“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Dr. Kline lives in Raleigh, in the Great State of North Carolina. He not only treats patients suffering with chronic pain, but also advocates for them. Many of whom rely on opioid analgesics to survive.
He has more than 40 years experience with long-term diseases, and has a very distinguished resume, including as the former Chief of Hospital in Home Service at Harvard Medical, a physician at Boston Children’s Hospital, his MD from The University of Maryland, completed his residency at the distinguished Stanford University, and he also has a PhD from The University of Oregon.
Dr. Kline has also authored several publications, been quoted in various medical articles, has been a guest on the Roy Green Radio Show, and is featured in a number of YouTube videos.
The US Food and Drug Administration (FDA) announced on Thursday that five companies have now voluntarily recalled extended-release metformin drugs because of elevated levels of N-nitrosodimethylamine (NDMA), a potential carcinogen.
The five companies who were notified of the agency’s testing results and who are recalling their extended-release (ER) product, and specific labeling and lots recalled, are:
There are additional companies that manufacture ER metformin and supply a significant portion of the US market, whose products are not being recalled at this time,” said FDA. Immediate release metformin formulations have not contained NDMA in the FDA’s testing thus far. The substance is ingested in low levels through normal dietary pathways but can raise the risk of cancer with long-term elevated exposure.
The agency has now posted updated results of its NDMA testing in a sortable tabular format that includes all companies whose product has been tested, which formulations and lots were tested, and what levels, if any, of NDMA were found.
A second testing method using liquid chromatography-electrospray ionization-high resolution mass spectrometry has been posted by the FDA “to provide an option for regulators and industry to detect eight different nitrosamine impurities in metformin drug substances and drug products,” said the agency.
Companies manufacturing ER metformin should evaluate the risk that it contains NDMA at elevated levels. Companies should conduct per-batch testing, notify the FDA of any test results showing NDMA above the acceptable intake limit, and not release that batch to the US market.
About half of large business returns audited were closed without change
The IRS is wasting time paying employees to audit returns that generate no additional revenue for the agency, a watchdog report released Thursday found.
Of the 10,755 returns that were analyzed – and closed – during fiscal years 2015 through 2018, a report by the Treasury Inspector General for Tax Administration found that 47.2 percent were closed with no change to the return. The agency estimated that – accounting for the costs of examining the returns – about $22.7 million was spent on these returns, which generated no additional revenue for the government.
These returns were examined in the IRS’ large business and international audit group, which is responsible for the tax administration of domestic and foreign businesses with assets exceeding $10 million.
Among these businesses with assets over $10 million, the no-change rate of returns examined ranged from 44 percent to 66 percent across all total asset amount ranges. Theoretically, there should be a lower no-change rate for categories of businesses and individuals with a higher risk of noncompliance, which TIGTA largely did not observe from the data.
The division’s closure rate was also 37 percent lower in fiscal 2018 when compared with fiscal 2015, according to the report, which was attributed to a decline in employees.
TIGTA suggested the division could better allocate its time and resources, spending less time on “no-change work.” It also said that due to the evolving nature of the business environment – including the implementation of the Tax Cuts and Jobs Act and an expanded use of virtual currency – the group needs to update its formula to better identify companies that are at higher risk of noncompliance.
In a response to the report, the IRS said it did not agree with the watchdog group’s monetary estimates based on the hours it assumed workers spent on no-change work. It also did not agree with some of the recommended policy changes.
The IRS estimates the average annual gross tax gap for tax years 2011 through 2013 is $411 billion, with the largest percentage stemming from under reporting
Russell Jones has been involved in the “War on Drugs” on various fronts for more than 40 years. For 10 of those years, Russell worked as a San Jose, California narcotics detective. Later he was assigned to a DEA-run task force. As a government intelligence agent, Russell worked in Latin America observing narcotics trafficking during the Nicaragua-Contra conflict. In academia, he conducted studies of the impact of drug abuse on the crime index, wrote training programs for identifying the psychological and physiological symptoms of narcotics use, and developed rehabilitation programs designed specifically for the court-mandated client. He has traveled throughout the former Soviet Union and China to study their drug problems and policies. In the field of drug rehabilitation, Russell implemented and taught courses for various California and Texas counties, as well as for privately run programs. Russell is a court-recognized expert (on both the federal and state levels) in the field of narcotics enforcement. His journey to the Soviet Union made it clear to Russell that the “War on Drugs” cannot be won. “Drugs were prevalent even behind the Iron Curtain,” he reports. “If a country, as controlling of its citizens as the Soviet Union was, still had such a large a problem – drug-dealing on Moscow street corners, meth labs in Leningrad – how could a free society such as ours handle the problem from a law-enforcement perspective?” Russell rightly attests that from the advent of drug prohibition in 1914 to the declaration of “War on Drugs” in 1970, to our present-day policies and tactics, the US government has not significantly reduced the use and abuse of drugs. Instead we have incarcerated millions, destroyed the lives of countless youths, while corrupting police, judges, and politicians. “We are taxing our population at over 69 billion dollars a year to support this ‘War on Drugs,'” he notes, “and the result is the enrichment of drug lords, foreign government officials, and our own government agencies that are involved in this folly.” Russell champions a three-pronged approach to reform: 1) treat addiction as a health problem – not a crime, 2) remove the profit motive from the drug trade, and 3) redirect a portion of the billions of dollars in enforcement costs that ending prohibition would save toward real, honest education about drugs. Education programs cut the use of nicotine, the most addictive drug known to humans, in half in a 20-year period and we didn’t have to arrest or imprison anyone to achieve that success.
Check out this video of one of Russell’s public speeches:
With Trump under fire for his handling of the outbreak, his advisers are eyeing the federal bureaucracy for other culprits ahead of the election.
White House officials are putting a target on the Centers for Disease Control and Prevention, positioning the agency as a coronavirus scapegoat as cases surge in many states and the U.S. falls behind other nations that are taming the pandemic.
Trump administration aides in recent weeks have seriously discussed launching an in-depth evaluation of the agency to chart what they view as its missteps in responding to the pandemic including an early failure to deploy working test kits, according to four senior administration officials. Part of that audit would include examining more closely the state-by-state death toll to tally only the Americans who died from Covid-19 directly rather than other factors. About 120,000 people in the U.S. have died of the coronavirus so far, according to the CDC’s official count.
Aides have also discussed narrowing the mission of the agency or trying to embed more political appointees in it, according to interviews with 10 current and former senior administration officials and Republicans close to the White House. One official said the overall goal would be to make the CDC nimble and more responsive.
Politically, Trump aides have also been looking for a person or entity outside China to blame for the coronavirus response and have grown furious with the CDC, including its public health guidance and actions on testing, making it a prime target. But some wonder whether the wonky-sounding CDC, which the administration directly oversees, could be an effective fall guy on top of Trump’s efforts to blame the World Health Organization.
“WHO is an easy one,” said one former administration official. “It is foreign body in Switzerland. CDC will be tough to create a boogeyman around for the average voter.”
The moves are among the White House’s efforts to deflect attacks on President Donald Trump and place blame elsewhere in the federal bureaucracy. Protecting the president is seen as increasingly important by political aides as the general election approaches in just over four months and criticism mounts from former Vice President Joe Biden, other Democrats and even former national security adviser John Bolton, who say the blame rests squarely on Trump.
The efforts risk backfiring if they blame career health experts at the CDC, whose warnings early in the crisis were dismissed by Trump and his top aides as fearmongering.
Juliette Kayyem, an Obama-era former Homeland Security official who aided the response to the 2009 H1N1 pandemic, said it can be valuable for agencies to revisit their performance after a crisis — but that there’s no reason to single out the CDC.
“When the history books are written about this crisis, is anyone actually going to believe that America’s abysmal performance and its high death rate was because of some bureaucratic impediment at the CDC?” Kayyem said. “The core of America’s problem is a White House that clearly was not pressed into action in January. And every flaw — from CDC and testing to FEMA and the stockpiles to the supply chain and the states — every systemic problem is rooted in White House malfeasance.”
The discussion is ongoing about the best way to revamp an agency White House aides view as distant from the West Wing — and filled with government career officials who do not respect or follow the Trump agenda.
No single plan for tweaking the CDC has gained traction inside the administration, and the time frame for any evaluation or audit remains unclear. One administration official said aides have discussed having someone inside the administration do the evaluation, or possibly bringing in an outside public health expert to lead it.
During a visit to the CDC last week, Health and Human Services Secretary Alex Azar spoke with CDC Director Robert Redfield and other senior officials about how to move forward with the need for reforms of the agency, a senior administration official said. But the official said discussions are in their early stages, and they strongly disputed the suggestion that any evaluation of the CDC would amount to a scapegoating exercise.
An HHS spokesperson said the department does not comment on internal deliberations, and the CDC referred questions to the White House.
After this story first published, a senior White House official said the CDC was not being maligned. “We found a few inconsistencies in CDC data based on data that we’re getting from hospitals,” the official said. “This is not about minimizing the role of CDC but ensuring that the American public gets accurate and verified data.”
The CDC, with a staff of 20,000 people, has long served as a model for public health agencies around the world, with a global stature held by few U.S. agencies.
But even before the pandemic, Trump administration health officials had discussed shrinking the CDC’s purview — stressing to Redfield after his 2018 arrival that he should consider reorganizing and refocusing the public health agency.
The CDC had taken on a growing range of research projects and areas of study over the past several years, they argued, a steady expansion that risked distracting from its primary mission as the nation’s leading authority on identifying and responding to infectious disease threats. The CDC later published a strategic framework that defined the agency’s “five core capabilities.”
In Trump’s proposed budget for fiscal year 2021, the administration proposed a roughly 19 percent cut to the agency’s discretionary budget. This year’s budget plan also proposed to refocus the CDC on “its core mission of preventing and controlling infectious diseases and other emerging health issues, such as opioids.”
The coronavirus crisis — and the CDC’s high-profile missteps — have only strengthened the case for an overhaul, said a former senior official who was involved in those discussions.
“The thing to do is take a hard look at the CDC and say what are the five things that they really need to do, and do it to the exclusion of everything else,” the former official said, adding that Redfield had agreed with the prepandemic concerns that the agency’s activities were too scattered. “People have been talking about back to basics, core mission.”
Redfield’s job is not in danger with an election so close, but officials from across the White House orbit have zeroed in on the CDC as a major problem within the coronavirus response. The vice president’s office has expressed concern about the accuracy of the coronavirus death toll, while parts of the Office of Management and Budget, such as the United States Digital Service, have been involved in reviewing the data at the state level.
As the nation’s top public health authority, the CDC has traditionally played a central role in crafting the federal government’s response to health crises and communicating with the public. But the agency has assumed a far lower profile amid the pandemic, after a series of slip-ups that drew the ire of White House officials and hampered the administration’s early response effort.
Initial coronavirus tests developed by the CDC in February proved faulty, delaying widespread plans to screen for the virus and allowing it to spread throughout the nation for weeks. An internal HHS investigation released last week found that the faulty test kits were likely contaminated at the CDC.
Messages from CDC officials early in the crisis, while in line with assessments from the scientific community, have embarrassed White House officials trying to contain the political fallout.
Nancy Messonnier, a top CDC official, surprised the White House in late February when she told reporters that a coronavirus outbreak was inevitable — contradicting top officials’ assertions at the time that the disease was largely contained.
In April, Redfield drew Trump’s attention after he warned that the country could face a brutal second wave of the disease come the fall — a statement he was forced to clarify the next day.
And more recently, the agency has come under scrutiny from the White House over guidelines for reopening schools and institutions that were initially seen as overly prescriptive, and from public health experts for conflating two different types of coronavirus tests in its overall testing numbers.
One administration official said the main problem with the CDC has been with the data it receives from states about the Covid-19 death toll — creating a larger problem clouding the U.S. response.
“In Pennsylvania, if you have coronavirus and you die from a gunshot wound, it gets classified as a coronavirus death,” the administration official said. “If the data drives the decision-making, you want to make sure you have good data. When you have different ways of counting things, it can lead to distortion. The audit was suggested as means to confirm that or disprove that.”
During the 80’s and 90’s our independent pharmacy was the largest respiratory supplier in two counties. We had a couple of hundred pts on home oxygen.. when a pt was on supplemental oxygen typically it was via nasal cannula at 2 LPM.. In those rare incidents where pts needed to put on a oxygen mask… it was necessary to bump up the oxygen flow to 5-6 LPM… so that the mask was flushed out between pt’s breaths of the CO2 the patient exhaled. If this was not done, CO2 is heavier than air and if not this higher flow and re-breathing CO2 could settle in the bottom of the lungs and block the Alveoli which exchanges the Oxygen in the air we breathe and getting it into the pt’s artery system.
I suspect that if the oxygen level could have been measured at the bottom of this pt’s lungs… it would probably been LOWER …
The chronic pain community has a new venue where a number of chronic pain advocates and chronic pain pts themselves are having a place to talk about how chronic pain is impacting pts and how changes are coming down the pike – both good and bad.
Last night I had the privilege to be in the Rapp Report’s “hot seat” and ended up talking about 90 minutes about issues all over the spectrum of issues that are impacting the chronic pain community and other pts that are dealing with subjective diseases.
I am sure that they would welcome input from the community on a topic/subjective material that some/many would like to have someone on the show to discuss. Here is their emailtherappreport.podcast@gmail.com
I was recently asked to review a new documentary called Pain Warriors. I think that it’s a really important film and want to do my part to help promote it. The mission of the film is to “tackle the other side of the OPIOID CRISIS ~ that of under treated pain patients and the slow death of compassion that surrounds them.” The film does a beautiful job of documenting the suffering of multiple chronic pain patients as well as following a Montana-based doctor who treated pain patients until being sanctioned by the board of medicine and losing his practice in 2015.
The film opens up by stating “100 million Americans live in daily pain that diminishes their ability to function. The opioid crisis has left patients with chronic pain undertreated, shunned, and disbelieved.” This is a huge problem that the media doesn’t focus on. The film does a wonderful job of showing the heartbreaking reality of chronic pain and the lack of access to adequate treatment.
The first patient that the documentary focuses on is Sherri, who has multiple chronic illnesses and suffers with chronic pain. She states how she feels she’s at the end of her rope with her pain. Sherri speaks about how desperate she is when she reaches out to a patient advocate to help her. After feeling like she has nowhere else to turn, Sherri and her advocate go to the ER, where, after waiting many hours, she is finally treated for her pain. Her advocate eventually leaves, confident that Sherri is getting adequate treatment and she’ll be notified if any issues arise. Heartbreakingly, Sherri does not continue to receive the treatment that she needs and checks herself out of the hospital only to go on to commit suicide.
She wrote to her advocate, “Please use my life and death as an example of where empathy is sorely needed for misunderstood illness.” This film is dedicated to Sherri’s life.
Credit: painwarriorsmovie.com
It’s so heartbreaking to me that Sherri got to the point that she chose to take her own life. She lived with chronic pain for over 30 years and the experience in the ER only served to push her over the edge. I’ve experienced the lack of empathy that Sherri talks about from doctors, especially in the ER. Legitimate pain patients are so often made to feel like nothing more than drug seekers who are wasting the time of emergency medical services. The lack of empathy and understanding for pain patients is a huge problem in this country and I think this documentary does an excellent job of highlighting this sad truth.
The next patient that the documentary follows is Hunter, who is an adorable young boy that was diagnosed with cancer years earlier and was on chemotherapy and steroids for 4 years. He was 7 when his cancer went away but now he suffers from chronic pain all over his body. The film shows his suffering and the way that it’s impacted him and his family. It’s heartbreaking to see this beautiful little boy say, “I kind of just think about giving up, I don’t think anything’s going to help. It’s kind of just my reality, like this is my normal; I can’t really change it.”
Hunter – Credit: painwarriorsmovie.com
I have so much admiration for this strong little boy who has had to deal with chronic pain and illness for as long as he can remember. I can only pray that advances in medicine and treatment of chronic pain will one day allow him some relief from pain in his lifetime.
The last chronic pain patient in the documentary is Karen, whose story is very near and dear to my heart. Karen suffered from the same chronic pain that I did for many years, from cerebrospinal fluid leaks. I know how brutal CSF leak pain is and how frustrating it can be to get the right diagnosis and care for this problem because so few doctors in this country know how to diagnose and treat it.
Karen was treated many times for her CSF leaks, flying back and forth across the country for patches and surgeries. Her patches did not last, and her symptoms kept returning after multiple treatments and procedures. She suffered for years from relentless pain until things eventually got so bad that she took her own life.
Karen’s husband, Bob, holding her photo – Credit: painwarriorsmovie.com
By the time I finished watching Karen’s story play out, I was in tears. I know the roller coaster of emotions that a CSF leak can cause and the hopelessness that one can feel after treatments fail, which happens far too often with this complicated condition. The fact that Karen got to the point with her pain that she chose to take her own life is so devastating to me. We desperately need more doctors to become educated on chronic CSF leaks so that patients don’t suffer in pain for years like Karen did.
I suffered from chronic pain for over 16 years because of my undiagnosed cerebrospinal fluid leak so I can relate wholeheartedly to each of the pain patients in this film. I know the hopelessness and despair that chronic pain can cause. I myself have reached the point of not wanting to live anymore at times. I’ve witnessed the lack of empathy from so many doctors and have experienced the lack of adequate treatment for chronic pain firsthand. We need more doctors who truly care and aren’t afraid to treat chronic pain patients.
The film also follows one of these caring doctors, Dr. Ibsen, who opened up a practice in Montana and started seeing patients who had been dropped by their family doctors and lost access to their pain medication. He saw patients who had been on pain medications for 10 or more years and were suddenly cut off because of the opioid crisis. Dr. Ibsen speaks about what happens when chronic pain patients are cut off from their pain medications: “They become suicidal, depressed, go to bed, fail to go to work, can’t take care of their kids. I felt obligated to step in and support them in their wellbeing and function.”
In 2015, he was sanctioned by the medical board for taking on these patients and treating them with opiods. Although he was actually tapering them down on their medications, the board felt that he was overprescribing and suspended his license. By December 2015, his practice was closed. Dr. Ibsen is now practicing medicine in India.
Dr. Ibsen says of his pain patients, “we have to address this invisible public health crisis of chronic pain and get them the care that they need so that they can live the functional lifestyle that they are entitled to.”
Dr. Ibsen is right. Chronic pain and the lack of treatment and empathy for pain patients is a public health crisis that deserves so much more attention. The suffering of pain patients on the other side of the opioid crisis needs to be addressed. The Pain Warriors website states “addiction and overdose deaths are serious issues that warrant being faced head on. Equally important but not addressed in any depth, are the lives of abandoned pain patients and the doctors treating them, left with limited options. Legitimate, responsible patients are being denied treatments that in many cases, have been their only lifeline to some small moments of function and dignity in an otherwise bleak future.” This film does a beautiful job of highlighting and finally addressing this important issue.
I also think that this is a really great film for people who suffer from chronic pain to show to the people in their life who may not understand the impact of their pain. This documentary really shows the devastation that chronic pain can cause in a person’s life and just how it can affect a person.
My summary of this film really doesn’t do it justice; you have to see it for yourself. It highlights the heartbreaking reality of chronic pain and sheds light on the other side of the opioid crisis, the one that isn’t shared in the news and by the mainstream media. The increasing number of suicides in the pain community from the lack of access to adequate treatment needs to be addressed. We need to do a better job of raising awareness of this public health crisis. This documentary is a wonderful beginning. If you’d like to watch this amazing movie for yourself, you can find it here:
[6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. FDA has identified the following products manufactured by Eskbiochem:
All-Clean Hand Sanitizer (NDC: 74589-002-01)
Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)
FDA tested samples of Lavar Gel and CleanCare No Germ. Lavar Gel contains 81 percent (v/v) methanol and no ethyl alcohol, and CleanCare No Germ contains 28 percent (v/v) methanol. Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.
Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
On June 17, 2020, FDA contacted Eskbiochem to recommend the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. To date, the company has not taken action to remove these potentially dangerous products from the market. Therefore, FDA recommends consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush or pour these products down the drain.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.
FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. Additionally, the agency is concerned with false and misleading claims for hand sanitizers, for example that they can provide prolonged protection such as 24-hours against viruses including COVID-19, since there is no evidence to support these claims.
To date, FDA is not aware of any reports of adverse events associated with these hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:
