The Opioid Crisis Obeys the Law of Unintended Consequences

Capture71A letter to the editor of the New England Journal of Medicine back in 1980 is thought to have been the nudge that set the opioid crisis in motion. The letter claimed only four addictions were documented out of nearly 40,000 patients who were prescribed powerful opioid pain pills. The article arguing addiction to prescription opioids is rare has been cited 600 times — often incorrectly.  Doctors and drug makers used this as evidence that it was safe to prescribed opioids to more patients with chronic pain.

Fast forward nearly 40 years and it has become clear that opioids can be dangerous in the wrong hands. There is also significant risk of diversion to the illicit market. After states began closing down so-called “pill mills,” heroin and fentanyl began flooding the US to take the place of the prescription drugs that were no longer available. Whole regions of the country have been hard hit by prescription drug abuse, including large areas of Appalachia. Other disease also tend to accompany IV drug abuse, including as hepatitis C and HIV.

I became aware of the 1980 letter on Real Clear Health. Notice the stock photo on the page linking to the article (AP Photo credit Mary Altaffer). It’s not an opioid pain reliever, it’s Bextra. Bextra is a pain reliever from a class of selective cyclooxygenase-2 inhibitors known as COX-2 Inhibitors. That photo got me to thinking: The opioid crisis isn’t just due to a letter to a medical journal back in 1980. It is also due to risk aversion at the U.S. Food and Drug Administration and trial lawyers.

Bextra was withdrawn from the market in 2005 due to some claimed (rare) side-effects that included slightly elevated risk of heart attack and stroke. Vioxx is another COX-2 inhibitor that was withdrawn from the market (in 2004), also due to safety concerns when prescribed for long-term use or in high doses.

Vioxx and Bextra are both anti-inflammatory drugs once used to treat arthritis and acute pain. They were popular because they do not irritate the stomach like other non-steroidal anti-inflammatory drugs (NSAIDs). The millions of people worldwide who benefitted from access to Vioxx and Bextra are the real losers in withdrawal of the once popular prescription pain relievers.

The evidence that Vioxx is dangerous was pretty slim, but try telling that to the trial lawyers. Over the course of a multi-year study that followed nearly 2,600 people, 45 of the patients taking Vioxx experienced heart attacks or strokes, compared to 25 people taking a placebo. The number of people in each group who actually died was five. Even though the death rate was equal, Merck removed Vioxx from the market — probably to reduce its liability. The makers of both Vioxx and Bextra paid out huge sums to settle lawsuits for people who died while taking the drugs.

Of course, it’s easier to count those few people whom statistics suggest may have died in greater numbers than expected, even if only from natural causes, than to count those whose lives might have been extended by access to a drug that has been taken off the market. The latter have no right to sue. One reason people paid more for Vioxx (10 to 15 times more) than less-expensive pain relievers was because it caused less post-operative bleeding and protected the stomach against ulcers cheaper medications often cause. The family members of the 16,500 patients who die annually of bleeding ulcers caused by older pain relievers can hardly be expected to attribute the deaths of their loved ones to a drug they couldn’t take. Yet under current law, those who die of a heart attack while taking a drug have every right to sue–even if the drug did them far more good than harm. They also have a right to sue even if the death of a family member cannot be proven to have been caused by the drug itself. The less effective, less expensive generic and over-the-counter pain relievers are poor targets for lawsuits.

More than 100 million people took Vioxx before it was removed from the market. The use of COX-2 pain relievers also precludes taking aspirin daily to prevent heart attacks. Maybe that explains the slightly elevated risk of heart attacks and strokes from these drugs.

How many of the people in chronic pain who became addicted to opioids could have safely taken Vioxx or Bextra? We will never know. There is little reason to deny patients access to drugs like Bextra and Vioxx. The ones who suffer the consequences are the patients, and they should be allowed to decide whether drugs are worth the risk, rather than having the decision made for them by a risk-averse FDA and other people’s lawyers.

 

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  1. Ron Greiner says:

    NCPA Propaganda Alert: Blue Cross of NC is the single-ACA-player and the Tar Heels are being fed the garbage, “We own the State and we are going to raise premiums on IM 25%!” But, to make it sound better BCNC is saying, “23% increase and we don’t want to do it. It’s President Trump’s fault.”

    Blue Cross of IA is saying that it is ONE male teenager who has destroyed IM in Iowa, I kid you not. This kid is costing $1 million a month or only $12 million a year. Blue Cross CEO John Forsyth is probably the one who came up with this bright idea. The truth is Blue Cross of IA is scamming the good taxpayers of IA out of billions and billions and $12 million is a drop in the bucket.

    Blue Cross in VA has requested over 50% increase for 2018 but they forgot to blame President Trump. Blue Cross of FL owns 70% of the FL counties so that is close to single-payer in the Sunshine State so expect them to take a very healthy increase of 25%, but no problem, Federal taxpayers are in the hook for the Obamacare income-based tax credits. So the word is, nobody will even notice these ESCALATING prices.

    The smart move for IA is to take a collection from the 3.1 million people and move this kid to CA. Buy him beach front property and give him a boat to move. CA is in so much trouble financially that anther $12 million a year won’t make any difference anyway.

    The quickest way to break a North Carolinian’s heart? Say the words, “We don’t have sweet tea, but there’s sugar on the table.”

    In my travels I have noticed that these older Millennials understand that employer-based health insurance stops older people from being able to get a job. Now that these Millennials are 37-years-old it will be just a blink of the eye before they won’t be able to get a job because they are too old for hiring managers. Darn, can’t get a job.

    Well, I live at the 7-11
    Well, I’m tryin’ to play this guitar
    Well, I’m learning “Stairway to Heaven”
    ’cause Heaven’s where you are

    I can’t go to school
    ‘Cause I ain’t got a gun
    I ain’t got a gun
    ‘Cause I ain’t got a job
    I ain’t got a job
    ‘Cause I can’t go to school
    So I’m looking for a girl with a gun and a job
    Don’t you know where you are

    Lost in America

    https://www.youtube.com/watch?v=8g6zV-FIxGU

    She also needs a house, with cable.

  2. Ron Greiner says:

    HSA Field Forces: The IRS has just released its 2018 annual inflation adjustments for Health Savings Accounts (HSAs) as determined under Section 223 of the Internal Revenue Code.

    Specifically, IRS Revenue Procedure 2017-37 provides the adjusted limits for contributions to a Health Savings Account (“HSA”), as well as the high deductible health plan (“HDHP”) minimums and maximums for calendar year 2018.

    The 2018 limits are as follows:

    Annual Contribution Limit
    HSA Single Coverage: $3,450
    HSA Family Coverage: $6,900
    HSA Qualifying Deductibles – Minimum Deductible
    HSA Single Coverage: $1,350
    HSA Family Coverage: $2,700
    HSA Qualifying Maximum Annual Out-of-Pocket Expenses (including deductibles, co-payments and other amounts, but not including premiums)
    HSA Single Coverage: $6,650
    HSA Family Coverage: $13,300
    The catch-up contribution for eligible individuals age 55 or older by year end remains at $1,000.

    Plans and related documentation, including employee communications, should be updated to reflect these new limits.

    So, if you have a HSA family ONE deductible of $13,300 and you get cancer in October, you will owe 2 deductibles or $26,600 by January 1st. That is why everybody and their dog is getting HSA Life Insurance so they get a mountain-of-money (MOM) with a Critical Illness.

    A 30-year-old woman can get $190,000 with a cancer for just $30 a month. A 64-year-old male will cost $313 a month.

    HSA Life Insurance is the product of the future because the DC regulators have not yet destroyed the product. Give these regulators TIME and they will.

    Liberals will start screaming, “Life insurance is charging older people 10 TIMES more!” We need single-payer Life Insurance so we can strip out all of the GREED!”

  3. Ron Greiner says:

    Historic: Trump rejects Paris ‘climate’ treaty

    by Jon Rappoport

    June 1, 2017

    June 1, 2017, a day that will live in infamy for the liars, thieves, and killers of the new international economic order. They will see it as infamy, because their plan to sink the economy of America into a final death rattle has been rejected by Trump.

    Fake climate science has been the lynch pin, justifying orders to cut CO2 emissions—but make no mistake about it, cutting emissions means cutting energy production in almost all countries of the world. THAT’S THE GLOBALIST TARGET. ENERGY PRODUCTION.

    Get that one straight. The Globalist “utopia” isn’t a trillion solar collectors or a trillion windmills—it’s lights going out all over the world.

    It’s LOWER ENERGY PRODUCTION.

    That’s the monster hiding in the closet. That’s the outcome arch-Globalists are determined to foist on the planet, because that’s the society they want to control—poverty-stricken, abject, shuffling along a bleak path to nowhere.

    Trump just stuck a knife in that scheme.

    Yes, I fully understand the devil is in the details, but it is up to people everywhere, who have active brain cells and can see through the climate hoax, to take this opportunity to reject, publicly, the whole climate agenda.

    CO2 is not the enemy.

    Do the research yourself and see if there is any way these so-called scientists can assess, now or in the past, THE TEMPERATURE OF THE WHOLE PLANET.

    The science is settled? There is no room for argument?

    Freeman Dyson, physicist and mathematician, professor emeritus at Princeton’s Institute for Advanced Study, Fellow of the Royal Society, winner of the Lorentz Medal, the Max Planck Medal, the Fermi Award: “What has happened in the past 10 years is that the discrepancies [in climate change models] between what’s observed and what’s predicted have become much stronger. It’s clear now the [climate change] models are wrong, but it wasn’t so clear 10 years ago… I’m 100 per cent Democrat myself, and I like Obama. But he took the wrong side on this [climate change] issue, and the Republicans took the right side…” (The Register, October 11, 2015)

    Dr. Ivar Giaever, Nobel-prize winner in Physics (1973), reported by Climate Depot, July 8, 2015: “Global warming is a non-problem…I say this to Obama: Excuse me, Mr. President, but you’re wrong. Dead wrong.”

    Green Guru James Lovelock, who once predicted imminent destruction of the planet via global warming: “The computer models just weren’t reliable. In fact, I’m not sure the whole thing isn’t crazy, this climate change.” (The Guardian, September 30, 2016)

    And these are but a tiny fraction of the statements made by dissident scientists who reject manmade global warming.

    But regardless, never lose sight of agenda based on this “settled science.”

    VASTLY LOWER ENERGY PRODUCTION FOR PLANET EARTH.

    And at the same time, truly viable forms of energy production (e.g., water turbines, hydrogen), that could be brought online with but a fraction of previously chiseled government subsidies for oil and nuclear, are sitting on the shelf gathering dust—BECAUSE THE MODEL OF SCARCITY FOR THE PLANET IS WHAT THE GLOBALIST EMPIRE DESIRES.

    Until such time as that model is destroyed, Earth needs energy, all the energy it can produce.

    The climate criminals, working for Globalism Central, staged their Paris “Treaty” to try to torpedo that production. Obama signed on in Paris, knowing full well he was committing a criminally unconstitutional act by disregarding the vote of the US senate, a vote that was needed to confer legitimacy to the agreement.

    There is nothing binding about the Paris “Treaty.” Nothing.

    And today, Trump squashed it.

    Might he re-enter negotiations and give away some of what he’s just taken back for America? Anything’s possible. But for now, the Paris Accord is a dead duck here in the US.

    Trump is going to catch a new version of Hell for what he’s just done. But if enough Americans, and people around the world, realize the true implication of this historic day, and proclaim it, they’ll win. We’ll win. Each one of us.

    Don’t give up. Don’t give in.

    https://www.youtube.com/watch?v=VjEq-r2agqc

    I was counting on Global Warming to take the chill off of these cold winter nights here in Tampa Bay. My wife has me putting blankets on our Fox Tail palm trees on the coldest nights. I guess I will have to move further south to Naples for a decent climate.

  4. Ron Greiner says:

    Hillary is really detestable. But politics was exceptionally corrupt after the Civil War because there was no real effective opposition. The political scandals were just one after the other.

    The scandals were so numerous that Puck Magazine ran this cartoon picturing the Grant Administration as just a circus.

    The Whiskey Ring was diverting tax money on whiskey to private accounts shared by government officials. Can you imaging you owe $100,000 in taxes and the IRS Agent says here, wire the money to my account and we will call it just $50,000.

    There were too many scandals all involving corruption that was off the charts. It was literally one scandal after another. Mark Twain’s book, The Gilded Age, was a satire of greed and political corruption in post-Civil War era in America history.

    I have given up any hope on career politicians. They cannot possibly represent the people for their votes are always for sale. Republics never last because they have always turned into Oligarchies. Hillary is filthy rich, yet she has worked only for government. Nobody asks how!

    https://www.armstrongeconomics.com/international-news/politics/corruption-was-crazy-during-19th-century/

  5. Ron Greiner says:

    Devon, JAMA reported that over-dose deaths drop 25% when medical pot is legalized in a State. That is a whole bunch of people that don’t die. Florida passed Medical Weed by 70% but our politicians are pretending it didn’t happen.

    So Florida’s next Governor is riding to the rescue. –“Florida Commissioner of Agriculture and Republican candidate for governor Adam Putnam wants state lawmakers to come back to Tallahassee in a special session to finish the work on medical marijuana that they started but didn’t finish earlier this month.

    “I think for a constitutional amendment’s implementation, it’s important for the elected officials to do it, not the bureaucrats at the Department of Health,” Putnam said.–

    Republican candidate for governor Adam Putnam, who is sitting on $10 million in cash-on-hand from contributions, has released fundraising numbers showing what his campaign calls his “wide range of grassroots support.”

    The numbers came in a Thursday email from Amanda Bevis, Putnam’s campaign spokeswoman. He’s now finishing his second term as Florida’s elected agriculture commissioner; he is term-limited in that post in 2018.

    He “collected more than $2.1 million in the first month (May) since he filed to run for Governor of Florida, with more than $1.1 million in hard dollar contributions to the Adam Putnam for Governor campaign,” she wrote.

    I’m a Putnam Republican. Putnam needs to high pressure Humana into offering the tax-free MSA Option in Medicare so the money stays in Florida. Currently, Humana sells Florida seniors garbage HMOs with $6,700 Out-Of-Pocket, for $95 a month, and all of the money goes to KY. This has to stop.

  6. .allan. says:

    Devon

    Problems posting again. There is no email to inform the NCPA that the blog isn’t functioning appropriately.

    Will try and post my response of a few days ago without links if this goes through.

  7. .allan. says:

    Devon, my understanding is that similar drugs are still on the market such as Celebrex though they had and may still have a black box warning. Though I don’t know what to believe about claims that Vioxx contributed to tens of thousands to hundreds of thousands of deaths (calculations not actually proven deaths), I do believe the processes at the FDA were and continue to be faulty. Also of note all NSAID’s have been implicated at some time to some extent even the ones that are over the counter.

    There is always a risk when taking a drug and as you point out a risk to the public when a drug is withdrawn or not approved so we have to be very careful in how we assess problems and should leave more decision making elsewhere. The FDA is influenced by politics.

    “Graham says that he thinks there should be formal, periodic reviews of the safety of new medicines–and that the FDA should release documents that explain its reasoning.

    “The FDA does not think anything it did is a mistake,” he says. “None of its decisions are evidence-based.” “

  8. .allan. says:

    I sent two links to forbes that were not permitted through.

  9. .allan. says:

    and the second. ” I decided to do a quick search to refresh my memory and I thought this Forbes 2005 article was interesting.

    and this https://www.forbes.com/2004/12/13/cx_mh_1213faceoftheyear.html Graham was at the FDA.

  10. allan says:

    Now testing with my name void of the “.” and using my usual email account.

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