FDA approves first continuous glucose monitoring system that does not require finger stick test

FDA approves first continuous glucose monitoring system that does not require fingerstick test

https://drugstorenewsce.com/editorial-news-item/5/12420?tp=i-H55-Q5U-2Qi-3j5rF-1v-164o-1c-XKV-3iwI3-1Fvxlh&

WASHINGTON, D.C. — The U.S. Food and Drug Administration approved its first continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation via a traditional fingerstick test. The FDA announced it expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.

The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.

“The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions. This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”

The G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device running a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds. The system measures glucose in fluid under the skin and must be calibrated at least two times per day using blood obtained from fingerstick tests. However, additional daily fingerstick blood tests are generally no longer necessary because unlike other continuous glucose monitoring systems, results from this device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test, stated the FDA.

The cartels.. know increased seizures… so they ship a little bit more, knowing that it is going to be intercepted

Heroin Epidemic Drives Surge In Drugs Busts On DC Highways

Relentless drug trafficking efforts from gangs and cartels are causing a spike in the number of drug busts by authorities on highways in the Washington, D.C., region.

Roadside drugs arrests rose from 1,752 in 2015 to 1,971 in 2016 in Maryland. Virginia experienced a similar increase between 2014 and 2015, with roadside drug busts rising from 3,163 to 3,354. Officers patrolling the highway corridors around Washington, D.C., are also reporting a noticeable surge in drug arrests, many relating to heroin or synthetic opioids. Officials believe increased trafficking efforts from criminal organizations are responsible for the rising busts, reports NBC Washington.

Police in the region said the drugs primarily flow from north to south on Interstate 95, where authorities are focusing their efforts. Drug traffickers are aware of this, however, and compensate by flooding the highways with even more drugs.

“The cartels, other major organizations, crime syndicates who are in the business of shipping drugs, they know this – so they ship a little bit more, knowing that it is going to be intercepted,” Neill Franklin, a former Maryland state police trooper and transit officer, told NBC4. “And what they want to arrive in New York or Miami or Baltimore city or Philadelphia, it arrives.”

 

Heroin trafficking is contributing to the uptick in arrests, but authorities say marijuana continues to be the primary drug they find. Police recently seized 347 pounds of marijuana being transported along I-95 in a box truck heading north. Narcotics trafficking is also thriving, however, and authorities are finding it increasingly difficult to thwart.

“The narcotics industry is a billion dollar industry,” Maryland State Police Corporal Brian Hirsch told NBC4. “They’re spending all day, every day, trying to deceive the police officers on the road.”

Officials in the region are attributing a large amount of the spike in trafficking to the heroin epidemic plaguing states in the area. Heroin-related deaths are rising at an alarming rate in Maryland, which is suffering the fifth highest rate of death from drug overdoses in the country. Heroin-related deaths tripled from 247 in 2011 to 748 in 2015, according to data from the Maryland Department of Health and Mental Hygiene.

Deaths from fentanyl-laced heroin in the first half of 2016 doubled when compared to the same period in 2015 in the state.

 

Should people holding a vendetta be put in a position of power ?

In this Monday, Dec. 19, 2016 photo, interim U.S. Attorney Bruce Brandler poses for a photograph at his office in Harrisburg, Pa. The top federal prosecutor for central and northeastern Pennsylvania announced a strategy to combat the heroin and prescription painkiller epidemic. What few people know is that Bruce Brandler, a veteran prosecutor recently named interim U.S. attorney, lost his own son to a heroin overdose. Photo: Matt Rourke, AP / Copyright 2016 The Associated Press. All rights reserved.Federal prosecutor tackles heroin scourge that claimed son

http://www.sfgate.com/news/medical/article/Federal-prosecutor-tackles-heroin-scourge-that-10830627.php

HARRISBURG, Pa. (AP) — The phone at Bruce Brandler‘s home rang at 3:37 a.m. It was the local hospital. His 16-year-old son was there, and he was in really bad shape.

A suspected heroin overdose, the nurse said.

Brandler didn’t believe it. Erik had his problems, but heroin? It seemed impossible.

Nearly 10 years later, the nation is gripped by a spiraling crisis of opioid and heroin abuse — and Brandler, a veteran federal prosecutor recently promoted to interim U.S. attorney, suddenly finds himself in a position to do something about the scourge that claimed his youngest son’s life.

Until now, he has never publicly discussed Erik’s overdose death. It was private and just too painful. But Brandler, now the chief federal law enforcement officer for a sprawling judicial district that covers half of Pennsylvania, said he felt a responsibility that came with his new, higher-profile job.

“It’s easier to cope with the passage of time, but it never goes away,” Brandler told The Associated Press in an interview. “And, frankly, this whole heroin epidemic has brought it to the forefront.”

Fatal heroin overdoses have more than quintupled in the years since Brandler lost his son. The illicit drug, along with highly addictive prescription pain relievers like oxycodone and fentanyl — a substance more powerful than heroin — now rival car crashes as the leading cause of accidental death in the U.S.

Erik’s death proved that heroin doesn’t discriminate, Brandler said. He urged parents to “open their eyes” to the threat and talk to their kids.

“I want to evaporate the myth that heroin addicts are just homeless derelicts,” said Brandler, who, before his son’s overdose, held that impression himself. “This epidemic hits everybody, and I think my situation exemplifies that.”

The opioid crisis was already taking root when Brandler began having problems with Erik, the youngest of his three children. The teenager’s grades dropped, his friends changed and he began keeping irregular hours. Brandler found marijuana in his room and talked to him about it, figuring that was the extent of his drug use.

Then, in spring 2007, Erik overdosed on Ecstasy and had to be treated at a hospital.

“That elevated it to a different level as far as I was concerned, a much more serious level, and I took what I thought were appropriate steps,” Brandler said.

He called the police on his son’s dealer, who was prosecuted. That summer, Erik completed an intensive treatment program that included frequent drug testing. Brandler thought his son had turned a corner.

He was mistaken.

On the night of Aug. 18, 2007, Erik and an older friend paid $60 for three bags of heroin. After shooting up, Erik passed out. His breathing became labored, his lips pale. But his companions didn’t seek medical treatment, not then and not for hours. Finally, around 3 a.m., they dropped him off at the hospital.

At 5:40 a.m., he was pronounced dead.

Five people were charged criminally, including Erik’s friend, who received more than five years in prison.

Brandler still doesn’t know why his son, who excelled at tennis, went to a good school and had loads of friends, turned to heroin.

“I thought about that, of course, but it’s really a waste of energy and emotions to go down that road because I’ll never know the answer,” Brandler said from his office near the Pennsylvania Capitol, where a framed photo of Erik — strapping, shaggy-haired and swinging a tennis racket — sits on a credenza.

What he can do is join his fellow prosecutors in tackling the problem.

In September, the Justice Department ordered all 93 U.S. attorneys across the country to come up with a strategy for combating overdose deaths from heroin and painkillers. Brandler released his plan, covering 3.2 million people in central and northeastern Pennsylvania, last month. Like others, it focuses on prevention, enforcement and treatment.

He said his office will prioritize opioid cases resulting in death, and aggressively prosecute doctors who overprescribe pain pills.

Additionally, prosecutors will hit the road — bringing physicians, recovering addicts, family members of overdose victims and others with them — to talk to schools and hard-hit communities.

Parents need to know that “if you think it can’t happen to you, it can,” Brandler said. “If it happened to me as a federal prosecutor, I think it can happen to anyone, and that’s really the message I want to get out.”

Federal appeals Judge Thomas Vanaskie said it’s a message that needs to be heard.

“Education is the most important thing to me,” said Vanaskie, who helps run a court program that gets federal convicts back on their feet and who has been working with a former heroin addict who robbed a bank to feed his addiction. “We’ve got to prevent people from becoming users.”

Vanaskie, who has known Brandler for years, commended him for speaking out.

“Hearing it from him becomes so much more powerful,” Vanaskie said. “I know it causes great personal pain on his part, but he personalizes, humanizes this matter.”

 

Uncle Sam: Growing/selling MARIJUANA in MS since 1970 ?

Big Pharma Gets Green Light

cannabisnow.com/big-pharma-gets-green-light/

Guess who benefits when Uncle Sam opens the research weed supply chain?

Cannabis is still highly dangerous and has no place in modern medicine, according to the U.S. government – who still wants a bigger and better supply of the troubled stuff on hand anyway, just in case.

And Uncle Sam wants you – yes, you – to try and grow some research-grade cannabis for your country. But good luck with that. It won’t be easy.

This past summer, after several unexplained delays, fueling unfounded rumors that the Obama Administration would legalize marijuana of its own volition, the Drug Enforcement Administration announced on Aug. 12 that it would not be removing marijuana from Schedule I of the Controlled Substances Act.

Despite a growing body of knowledge in other countries and a majority of American states with some kind of medical marijuana program, the decision to leave marijuana in the Schedule I designation means pot is still officially as dangerous as heroin and LSD. Cocaine and methamphetamine (both Schedule II) are officially safer and more beneficial.

The reasons why, given by Acting DEA Administrator Chuck Rosenberg, is a continuation of the circular logic that’s fueled the U.S. war on weed for more than four decades. And the DEA’s own language now seems to suggest that Big Pharma – not the cannabis industry – will have the inside track to a better supply.

“There is growing public interest in exploring the possibility that marijuana or its chemical constituents may be used as potential treatments for certain medical conditions,” Rosenberg wrote in a letter published in the Federal Register on Aug. 12. “One of the ways DEA can help to facilitate research involving marijuana is to take steps to increase the lawful supply of marijuana available to researchers.”

Research Monopoly Ends

Currently, there is a single government-approved marijuana supplier: the University of Mississippi. Holding this monopoly for nearly 50 years, access to its supply is extremely limited, granted only to funded researchers receiving several onerous layers of bureacratic approval.

According to NIDA, just eight shipments of government bud went out to researchers in 2015, with another eight shipments in 2016 as of late August.

But this federal marijuana supply chain is set to expand. The DEA now says it will consider applications from commercial enterprises as well as from research universities – which thrilled some researchers.

“It’s a complete and total end of the NIDA monopoly,” said Dr. Sue Sisley, whose DEA and NIDA-approved study into whether smoked cannabis helps combat veterans with PTSD is scheduled to begin this fall.

“This new policy permits commercial growing operations to be approved with the purpose of producing a product that can be used in research and also for potential commercial sales,” she said. “The federal monopoly on the production of marijuana for federally-regulated research, in existence since 1968, is now over.”

Despite this, a DEA spokesperson contacted by Cannabis Now said no applications had yet been received by the end of August.

 Photo Gracie Malley for Cannabis Now

Government-Grade Ganja

Ole Miss grows a single strain, its terpene content unknown, available in either bulk at $2,497 a kilogram or $14 per joint in one of 13 strengths – low, medium, high, or very high THC or cannabidiol (CBD); placebo, or a combination.

And “very high” THC and CBD caps out in at 13 percent THC, meaning researchers are forced to give human subjects less than half as strong as cannabis from recreational stores or dispensaries.

This is the marijuana still being supplied every month – mailed out in half-pound tins of prerolls to the surviving patients in the Compassionate Investigational New Drug Program. Started in the 1970s, after a glaucoma sufferer named Robert Randall sued the government and accepted a settlement of free government-supplied weed for life, enrollment in that program capped at 30 people, of whom four are still alive. One, Irvin Rosenfeld has been receiving nine ounces monthly since 1982 for a rare bone disorder; Elvy Musikka, who suffers from glaucoma, began receiving eight ounces monthly in 1988. The program closed to new patients in 1992.

While this weed has kept Rosenfeld and Musikka alive and healthy, researchers have long complained that the hard-to-get supply is also insufficient. Today, there’s an increase in demand for research into extractions high in cannabidiol (CBD) and low in THC – research clamored for even by longstanding drug warriors like U.S. Sen. Dianne Feinstein. High-CBD, low-THC oil has been approved by state governments even in reliably red Republican parts of the country that still have punitive anti-marijuana laws on their books.

“DEA fully supports research [of extracts],” Rosenberg insisted in the Aug. 12 letter. “DEA has concluded that the best way to satisfy the current researcher demand for a variety of strains of marijuana and cannabinoid extracts is to increase the number of federally authorized marijuana growers.”

But there’s a catch – several of them, really.

Not So Fast

The DEA does not specifiy the number of new applicants allowed or how much they’ll be able to grow. The organization does state suppliers will be “limited” in order to avoid diversion of government-grade weed to the black market. It also outlines that while experienced suppliers will be considered, violations of the Controlled Substances Act, for, say, growing marijuana, may count against them.

The DEA’s language surrounding those who will be accepted for the program highlights an advantage for pharmaceutical companies over cannabis growers striving to work within the system.
“Should… a marijuana-derived drug [be] shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States – independent of the NIDA contract process.”

Meanwhile, other obstacles remain. In the early 2000s, University of Massachusetts professor Lyle Craker received initial approval to grow research cannabis, but never got the chance. His application was personally rejected by then-DEA Administrator Michele Leonhart in 2005. Craker says he plans to apply for federal government approval – but first, he needs the permission of his state government, which has yet to offer a response.

And even if the government adds supply, there’s no guarantee research will be funded or approved.

Research hit a peak – 17 applications in a five-year period after the California Legislature used $9 million to create a medical cannabis research institute in 1999.

Once the state stopped funding the research, the studies stopped.

Sisley’s research is also state-funded, with $2 million from the Colorado Department of Public Health. It’s very unclear if more money will be forthcoming from other sources.
Still, “You’ll agree the handwriting is on the wall…  this product needs to be studied,” Craker says. “We need to be able to supply various strains to medical professionals. We need to test and see if these strains are different than others, we need to look at the terpenoids, not just the stuff that makes you high.”

“The DEA must be recognizing that to some extent that they are losing control.”

Just how much control the DEA will ultimately relinquish, however, remains to be seen.

Troubling Pharmacies: series links

Troubling Pharmacies: series links

http://www.newsleader.com/story/news/local/health-care/2017/01/02/troubling-pharmacies-links-all-stories-series/96079540/

Last week’s series about local pharmacies and pharmacists who’ve run afoul of the Board of Pharmacy, and the transparency issues with how the board notifies the public, are collected below. 

Under the story links you’ll find information about how to check the board’s case decisions or to look up the license status of your pharmacist, doctor, nurse, or other health professional.

Seventeen local pharmacies were cited by inspectors since 2010. One pharmacist committed over forty violations across 27 years and was never suspended for a day:

Augusta Health officials explain the corrective process after state inspectors paid a visit during a major renovation of their on-site pharmacy:

You could be visiting a pharmacy that had been cited for violations and was still in the midst of corrective actions, or accepting a prescription from a pharmacist on probation, without ever knowing it:

These area pharmacies were cited for violations since 2010:

A small but important improvement to how the state just made it easier to find out important information about your local health professionals:

Even if you have a clean record, inspections can be anxiety-inducing:

Case decisions from our area illustrate the type of mistakes that can endanger customers:

Complaints can be made online at http://www.dhp.virginia.gov/Enforcement/complaints.htm; by calling (800) 533-1560 or (804) 367-4691 or faxing (804) 527-4424; or by emailing enfcomplaints@dhp.virginia.gov when there is awareness of possible violations by one of DHP’s licensees.

Is Suicide a Consequence of the CDC Opioid Guideline?

Is Suicide a Consequence of the CDC Opioid Guideline?

http://www.painmedicinenews.com/Commentary/Article/08-16/Is-Suicide-a-Consequence-of-the-CDC-Opioid-Guideline-/37442/ses=ogst

By Lynn R. Webster, MD

imageThe law of unintended consequences states that the actions of people, and especially of governments, always have effects that are unanticipated, as when legislation and regulation aimed at righting a problem go wrong in other ways (Unintended consequences. http://tinyurl.com/?8p8g). An example may be the guideline issued by the Centers for Disease Control and Prevention (CDC) discouraging the use of opioids in treating chronic pain, excluding cancer and end of life (MMWR Recomm Rep 2016;65:1-49).

The guideline was not intended to be mandatory; yet, as I predicted in a previous roundtable discussion, the stature of the CDC appears to have resulted in it being viewed by many as more than a guideline (“Draft CDC Opioid Guideline: Pain Medicine Experts Discuss,” Pain Medicine News January/February 2016). A growing number of reports suggest that the guideline is responsible for people with chronic pain throughout the country being tapered or withdrawn from opioids or dropped entirely from physicians’ practices, even if the patients have been on stable doses of opioids for years with attendant improved pain and quality of life (Chronic pain patients are suffering because of the US government’s ongoing War on Drugs. Quartz. http://qz.com/?694616).

Pain News Network reports that dozens of patients have contacted the editor since March, when the guideline was made public, to say that their doctors have “fired” them on flimsy excuses, or that their doctors suddenly are weaning them off opioids or abruptly cutting them off from the medications (Are CDC Opioid Guidelines Causing More Suicides? Pain News Network May 27, 2016).

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Worse is that some patients are so despondent and in so much pain that they have given up and looked to suicide as a way out. As Pain News Network reports, nearly 43,000 Americans committed suicide in 2014, more than twice the number of deaths that have been linked to overdoses of opioid pain medications. Anecdotal reports that chronic pain contributes greatly must not be dismissed. I am certain this is not a consequence intended or anticipated by the CDC, but tragically it is playing out.

‘Everyone Has a Breaking Point’

The following are passages from a message I received from a person in pain, in response to one of my blogs. (They have been edited for clarity.)

“After this Easter, my life turned off a cliff and nosedived. My best friend in the world, who suffered with chronic pain, checked out because he was tired of living with pain, doctors and judgment. He was just tired of it all. So many people are disgusted with the CDC’s guidelines—as am I—as they cast far too wide of a net and caught a lot of innocent victims in it.”

image

This man, a veteran, goes on to write of his personal involvement and knowledge of the opioid crisis as a sufferer of chronic pain and father who lost a 21-year-old daughter to—as he puts it—“the OxyContin Express that roared through Florida.”

“Persons in power too often see the world in black and white. They forget there is a gray area where most of us live—reality.”

The Department of Veterans Affairs is adopting the guideline, which was written to be voluntary, “as law,” he writes, “ripping 12-year–compliant patients off meds.” He is one of those patients with many years of passed urine drug screens and prescription drug monitoring checks behind him.

“This is the kind of foolishness that pushed my pal to the point he felt backed in a corner, put a gun to his chest, and pulled the trigger. I knew this man 35 years. … Everyone has a breaking point.”

This friend had shared his fears of having his treatment taken away.

“He asked me if I would forgive him if he took his own life. I told him I would. This has been a heavy burden to carry. But loving someone unconditionally comes with a heavy load.”

Now 58, the man who wrote this letter said he flinches now when he hears of anyone taking his or her life due to untreated pain. Further, he is steeling himself to deal with his own pain issues as changes to his medical treatment appear inevitable and also—as he puts it—impersonal.

“So now at 58 years old, here we go again. … The way my medical conditions were being treated for the past 12 years was about to change. … I’m no doctor, no pharmacist, no rocket scientist, but even I know you can’t do that to a human being without reprisal. So here I am picking up the pieces. I hope and pray others make it through the changes OK. I hope I make it OK.” Making it through is all he wants.

Innocent Victims

Undeniably, the country is experiencing a serious opioid crisis, which must be addressed. However, the steps to reverse the opioid crisis should not cause greater harm to the innocent and those hurting the most in our society. Our politicians and policymakers must be advised that their actions have unintended consequences. If the unintended consequences of the guideline cause greater harm than the intended positive consequences, then the only rational and compassionate path forward is to change the focus and direction. Perhaps it is time to recognize the needs of people in pain with an urgency equal to that for people with opioid addictions.

AgeWise: Making a trip to the ED less stressful

 

AgeWise: Making a trip to the ED less stressful

http://www.journalnow.com/news/local/agewise-making-a-trip-to-the-ed-less-stressful/article_ffe0f0ea-0d95-5867-ba70-a423d0aea9e6.html

Q: We had an emergency over the holidays with my mother that almost required an emergency department visit. It got me wondering are there certain things we should look for in a hospital/ED? What is being done to make them senior friendly?

MJ

Answer: A trip to an Emergency Department (ED) can be difficult and stressful at any age. It can be particularly difficult for older adults, who often have a number of health problems and take multiple medications. Because EDs tend to be noisy and hectic, older people can feel overwhelmed. And, if they have to spend a lot of time there, they have a greater chance of developing delirium — serious mental confusion that can sometimes lead to difficulty thinking and remembering.

 

Fortunately, EDs are becoming more “senior-friendly” as hospitals are making changes so they are safer for older people. Some hospitals are even creating special EDs just for older adults. If you are older, or if you care for an older person, it can be helpful to learn more about the Emergency Department that is closest to where you live as this is where you will likely be taken if you need emergency care. When you visit, ask the staff the five questions below. According to the Health in Aging Foundation, these five questions are important to know and consider:

  1. Is there someone on the ED staff with specialized training in the care of older adults? Geriatricians are doctors with advanced training in caring for older people. Nurses, physician assistants, and other members of the health care team may also have advanced training in geriatrics. These professionals are important members of the ED team because older people may respond differently to medications and other treatments than younger people do.
  1. Geriatrics health professionals are well aware of these differences.
  1. Is there someone at the hospital I can speak with about advanced directives? Advanced directives are legal papers that explain what kind of end-of-life care a person wants, and doesn’t want. For example, in an advanced directive an older person may note that he does not want to be kept alive with a respirator — a device that can breathe for you if you can’t breathe on your own.
  2. How do you help make triage less stressful for older people? Triage is a standard system for deciding which patients at an ED get treated first. With triage, patients who need care the most get treated first. Because Emergency Departments are often busy, waits can be long for those who don’t need immediate help. This can be a problem because older adults who have long waits may run an increased risk of developing delirium. Ask the staff if they can move an older person to a quieter, calmer room if they have a long wait. Ask what else they do to make older people’s time in their department less stressful.
  3. Does the hospital use medication reconciliation and full pharmacy reviews? These practices lower the chance that an older patient will get incorrect medications or medicines at the wrong doses. Medication errors are the most common medical errors. Many of these errors can be avoided with regular medication reconciliations. These reviews involve making a complete list of a patient’s medications, and then comparing that list with the list of medications in the patient’s record. Pharmacy reviews involve creating a complete and correct list of the current medications a patient should be taking, every time the patient moves from one health care setting to another
  1. — such as from the ED to a hospital room to a rehabilitation facility
  1. .
  2. What do you do to limit the number of “transitions of care” that older adults go through after they reach the ED? Between the time they reach the ED and the time they return to their home, older adults may be moved to new locations several times. For example, they may be transferred to an Intensive Care Unit
  1. (ICU)
 
  1. , to a hospital room, to a rehabilitation facility, and back to where they live. With each move
  1. (care transition)
  1. , patients get care from different health care providers. However, research shows that older people who go through fewer transitions are given fewer inappropriate medications and have better health outcomes.

For more information about this and other topics related to the health of older adults, visit Health in Aging Foundation at www.healthinagingfoundation.org.

Frieden to Resign as CDC Director

Frieden to Resign as CDC Director

www.painnewsnetwork.org/stories/2016/12/31/frieden-to-resign-as-cdc-director

Dr. Thomas Frieden, who has headed the Centers for Disease Control and Prevention for nearly eight years and played a pivotal role in the agency’s opioid prescribing guidelines, plans to submit his resignation on January 20, the day of President-elect Donald Trump’s inauguration.   

Frieden disclosed his plans in a year-end interview with Reuters. The former New York City health commissioner did not say what he planned to do next.

Frieden’s resignation is not surprising, as incoming administrations usually do not retain the heads of federal agencies, most of whom are political appointees.  Food and Drug Commissioner Robert Califf, MD, who has only been in office for 10 months, has not been contacted by the Trump transition team and is also expected to be replaced, according to The Washington Post.

President-elect Trump has not yet said who he will nominate to succeed Califf or who he will appoint to replace Frieden.

Frieden has an extensive background in epidemiology and infectious diseases, and his tenure at the CDC was marked by major efforts to combat outbreaks of the Ebola virus, fungal meningitis, influenza and the Zika virus. He also doggedly pursued a controversial campaign to put prescribing limits on opioid pain medication, an area traditionally overseen by the FDA.

“One of the most heartbreaking problems I’ve faced as CDC director is our nation’s opioid crisis,” Frieden recently wrote in a commentary published by Fox News. 

“This crisis was caused, in large part, by decades of prescribing too many opioids for too many conditions where they provide minimal benefit and is now made worse by wide availability of cheap, potent, and easily available illegal opioids: heroin, illicitly made fentanyl, and other, newer illicit synthetic opioids. These deadly drugs have found a ready market in people primed for addiction by misuse of prescription opioids.”

thomas frieden, md

thomas frieden, md

But Frieden’s campaign to reign in opioid prescribing has failed to slow the soaring number of overdose deaths, which continued to rise throughout his tenure at CDC, killing 52,000 Americans last year alone.

His repeated claim that the use of prescription opioids by legitimate patients is “intertwined” with the overdose epidemic is also not supported by facts. Only a small percentage of pain patients become addicted to opioid medication or graduate to heroin and other illegal street drugs.

Yet Frieden remains a staunch supporter of the CDC guidelines, calling them an “excellent starting point” to prevent opioid abuse, even though the guidelines themselves state they are based on scientific evidence that is “low in quality.”

“There are safer drugs and treatment approaches that can control pain as well or better than opioids for the vast majority of patients. We must reduce the number of Americans exposed to opioids for the first time, especially for conditions where the risks of opioids outweigh the benefits,” Frieden wrote.

“We must not forget what got us here in the first place. Doctors’ prudent use of the prescription pad and renewed commitment to treat pain more safely and effectively based on what we know now about opioids—as well as healthy awareness of the risks and benefits among patients prescribed these drugs—can change the path of the opioid epidemic.”

Frieden undoubtedly had good intentions, but his agency repeatedly showed a penchant for arrogance and contempt for the public while drafting the guidelines.  The CDC held no public hearings, and secretly consulted with addiction treatment specialists and special interest groups, but few pain patients or pain physicians.

The CDC finally unveiled the guidelines publicly in September 2015 to a select online audience. The agency didn’t make the guidelines available on its website or in any public form outside of the webinar, and allowed for only a 48-hour comment period. Only when faced with the threat of lawsuits and growing ridicule from patients, physicians and other federal agencies, did the agency reverse course and delay the guidelines for several months. They were released virtually unchanged in March 2016.

Although “voluntary” and meant only for primary care physicians, the guidelines have been widely adopted by pain specialists and other prescribers, and have even become law in several states. This was always the goal of the CDC.

Within a few months of their release, an online survey of nearly 2,000 pain patients found that over two-thirds had their opioid medication reduced or stopped by their doctors. Over half said they had contemplated suicide.

There have been anecdotal reports of suicides increasing in the pain community. A recent story we did about the suicide of a Vermont man who was cut off from opioids and abandoned by his doctor provoked quite a response from readers.

“This situation has got to be stopped before any more people commit suicide to escape the pain. I also suffer from chronic pain and my medications have been cut back so far they no longer work worth a damn,” Michael wrote to us.

“I’m facing the very same thing right now. I’m in utter agony,” said LadyV. “In my doctor’s office I was told I have to reduce you, wean you off. I through no fault of my own suffered a horrible spinal injury and now no one cares.”

“When I was forcibly weaned off my pain meds last spring, due to the push by the DEA and CDC, I wrote a letter to the White House,” wrote Judith Metzger. “I mentioned a need for them to be watching suicide statistics related to uncontrolled chronic pain. There was never any mention that I was suicidal. Still, I got several calls from a suicide crisis team in DC! Reading this tragic story makes it clear that my prediction was sadly correct. When will they ever listen?”

In his commentary for Fox News, Frieden said it was “important that we look upstream and prevent opioid use disorder in the first place.”

In his final weeks at the CDC, now may be a good time for Frieden to look downstream at the havoc his prescribing guidelines have created.

If you want to make a difference…

I have created a Twitter account @painedlives and intention is to use this to send out information to Congress, media that seldom get to them. Because all that gets sent to them is what the DEA press release machine puts out…  https://www.dea.gov/pr/news.shtml

Below is a – cloud based – google spread sheet that I have created – I need people to go to the website and use the link before www.usnpl.com/ to create a database of twitter names for media. The spread sheet can be worked on by a number of people at the same time and it is automatically updated in real time.

We have a new President and Congress as of Jan 23 2017 and the only way that we can get their attention and hopefully cause change is to communicate with them.  Twitter is the first attempt into getting their attention.. without cooperation of those within the chronic pain community to get this database together.. IT WILL NOT GO FORWARD… and most likely the politicians, bureaucrats, and the bureaucracy will continue on the path that it is on and your ability to get adequate pain management and optimize your quality of life will continue to be compromised and deteriorate.

https://docs.google.com/spreadsheets/d/1DpY4MNPiHxFUdVJPpnQxdq7wCduIHC9Y5AOmm0ZPgc0/edit#gid=0

www.usnpl.com/

 

A Fed Agency as a FOR-PROFIT Company ?