no randomized clinical trials support opioids’ extended use, because of the risks

More Long-Term Opioid Prescriptions Drive Increasing Use

https://www.uspharmacist.com/article/more-longterm-opioid-prescriptions-drive-increasing-use/

Baltimore, MD—Pharmacists are filling many more prescriptions for opioids now than at the end of the last century, and a disturbing percentage of them are for long-term use.

That’s according to a new study from the Johns Hopkins Bloomberg School of Public Health, which determined that opioid prescription use jumped significantly between 1999 and 2014. Much of the increase was related to prescriptions for 90 days or longer, notes the article, published online by the journal Pharmacoepidemiology and Drug Safety.

Results of the review were based on data from the National Health and Nutritional Examination Survey, which the National Center for Health Statistics has conducted every 2 years since 1999–2000. Prescription opioid use increased from 4.1% of U.S. adults in 1999–2000 to 6.8% in 2013–2014, a 60% increase. At the same time, long-term prescription opioid use, defined as 90 days or more, increased from 1.8% in 1999–2000 to 5.4% in 2013–2014.

Of all opioid users in 2013–2014, 79.4% were long-term users compared with 45.1% in 1999-2000, according to the researchers, who point out that long-term use was associated with poorer physical health, concurrent benzodiazepine use, and history of heroin use.

“What’s especially concerning is the jump in long-term prescription opioid use, since it’s linked to increased risks for all sorts of problems, including addiction and overdoses,” explained study author Ramin Mojtabai, MD, PhD, MPH, a professor in the Department of Mental Health at the Bloomberg School. “The study also found that long-term use was associated with heroin use as well as the concurrent use of benzodiazepines, a class of widely prescribed drugs that affect the central nervous system,” he says.

Combining opioids and benzodiazepines significantly increases the risk of overdose, even if the patient is taking a moderate dosage of opioid medication, Mojtabai points out.

For the report, Mojtabai examined eight consecutive biannual surveys, each of which included over 5,000 adults living throughout the U.S. Interviews were conducted via computer in participants’ homes. Participants, totaling more than 47,000 over the eight surveys, were asked to identify prescription medications they had taken in the past 30 days, and for what length of time. The response rate ranged from 71% to 84%.

Opioid-medication use overall and long-term use was more common among participants on Medicaid and Medicare versus private insurance, noted Mojtabai, who added that no randomized clinical trials support opioids’ extended use, because of the risks.

A survey of 5000 people, when there is a estimated 100 + million chronic pain pts… seems like a rather SMALL SAMPLING… and just how were these pts selected for this survey ?

A reported 60% increase in opiate prescriptions from 1999-2000 to 2013 – 2014… does that number compensate for the fact that our population grows about 3%/yr… so in the same time frame our population was abt 40% greater… so based on per million population.. the growth was really MAYBE – 20% ?

This report time frame mostly encompasses what was declared the “decade of pain” when the Joint Commission that accredits all hospitals to be eligible for Medicare/Medicaid payments  declared pain the “Fifth Vital Sign” and made it a MAJOR STANDARD for hospitals to meet and the failure to meet that standard could mean that the hospital loss their accreditation…

Imagine that there is… “….no randomized clinical trials support opioids’ extended use, because of the risks …”

ALL CLINICAL TRIALS HAVE RISKS !!!

perhaps clinical trials of new/unproven medications have MORE RISKS than a clinical trial of a otherwise known safe medication.  Can you say… LAME EXCUSE ???

Denial of care because of the ZIP CODE you live in ?

Recovering addict says Walgreens pharmacist denied to fill Rx that helps her stay sober

http://fox45now.com/news/local/recovering-addict-says-walgreens-pharmacist-denied-to-fill-rx-that-helps-her-stay-sober

KETTERING, Ohio (WKEF/WRGT) – A young woman in recovery came to FOX 45 for help after she said a pharmacist denied to fill her prescription for the medicine that helps her maintain her sobriety.

April Erion told FOX 45 it’s a generic form of the medicine Suboxone, and that the incident happened at the Walgreens store on Far Hills Avenue in Kettering.

Erion told FOX 45’s Kelly May she went to Walgreens because it’s the only pharmacy that carries the generic that works for her.

A Walgreens spokesperson confirmed to FOX 45 that filling a prescription is at the discretion of the pharmacist.

“I needed a specific generic brand- my pharmacy does not carry the brand that I need so I went to the closest one to my doctor,” Erion said.

Erion said she had a paper prescription from her doctor in hand when she went to the store.

She said the medicine made by Actavis stops her from craving opiates.

She has been in recovery from her opiate addiction for more than a year.

“I even asked if they had it in stock because I wanted to be prepared if they didn’t,” Erion said about her conversation with the pharmacy technician, “She said, ‘Oh, it’s fine, we have plenty. I can get the pharmacist fill it for you right now’.”

“The pharmacist came over and she basically just said you don’t live in this area code-in this zip code, so it’s my personal policy to not fill these kinds of medications for people that live outside the zip code.”

Erion said she was embarrassed and felt discriminated against because of the type of medicine she needed.

“What if it were your child trying to get a medication that they needed, doing everything that they’re supposed to be doing, doing everything they need to be doing to stay out of a casket,” Erion explained, “and turn them away because they live in another zip code and its ‘that medication, ‘those kinds’ of medications.

Erion said the form of generic Suboxone that Walgreens carries is the only generic form that dissolves adequately, and is covered by her Medicaid.

Prior to being prescribed the Actavis generic, she said she had been paying more than $300 each month out of pocket for brand name Suboxone strips at another pharmacy chain.

“Her discretion is discriminating against an entire class of people and she just assumes that anyone taking an opiate based medication is just a drug addict and she doesn’t want to help them?” an upset Erion explained.

FOX 45 reached out to Walgreens about the incident.

A spokesperson did not give a specific reason why Erion’s prescription was not filled, but released a statement:

“Our pharmacists exercise professional judgement when dispensing prescriptions. We work to ensure that our patients continue to have access to the medications they need while fulfilling our role in reducing potential abuse and misuse of controlled substances.”

Erion said she’s aware that pharmacists are allowed to use discretion when filling prescriptions, but said, “There’s going to be things that don’t look right, you don’t want to fill a prescription that you’re not sure about, if you need them to come back, to come back later all these things that they use their discretion for. What you don’t use your discretion for is to discriminate against an entire class of people in the middle of an opiate epidemic.”

Erion said she was able to get her prescription filled at another Walgreens location.

Fox 45 asked the pharmacy chain if the incident was being discussed with the pharmacist involved, but they did not give an answer.

In the state of Ohio, there are discretions that pharmacists are legally protected to use. To see those rules, click here.

Here is a quote from the above Ohio rules link

“A pharmacist is not required to dispense a prescription of doubtful, questionable, or suspicious origin or if a prescription poses a risk to the health of the patient “

A pt normally gets their prescriptions filled in a pharmacy close to their home, their work or their doctor.

Not all doctors are authorized to prescribe SUBOXONE… so some pts who are trying to “stay sober” will probably have to travel some distance to find a prescriber that can provide Suboxone prescriptions.

According to the quote from the Walgreen’s Pharmacist that refused to fill this person’s prescription for Suboxone was …. 

“The pharmacist came over and she basically just said you don’t live in this area code-in this zip code, so it’s my personal policy to not fill these kinds of medications for people that live outside the zip code.”

So, it would appear that this Pharmacist’s personal policy is that any prescription for a person that lives outside of the pharmacy’s zip code AUTOMATICALLY falls under the Ohio law that it isdoubtful, questionable, or suspicious origin or if a prescription poses a risk to the health of the patient.

So according to the quote in the article from Walgreens….

“…Our pharmacists exercise professional judgement when dispensing prescriptions…”

That Walgreens condones their Pharmacists refusing to fill legit prescriptions based on “professional judgement” that is derived from the Pharmacist’s personal opinion, phobias, biases … which has nothing to do with them using their 5-6 year education to come to a conclusion based on FACTS…

The question begs to be asked… Is this particular pharmacist violating her “corresponding responsibility” by having a “just say no” based on the zip code that the pt lives in ?  If so, who believes that the Ohio BOP… would ask her to come before the BOP and explain how her actions and decision making process should not be considered UNPROFESSIONAL CONDUCT ?

In this country we have a serious – and growing – pharmacist surplus… so apparently Walgreens condones such actions of their pharmacists denying care for seemingly nebulous reasons are kept employed… when there are plenty of other pharmacists that are applying for jobs.

 

The law allows for the individual to be put into an inpatient substance abuse program for up to 90 days

Massachusetts Section 35: What it is and how it works

http://www.masslive.com/news/worcester/index.ssf/2014/04/massachusetts_section_35_how_i.html

Before he left the Dudley District Courthouse Wednesday morning for a meeting, Judge Timothy M. Bibaud saw three families trying to civilly commit their children for substance abuse treatment.

He expected that there would be three more at his desk on Thursday morning and maybe even five more on Friday. A few years ago he had maybe one such request a week.

Throughout his lengthy career, first as a prosecutor with the district attorney’s office focusing on drugs and gangs, and now as a superior court judge, Bibaud said he has never seen so many people coming to the court desperate for help and asking to be part of what is commonly known as Section 35.

“Parents come in with a deer in headlights look,” he said. “They wonder how this happened to their kid. It’s not just their kid, though… It’s not a disease that confronts a certain group or demographic.”

Section 35 is a Massachusetts General Law that allows a judge to “involuntarily commit someone whose alcohol or drug use puts themselves, or others, at risk.”

The law allows for the individual to be put into an inpatient substance abuse program for up to 90 days, but the level of commitment and the location of treatment varies. The section allows families and/or the judge to choose a licensed treatment facility. If no beds are available, the individual might be sent to a separate unit at the correctional facility at Bridgewater for men or Framingham for women.

Worcester County District Attorney Joseph Early Jr. said the section is what he considers to be the route that many families or friends of addicts take when their at their wit’s end.

It happens often enough,” Early said recently. “It’s a last resort. You hope you don’t get to that point, you hope that they acknowledge a problem, but they are completely taken over and live through an overdose or a suicide attempt. They’ve lost control.”

Early said he has special prosecutors who are familiar with substance abuse situations and knows what questions to ask the court and clinician assigned in the Worcester County courts for Section 35 cases. He didn’t know whether the increase in requests occurring in Dudley are also happening throughout the district, although the courts have seen an increase in minor criminal cases related to heroin addiction.

Judge Bibaud said when an 18-year-old woman is standing before him with no criminal record, strung out on heroin, and her parents are with her asking for help, it’s a difficult call to make whether or not to send her to a prison for treatment if no beds are available at another facility.

It’s also difficult for him to help them access the care under the act because so many people are coming to the courts for help now that clinicians or doctors are not available to do an initial assessment because they’re so busy with trying to treat the patients they already have.

The process is not as easy as just popping in on the judge and asking for a Section 35 intervention, though. A spouse, blood relative, guardian or law enforcement official files a petition for court intervention. From there, the court must decide whether there is a likelihood of serious harm to the person or has a medical diagnosis of addiction.

Once a referral to a private or state facility is made, the type and extent of the treatment will vary. If there is also a mental health problem, the individual will most likely be sent to a psychiatric hospital.

For more information about Section 35, the state department of health and human services provides a detailed outline of the process on its website.

39 AG’s believe that ADDICTION IS A DISEASE – what a bunch of idiots ?

Attorneys GeneralAttorneys general in Appalachia pressure, sue health insurers over opioids

http://www.cnhinews.com/cnhi/article_73975d9e-9d4f-11e7-b68b-f3d8febecaf0.html

HUNTINGTON, W. Va. — The nation’s advancing opioid epidemic has officials and lawmakers in the most impacted states taking on the entities they deem responsible for skyrocketing drug addiction and overdose numbers.

Kentucky Attorney General Andy Beshear and West Virginia Attorney General Patrick Morrisey announced at Marshall University Monday they will press the health insurance companies that have made billions off the sales of opioids to help curtail the nation’s largest drug problem to date.

They joined 37 other attorneys general in writing a letter to insurers requesting they adopt a “financial incentive structure” for the use of non-opioid pain management techniques when viable for chronic, non-cancer patients.

 In the letter, the attorneys general asked insurers to promote non-opioid pain management alternatives that may not be currently covered at the same level as prescription opioids — rather than highly-addictive pain pills.

They argued insurance companies have the power to reduce opioid prescriptions and simplify patient access to other forms of pain management treatment.

“We’re not physicians, and we’re not going to be writing these policies,” Morrisey said. “What we’re doing today is asking these insurance companies to look closely at their coverage and payment policies so those unintentional payment incentives don’t exist.”

As opioid addiction and resulting fatalities have swept the country, both Kentucky and West Virginia have been especially hard hit by the epidemic. Last year, Kentucky had more than 1,400 opioid-related overdose deaths reported, according to a state report.

Last week, an additional Kentucky county joined nearly 20 others to file suit against the nation’s top 3 opioid producers in hopes of fighting to curb the rampant prescription drug problem in the Bluegrass State.

Beshear announced in June that his office intends to file multiple lawsuits against drug manufacturers, distributors and retailers where there is evidence that they contributed to the opioid epidemic by illegally marketing and selling opioids to Kentucky residents.

Beshear issued a request for proposal (RFP) for legal services to assist the Commonwealth in multiple lawsuits and to ensure that Kentucky tax dollars are not used for the costs of the litigation.

Beshear, a Democrat, and Morrisey, a Republican, said the deadliest overdose epidemic in U.S. history is a bipartisan issue.

Suppliers of prescription opioids are partly to blame for the rise in heroin use in the Tri-State region, Beshear said.

“Nearly 80 percent of heroin users first become addicted through prescription pills,” Beshear said. “If we can reduce opioid prescriptions and use other forms of pain management treatment, we will slow or even reverse the rate of addiction.”

Beshear suggested insurers could cover costs for physical therapy treatments rather than simply provide pain pills, for instance. “Every one knows some patients will need prescription pills,” he said. “But a lot of people should have access to other forms of treatment.”

 Some of those people include teenagers, Beshear said. The attorney general from Kentucky said many middle and high school athletes injured in sports in the Bluegrass often receive a consultation and prescription opioids, that could lead them down a path of addiction or dependency.

“There are steps that should be taken before subjecting a young mind to the power of these addictive pills,” Beshear said.

Morrisey said he’s optimistic every insurance company will “respond positively” to the letter from the attorneys general.

“I think 37 attorneys general provides a tremendous amount of pressure. We start how you’re supposed to start — asking nicely,” Beshear said. “But ultimately, when you don’t work with attorneys general and you end up working against them, you can ask the tobacco companies how that works out.”

Beshear told the Ashland, Kentucky Daily Independent the attorneys general don’t “want to go in with threats” but instead open a dialogue with the insurers, and it would be a “long way down the road” before any type of litigation is considered.

In addition to Kentucky and West Virginia, attorneys general from Illinois, Indiana, Missouri, Virginia joined in sending the letter to health insurers.

Our previous Surgeon General stated publicly that addiction is a mental health issue and not a moral failing http://www.huffingtonpost.com/entry/vivek-murthy-report-on-drugs-and-alcohol_us_582dce19e4b099512f812e9c

Since it is highly unlikely that taking a opiate can cause a MENTAL HEALTH ISSUE.. who with “three brain cells hold hands” could come to the conclusion that addiction is nothing more than a symptom or manifestation of a person with undiagnosed/under/untreated mental health issues.

Keep in mind that our judicial system in 1917 declared that opiate addiction was NOT A DISEASE BUT A CRIME… and apparently out judicial system is still functioning under that century old edict.

Here is a picture of a Ford automobile from that era… how many of us would want to use such a vehicle as our primary mode of transportation TODAY ?

In 1917 women still did not have the right to vote, alcohol prohibition was still yet to come, it was just abt ONE DECADE after the Wright Brothers first took to flight.

There is a simple 24 questions – 5 minute – test http://nationalpaincentre.mcmaster.ca/documents/soapp_r_sample_watermark.pdf 

Imagine if it was a required test before the first refill of a opiate for anyone treated with a opiate for acute pain.

Imagine if PMP’s were indexed by digital finger or palm print, digital eye scan, or facial recognition.

Delta to roll out facial recognition technology at airport bag check   

Delta is using facial recognition to self-check baggage at airports and many software systems already use digit finger print recognition to login to pharmacy and point of sale equipment. Why the “push back” from implementing this for PMP and opiate prescribing and dispensing ?  If the bureaucrats are really interested in trying to deal with opiate addiction… shouldn’t they be interested in pulling out all the “digital stops”

Maybe the same bureaucrats that are failing to implement these “state of the art” tools are the same ones that are now attempting to extract untold millions of dollars from the same businesses that are part of the opiate manufacturing and distribution system ?

Remember the Tobacco settlement money will be running out in a few years… are they just looking for another “golden goose” that they can “milk” to replace that Tobacco money for another 10-20 yrs.

Maybe this fabricated OD crisis is more of a “smoke screen” for another agenda

6 Stages of Fibromyalgia

6 Stages of Fibromyalgia

https://www.life-enthusiast.com/articles/6-stages-of-fibromyalgia

Stage 1

You started experiencing pain and fatigue more than before, you’re not sure what is going on but you hurt and you are tired. You can hold a job, you can make it through your day, but you know something isn’t right… so it’s something you’re going to start researching.

Stage 2

You are in pain a lot, sometimes taking an anti-inflammatory drug or what have you. You do not get much relief, and you have accepted the fact this is something you are going to have for a while. you feel a lot of pain and you are exhausted almost every day, but for the most part you keep going and hold down a job, can still go to events, spend time with your friends and loved ones, and have some good time here and there.

Stage 3

You are in constant pain, you are constantly tired, you wonder whether you will be ever able to function normally again. You are considering not working, because you no longer have the energy you once had, you come home from work and all you can do is rest. You have to turn down invitations, you have no energy left and you have to rest up just to go back tomorrow. In this stage you start to feel more alone, and more and more people are beginning to think you whine too much. This stage can last a long time, perhaps years.

Stage 4

You are in unrelenting pain all the time, good days are few and far between. You are calling into work sick more than you even make it in. You are in bed a good portion of your day. When you do have a good day you take advantage of it, and do as much as you can, all the things you have left in the past weeks you cram into your day, knowing well that tomorrow you will be paying for it. Your flares last for days. By this time your friends make plans without you, they already know your excuses and are nearly certain you will not be able to join in. Your family begins to think you are using fibromyalgia as an excuse to not do things, because stages 1-3 you were able to do much of what you just can’t do now. They think you are using your illness as an excuse, you feel alone, isolated, worried, emotional, sad. This stage can last years.

Stage 5

You have already been let go or have quit your job, you are asking questions about permanent disability and how long it takes to get it. You have heard horror stories about people being denied and the process taking years. You are struggling to make ends meet. Maybe have a person who takes care of you. You spend a lot of your day in bed, although you still take advantage of that one good day once in awhile. You are sore, very sore, you cry a lot, you feel like a prisoner in your own body. By this time you have already explained to your friends that it still feels good to be invited even if you don’t go. You have found that the only people that can relate to you are in a similar predicament. You wish your friends and family could understand.

Stage 6 (The Final Stage)

You may or may not still be waiting for disability pension. You cannot hold down a job. Fibromyalgia is now your lifestyle, most of your friends are living with fibromyalgia themselves, everything you do takes all your precious energy, simple daily tasks you took for granted in earlier stages, going to the bathroom, washing your hair, taking a shower, getting dressed, tying your shoes, take all you can give. You get irritated by your hair or clothes touching your skin, you have no energy or desire to put on “your face” before going out, no energy to keep a neat home. With all the medication you are on now or have tried, you are dealing with side effects and constant pain.

You are a human and still enjoy some things, like watching TV. You try to stay current on any news regarding fibromyalgia, in hopes they are closer to finding a cure. Most of your old friends are not around anymore, they have things to do. You need to rest a lot. It’s easy to feel overwhelmed in this stage, because things are piling up around you: bills, laundry, dishes. You do a little everyday, you push yourself so you don’t feel like your day was wasted in bed, you feel guilty that you no longer pull your own weight in the house. Your kids, spouse or family do things for you more than ever. They try to do it in a nice manner but you still feel like a burden, you can’t remember anything, cannot recall names or dates and you lose your train of thought mid-sentence. Also you know more about fibromyalgia in this stage then your own doctor and basically laugh when trying a new medication. You are without hope, same drill as before, same results, nothing helps much.

35 Attorney Generals as insurance company to “play doctor” with pain meds ?

PHOTO: Kentucky Attorney General Andy Beshear (right) speaks about opioid addiction at a news conference, Sept. 18, 2017, in Huntington, W.Va. At left is West Virginia Attorney General Patrick Morrisey. States ask insurers to prioritize non-opioid pain treatment

http://abcnews.go.com/Health/wireStory/states-insurers-prioritize-opioid-pain-treatment-49937810

Attorneys general representing the majority of states asked health insurers Monday to encourage pain treatment through means other than prescriptions for opioid painkillers, which are responsible for tens of thousands of deaths a year in the U.S.

The top government lawyers in 35 states signed a letter to the trade group America’s Health Insurance Plans. The group, which also includes attorneys general for Puerto Rico and the District of Columbia, asked insurers to make coverage of non-opioid treatments such as physical therapy and massage a priority.

“The status quo, in which there may be financial incentives to prescribe opioids for pain which they are ill-suited to treat, is unacceptable,” the attorneys general wrote.

The letter targets prescribing powerful drugs for chronic pain, a practice several studies have found is not effective.

The insurers group did not immediately respond to requests for comment.

Opioid-related overdoses have hit especially hard in the Appalachian states. On Monday, the attorney generals from two of them, Kentucky and West Virginia, held a joint news conference to highlight the pressure on the health insurance industry.

“If we can get the best practices changed with insurance companies and the payment incentives are just a bit different than what they are today, I think that’s going to continue to see the number of pills prescribed and dispensed drop dramatically,” said West Virginia Attorney General Patrick Morrisey, a Republican. “This is an important new front to open up.”

Kentucky’s Andy Beshear, a Democrat, said the number of overdoses might not fall quickly if companies follow the requests, but said it could help prevent more people from becoming addicted in the future.

The nation is in the thick of an opioid epidemic. In 2015, more than 52,000 people across the country died from drug overdoses — more than from car crashes or shootings.

Nearly two-thirds of those overdoses were from opioids, including prescription drugs such as OxyContin and Vicodin and illicit drugs including heroin and fentanyl. Often, abusers switch between prescription and illegal drugs.

A few years ago, governments were reacting mostly through measures such as creating databases of prescriptions to identify abusers or by increasing the availability of a drug that counteracts overdoses.

Lately, they’ve been getting more aggressive.

More than 60 local and state governments have filed, announced or publicly considered lawsuits against drug makers or distributors. In June, several attorneys general announced a multi-state investigation of the industry.

Since last year, states have been adopting laws limiting initial prescriptions to opioids in the hopes of cutting down on misuse.

 

Tylenol Isn’t So Safe, But At Least It Works, Right?

Tylenol Isn’t So Safe, But At Least It Works, Right?

https://www.acsh.org/news/2017/09/18/tylenol-isnt-so-safe-least-it-works-right-11827

I’m not a big fan of Tylenol, which becomes rather obvious if you read the first part of this two-part series. For a drug that is so widely used, it is quite easy to consume enough, accidentally or otherwise, to take enough to suffer a toxic overdose due to irreversible liver damage.

But drugs cannot be judged by safety alone. Both the good and the bad – benefits and risks – must be taken into account to get the true measure of the quality of a drug. So if Tylenol isn’t all that safe, you might expect that, at the very least, it should work well. Otherwise, why would so many people be taking it?

That’s the $64,000 question, and here’s the answer. In reality, Tylenol doesn’t work very well at all, and there is plenty of evidence to back this up, especially in systematic Cochrane Reviews – highly regarded, evidence-based reviews that carefully evaluate the quality of data in multiple studies. Here are some representative analyses.

Osteoarthritis of the Knee and Hip

A group of five pain specialists and pharmacologists in Denmark examined seven studies of patients with hip- or knee osteoarthritis. All seven included a comparison between acetaminophen (used continuously for more than two weeks) with placebo. The review, entitled “Acetaminophen for Chronic Pain: A Systematic Review on Efficacy” was published in the journal  Basic & Clinical Pharmacology & Toxicology. The conclusion:

“All included studies showed no or little efficacy with dubious clinical relevance. In conclusion, there is little evidence to support the efficacy of acetaminophen treatment in patients with chronic pain conditions. Assessment of continuous efficacy in the many patients using acetaminophen worldwide is recommended.”

Z. Ennis, et. al., Basic & Clinical Pharmacology & Toxicology, 2016, 118, 184–189

Well, that doesn’t sound so marvelous. Perhaps it’s just a single bad paper. Or not.

Acute and Chronic Lower Back Pain

A 2016 Cochrane Review entitled “Paracetamol for low back pain” (1) examined the utility of Tylenol in treating lower back pain. The review included three trials with a total of 1825 participants, mostly middle-aged, who had acute back pain, and another trial in which the participants had lower back pain for more than six weeks. All of the trials also had a placebo arm. The drug was administered either orally or by IV in doses that ranged from one gram to four grams. How did that work? Ouch.

“We found high-quality evidence that paracetamol (4 g per day) is no better than placebo for relieving acute LBP in either the short or longer term. It also worked no better than placebo on the other aspects studied, such as quality of life and sleep quality.”

B.Saragiotto et. al., Cochrane Review, June 2016

Back Pain, and Hip and Knee Osteoarthritis

The hits keep coming. A 2015 review in the British Medical Journal entitled “Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo-controlled trials” examined reports of 13 randomized trials. The review examined several measures of pain relief: pain intensity, disability, and quality of life in people with low back pain, and hip or knee osteoarthritis. and concluded:

“Paracetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis. These results support the reconsideration of recommendations to use paracetamol for patients with low back pain and osteoarthritis of the hip or knee in clinical practice guidelines.”

M. Ferreira, et. al, BMJ 2015; 350

Headaches

OK, so it doesn’t work for back pain or arthritis, but that’s OK because most people use it for headaches. Well, it works. Sort of. A Cochrane Review entitled “Oral paracetamol for treatment of acute episodic tension-type headache in adults” looks at just that. This may surprise you. 

Things look OK at the beginning of the results sections: “The International Headache Society recommends the outcome of being pain free two hours after taking a medicine. The outcome of being pain free or having only mild pain at two hours was reported by 59 in 100 people taking paracetamol 1000 mg…”

It may not be perfect, but a 59% response isn’t all that terrible. Until you read the rest of the sentence: “…and in 49 out of 100 people taking placebo. This means that only 10 in 100 or 10% of people benefited because of paracetamol 1000 mg.

Now, *that’s* pretty bad. Of the 59 of you who are getting headache relief from the stuff either believed that their headache went away, or it went away within two hours on its own, not from the drug. So, the real efficacy of Tylenol is 10%. That’s enough to give you a headache. 

Colds

Tylenol is often used to treat symptoms of a common cold. For a cold, the data are not as conclusive as in the studies about, but there is little evidence that acetaminophen is effective.

“Acetaminophen may help relieve nasal obstruction and rhinorrhoea [runny nose] but does not appear to improve some other cold symptoms (including sore throat, malaise, sneezing, and cough). However, two of the four included studies in this review were small and allocation concealment was unclear in all four studies. The data in this review do not provide sufficient evidence to inform practice regarding the use of acetaminophen for the common cold in adults.”

S . Li, et. al, “Acetaminophen (also called paracetamol) for the common cold in adults.” Cochrane Review, June 2013

Tooth Pain

For a pain following wisdom tooth extraction, Tylenol is inferior when compared with ibuprofen (Advil), but when two are combined there seems to be a synergistic effect.

“There is high quality evidence that ibuprofen is superior to paracetamol at doses of 200 mg to 512 mg and 600 mg to 1000 mg respectively based on pain relief and use of rescue medication data collected at six hours postoperatively. The majority of this evidence (five out of six trials) compared ibuprofen 400 mg with paracetamol 1000 mg, these are the most frequently prescribed doses in clinical practice. The novel combination drug is showing encouraging results based on the outcomes from two trials when compared to the single drugs.”

E. Bailey et. al, “Ibuprofen versus paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth  Cochrane Review, December 2013

Fever

Tylenol is given to children to lower fever, and it does so successfully. So do NSAIDs, such as aspirin and ibuprofen. There is some indication that giving the two together or alternating the drugs may be more effective, but the evidence is weak. 

“Paracetamol (also known as acetaminophen) and ibuprofen lower the child’s temperature and relieve their discomfort…. There is some evidence that both alternating and combined antipyretic therapy may be more effective at reducing temperatures than monotherapy alone. However, the evidence for improvements in measures of child discomfort remains inconclusive.”

T. Wong, et.al., “Alternating and combined antipyretics for treatment of fever in children.” Cochrane Review, October 2013

This article is not intended to be a comprehensive examination of every review about the efficacy of acetaminophen. There are undoubtedly studies that demonstrate efficacy, however, I chose to include (mainly) information from Cochrane, since it is widely considered to be a high-quality source for evidence-based medicine. 

To wrap this up: acetaminophen largely ineffective. And I have already demonstrated why it is only marginally. This makes it one lousy drug.

Note:

(1) Paracetamol is another name for acetaminophen, the generic name of Tylenol. It is commonly used in Britain.

If you own Johnson and Johnson stock you probably have enough problems on your hands. The company keeps getting hammered by lawsuits alleging that talc in baby powder has given women cancer (1). So you sure don’t need me smacking down Tylenol, which had worldwide sales of almost $2 billion in 2016.

But, don’t blame me. This is not my quote. It’s part of a written interview I did back in July with Aric Hausknecht, M.D, “Pain In The Time Of Opioid Denial: An Interview With Aric Hausknecht, M.D.” 

“Tylenol Is By Far The Most Dangerous Drug Ever Made”

Aric Hausknecht, M.D. July 30, 2017 

Why would Dr. Hausknecht, a New York neurologist and pain management specialist, say this? Taken out of context, such a sweeping statement may seem to be hyperbolic. The most dangerous drug ever made? I asked him to elaborate. He did:

“Each year a substantial number of Americans experience intentional and unintentional Tylenol (acetaminophen) associated overdoses that can result in serious morbidity and mortality. Analysis of national databases show that acetaminophen-associated overdoses account for about 50,000 emergency room visits and 25,000 hospitalizations yearly. Acetaminophen is the nation’s leading cause of acute liver failure, according to data from an ongoing study funded by the National Institutes for Health. Analysis of national mortality files shows about 450 deaths occur each year from acetaminophen-associated overdoses; 100 of these are unintentional.”

Therapeutic Index – A cornerstone of pharmacology

When evaluating drug toxicity, a critical parameter is called the therapeutic index (TI). The TI is the ratio of the toxic dose to the effective dose. Obviously, the higher the TI the better, since the greater the separation of the therapeutic and toxic doses, the less likely an overdose. Here are some examples of low TI drugs:

  • Lithium (bipolar disorder)
  • Warfarin (blood thinner)
  • Theophylline (asthma)
  • Digoxin (various heart conditions)

And some examples of high TI drugs:

  • Benadryl (diphenhydramine, antihistamine, sleep aid)
  • Valium (sedative, hypnotic) (2) 
  • Neurontin (gabapentin, restless leg syndrome, multiple off-label neurological indications)

Tylenol (acetaminophen) an analgesic (pain reliever) gets a free pass in the minds of many people because it doesn’t come with the liabilities of the NSAIDs, such as aspirin and ibuprofen – bleeding, heartburn, kidney toxicity. ulcers, and salicylate allergy. The absence of gastrointestinal toxicity is responsible for the widespread perception that Tylenol is safer. In some ways it is, but in others, it is not. It may leave your stomach alone, but not your liver. 

Dr. Hausknecht’s statistics may seem puzzling. How can there be 50,000 emergency room visits and 25,000 hospitalizations, yet only 450 deaths per year?  This is because, when treated in time, irreversible liver damage from an acute overdose of acetaminophen can be prevented. There is an antidote called N-acetylcysteine. But the danger of the drug is not only from acute doses. Both acute and chronic use of acetaminophen can lead to permanent liver damage, not because acetaminophen itself is toxic, but because the liver converts it into something that is (Figure 1), sealing its own fate in the process. (Apologies for the biochemistry.)

Figure 1: Metabolic activation and detoxification of acetaminophen. Oxidation by liver enzymes forms N-acetylbenzoquinoneimine, a chemically reactive, toxic molecule. The carbon atom (red arrow) irreversibly “attacks” various proteins in the liver. The antidote, N-acetylcysteine sops up (deactivates) the benzoquinone imine, but only if given in time. It does not reverse liver damage. 

So, what is the therapeutic index for Tylenol? You may be rather surprised. Before 2011 the maximum daily dose of acetaminophen recommenced by the FDA was 4,000 mg. It is now 3,000 mg. The estimated lethal dose of the drug is 10 grams in one day, which is not terribly different from the maximum daily dose. The TI is thus about 3, which is pretty bad, especially compared to other drugs which are perceived as far more dangerous:

References:

a) http://www.acutetox.eu/pdf_human_short/1-Acetaminophen%20revised.pdf

b) https://medlineplus.gov/ency/article/002542.htm

c) https://www.fda.gov/ohrms/dockets/dailys/03/Aug03/082903/03p-0398-cp0000…att-6-vol1.pdf

d) https://www.ncbi.nlm.nih.gov/pubmed/357765

** Therapeutic index (TI) is an approximate, but indicative measure of the likelihood of a toxic or lethal overdose. It is not a measure of absolute toxicity, rather, the safety margin between therapeutic and toxic or lethal doses.

Approximate therapeutic indexes for some common drugs. The higher the TI, the lower probability of an overdose. 

 

Rather interesting that the CDC, which has inserted itself firmly up your doctor’s anus for writing scripts for Valium or hydrocodone, is only too happy to recommend that pain patients take a drug that is more likely to cause an overdose than either of them.

“Several nonopioid pharmacologic therapies (including acetaminophen, NSAIDs, and selected antidepressants and anticonvulsants) are effective for chronic pain. In particular, acetaminophen and NSAIDs can be useful for arthritis and low back pain…”

CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016

Next: “So, Tylenol isn’t that safe, but at least it works, right?”

NOTES:

(1) It would seem that evidence of harm is totally irrelevant in the courtroom. It is far from clear that talc is harmful. But it is even further from clear that there is *any* proof that Eva Echeverria, a victim of ovarian cancer who used baby powder her whole life, contracted the disease from the powder. Lawyers 1, Science 0.

(2) It is very difficult to die from a Valium overdose in the absence of alcohol, opioids or other central nervous system depressants. (See: “Can Valium Kill You?”). In two case studies, people survived overdoses of 500 and 2,000 mg (50 and 400 five milligram pills, respectively). But, 50 regular strength Tylenol pills (16.25 g) is approximately twice the estimated lethal dose. Yes, a single dose of 500 Valium pills is less dangerous than 50 Tylenol pills. 

Has “professionals oaths” become nothing more than “just words” ?

Hippocratic Oath: Classical Version

I swear by Apollo Physician and Asclepius and Hygieia and Panaceia and all the gods and goddesses, making them my witnesses, that I will fulfill according to my ability and judgment this oath and this covenant:

To hold him who has taught me this art as equal to my parents and to live my life in partnership with him, and if he is in need of money to give him a share of mine, and to regard his offspring as equal to my brothers in male lineage and to teach them this art—if they desire to learn it—without fee and covenant; to give a share of precepts and oral instruction and all the other learning to my sons and to the sons of him who has instructed me and to pupils who have signed the covenant and have taken an oath according to the medical law, but no one else.

I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.

I will neither give a deadly drug to anybody who asked for it, nor will I make a suggestion to this effect. Similarly I will not give to a woman an abortive remedy. In purity and holiness I will guard my life and my art.

I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.

Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both female and male persons, be they free or slaves.

What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.

If I fulfill this oath and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot.

“Thank you so much for accepting my friend request. I have no idea what prompted me to contact you but I sit here tonight preparing to check into a psychiatric hospital to detox off the opiates that I was prescribed for almost 15 years and now I can not find a single soul to prescribe them to me. Mine is a textbook case of the hysteria that has overcome our nation. In 2013, after ten years with the same prescribing physician, I was informed that he would no longer be giving any of his patients opiates any longer due to a patient’s death. Obviously, not mine nor did I ever breach the contract, fail a drug screen or ask for early refills. I was on a stable dose for three years, yes it was above the 90mme that is being “suggested” but, it worked for me. I was given a three month supply and sent on my way to pain management where no sooner did the door close behind the PA/NP was I informed that if I didn’t have terminal cancer I would be titrated off all opiates. My thoughts on the matter were irrelevant. I signed myself out of that clinic and then spent the next three years trying to find another pain clinic that would keep me on my prior dose that I was stable and content on. I found no one. My PCP had agreed to “bridge” the gap until I was able to find a provider but that day never came. I was on a medication that didn’t alleviate my pain whatsoever but since he was my primary care doctor he said his hands were tied and that he was out of his comfort zone even prescribing them to me and therefore he wouldn’t adjust the medication the first pain clinic had reduced me to.

I have medical records inches think that document me need for opiates yet each time I would visit a pain doctor I was told that my condition didn’t cause pain or that I was addicted and needed “Suboxone”…blah, blah, blah. My orthopaedic surgeon has written letters that confirm I have a connective tissue disorder and that my bones are the age of a 75-85 year old woman when I am only 46. They don’t want to operate until I am older as the replacement surgery has a high failure risk due to my disorder. I have yet to have one pain doctor even take the time to read my MRI results let alone give me an examination. I can not go to the ER to receive pain relief as they all say they won’t treat chronic pain. The guidelines say this and that. Sorry, see ya’!

So now, my PCP is leaving his clinic and I have no other option but to check into a detox facility. What’s even worse, is that I can not use marijuana as I have a rather strange reaction to it. I’ve tried Kratom as well, nada. Neurontin and gabapentin (spell) both make me feel drunk and stupid. Also, I have been tested and have a confirmed diagnoses of being a poor metaboliser involving the CYP-450 enzyme (I have one allele working at 50%) group with being a rapid metaboliser of methadone enzyme. (C19 I think??) The doctors don’t care. Even with the proof right in front of them. CBD oil is about the only thing I haven’t tried and I have little hope that it will be successful. This is very disappointing and discouraging and if I have to go through withdrawal after 15 years I will too be suicidal which is why I’m checking in. Now, I will definitely be labeled an addict and most likely end up never being prescribed opiates again. I’m supposed to have right foot reconstruction on December 12th and I desperately tried to find a doctor to prescribe to me before because if I have to go through detox I will most likely cancel the surgery so I don’t have to go through this all over again! So, basically I am going to be worse off instead of better after I go through “treatment” for opiate dependence. 

Thank you again, I just wanted to share my story because I honestly do not know what to do at this point, other than wave my white flag and surrender. I love what you’re doing and I sure hope things go back to normal for you soon!! Thanks for reading.

 

Please forgive any errors as I wasn’t able to go back and proofread! Lol. ☺️”

Law Enforcement Oath of Honor

On my honor, I will never betray my badge, my integrity, my character or the public trust.

I will always have the courage to hold myself and others accountable for our actions.

I will always uphold the constitution, my community, and the agency I serve.
Everyone – especially professionals – take a oath to uphold certain standards of their profession. Over the last decade or so… certain professionals seems to regard those oaths as JUST WORDS, and their day to day actions seem to have become more focused on SELF-SERVING.

 

DEA Agent: no one should be taking opiates unless they have cancer

As pharmacists we are in a tough spot. I had a DEA agent stand in my pharmacy and watch as a lady handed over a stack of narcotics rxs to the technician. He said no one should be taking those unless they have cancer. ( his words, not mine). This same DEA agent told me I shouldn’t be dispensing diet pills to someone if I judge them to be thin. ( now, my definition of thin bight be different than his). My point is I don’t think it’s my place to be the judge. Also, I don’t see the patient in an office to get all the facts. I don’t always know why someone is taking those pills. According to him, it IS my job to be the judge. I trust the doctor to make that decision, but we aren’t supposed to do that either!

sadly when they are standing there with a gun, you just end up doing what they say when they threaten you…..
No doubt this guy is a total jerk. I did ask him if he was a pharmacist or doctor, as an indication that I thought he had no expertise. He’s not either and didn’t care.

Montana: the “land of denial of pain” ?