the safety of the food and drug supply, curbing the opioid epidemic, developing a “systematic approach” to evidence generation, protecting children from tobacco products, and “attracting and retaining” the agency’s scientific workforce.

Califf is the head of clinical and policy strategy for Verily Life Sciences, and was a professor of cardiology at the Duke University School of Medicine. He was previously FDA commissioner from February 2016 to January 2017, confirmed by the Senate in a vote of 89-4.

The committee’s leaders on both sides of the aisle praised his experience and fitness for the role.

Sen. Patty Murray (D-Wash.) noted that families trust the FDA to ensure the foods they eat are safe and that the prescriptions they receive help rather than harm them. The agency needs a strong hand to address public health emergencies like the COVID-19 pandemic and the opioid crisis, she said.

“Families also deserve to know they have an experienced leader at the FDA who understands the many challenges our nation is facing and the importance of ensuring science comes first,” Murray added.

When he last led the agency in 2016-2017, Califf was confirmed with strong bipartisan support, she noted.

Ranking Member Richard Burr (R-N.C.) hailed Califf as a “wonderful father, grandfather, great doctor and great man … I’m not sure you could write a resume of somebody more qualified to be considered for commissioner of the FDA than Rob Califf.”

While underscoring the “historic progress” the agency has made over the last 2 years, swiftly and safely authorizing three COVID vaccines and more than 420 COVID tests, Burr also stressed that “the next commissioner cannot take their foot off the gas.”

FDA’s Role in the Opioid Crisis

In response to questions from Murray, Califf outlined the steps he plans to take to help address the opioid epidemic, such as expanding efforts around prescriber education, “crack[ing] down” on people who use opioids inappropriately or those who prescribe them inappropriately, and strengthening efforts to develop alternative medications and behavioral health therapies for pain.

But Sen. Maggie Hassan (D-N.H.) was more interested in what she viewed as a “troubling” lack of any acknowledgement by FDA officials about their own role in exacerbating the opioid epidemic through “mistakes” in regulating Oxycontin.

Given that many people with substance use disorders first became addicted to opioids through legal prescriptions for Oxycontin, Hassan asked whether the FDA’s initial approval of the drug and its 2001 decision to expand its indication to include the treatment of chronic pain were mistakes.

Califf said that, in hindsight, approving a drug without any long-term studies or assessment of its addictive potential “is something that could have been done differently.” With regard to expanding the drug’s indication to include long-term use for chronic pain, Califf again said that long-term studies should have been required before permitting use of the drug for long periods.

“Why didn’t you take action to change the Oxycontin label when you led the FDA in 2016?” Hassan asked.

He did take certain measures, Califf said, including supporting the long-term studies that were needed to collect evidence about long-term use, and contracting with the National Academy of Medicine to overhaul the protocol for opioid evaluation.

Usually, the risk-benefit calculus focuses solely on the individual to whom a drug is prescribed, but opioids impact “many other people in society,” Califf noted, arguing that the change to the evaluation process was “successfully done.”

However, Hassan pointed out that Califf, in his opening remarks, mentioned a family member who had been given a 30-day prescription for opioids after a minor surgery and asked if there’s a reason the FDA should not be “aggressively … pursuing relabeling.”

As more evidence is collected, “we are going to need to aggressively look at relabeling,” Califf replied.

Hassan, citing the hundreds of thousands of deaths from overdoses, strongly disagreed: “There is plenty of evidence about what we need to do about this epidemic and the FDA needs to take the lead.”

Later in the hearing, Califf acknowledged that he had “certainly made a number of mistakes,” adding that coordination among agencies is “more human and complicated than you would think on the outside.”

Mifepristone Restrictions

The risk evaluation and mitigation strategy (REMS) for the abortion drug mifepristone was another flashpoint at the hearing, with Republican senators arguing that the REMS protocol should not be relaxed.

Sen. Mike Braun (R-Ind.) said the FDA “weakened” the REMS for mifepristone under Califf’s watch in 2016 and asked whether that “relaxed kind of interpretation” of the procedure was something he planned to pursue.

In April, the FDA unveiled a policy of “enforcement discretion” around the in-person dispensing of mifepristone, which enabled patients to receive the medication by mail. In May, the FDA announced a review of the restrictions around the drug.

Califf, who cited a court document regarding a review of the data on mifepristone, said a re-evaluation of the REMS for the drug is “imminent.”

While he will not be involved in the process, Califf said he knows the team responsible for the review and is confident that those individuals “will be looking at the latest data and applying the best science and make the best possible decision.”

Braun ended his questioning by asking permission to submit testimony, for the record, from an individual who “experienced complications resulting from a chemical abortion drug.”

Murray accepted the submission and also included her own submission to the record of a recent study on the safety of mifepristone from the New England Journal of Medicine.

Ties to Big Pharma

Sen. Bernie Sanders (I-Vt.) raised concerns over the revolving door between the FDA and pharmaceutical industry. He flagged one person in particular, Curtis Wright, who served as a “high-ranking official.” After leaving the agency in the mid-1990s, he received a $400,000 compensation package from Purdue Pharma “less than a year after [the FDA] approved Oxycontin with a label that said it was, quote, very rare, end quote, for patients to become addicted to that opioid.”

Since leaving the FDA, Califf has made “several hundred thousand dollars” from pharmaceutical companies, Sanders noted, and according to his own financial disclosure statements, currently owns “up to $8 million in stock of major pharmaceutical companies.”

Given these close industry ties, Sanders asked what reassurance Califf could offer Americans that he will be “an independent and strong voice” for the agency?

“I am a physician first and foremost,” Califf said, citing his work in intensive care units in the early part of his career.

But Sanders persisted, calling out Califf’s work as a consultant in the pharmaceutical industry. “How can the American people feel comfortable you’re going to stand up to this powerful special interest?” he asked.

Califf urged Sanders to look at his track record, adding that the Biden administration’s ethics pledge is “the most stringent ethics pledge in the history of administrations.”

Shifting gears, Sanders asked Califf whether he believed Medicare should be allowed to negotiate prescription drug prices.

“I’m on record of being in favor of Medicare negotiating with the industry on prices,” Califf responded.

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Bob Sheerin (APDF VP) Up to bat – FOUR TIMES – NO STRIKES – just SOLID HITS

Vanderbilt Hospital Nashville , TN

Pt: Lilly Demond 14 y/o  Stage 3 Leukemia

Dad:  Mechanic

Mom: Waitress

 Lilly: 9th grade and does well in school 9 months at Vandy

Allergies: Pencillin, Morphine, nuts, cancer free only 10 months in her whole life.

Lilly: youngest of 4 siblings : rides bike, yoga, PT injections

5 doctors in 16 months, Pharmacies have given parents hell. 

Lilly has experience extreme pain in abdomen, back pain, kidney stones, mouth sores, and chemo rash

Lilly has begged for  pain management, mom has been  administrating different medications several times. Lilly was previously  prescribed Hydrocodone with motrin, Robaxin,  face cream and has used antibiotics for rashes. Z pak is given every 3 months  and she will discontinue Ultram 50 mg to start new regiment of opioids. Dr admits to having tried “everything” previously. Lilly’s parents has agreed to UAs and random pill counts and Lilly will take 2 weeks off of chemo until pain gets better managed.  Dr informed everyone on the potential dangers of opioids and addiction . Parents signed wavers and Lilly will continue high school as normal, will start regiment at observation center ASAP and prescriptions will be brought to parents after observation is completed. New appointment set up for Feb 2021 Robert Sheerin American Pain and Disability Foundation VPO

APDF is a non-profit all volunteer organization in its third year and goal is to help help pts with chronic health issues to improve their QOL ( Quality of life).

Volunteers and donations are welcomed and needed.

We realized that many pts are often struggling financially but Amazon provides a Experience feel-good shopping Shop at smile.amazon.com and we’ll donate to your favorite charitable organization, at no cost to you.. Get started same products, same prices, same service. Amazon donates 0.5% of the price of eligible purchases.

login to https://smile.amazon.com/  and designate American Pain and Disability Foundation as the non-profit you chose as your non-profit that you wish Amazon to deposit your charitable donations to. Encourage your family and friends to do the same.

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The DEA Is Making It Impossible for Many to Get Addiction Meds

https://www.vice.com/en/article/xgdynj/dea-restricting-access-to-opioid-agonists-suboxone

As the overdose crisis rages, access to methadone and buprenorphine remains hindered by bureaucracy and stigma.

Jennifer Hornak’s son died after he could not find a halfway house that would accept people taking buprenorphine. Photo submitted

Martin Njoku never imagined his decision to dispense buprenorphine—a medication used to treat opioid addiction—would be the death knell to his career as a pharmacist. 

But that’s exactly what he said happened after the Drug Enforcement Administration issued him an immediate suspension order in August 2019, after showing up for a surprise inspection the year before.

The order, issued on the grounds of an “imminent danger to public health or safety,” meant that Njoku could no longer fill prescriptions for controlled substances. Despite having two judges rule in his favor, with one saying the DEA “has not pointed to a single instance of violation of the law,” Njoku said he had to shut down both of his West Virginia pharmacies because he lost lucrative contracts from insurance companies.

“It cost me my business and ruined my whole entire life,” Njoku, 63, told VICE News. “For 40 years I have worked hard. Now I have nothing, thanks to the DEA.” 

Njoku, whose situation was highlighted in a recent story by Kaiser Health News, said he began filling buprenorphine prescriptions after customers from neighboring counties—displaced by flooding—called to say they couldn’t get it elsewhere. 

Martin Njoku said he was trying to help people with opioid use disorder when the DEA raided him. Photo submitted

To him, it was no different than dispensing medicine for heart disease or diabetes. But he said the message the DEA is sending by raiding pharmacies like his is “clear.” 

“They don’t want you to take care of people with an opioid addiction,” he said. “In my opinion, they want to see these guys on the street dead with fentanyl.” 

A DEA spokesperson did not comment on the order against Njoku but said the agency is committed to helping “those who are harmed by drug trafficking.” 

“In this spirit, DEA is committed to doing all it can to expand access to medically-assisted treatment to help those suffering from substance use disorder,” they said. 

Trey Strange, Gabrielle Caplan

04.03.20

Njoku’s situation illustrates just one of many ways access to buprenorphine and methadone—known as opioid agonist treatment—is limited, in spite of the fact that both drugs reduce illicit opioid use, the risk of overdose, and disease transmission. According to Pew, 1.6 million Americans had opioid use disorder in 2019 but only 18 percent of them were able to access buprenorphine, methadone, or naltrexone. One study from the National Institutes of Health looked at 17,568 people in Massachusetts who received either methadone or buprenorphine after a non-fatal overdose and found the medications reduced deaths by 59 percent and 38 percent respectively. 

Though some of the regulations around opioid agonist treatment have loosened as a result of the pandemic, doctors, academics, and patients who spoke to VICE News painted a picture of a heavily stigmatized and overly bureaucratic system that is nowhere near serving demand. 

In the context of an overdose crisis that killed 100,000 people in the first year of the pandemic—a historical high—experts say it’s unacceptable that access to these drugs is so limited. 

“It’s criminal, during a time of crisis to have life-saving medication and to have those medication options be so tightly restricted,” said Leo Beletsky, a professor of law and health sciences at Northeastern University.  “These restrictions are killing people, and the agency in charge of regulating access is not a health care agency; it’s a law enforcement agency.” 

The DEA did not respond to a list of questions from VICE News about its approach to regulating opioid agonist treatment.  

The DEA is in charge of regulating both methadone and buprenorphine, ostensibly to prevent them from being diverted into the black market or misused. (Because buprenorphine is a partial opioid agonist, it causes less euphoria than other opioids, making it less susceptible to misuse; it also has a lower overdose risk than methadone, which is more likely to cause overdoses when someone is starting treatment or when mixed with other drugs.)

Doctors who want to prescribe buprenorphine need to apply for a special waiver from the DEA, while methadone clinics need to be registered with the law enforcement agency. 

One of the main issues surrounding buprenorphine, most commonly sold under the brand names Suboxone or Subutex, is that many doctors and pharmacists are worried about being subject to intense DEA scrutiny or raids. According to the Substance Abuse and Mental Health Services Administration, only around 7 percent of practitioners have obtained the waiver required to treat the maximum patient load of 275 people. Finding a clinician or a pharmacy that has it is even more difficult in rural areas. 

“We’re all basically monitored by the DEA in order to be able to prescribe a controlled medication,” said Dr. Payel Roy, assistant professor of medicine and clinical director of the Addiction Medicine Consult Service at the University of Pittsburgh.

People prescribing buprenorphine also have to complete a course if they want to treat more than 30 patients. 

“It makes it seem like you need specialty training in order to prescribe buprenorphine, even though it’s a safer medication than other opioids that we all are prescribing,” Roy said. 

Roy said medication-assisted treatment for opioid use disorder is heavily stigmatized—particularly for those on methadone.

Patients who manage their opioid withdrawal with either methadone or buprenorphine often can’t find a rehab that will accept them, she said. Some clinics fear they might sell them to other rehab clients, while others believe abstinence is the only form of real recovery. It can also be disruptive—they don’t want clients to come and go if they have to pick up their medication daily (which is often the case with methadone). 

It’s a scenario that turned into a tragedy for Jennifer Hornak’s family. 

As he was finishing up his second stint in rehab for fentanyl addiction in June 2020, Hornak’s son, Quincie Berry, began looking for a halfway house in Daytona, Florida. But the 31-year-old couldn’t find one that would accept him while he was taking buprenorphine. 

So his rehab weaned him off of it, but he relapsed—particularly dangerous because of fentanyl’s potency and the fact that his opioid tolerance may have been significantly lower at the time. 

“Quincie was dead 27 days later,” Hornak told VICE News. He had fentanyl, cocaine, meth, and the animal tranquilizer xylazine in his system. 

Hornak believes if her son had found a halfway house that supported buprenorphine as a treatment for his opioid use disorder, he would still be alive. “These recovery residences didn’t want to deal with people that were on buprenorphine.” 

Quincie Berry died after weaning off buprenorphine. Photo submitted

Berry’s mother Jennifer Hornak says medication-assisted treatment is stigmatized. Photo submitted

She said medication-assisted treatment for addiction is heavily stigmatized, in part because of the DEA’s heavy-handed approach to regulation.

“They don’t understand that this medication is not just a medication for detox. It’s a medication for the rest of your life if you need it,” she said. 

Over the last year, the DEA and the federal government loosened up some of the rules around methadone and buprenorphine, allowing for the expansion of mobile methadone van clinics and take-home doses of a month’s supply of methadone, for instance. There’s a more streamlined process for DEA-registered health practitioners looking to prescribe buprenorphine, and patients who can see their doctors via telemedicine to get a prescription. 

In November, Pittsburgh became the third city in the U.S. to allow paramedics to administer buprenorphine to people experiencing withdrawal from opioids outside of a hospital setting. 

But harm-reduction advocates say these changes aren’t happening fast enough to keep up with the pace of overdose deaths. 

For David Frank, the goal of starting methadone was never abstinence. A medical sociologist at New York University, Frank started using methadone nearly 20 years ago when his opioid addiction made his life “impossible.” 

“You run out of money; you’re having to commit crimes every day,” Frank told VICE News. “You’re always trying to stay one step ahead of being dope sick.”

After he began using methadone regularly, he said his life began to stabilize. 

“I went to school because I was not happy with the way methadone  was talked about by researchers, by academics.” 

Zachary Siegel

11.15.18

Methadone for opioid use disorder must be obtained in standalone clinics—it can’t be prescribed by a doctor and dispensed through a pharmacy. Clients generally have to show up daily to get doses. The clinics began to expand in a significant way in the 1970s, but were—and still are—stigmatized and seen as undesirable in many communities.

Frank considers himself lucky because his clinic allows him to take home a 28-day supply at once. Even when he lived in Chicago, he said his clinic was on the street he lived on. “There’s no way I would have been able to get a PhD or do any of the things I’ve done,” he said, if he had had to frequent a methadone clinic.

“They make it almost more difficult to be at a methadone clinic than it is to get your opioids from the street.” 

With fentanyl and other synthetic drugs increasingly replacing heroin, the street supply of drugs has never been more volatile. 

“The DEA plays this dual role, which is enforcement on the illicit supply side and then regulating the pharmaceutical access and treatment access. And they really have completely bungled both of those realms of regulation,” said Beletsky. 

“The supply continues to proliferate and there’s increasingly more toxic illicit supply. While their efforts on the regulation of legal supply have been abysmal and have done far more harm than good because they’ve pushed a lot of people from the legal channels into illegal channels.” 

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https://www.waaytv.com/news/trial-for-florence-woman-accused-of-refilling-prescription-while-pregnant-to-start-monday/article_eaa5915c-5c1e-11ec-a82a-93cbaf078081.html

The trial of a Florence mother accused of refilling a prescription while pregnant is scheduled to start Monday.

Kim Blalock, 36, is charged with unlawful possession of a controlled substance after refilling a prescription about six weeks before giving birth.

That child then tested positive for opiates. She failed to tell her doctor she was pregnant while getting the refill. Her lawyers argue the doctor never asked.

The Lauderdale County District Attorney says he’s charging Blalock to address a bigger, more chronic drug problem in the area.

Jury selection begins at the Lauderdale County Courthouse at 8:30 a.m. Monday.

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“RACIAL BIAS IN PAIN CARE PROTECTED AFRICAN AMERICANS,” CONCLUDED ANDREW KOLODNY, MD., TOP U.S. GOVERNMENT EXPERT AND “AMERICA’S MOST DANGEROUS PSYCHIATRIST”

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Under staffing issues have been at a ever increasing problem for several years… with the COVID-19 pandemic… many chain pharmacies – particularly the two BIG BOYS in the country… have resisted adding Rx dept staff… while adding services of COVID-19 testing, shots and then came the flu vaccinations starting in Aug. and probably peaking in Oct-Nov…  staffing issues and work environment has apparently came to a HARD BOIL…  and Rx dept staff are apparently quitting in large numbers..

For years, many of us “old timers/legacy pharmacists” have been telling the younger Pharmacists that they need to stand up for every increasing bad/dangerous work environments.  The chains budget $$$ to settle mis-filled Rxs and as long as the profit of under staffing is greater than the cost of settling the mis-fills things will continue to deteriorate…  Most would reply that the “pts count on me, I can just abandon them” and legacy pharmacist would tell them.. they come because of the company’s name on the front of the building.

What we are now seeing on airplanes as passengers act up and get out of hand… mostly because they are pretty liquored up… From what I have been hearing from the “pharmacy front lines”…  some sick pts – who are not feeling very well – are becoming very belligerent, and demanding and have been do so for some time.  As more and more chains are using pharmacists from a “floater pool” … these staff pharmacists of these chains are starting to realize that the pts are not coming to a particular store because of them.

there has been some reports from some of the major chains, by their staff pharmacists that they have 10 days worth of prescriptions “stacked up in the computer ques” and District Managers/Supervisor telling them to just FOCUS ON THE Rx WAITERS !

I wonder what those Pharmacists think today about all those pts coming to their store…. because of them.

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Apparently some have to do studies … just to get money grants –  In this example, they use data of low methodologic quality  and Risk factors were contradictory and remain unclear, they come to the conclusion Given the lack of clear evidence regarding short-term therapeutic exposure.. that prescribers should basically come to using “sound clinical judgement in prescribing opiates.” One must wonder how many of our tax dollars was spent for 2 reviewers to “dissect” 21 observational studies’ data to created a narrative summary that the data in the chosen studies was of poor quality, contradictory and only a UNCLEAR CONCLUSION was the determination in the end.

Nonmedical Opioid Use After Short-term Therapeutic Exposure in Children: A Systematic Review

https://pubmed.ncbi.nlm.nih.gov/34816280/

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Massachusetts returns car to grandmother six years after mistakenly seizing it

https://www.foxnews.com/politics/massachusetts-returns-car-grandmother-six-years-after-mistakenly-seizing

Police suspected the car had been a part of a crime in Berkshire County

A Massachusetts grandmother is calling for reform of the asset forfeiture system after the state wrongfully suspected her car had been involved in a crime and seized it for six years.

Malinda Harris, now a 61-year-old single mother who resides in Springfield, looked on in March 2015 as police confiscated her 2011 Infiniti G37 after it was believed to have been involved in the commission of a crime in Berkshire County. On the same day the vehicle was seized, Harris, who was living in a shelter at the time, had loaned the car to her son, Trevice, who police suspected was dealing drugs.

It was not until October 2020, five years after the seizure, that Harris received legal notice that the state would be keeping her car permanently unless she talked to them. After receiving the notice, and not being able to afford a lawyer at the time, Harris received assistance from the Goldwater Institute – which helped her get her car back earlier this year.

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State Pharmacy Board meets to discuss Walgreens closures

https://wgme.com/news/local/state-pharmacy-board-meets-to-discuss-walgreens-closings

PORTLAND (WGME) — The state is taking action in the face of sudden disruptions at Walgreens pharmacies.

The group that regulates pharmacies in Maine met Thursday to talk about the issue.

The issue is going before the State Pharmacy Board because the closures are repeatedly happening at the same locations.

It’s impacting people’s access to vaccines, COVID testing and medications.

“This is the most unusual grouping of reports,” Office of Professional and Occupational Regulation Administrator Geraldine Betts said.

When pharmacies change their hours to their posted schedule, the State Pharmacy Board has to be notified.

If that happens four or more times in a calendar month, the board can eventually require the site to change its hours.

“The board has, not that I recall, ever gone into that,” Betts said.

The repeated problems discussed Thursday reportedly happened at 13 Walgreens pharmacies from Buxton to Bar Harbor, Lewiston to Brunswick.

One site in Auburn was closed nine times in October.

“Always closed, but it’s happening all around town though,” pharmacy customer Melissa Fisher said. “There’s not enough people to keep it open.”

The location on Congress Street in Portland closed four times in October and another four times in August.

“When you call, they say they’re open, but when you get here, they’re not open,” Fisher said.

Others were shocked it was such an issue.

“Anna the pharmacist, I’ve seen her work from open to close day after day after day,” pharmacy customer Peter Winchester said.

All of the reports presented to the board blamed staffing problems.

“Did I hear this was happening with other chains and or individual pharmacies as well?” Pharmacy Board Member Tim McCormack said.

“We have not seen reports from others just yet,” Betts said.

That is something the state is looking out for, but so far, the problem seems limited to Walgreens.

“We’re kind of tired of using the term ‘unprecedented times,’ but I’ve been doing this for 20 years and have never ever seen it as tough as it is,” Pharmacy Board President Brad Hamilton said.

The state is going to remind Walgreens that it has to clearly post changes to the hours and customers have to be notified of another nearby location that can help.

The state has already reached out to the chain to get more info about why this is happening.

The board even discussed having a meeting with a representative.

In a statement to CBS13, Walgreens said, “We apologize for any inconvenience to our customers and patients, as we have adjusted pharmacy hours in our stores to accommodate current staffing needs, while also working to ensure minimal disruption to our customers. “

The pharmacy chain added that it was proud of the extraordinary efforts of its pharmacy and store teams.

“Throughout this greater demand for COVID-related services, they are working to ensure that our patients and customers are cared for, even as we address staffing challenges due to the ongoing labor shortage. What we are seeing currently is consistent with what many other healthcare entities have been experiencing,” Walgreens said. “We’ve expanded our recruitment efforts amidst a pronounced labor shortage, and we’re taking every step possible to help meet current heightened demand for COVID-19 vaccinations, as well as testing and other pharmacy services.”

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Mom Is Suing Hospital for Performing an Emergency C-Section Without Anesthesia

https://www.parents.com/pregnancy/giving-birth/mom-is-suing-hospital-for-performing-an-emergency-c-section-without/

A woman and her fiance are suing Tri-City Medical Center in Oceanside, California after she says doctors performed an emergency cesarean section on her without anesthesia.

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