I reserve the right of editorial censorship

It looks like the political “mud slinging” has already started – IMO – worse than the national election two years ago… I am taking a stand – in particular – against “slanderous name calling”  directed toward specific politicians, particular political parties and/or specific people.  I don’t mind political debate – based on FACTS… when the debate drifts off the road based on FACTOIDS, FAKE NEWS, opinions stated as FACTS.. is where I am going to draw the “line in the sand” and delete comments that go down that path.

While personally, I am not a big fan of our political/bureaucratic system.. IMO.. it is too self serving… Admittedly, politically I tend to lean to the POLITICAL RIGHT but that is because the Libertarian party is seemingly always kept in their place by our dominating “two party system”.

I have belonged to a national pharmacy association for 35 yrs… that promotes the saying “get into politics … or get out of pharmacy ..” If you don’t attempt to influence politicians… someone else will…. and IMO this saying applies to those in the chronic pain community and/or pts who are dealing with subjective diseases.  Legislatures, bureaucrats are doing things that are adversely effecting the quality of life of those pts.  As long as those being affected continue to lack unity and/or a large segment chooses to stand on the sidelines, whoever is successfully “bending the ear” of these politicians … they will continue to do so because they have  little/no concern about the consequences and/or collateral damage that they cause to those suffering and dealing with subjective diseases.

I am sure that the vast majority of my readers will understand and cooperate…those who try to challenge this policy…  It is THREE STRIKES and you are out/banned… and WORDPRESS gives me your IP ADDRESS attached to your comment(s)… Once banned, just posting under a different name – WILL NOT WORK !  Everyone needs to “play nice “

Lastly, please do not post anything promoting a particular vendor or any entity or person selling a product/particular service. Because some may perceive/believe that they have my endorsement which may or may not be the case. Anyone posting a link to a professional selling a product/service will be edited out

Importing Drugs from Canada is a Flawed “Solution” for Failures in the U.S.

Importing Drugs from Canada is a Flawed “Solution” for Failures in the U.S.

https://pharmacistactivist.com/2019/December_2019.shtml

Prices in the United States for many medications, primarily generic products, are reasonable and even inexpensive considering their value in maintaining and improving health. HOWEVER, the prices for many other medications are excessive and unjustifiable.

It is the pharmaceutical companies that establish the initial list prices for these drugs, but health insurance companies and pharmacy benefit managers also extract large profits from the continued worsening of the drug pricing debacle.

It is ironic that these industries take turns blaming each other for the high costs of drugs while, at the same time, all of them are being further enriched by the secretive and cyclical process in which they continue to increase the prices of drugs. The victims of this “system” are patients who often can’t afford the medications, our society that must assume the financial burden for excessive drug prices, and the pharmacies that are not adequately compensated for their important role in the distribution and appropriate use of medications.

The recognition of these problems is not new. Indeed, the outrage, rhetoric, and debate regarding drug prices have continued for decades, but what has been accomplished? In a word, “NOTHING!” The financial interests, bureaucracy, politics, and lobbying of those who might lose a fraction of their riches have prevented any progress in developing better drug pricing, distribution, and availability strategies.

Because of policies and controls on drug prices that have been established in Canada, many drugs are available at much lower prices there than in the U.S. Approximately 15 years ago, there was strong activity on the part of patients and others in the U.S. to obtain drugs at lower prices from pharmacies in Canada. Although some were successful in this effort, there were also negative ramifications and, for the most part, this strategy failed. One might think that relatively recent experience would still be fresh in our memories. However, once again, some state and national government officials are actively developing plans to facilitate importation of drugs from Canada because we have failed to establish equitable drug pricing strategies in this country. There is a saying that those who ignore history are destined to repeat it. Importation of drugs from Canada was a flawed and failed strategy 15 years ago, and it will fail again now.

The importation of drugs from Canada is not only an unworkable and ineffective strategy, but it is also extremely unfair to inflict certain of the consequences of the drug pricing and distribution failures in the U.S. on our neighboring country. The population of Canada is far smaller than that of the U.S. and the supplies of medications in that country are also correspondingly smaller. If large quantities of certain individual or classes of medications were imported by the U.S. from Canada, this could create havoc in the supply and availability of these medications in Canada. As just one of the many potentially negative consequences of significantly expanded importation of drugs, we are not close to addressing the problems of shortages of important medications in the U.S., and it is inappropriate to burden our neighbor with the risk of consequences resulting from failures in this country to establish an adequate and equitable drug pricing and distribution system. These challenges originated in the U.S., and it is up to the citizens and government of the U.S. to resolve them in this country.

There are concepts and strategies that can greatly improve the affordability of drugs and the quality and effectiveness of the drug distribution system in the U.S. Although they are beyond the scope of this commentary, such strategies are identified in previous editorials in The Pharmacist Activist. However, the courage, will, and determination to take action are essential!

Daniel A. Hussar
danandsue3@verizon.net

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-not-including-most-serious-risks-advertisement-medication-assisted

The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Known as medication-assisted treatment, the use of medications like Vivitrol, in combination with counseling and behavioral therapies, is effective in the treatment of opioid use disorder (OUD) and can help some people to sustain recovery. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk.

“One way the FDA protects the public health is by ensuring that prescription drug information disseminated by drug sponsors is truthful, balanced and accurately communicated. We do this by reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading,” said Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research. “Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner. This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”

The FDA is requesting the company immediately cease advertising practices that misbrand Vivitrol. In addition, because the violations described in the warning letter are serious, the FDA is also requesting the company include a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.

Specifically, the labeling states that after opioid detoxification, patients are likely to have reduced tolerance to opioids. For approximately 28 days after administration, Vivitrol is designed to block the effect (known as blockade) of an opioid. As the blockade wanes and eventually dissipates completely, patients who have been treated with Vivitrol may respond to lower doses of opioids than previously used. Therefore, if a patient uses opioids at the same dose they previously used, after taking Vivitrol and as the blockade wanes or after missing a dose or discontinuing treatment, it could result in an opioid overdose. There is also the possibility that a patient who is treated with Vivitrol could overcome the opioid blockade effect of Vivitrol. The print advertisement about Vivitrol also omits other important warnings and precautions including the risk of injection site reactions and other common adverse reactions associated with the use of drug. The FDA has requested that Alkermes, Inc. provide a written response to the warning letter to the FDA by Dec. 16.

The warning letter posted today reflects the agency’s commitment to protect the public health by ensuring that prescription drug information is truthful, balanced and accurately communicated as well as the agency’s focus on addressing the opioid crisis, which remains one of the FDA’s top public health priorities. The FDA continues to look at ways to facilitate treatment options to address OUD as a chronic disease with long-lasting effects. There are three drugs approved by the FDA for the treatment of opioid dependence: buprenorphine, methadone and naltrexone. All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support.

Health care professionals and consumers should report any adverse events related to these and other drugs to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research. The program’s goal is to help raise awareness among health care professionals about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency. To report potentially false or misleading promotion, health care professionals can send an email to badad@fda.gov or call 855-RX-BADAD.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Four in five pharmacists at high risk of burnout; many reconsider career, survey reveals

Four in five pharmacists at high risk of burnout; many reconsider career, survey reveals

https://www.pharmacy.biz/four-in-five-pharmacists-at-high-risk-of-burnout-many-reconsider-career-survey-reveals/

A new survey has revealed that 80 per cent pharmacists are at high or very high risk of burnout because of exhaustion, with over half of them thinking of a career switch.

The survey conducted by the Royal Pharmaceutical Society (RPS) and Pharmacist Support details the shocking impact of workplace pressures on pharmacists’ mental health.

Nearly three-quarters of the pharmacists said their training or working life has had an impact on their mental health and well being at some point.

More worryingly, some 44 per cent are concerned about potentially making mistakes or providing poor quality service to their patients.

“It’s incredibly tough in frontline practice right now. Demands are increasing and resources are scarce. This is not specific to one sector but impacts pharmacists wherever they work,” said Sandra Gidley, RPS President.

Gidley repeated the organization’s call for equal access to an NHS-funded support service for all pharmacists. At present, only the pharmacists employed directly by the NHS get access to help.

“The Government must address this as a matter of urgency. The NHS is at risk of creating workforce inequalities by providing support service for some staff and not others,” she said.

Responding to the survey, one in five pharmacists each quoted lack of support staff and unrealistic expectations from their manager or organization as the key reason for workplace pressures.

Commenting on the research results, Danielle Hunt, Pharmacists Support Chief Executive said the charity will work with RPS to find more ways to provide funded support.

“At Pharmacist Support, we hear from people every day struggling to deal with the pressures faced at work, so sadly we are not surprised by the statistics around stress and burnout revealed through this survey. Unfortunately for some, by the time they reach out for help, they have already reached crisis point,” Hunt said.

RPS and Pharmacists Support said the organizations will use the evidence to campaign for NHS-funded well being support for all pharmacists.

The organizations will also publish a more detailed analysis in Spring 2020 to inform a round table with the NHS, government, employers and others to identify solutions.

According to the statement made in the article “mistakes” are separate and distinct from “poor service”. Getting healthcare workers to continuously functions at ABOVE 100% is most certainly a formula for mistakes and poor service.  Could those two issues cause some pts to have poor outcomes ?  This article appears to be from England, but the USA is having the same problems.. to few healthcare dollars to provide proper staffing and proper care for pts.

 

Apparently Express Scripts (PBM) is trying to eliminate independent pharmacies by “hook or crook”

Apparently Express Scripts (PBM) is trying to eliminate independent pharmacies by “hook or crook”

Johnson & Johnson appeals opioid verdict

Johnson & Johnson appeals opioid verdict

https://journalrecord.com/2019/12/10/johnson-johnson-appeals-opioid-verdict/

OKLAHOMA CITY – Johnson & Johnson and Janssen Pharmaceuticals, companies ordered to pay $465 million to help Oklahoma recover from an opioid addiction epidemic, will press an appeal with the Oklahoma Supreme Court on claims that a judge made numerous errors in a trial held earlier this year.

The state alleged in a 2017 lawsuit filed against J&J and other drug companies that they created a public nuisance by engaging in aggressive, deceptive marketing that led to a vast oversupply and widespread abuse of prescription painkillers. Tens of thousands of Oklahomans have become hooked on the drugs and many have died.

Some 2,000 similar cases are pending across the nation, including dozens filed separately by towns and counties in Oklahoma. The White House Council of Economic Advisers published a report in 2015 estimating costs of the opioid crisis at more than $500 billion.

Cleveland County District Judge Thad Balkman, who presided over a 33-day non-jury trial held in Norman, ruled that J&J and Janssen did create a public nuisance that affected entire communities and innumerable Oklahomans.

“The defendants’ acts and omissions were a direct cause of the public nuisance in Oklahoma. No act or omission by the state was a direct or proximate cause,” his ruling stated.

On Monday, attorneys for J&J filed paperwork arguing that the judge applied too broad an interpretation of public nuisance law.

“Disregarding a century of precedent, the court ruled for the first time that nuisance liability extends beyond real property use … (and) instead of limiting the state’s claim to Janssen’s allegedly misleading marketing, the court held Janssen responsible for third parties’ statements about medical science and for raw material sales authorized under DEA quotas,” the filing states. “Without explanation, the court found Janssen liable for the entirety of a complex crisis implicating a multitude of criminal, governmental, and medical actors.”

J&J attorneys also claim in their appeal that the company’s marketing of medications approved by the federal Food and Drug Administration should have been protected as free speech, and also that evidence presented by the state wasn’t enough to establish that either J&J or Janssen made false or misleading statements in their marketing of opioids.

“We recognize the opioid crisis is a tremendously complex public health issue and have deep sympathy for everyone affected. We do not believe litigation is the answer and are continuing to work with partners to find solutions,” J&J said in a press release.

The state has filed notice of its own intent to appeal the case. Attorney General Mike Hunter has said $465 million won’t be enough to reverse effects of the opioid epidemic and that the judge should have allowed for periodic reviews to determine if the drugmakers should be ordered to pay more. Hunter’s office didn’t issue any additional comment this week.

This Oklahoma judge DENIED J&J a trial by jury and that meant that this judge basically controlled the entire process and he was a ONE MAN JUDGE/JURY … This appeal doesn’t surprise me because of how this judge handle the whole process.  Unfortunately AK will be able to once again state his “opinion” as expert facts AND GET PAID HUNDREDS OF DOLLARS A HOUR DOING IT 🙁

 

Reconciling the New HHS Opioid Tapering Guideline with CDC and State Policies

Reconciling the New HHS Opioid Tapering Guideline with CDC and State Policies

https://www.practicalpainmanagement.com/resources/ethics/reconciling-new-hhs-opioid-tapering-guideline-cdc-state-policies

How clinicians can best approach opioid prescribing – as well as discontinuation – going forward.

The US Department of Health and Human Services (HHS) released in October a Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.1 In the new document, HHS emphasizes that “Opioids should not be tapered rapidly or discontinued suddenly due to the risks of significant opioid withdrawal.” National media portrayed the new guideline as a “reverse course on strict restrictions”2 from the federal government—but does this guidance really reflect such a massive shift? How do the new recommendations interact with pre-existing laws?

The new HHS guideline makes clear that, while there are many instances in which opioid tapering is recommended, rapid tapering or sudden discontinuation of opioids can lead to acute withdrawal symptoms, increased pain, serious psychological distress, and suicidal thoughts. Sudden discontinuation may also increase the chance that a patient will seek out illicit opioids in an effort to manage pain and withdrawal symptoms.

Therefore, in the absence of a life-threatening issue, the agency does not recommend abrupt opioid dose reduction or discontinuation.

Many have questioned why the HHS issued a new guideline given its alignment with the CDC and FDA communications on opioid tapering and discontinuation. (Image: iStock)

Where the HHS and CDC Align

The CDC’s Guideline for Prescribing Opioids for Chronic Pain,3 treated as the gold standard of opioid prescribing guidelines since its release in 2016, made a number of recommendations related to opioid tapering. In nearly every way, the CDC’s recommendations are mirrored by the new HHS guidance. Both federal agencies agree that tapering or discontinuation of opioid therapy should:

  • be considered when pain and function are not meaningfully improved as compared to pain and function prior to opioid use
  • be considered when the benefits of opioid use no longer outweigh the risks, but should not be considered when the benefits of opioids continue to outweigh the risks
  • be done safely and slowly enough to minimize opioid withdrawal symptoms and signs (eg, drug craving, anxiety, insomnia, abdominal pain, vomiting, diarrhea, diaphoresis, mydriasis, tremor, tachycardia)
  • be done with appropriate expertise and care in the case of pregnancy, as opioid withdrawal is dangerous for the patient and the fetus, including an increased risk of spontaneous abortion and premature labor.

Given the agreement between the two documents, it’s easy to question why the HHS Guide was even developed. The answer? To resolve misconceptions regarding tapering and discontinuation that have existed since the release of the CDC’s original guidance.

Within the CDC opioid prescribing guideline, recommendations related to tapering and discontinuation represented a very small part of the document. In large part, the CDC focused on initiating opioid therapy, establishing treatment goals, opioid selection, dosage, dura­tion, and follow-up. Perhaps most notably, and most at-play when it comes to miscon­ceptions that have result­ed in unwarranted opioid tapers, is the CDC’s rec­ommendation to avoid increasing dosage to ≥ 90 MME/day.

Mis­application of “90 MME/day” recommendation has been so prolific that both the FDA, as well as the CDC, recently addressed the issue. In early 2019, the FDA issued a Drug Safety Communication4 stating that it had received reports of serious harm in patients who were physically dependent on opioid pain medicines suddenly having their medicines discontinued or the dose rapidly decreased, going so far as to caution against abrupt discontinuation. Not long after, the CDC re­leased its own media statement5 in which it emphasized that 90 MME/day is not a hard limit, and that its dosage recommendation does not suggest discontinuation of opioids already pre­scribed at higher dosages.

Further, the CDC made it clear that its guideline does not support abrupt tapering or sudden discontinuation of opioids. They went so far as to say that, “…policies that mandate hard limits conflict with the Guideline’s emphasis on individualized assessment of the benefits and risks of opioids given the specific circumstances and unique needs of each patient.”

HHS Guide Supports State Policies—With One Possible Exception

In recent years, most states have adopted their own laws, rules, and guidelines related to opioid prescribing, and a number of those policies have sections related to tapering and discontinuation. In Arizona, for example, in regard to Workers’ Compensation, a patient’s treatment plan must include the criteria and procedures for tapering and discontinuing opioid use.6 In South Carolina and West Virginia, among other states, guidance states that if opioid therapy is discontinued, a patient who has become physically dependent should be provided with a safely structured tapering and withdrawal regimen.7,8 In all of these cases, state recommendations and requirements may easily be followed while still working within the federal recommendations from HHS.

While the new guidance from HHS aligns with state policies in nearly all cases, there is one state in which clinicians may feel a certain amount of confusion and unease when trying to reconcile local mandates with federal guidance: Kentucky.

The Kentucky Board of Medical Licensure has a rule which states that, when a drug screen or other available information indicates that a patient is non-compliant, the physician shall: do a controlled taper; stop prescribing or dispensing the controlled substance immediately, or refer the patient to an appropriate specialist.9 While this requirement does not completely conflict with federal guidance, in that the “or” statement allows for referral to a specialist rather than tapering or discontinuation, it would be easy for a clinician to assume that they must taper or immediately discontinue—particularly if they intend to keep treating the patient themselves.

It is worth noting that Oregon-based clinicians may also feel a disconnect between state and federal policies, as Oregon’s Medicare program previously had a strict tapering mandate for certain patients, but this mandate has recently been relaxed to allow for individualized tapering plans.10

What about Individualizing Care?

For clinicians that have been operating under both real and perceived pressure to reduce and/or discontinue their patients’ opioid prescriptions, it may feel as if the new HHS guidance is a huge shift in federal policy. Upon closer inspection, however, the new guidance supports nearly all pre-existing federal and state guidance in regard to opioid tapering. What the guidance does differently is to rephrase and clarify opioid tapering recommendations in order to help clinicians avoid the many misperceptions and misapplications that have been associated with the opioid prescribing policies released in recent years at the federal, state, and even local levels.

Who Has the Final Say?

If your state currently has, or later implements, a policy related to opioid tapering that conflicts with a federal policy, which policy is controlling?

  • If a federal law or rule directly conflicts with a state policy (whether a law, rule, or guideline), the federal law will be controlling. This scenario should not apply at this time, as federal policy related to opioid tapering is currently guidance, not law.
  • If federal guidance or recommendations conflict with a state law or rule, the state requirements will be controlling since they have the force and effect of law, while the federal guidance does not. This scenario would occur, for example, if your state implemented a rule that mandated immediate discontinuation based on certain factors—something that federal policy currently recommends against.
  • If federal guidance or recommendations conflict with state guidance or recommendations, clinicians must carefully use their best judgment to weigh both sets of recommendations against the risks and benefits of opioid therapy to their particular patient’s situation. In cases where a clinician feels their judgment may be questioned because they’ve opted to take the advice of one set of recommendations over another, it is strongly recommended that the clinician clearly document their thought process and ultimate decision in the patient’s medical record.

So, what is the bottom line for your practice and patients? As with all medical decisions, opioid tapering and discontinuation should be based on the individual patient’s circumstances. There is no one-size-fits-all approach and in every case the clinician needs to weigh the risks and benefits of the current therapy, develop an individualized care plan with their patient, and re-evaluate and adjust that plan regularly.

 

Practical Takeaways with Jennifer P. Schneider, MD, PhD,

Based on direct quotes from the CDC and HHS opioid guidelines discussed in this column, here are some practical takeaways for clinicians to consider:

  • The guidelines are intended for treatment of chronic non-cancer pain; not acute, cancer, or end-of-life pain.
  • “Decisions to continue or reduce opioids for pain should be based on individual patient needs.”
  • The guidelines do not ban prescribing >90 MME/day but rather to “carefully justify this decision.”
  • “If the current opioid regimen does not put the patient at imminent risk, tapering does not need to occur immediately”…If a taper is indicated, ensure a “multimodal approach including mental health support if needed is in place prior to initiating taper.”
  • “At times tapers might have to be paused and restarted again when the patient is ready.”
  • “Slower tapers (eg, 10% per month or slower) are often better tolerated than more rapid tapers, especially after opioid use for >1 year.”
  • “Closely monitor patients who are unable or unwilling to taper and who continue on high-dose or otherwise high-risk opioid regimens.”

Thus, these guidelines clearly recognize that some patients with chronic pain benefit from opioid treatment, including those who may benefit, or are benefitting, from >90 MME/ day. They do not advocate: never initiating opioids above a specific dose; reducing every patient on opioids to a dose below that dose; tapering all patients off opioids; or avoiding starting any chronic pain patient on opioids. Instead, clinicians are encouraged to carry out careful initial and ongoing assessments that address function, behavioral health, red flags (eg, addiction risk, misuse, noncompliance), and other modalities.

Once again the DEA seems to be MIA… so what if they decide that they are perfectly happy with the original CDC guidelines and ignore these clarification(s) and revisions and continue to raid/shut down practitioners’ offices based on their previous interpretations of the CDC guidelines. Because what is the DEA going to do… go after the various CARTELS that it is claimed generated > 100 billion/yr and are heavily armed and tend not to take kindly to anyone who tries to interfere with their business plan.

we have had 115 LEO deaths in 2019 https://www.odmp.org/search/year        including 5 who work at the FEDERAL LEVEL ..https://www.odmp.org/search?state=U.S.%20Government&from=2019&to=2019&filter=nok9  none labeled as working for the DEA. Does this suggest that anyone working for the DEA has the lowest risk of anyone in law enforcement to be killed while on duty ?

“sick” pain joke :-)

Epidural Steroid Injections / APDU’s Warning Letter to Pfizer

Dr. Hooman Noorchashm of the American Patient Defense Union (APDU) recently sent a strong letter to Mr. Doug Lankler, the Executive Vice President and General Counsel for Pfizer Global in NYC. Alarmed by increased reports of severe medical events caused by the off-label epidural administration of Pfizer’s steroid, Depo-Medrol®, the APDU decided to step into the debate. (Note: Epidural Steroid Injections or ESI’s are NOT FDA approved nor are they approved anywhere on the planet due to reports of severe adverse events, including death.) Here I read Dr. Noorchashm’s letter where he not only requests that Pfizer’s risk-managers move swiftly to issue a warning to all practitioners that set the standards of care for spinal-related pain management, he strongly encourages Pfizer to try once again to force the FDA to place an absolute “Contraindication (ban) for the off-label epidural administration of Depo-Medrol” in the United States. It should be noted that back in 2013 Pfizer Inc. did send an amended label request to all global Health Authorities with major changes to the Warnings & Contraindication Sections for Depo-Medrol, including a new specific “Contraindication for Epidural Administration” at all levels of the spine. Many nations have complied without protest. Among them are New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending. Unfortunately the United States’ FDA is not among them. Why not? Aren’t we Americans worthy of the same protections? Even though Pfizer submitted their label change request 6 years ago to all Global Health Authorities, the FDA repeatedly refused to accept these changes because only they hold the CORE Data-Sheet (CDS) for the steroid, nowhere else. Therefore if Pfizer’s New Warnings were enacted into the US-FDA’s CDS for Depo-Medrol, they would then filter down to all versions of the drug (whether they be generic or compounded formulations, etc.). That would have ended the off-licensed, unsafe but lucrative practice of Epidural Steroid Injections using Depo-Medrol (Methylprednisolone Acetate) all over the world. Pfizer’s request in 2013 to initiate these very important safety warnings were met with strong oppositional forces from interventional pain management societies in the USA (we prefer to call them Injection-Mills). The powerful and lucrative ESI INDU$TRY have many friends embedded within the government. This conflict of interest tilted the FDA’s prime directive to prevent harm in favor of keeping them and “Wall Street” happy. ESI therapies are not as efficacious as advertised, carry severe risks and therefore are not FDA approved. Despite this, it appears the agency deliberately played down the seriousness of these off-licensed injections with Pfizer’s blessings. So what game are they playing with our health? Need proof of their game? Back in 2014 an FDA advisory panel of medical experts voted 15 to 7 to “Contraindicate (ban) CESI’s” after three days of testimony and yet the FDA ignored their recommendation and said “no”. The decision was therefore rejected by the FDA without any real explanation other than their fear of disturbing a lucrative industry and their Wall $treet investors. I can honestly say that the patient community I represent owes Dr. Noorchashm a debt of gratitude for his tireless efforts against the increased use of Pfizer’s Depo-Medrol for epidural administration despite its poor safety and efficacy records. The slaughter will sadly continue until Pfizer demands the FDA to do the right thing, adding an “ESI Contraindication” and a “NOT FOR Epidural Administration” Black Boxed Warning to the CORE Data-Sheet in the USA. Link to Pfizer’s 2014 Tracking Changes for Depo-Medol: https://jmp.sh/ooWuGCw Link to Pfizer’s Completed Global DataSheet for Depo-Medrol. (Only New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending accepted Pfizer’s urgent update. Unfortunately the United States’ FDA rejected their request fearing stock market reaction: https://jmp.sh/uxCiBGK Link to APDU’s Warning Letter to Pfizer: https://medium.com/@patientdefenseuni… PLEASE FILE A MED-WATCH VOLUNTARY ADVERSE EVENT REPORT WITH THE FDA if you believe that you or a loved one may have been harmed by an ESI… Please file a FDA MedWatch Report. Use Form 3500B Link: https://www.accessdata.fda.gov/script… Thank you for watching! Dennis J. Capolongo Director / EDNC TheEDNC@verizon.net

Canada Healthcare : over 300 patients in the province died waiting for surgery from 2015 to 2016 because of a shortage of anesthesiologists

Sally Pipes dispels myths surrounding single-payer health care proposals

https://www.foxnews.com/opinion/sally-pipes-sanders-warren-want-medicare-for-all-like-canada-but-canadian-health-care-is-awful

Health care

Democratic presidential candidates Sens. Bernie Sanders and Elizabeth Warren want you to believe Canada’s health care system is a dream come true. And they want to make the dream even better with their “Medicare-for-all” plans. Don’t believe them.

In truth, Canada’s system of socialized medicine is actually a nightmare. It has left hospitals overcrowded, understaffed and unable to treat some patients. Americans would face the same dismal reality if Canadian-style “Medicare-for-all” takes root here.

Canada’s health care system is the model for the “Medicare-for-all” plan that both Sanders, I-Vt., and Warren, D-Mass., embrace.

expert discusses the Affordable Care Act, rising prescription drug costs and the Trump administration’s plans for health care reform.

North of the border, all residents have taxpayer-funded, comprehensive health coverage. In theory, they can walk into any hospital or doctor’s office and get the care they need, without a co-pay or deductible.

More from Opinion

Sanders and Warren would one-up Canada by providing all Americans with free prescription drugs, free long-term care, free dental care, free vision care, and free care for people with hearing problems.

Who could possibly object to all that free care?

Well, politicians in Canada object. They say even their country can’t do what Sanders and Warren want because all this free care would cost too much and cause other problems.

But for Sanders and Warren, money is no object. They can just raise taxes as higher and higher and higher.

And the huge tax increases needed to fund “Medicare-for all” would hit us all – there aren’t enough millionaires and billionaires to foot the bill.

It’s true that everyone in Canada has health coverage. But that coverage doesn’t always secure care. According to the Fraser Institute, a Canadian think tank, patients waited a median of nearly 20 weeks to receive specialist treatment after referral by a general practitioner in 2018. That’s more than double the wait patients faced 25 years ago.

In Nova Scotia, patients faced a median total wait time of 34 weeks. More than 6 percent of the province’s population was waiting for treatment in 2018.

Waiting for care is perhaps better than not being able to seek it at all. The hospital emergency department in Annapolis Royal in Nova Scotia recently announced that it would simply close on Tuesdays and Thursdays. There aren’t enough doctors available to staff the facility.

Canadians can’t escape waits like these unless they leave the country and pay out of pocket for health care abroad. Private health insurance is illegal in Canada.

Private clinics in Canada are not allowed to charge patients for “medically necessary” services that the country’s single-payer plan covers. And the government has deemed just about every conceivable service “medically necessary.”

For the past decade, Dr. Brian Day, an orthopedic surgeon who runs the private Cambie Surgery Centre in British Columbia, has tried to offer Canadians a way out of the waits by expanding patient access to private clinics. He’s been battling his home province in court for a decade to essentially grant patients the ability to pay providers directly for speedier care.

During closing arguments in Day’s trial before the British Columbia Supreme Court at the end of November, Dr. Roland Orfaly of the British Columbia Anesthesiologists’ Society testified that over 300 patients in the province died waiting for surgery from 2015 to 2016 because of a shortage of anesthesiologists. And that was in just one of the province’s five regional health authorities!

Shortages of crucial medical personnel and equipment are common throughout Canada. The country has fewer than three doctors for every 1,000 residents. That puts it 26th among 28 countries with universal health coverage schemes. If current trends continue, the country will be short 60,000 full-time nurses in just three years.

In 2018, Canada had less than 16 CT scanners for every million people. The United States, by comparison, had nearly 45 per million.

These shortages, combined with long waits, can lead to incredible suffering.

In 2017, one British Columbia woman who was struggling to breathe sought treatment in an overcrowded emergency room. She was given a shot of morphine and sent home. She died two days later.

That same year, a Halifax, Nova Scotia, man dying of pancreatic cancer was left in a cold hallway for six hours when doctors couldn’t find him a bed. Yes, people must sometimes be treated on hallway floors because of severe overcrowding.

In fact, some Canadian hospital emergency rooms look like they belong in poverty-stricken Third World countries.
WBUR Radio, Boston’s NPR station, documented these terrible conditions in a story about a hospital in Nova Scotia earlier this month.

Americans who find the promise of free health care difficult to resist would do well to take a hard look north.

Sure, “Medicare-for-all” as pitched by Sanders and Warren sounds good. But the reality is far from what these two far-left candidates are promising. Like a drug that helps you in one way but causes even more serious problems, “Medicare-for-all” has dangerous side effects that can be hazardous to your health.

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Evernote complies with DEA

Evernote complies with DEA

https://dlike.io/post/@arunava/evernote-complies-with-dea

I don’t know if i should categorise this under Tech but anyways let’s mobe on with it. It seems Evernote which is a Note Taking App and very useful if I may add recently gave data on an User of theirs to the DEA. Now it has been notified that the user was allegedly a Dark Web Drug Dealer so that sounds good in a way but since it was only alleged this does leave a sour taste in my mouth.

The DEA did get warrants to do so but still Evernote should have resisted a little as the next one could be anyone else. This does serve as a breach of privacy as many people do keep important stuff on that App and after this news came out a lot of users are already jumping ship as they are looking for better Privacy options.

 

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