Email steve@steveariens.com 502-938-2414
Pay Attention
Terri Lewis PhD
Is looking for patients harmed by being turned away by their pharmacist
Or
Harmed by a prescription drug monitoring program.
anyone who wants to share their story of being harmed by a PDMP or risk scoring program can send me an email which I will forward to the investigator at Politico.
Tal7291@yahoo.com
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https://www.acsh.org/news/2019/05/07/neurontin-darling-anti-opioid-crowd-does-it-work-14005
The mad rush to purge this country of demonic prescription analgesic drugs (mainly Vicodin and Percocet) has pain patients and their doctors in an unprecedented dilemma. The tapering or complete discontinuation of painkilling drugs that pain patients have been using successfully for years, even decades, and the reluctance of physicians to write new prescriptions has left a vacuum, which was filled by drugs or therapies that were unapproved, worthless, or both.
There is another term for this: Human Experimentation. Last I looked this was frowned upon, except in Nazi Germany. One would hope that humanity had progressed to the point where this sort of thing might be considered unacceptable. And it was, at least until 2016, when the CDC, with the “help” of Physicians Responsible for Opioid Prohibition (PROP) (1) decided that it was time to take chronic pain patients off opioid drugs without having anything resembling a decent plan for what to do with them. This, by necessity, forced patients and their physicians to try other untested drugs and modalities (2) without having evidence that either would work. Nice work, fellas.
Some of the alternatives that were shoved down patients’ throats included Tylenol (useless, dangerous), NSAIDS (stomach and kidney killers), antidepressants (please) and most importantly Neurontin (generic name gabapentin and to a lesser extent Lyrica (pregabalin). Lyrica and Neurontin are so important that all two of them were recognized as a new class of drugs with a pretentious name – gabapentanoids (3).
Since Neurontin is now being handed out like Butterfingers at Halloween it is fair to ask whether there is evidence that it works. Fortunately, Drs. Christopher Goodman and Allan S. Brett ask just this in “A Clinical Overview of Off-label Use of Gabapentinoid Drugs,” which was published as JAMA Network Special Communication. Here are the highlights.
In 1993 Pfizer received FDA approval for Neurontin for the treatment of seizures. Shortly thereafter Pfizer began to push the drug’s off label indication for pain. In 2002 Neurontin was approved for pain, but only for postherpetic neuralgia. In 2004 Pfizer/Warner-Lambert pled guilty to improperly marketing the drug for off-label uses, coughed up 430 million of its favorite dollars and faced a class action lawsuit, all of which is documented by Landefeld and Steinman in 2009 (4).
Let’s look at some of the findings from Goodman and Brett.
The authors searched the PubMed database in September 2018, using the search terms “pain and gabapentin” (5) They excluded studies involving cancer pain and headaches.
The search turned up 54 studies, 34 of which were randomized controlled trials (very good) and 18 also included placebo in the study (even better). A total of 22 studies encompassing 13 painful conditions was selected. These are presented below. Prepare to be unimpressed.
TWENTY-TWO STUDIES RANDOMIZED CLINICAL TRIALS COMPARING NEURONTIN AND PLACEBO FOR 13 PAINFUL CONDITIONS
Table 1. Twenty-two randomized controlled trials examining the efficacy of Neurontin in treated 11 different painful conditions. Adapted from “A Clinical Overview of Off-label Use of Gabapentinoid Drugs, Christopher W. Goodman, MD; Allan S. Brett, MD JAMA Intern Med. 2019;179(5):695-701. doi:10.1001/jamainternmed.2019.0086
SUMMARY OF TABLE 1
Diabetic neuropathy (5 studies) – Studies A, B (blue letters) showed a statistically significant but very small difference between Neurontin and placebo for treating diabetic neuropathic pain. Study C showed a larger difference between the two.
Lower back pain with radiculopathy – Of the four studies, 3 showed no difference between Neurontin and placebo. Study D showed a significant difference between the two.
Unspecified neuropathy. One study (E) showed a statistically significant but minuscule difference between Neurontin and placebo. I don’t care what the statistics say. A difference in pain score of 0.5 on a scale of 0-10 means nothing, especially since pain is subjective.
Spinal cord injury pain. A small study (F) showed a significant difference between Neurontin and placebo. A smaller study showed no difference.
Chronic pelvic pain in women. No difference.
Phantom limb pain. One study (G) showed a small effect. Another showed none.
Carpal tunnel syndrome. No difference.
Complex regional pain syndrome (CRPS). No difference.
Fibromyalgia. Statistically significant but minuscule difference between Neurontin and placebo.
HIV neuropathy. No difference.
Masticatory Myalgia (facial pain from muscle spasms). A small but significant difference between Neurontin and placebo
Traumatic nerve injury. No difference.
Acute herpes zoster (shingles) pain. No difference.
IS THIS STUFF GOOD FOR ANYTHING?
Perhaps I missed it, but there ain’t much in here that even suggests that Neurontin has any utility whatsoever as a pain medication. In 59% (13/22) of the randomized controlled trials, it did not perform any better than placebo. In 18% (4/22, trials A, B, E, and H)) the difference between Neurontin and placebo was statistically significant but very small. Let’s toss them in with the first group and we have 77% of the trials showing little or no utility of Neurontin in treating pain. Of the remaining five trials – those that seemed to indicate some effect – three (14%, C, G, and I) had only a modest effect (pain reduction score of ~2 on a scale of 1-10).
That leaves two trials where a robust effect was seen. In trial D (lower back pain) a pain reduction score of 0.72 on a scale of 1-3 seems to be significant, but keep in mind that in the three other trials (above this one in Table 1) for lower back pain there was no difference between Neurontin and placebo. What does this mean? Who knows?
The only study (F) where Neurontin shows significant efficacy (a 4.3 reduction in pain score on a 0-10 scale) consists of 20 patients.
So it cannot be surprising that the authors conclude:
Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses.
C. Goodman and Allan S. Brett, MDs
So, it’s certainly fair to say that Neurontin is just about useless as a pain medication, at least most of the time. Yet it is being used like crazy, and there can be no one more responsible for its (mis)use than Dr. Andrew Kolodny, the godfather of the anti-opioid crusade. Which made me wonder what he had to say about the drug.
Prepare yourself…
“[Because of the abuse potential, Neurontin] should probably be scheduled as a controlled drug. Then people can’t doctor-shop for it. That’s where drugs with abuse potential belong,”
Andrew Kolodny, MedShadow April, 2018
That might be the funniest thing I’ve ever heard.
NOTES:
(1) A few months ago, in the interest of accuracy, I renamed Physicians for Responsible Opioid Prescribing (PROP) Physicians Responsible for Opioid Prohibition (PROP). No one has complained so far, so I’ll assume that the name is now official.
(2) Don’t you just want to smack someone who uses the word modalities? Pretentious much?
(3) Gabapentanoids???? Are you kidding me? There are TWO of them – Neurontin and Lyrica. They don’t deserve a classification, especially one ending in “oid.” Likewise, the assignment of the terms “opioid” and “opiate” is a false distinction, because it is based on the source of the drug, not the structure. This is a chemical no-no; the source of a chemical or drug is irrelevant. It is only the chemical structure that matters. Many think that “opioid” was invented to confuse people and cloud the issue.
(4) See: Landefeld CS, Steinman MA. The Neurontin legacy: marketing through misinformation and manipulation. N Engl J Med. 2009;360(2):103-106. doi:10.1056/NEJMp0808659
(5) Goodman and Brett also did the same searches for pregabalin (Lyrica). I have omitted these results to focus only upon Neurontin.
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https://www.acsh.org/news/2019/02/20/heroin-pills-are-now-reality-andrew-kolodny-finally-happy-13825
Sometimes a few words are worth 1,000 words.
“…[H]ydrocodone and hydrocodone combination products produce the same effects that other opioid agonists produce… but we could [include] heroin there, as well, because what we’re really talking about are heroin pills.”
Andrew Kolodny, President of PROP, Testimony at FDA hearing, Friday, January 25, 2013
“When we talk about opioid pain medicines, we’re essentially talking about heroin pills.”
Andrew Kolodny “Understanding the Basics about Prescription Painkillers.” PBS, 1/17/18
“There is very little difference between a heroin molecule and a hydrocodone molecule.”
Andrew Kolodny in U.S News and World Report, Jan. 24, 2013
OK, you get it. No need to dwell upon the obvious. Andrew Kolodny, a psychiatrist, who, despite his ignorance of even the most fundamental principles of pharmacology, is routinely cited as an expert in all matters pertaining to opioid use. It is not difficult to demonstrate this ignorance. His “heroin pill” crusade does the job quite well.
Vicodin is to heroin is as a pebble is to a boulder.
An analogy of Kolodny’s false argument is that the pebble and the boulder will do equal damage if they fall on your car because they are both made of rock. While it is true that the heroin and Vicodin belong to the same class of drugs, they can only be equivalent if you ignore the relative potencies, doses, methods of dosing, and the ease of crossing the blood-brain barrier of both drugs. But you can’t ignore them; these properties are critical in determining the pharmacological effect of a drug on a person. In the absence of these parameters, the pebble and the boulder are, indeed, identical.
Now it’s irony time.
According to a recent report by the Associated Press, we now have “heroin pills” and it is not the “pebble kind” that Kolodny has been harping on for years. Instead, we are now dealing with a deadly “boulder pill for which he and his anti-opioid zealot comrades bear (at the very least) partial responsibility (1). These pills are the real deal and the real killers. Thousands of deadly light blue tablets of what the DEA calls “Mexican Oxy” are pouring into the Southwest and taking quite a toll. But “Oxy,” which is slang for oxycodone, is neither oxycodone nor heroin. It’s worse – fentanyl dressed up to look like prescription oxycodone.
(Left) Mexican Oxy seized by the DEA. Photo: DEA (Right) A 30 mg oxycodone tablet. Photo: Drugs.com
Although it is more accurate to refer to Mexican Oxy, as “heroin pills,” they are worse. These counterfeit oxycodone pills contain varying amounts (2) of fentanyl, the drug which is responsible for, by far, the most opioid overdose deaths – three-times the number of deaths caused by oxycodone and six-times that of hydrocodone.
The “real” heroin pills. Original source: The 15 drugs responsible for most overdose deaths in 2011. Source: National Vital Statistics Reports
The irony of yet another mess created by the reflexive and ill-advised anti-opioid mentality that has the country in its grips becomes obvious: by falsely equating hydrocodone or oxycodone with heroin (hence, “heroin pills,”) Kolodny, et. al, succeeded in getting preposterous restrictions placed upon them, making it next to impossible for pain patients to find a doctor willing to prescribe them or a pharmacy willing to fill them.
Bad science leads to bad policy.
It’s almost funny. With the shortage of Kolodny’s imaginary “heroin pills,” we now have real ones, which contain a “substitute” drug that is far more dangerous than the drugs that have been effectively banned, or, at the very least, made almost unattainable.
But let’s give a pass to desperate pain patients who may not find this so amusing. After all, some of them have been forced to buy deadly garbage off the street because of the failure of our medical system to provide them with the drugs they need to function or even to survive.
For which we can thank the Kolodnys of the world for stamping their ignorant imprint on our drug policies.
Thanks for the poison pill, folks.
NOTES:
(1) See The Opioid Epidemic In 6 Charts Designed To Deceive You:
“Yes, they are. But Kolodny omits a vital bit of information — potency. While the physiological effect of hydrocodone on the brain may be the same as heroin (the two drugs hit the same receptors), the functional difference between the two drugs is night and day. The magnitude of the effect is conveniently omitted from this “equation.” Heroin packs a much more powerful punch than hydrocodone, especially at doses that are used by addicts. People can become addicted to heroin (or even die) from a single injection. It is virtually impossible for one hydrocodone pill to kill or addict anyone. The two drugs don’t even belong in the same sentence, even though they happen to belong to the same class of drugs.”
(2) Any chemist who works on the formulation of pills will tell you that it is no simple matter to mix different solids and come up with a uniform powder which contains the same relative composition of drugs no matter where a sample is taken and analyzed. Imagine a poorly equipped lab with untrained people pressing the tablets without any quality control. It is guaranteed that different batches of Mexican Oxy will contain varying amounts of fentanyl. Considering that 1-2 mg is a lethal dose it is not hard to see why people are dying from these pills.
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It is well known that the Drug Enforcement Administration or DEA, is not a particularly avid backer of the cultivation and legalization of marijuana. However, in a new Federal Register filing set to soon be published, the anti-drug agency is gearing up to increase the total amount of cannabis that can legally be grown in the US for research purposes. The increase is rumored to be more than fives times the amount of what is allowed at the current date, which is approximately 1,000 pounds and will increase to roughly 5,400 pounds by next year.
Meanwhile, the DEA is also planning to lessen the amount of certain opioid drugs-such as oxycodone, hydrocodone, morphine, fentanyl and others-that are manufactured in the United States. “We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” DEA Acting Administrator Uttam Dhillon said in a press release. “This significant drop in prescriptions by doctors and DEA’s production quota adjustment will continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine.”
US Attorney General Jeff Sessions, an adamant rival of marijuana ratification, added that “the opioid epidemic that we are facing today is the worst drug crisis in American history… Cutting opioid production quotas by an average of ten percent next year will help us continue that progress and make it harder to divert these drugs for abuse.”
The suggested distributions for cannabis and other drugs “reflects the total amount of controlled substances necessary to meet the country’s medical, scientific, research, industrial, and export needs for the year and for the establishment and maintenance of reserve stocks,” the DEA said.
The 2,450,000 grams of marijuana the agency wants the US to grow in 2019 is a significant jump from the 443,680 grams the agency authorized for 2018.
In addition to the surge in marijuana agriculture, the DEA is also proposing to permit the manufacture of 384,460 grams of tetrahydrocannabinols or THC, in 2019, essentially the same amount the agency approved for this year. The DEA’s huge increase in marijuana production quotas for 2019 could be a sign that it anticipates eventual approval of some of the additional grower applications.
“While the drastic increase in requested production of marijuana by the DEA is a positive sign, significant barriers still exist including but not limited to the NIDA monopoly on cultivation and undue hurdles for researchers to qualify for a permit,” NORML Political Director Justin Strekal said in an interview. “It’s time that Congress look at the 28,000 plus peer-reviewed studies currently hosted on the National Institute of Health’s online database and reform federal law by removing marijuana from the Controlled Substances Act all together.”
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Mexico has drafted plans to decriminalize all currently illegal drugs after admitting that the current “war on drugs” is endangering public safety.
Mexican President Andrés Manuel López Obrador sketched out the country’s radical change of plan in his administration’s National Development Plan for 2019-2024, released last week.
Under a new approach, drugs would not become legal, but arrests would be replaced by enforcing medical treatments including detoxification programs and attempts to break addictions.
“The only real possibility of reducing the levels of drug consumption is to lift the ban on those that are currently illegal,” Obrador’s policy statement read, “and redirect the resources currently destined to combat their transfer and apply them in programs— massive, but personalized—of reinsertion and detoxification.”
In 2006, Mexican President Felipe Calderon deployed more than 6,500 Mexican soldiers to battle drug traffickers in what is seen as the beginning of the country’s modern “war on drugs.”
A 2018 report from the Congressional Research Service has estimated that since that year, 150,000 people have died because of organized gang killings.
Obrador’s statement has described Mexico’s current prohibitionist strategy as unsustainable and a danger to everyday Mexicans.
“Public safety strategies applied by previous administrations have been catastrophic: far from resolving or mitigating the catastrophe has sharpened it.”
The U.S. Department of Homeland Security has estimated that as much as $29 billion in cash flows across the border to Mexican drug gangs each year.
Last month, President Donald Trump said he would give Mexico a year to stem the flow of illegal drugs and migrants over the southern border or he would impose auto tariffs, and potentially close the border.
Those comments rowed back from an earlier threat by Trump to close the border in April this year.
In Europe, Portugal decriminalized drug possession in 2001 and has maintained a non-prohibition stance ever since. A study conducted in 2015 by the CATO Institute suggested that while rates of heroin use in Portugal had not declined, drug-related outcomes — such as deaths due to drug usage and sexually transmitted diseases — had decreased sharply.
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Pharmacoeconomics (4) from Loren Pierce on Vimeo.
I have a specific example of how these PBM’s … in our case … Silver Scripts/Caremark which is part of CVS Health. Barb has a prescription that she has taken for 10+ yrs
This particular medication has always required a PA (Prior Authorization) from Silver Scripts, and they wanted a $600+ copay meaning that it was a Tier 4 medication. Which means that the total price of the 90 day prescription was in the $1500+ arena.
I asked the independent pharmacy that we patronize what their “cash price” was and it was $325.00. I started making some phone calls and found that a BIG BOX store would fill the prescription for CASH for $88.00
And the third time that I got it filled at the same BIG BOX store .. the CASH PRICE was $44.00.
It use to be that the pt was suppose to be charged the PBM contracted price in this particular case .. the copay would be abt 40% of a total price of abt $1500.00 ($600.00) OR the pharmacy’s CASH PRICE and in the first case would be $325.00. Maybe they have changed the contracts so that they can EXTRACT extra money out of pts.. especially those on Medicare Part D… most who are trying to make ends meet on their social security check.
In reality on this particular medications, CVS/Caremark/Silver Scripts was actually charging me – the pt – more than the cost of the medication – they actually had a POSITIVE CASH FLOW when we had that particular Rx filled, and we no longer had to screw around with a PRIOR AUTHORIZATION BS… every year.. when Barb had taken this chronic medication for over a DECADE.
To me, the “savings” from the Medicare Part D program is more “smoke and mirrors” than any real savings to Medicare pts.
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http://https://www.statnews.com/2019/05/09/pharmacy-benefit-managers-cancer-treatment
When I must tell a patient that she or he has cancer, that diagnosis comes with the explicit promise that I will provide timely treatment, including medicines aimed at curing cancer or extending life as long as possible.
But an insidious interloper now often comes between me and my patients. I’m talking about pharmacy benefit managers (PBMs), the middlemen that have introduced a bureaucratic and nightmarish system of delays and denials into filling prescriptions.
I’m not alone.
An oncologist in Florida determined that her patient with metastatic kidney cancer needed to start taking a standard, first-line oral medication. But the patient’s pharmacy benefit manager decided it knew better and refused to authorize the medication unless a surgeon first performed surgery to remove a tumor on the patient’s kidney — despite the fact that the patient’s surgeon had already determined that the procedure was too risky and the patient wasn’t a candidate for surgery, something the surgeon had previously told the PBM.
For three months, the patient’s oncologist and surgeon appealed the pharmacy benefit manager’s denial so the patient could receive the treatment he desperately needed. Although the PBM ultimately relented, the patient will never get those three months back. For anyone battling cancer, delaying treatment and allowing the disease to progress by even a week can mean the difference between life and death.
There’s the story of a young mother in Tennessee who was beating the odds against stage 4 pancreatic cancer but was left with a dangerously suppressed immune system. She was forced to delay critical treatment because the medicine she needed was on backorder at her pharmacy benefit manager’s mail-order pharmacy and the company wouldn’t pay for her to get it from her doctor’s office.
Working with cancer care providers across the country, the Community Oncology Alliance has compiled hundreds of these horror stories. They demonstrate time and again how pharmacy benefit managers come between patients and their doctors, with little regard for the pain and suffering they inflict.
Pharmacy benefit managers were supposed to help bring down the cost of drugs by negotiating with competing drug companies and by “encouraging consumers to use the most cost-effective drugs.” But they have done the opposite, fueling higher drug prices through manufacturer rebates and by extorting fees from pharmacy providers.
Those rebates and fees were the focus of a Senate Finance Committee hearing featuring top executives of five pharmacy benefit managers last month. The chair of the committee, Iowa Republican Chuck Grassley, noted that “the current system is so opaque that it’s easy to see why there are many questions about PBMs’ motives and practices.”
For health care professionals on the front lines of delivering timely care to people with cancer, there is no debate about the need for transparency: Pharmacy benefit managers are a roadblock to potentially lifesaving cancer care. For many of our patients, the groundbreaking cancer drugs they see in headlines are often out of reach because of PBM practices that restrict or delay access. While they won’t admit it, there is no doubt that every dollar a pharmacy benefit manager saves by stopping or redirecting a prescription means more upside for their profits.
The pharmacy benefit manager business model is built on a lucrative and shadowy network of drug manufacturer rebates and pharmacy fees squeezed from every level of the health care system. Congress is right to look into these rebates and fees to better understand exactly what roles pharmacy benefit managers play in the complex economics of drug prices.
A veneer of governmental indifference seems to be helping pharmacy benefit managers protect their egregious profits. But the system isn’t working for patients with cancer or the millions of other Americans who struggle to overcome red tape to get the medications they need.
Americans deserve better from our health care system and we should be able to count on our elected officials to support affordable, convenient, cutting-edge, patient-centered care. This includes access to the cancer therapies they need, when and where they need them.
The White House, members of Congress, policymakers, and the American public should ask themselves this important question: If your mom was facing breast cancer or your son had brain cancer, do you want a pharmacy benefit manager determining their care, or their doctor?
Jeff Vacirca, M.D., is CEO of New York Cancer and Blood Specialists and the immediate past president of the Community Oncology Alliance. The author reports being medical director of ION Solutions and on the board of directors of OneOncology, Odonate, and Spectrum Pharmaceuticals.
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In a huge victory for patients and pharmacists, Georgia governor Brian Kemp signed two PBM anti-steering bills into law yesterday. HB 233 is a bill that prohibits pharmacies from profiting off of prescriptions “steered” from their PBM and insurance affiliates, and HB 323 restricts PBM and insurer patient “steering,” strengthens anti-mandatory mail order, adds additional audit protections, prohibits PBMs from knowingly misleading patients, and restricts mining of patient data. These bills are the first in the nation of their kind to become law. Congratulations to the Georgia Pharmacy Association and all the Georgia pharmacists who worked hard to get these bills passed.
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