“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Knowingly ordering medically unnecessary items or services for patients
What Is Medicare Abuse?
Abuse describes practices that may directly or indirectly result in unnecessary costs to the Medicare Program. Abuse includes any practice that does not provide patients with medically necessary services or meet professionally recognized standards of care.
We know that both the FDA and Pfizer does not approve – or discourages – the use of Methylprednisolone and similar cortisteroids to be administered as epidural spinal injections (ESI).
How many pts have been told that they must get ESI in order to get oral opiates… even if previous ESI’s have provided little/no pain relief.
How many pts have been given additional ESI because the insurance will “pay for it again”.. after the pt has been told that the procedure will provide some pain relief for months, but in reality the pt is lucky to get some pain relief for days or weeks.
It has become rather routine for the DEA to charge prescriber’s offices that they have raided with “Medicare/Medicaid fraud” because the DEA has determined that the prescriber provided oral opiates that were not medically necessary.
Pts can call 800-MEDICARE to file a complaint but I doubt if they will take a complaint seriously… I doubt if those employees of CMS are interested in anything that would cause a downsizing of their agency. More action and attention may be achieved by contacting the pt’s Federal Senators and Representative.
If it were up to me, it’s unlikely I would be sitting down to write about my life with chronic severe pain, or the government policies and the social attitudes government encourages that generate unnecessary suffering for far too many Americans. I’d rather be going for a walk, doing some gardening or painting watercolors. But I have no choice.
According to the National Institutes of Health, nearly 50 million American adults suffer chronic pain. All face a system stacked against the pain patient. That’s why I decided to do something about it.
My pain became severe and constant in 1997. It began by suddenly waking me up in the early hours one morning, with the feeling of being skewered with a burning spear from the upper-left of my abdomen through to the middle-left of my back. It has been a permanent feature of my life that this constant pain is only controlled by taking opioid medications.
It took a year to get a proper diagnosis: pancreas divisum. This rare birth defect, a double-tailed pancreas, is a long-known cause of severe pain, though the mechanism behind it is unknown. I felt weirdly comforted by the knowledge that I was not the first person to complain that this hurts.
Other than the pain, my pancreas function is mostly normal. The opioid medications that relieve my pain also slow my intestines a little, making my function more normal than I’d had before. My frequency of nausea stays the same as I’ve always had.
When my pancreas defect was diagnosed, other problems were also discovered. My esophagus also had two defects—the upper half is floppy, the lower part rigid. And the top end of my stomach doesn’t close, making me vulnerable to acid reflux.
As a girl, I often heard, “No normal child gets this many bellyaches.” and “Tums aren’t candy.” My parents and teachers told me my stomach problems were all about not wanting to go to school. But I wasn’t just claiming bellyaches, I was often sent home for throwing up, and I barfed just as often on weekend and summer days as I did on school days. The adults didn’t seem to notice, but the other kids did. No one wanted to be in front of me on the bus, on the cafeteria line or in gym class.
Being a long-term, high-dose opioid patient means living under a suspected-murderer level of scrutiny.
In adulthood I mostly ignored my GI problems. If I needed to be horizontal, or only felt like eating bland food, it didn’t stop me doing things I wanted to do—college, travel, work, art, getting married.
Here’s a way to envision the effect of drug war policies on my life. I’ve had various health issues besides my pancreas: a benign colon polyp, thyroid nodule, breast fibroadenomas, endometriosis and uterine fibroids. Last year, a shoulder injury required surgery and physical therapy. My husband plays sports, and has had his share of sports injuries. But my pain—or rather, government-placed obstacles between me and pain treatment—creates 95 percent of the appointments, insurance expenditures and co-pays for my husband and me combined.
Being a long-term, high-dose opioid patient means living under a suspected-murderer level of scrutiny. The tangible form of supervision is the ‘pain contract”. Like all pain patients, in recent years, I’ve been required to sign contracts, usually yearly, by medical facilities. Most follow a model generated by the federal government.
Did I mention urinalysis costs me $200 per test?
The patient must adhere to conditions like paper prescriptions only, no phone-ins; an in-person appointment every 28 days; and urine tests and pill counts at any or all appointments, or on 24 hours notice any time I receive a call. Only one doctor and one pharmacy can handle the prescriptions. Other conditions can include no cigarettes, alcohol or illegal drugs (on the theory that pain patients must be discouraged from sliding into addiction), and being required to attend psychiatric or psychological appointments.
Did I mention urinalysis costs me $200 per test? (A multiple drug-screening kit sells at drug stores for $49.95).
Having only one doctor write my pain prescriptions doesn’t sound like a big deal, and usually isn’t. But when I had my hysterectomy, my OB-GYN didn’t want to release me without a pain prescription, which I was afraid to accept. My one prescriber was in a foreign country, with no internet access. Wanting to be released from the hospital because there was no medical reason for me to remain, I finally took—and later shredded—the hospital’s prescription. When I told my doctor he was ok about it.
Unlike an actual contract, only one party to a pain contract is required to follow any obligations. If a pain patient violates any of the terms, they can be abandoned. But following all the provisions is no guarantee of continuation of pain treatment. When my GP’s employer implemented an arbitrary limit on opioid prescriptions, the contract was irrelevant. Either my prescription would be cut by one-third, or I could go to a pain clinic.
I was fortunate, and for the past couple of years my clinic has been working for me. But, the federal government, state legislature, state boards for doctors, nurses and pharmacists, and my health insurer all have the power, at any moment, to end normal life for me—or for any Americans who benefit from opioid pain medications.
Common Suffering, Fueled by Media
Many other pain sufferers in my life endure terrible situations. After spinal stenosis surgery didn’t relieve his pain, a member of my family was prescribed Gabapentin, which caused dizziness and nausea without pain relief. A few years ago, prescribing an opioid would not have been routine.
A friend disabled by multiple injuries in the military got only acetaminophen for pain in his head, shoulder, hips and knees.
Two friends had kidney stones in the past year, and were not even offered opioids after the diagnosis was confirmed.
Another friend, awaiting a root canal last week, was warned by an acquaintance against taking his pain prescription. The guy issuing the warning said the government is trying to get rid of these drugs because it only takes three pills to get you hooked. My friend dismissed the claim. It’s extreme, but only by degree.
Many Americans have a hugely inflated sense of opioids’ ability to get you hooked, and to kill.
Thanks to blanket media coverage of the opioid-involved overdose crisis—which, while devastating, affects only a tiny proportion of all who use opioids, mostly people who are not prescribed these drugs and combine them with other substances—many Americans have a hugely inflated sense of opioids’ ability to get you hooked, and to kill.
The friends I mentioned are all old enough to remember over-the-counter codeine cough syrup, and coming home from the ER with an opioid prescription. No one worried then that this was a path to disaster or death.
Opioid overdose isn’t a blink-of-an-eye demise, unless there’s more than just the opioid. Injecting an opioid into someone who recently consumed alcohol can kill. More frequently, illicit-market opioids with substances added to stretch profits cause anaphylactic shock or Stevens Johnson Syndrome, with rapid, deadly shutting of airways. Mixing opioids with benzodiazepines can be deadly. But when Ohio attempted an execution via lethal injection using hydromorphone and midazolam (an opioid and a benzodiazepine), the condemned man struggled, gasping, for almost half an hour before dying.
Actual opioid overdose is slow and simple to interrupt. If uninterrupted for between one and 12 hours, the person can slowly stop breathing altogether. If the process is interrupted, the person survives with no permanent organ damage.
It is because of inaccurate and inflated claims about opioids—exaggerations of their potential involvement in addiction and death—that so many Americans have been suffering needlessly with untreated or under-treated pain.
Rising to the Challenge of Pain-Patient Activism
Opioid restrictions are worthy of First Amendment-based action. But pain patients have particular obstacles to exercising the right to assemble to petition on our own behalf. Without adequate medication, many pain patients can’t just head out to the streets, and so we remain invisible and silent in our suffering.
I was thinking that when pain patients gather, such as the Don’t Punish Pain Rallies, held at state capitols, an inflatable couch could be displayed at the event to represent all the people at home whose pain prevents their in-person participation. But those who are at home, while represented, would still not be they part of the action. If it were me, I’d still feel left out.
A message in a bottle sent from a desert island—a way for an invisible, suffering person to reach out to strangers who just might be able to help.
I began to think of the possibility for us to use the internet to make contact, share experiences and maximize our visibility. One article at STAT, for example, about increasing opioid prescriptions, has a long comment thread that has long been hosting posts by and discussions among pain patients.
I pondered the idea of combining internet and real-world activities to boost pain patients’ visibility and connections. The internet is a powerful tool, but real-world activities can reach different audiences and create fodder for further online discussion. Posting videos, photos and interviews is a way to create a growing archive of our activities. The most difficult part was how to engage the pain patients with untreated and under-treated pain, the people with the least capability to take to the streets.
Considering this need, I recalled the ancient trope of a message in a bottle sent from a desert island—a way for a stranded, invisible, suffering person to reach out to strangers who just might be able to help.
What I came up with is the Blue Balloon Campaign. Instead of floating our message in the ocean, we would float it in the sky.
The idea is that participants who are mobile will release balloons en masse from public places and distribute flyers to passersby; homebound individuals will launch balloons from their homes. This mechanism for people who suffer alone to be fully involved is vital. Other options include sending a balloon bouquet with a note—or a letter with the Blue Balloon logo—to a government official. The public will see these collective and single balloons, either in real life, or later in online videos and photos. Altogether, it should be a powerful symbol of just how many of us there are out there.
Our Day of Action—the first of its kind—takes place on Wednesday, May 15. A midweek day represents pain patients’ use of opioids to function within the community, to participate in the ordinary things that make up our lives: work, family, volunteering, travel and everything else that others take for granted.
If I had to describe the Blue Balloon Campaign on a scrap of paper in a bottle to be thrown into the ocean, here is what that message would be: Harsh laws, supported by falsehoods created and amplified by government, are sentencing too many Americans to unnecessary disability and suffering.
It might be the biggest price-fixing scheme in U.S. history. On Friday, Connecticut and a coalition of more than 40 states filed a 500-page lawsuit accusing the biggest generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. It’s a more sweeping version of a similar lawsuit the states filed in 2016 that’s still being litigated. The generic industry vehemently denies the allegations.
Congress established the current generic industry in 1984 to push prices down. The idea was that once patents on brand name drugs expired, generic makers would compete to make drugs more affordable. But 1,215 generics, many of them the most prescribed drugs, jumped on average more than 400 percent in a single year.
Connecticut has been examining the generic drug industry for almost five years. Tonight, we’ll take you inside its investigation and show you how two dogged attorneys built the cases the state attorney general calls the most egregious examples of corporate greed he has ever seen.
William Tong
William Tong: It’s an industry-wide conspiracy. And I think it answers one of the biggest questions all of us are asking, which is why are prescription drugs so expensive? And I think we know why now. Because the prices of generic drugs are fixed. And there’s a widespread conspiracy to rig the market.
Connecticut Attorney General William Tong says his office found evidence of price fixing by dozens of generic drug industry sales directors, marketers, CEOs dating back to 2006.
Bill Whitaker: How many drugs are we talking about?
William Tong: Hundreds. Hundreds of drugs.
Bill Whitaker: What kinds of drugs?
William Tong: Every kind of drug that touches our everyday lives. I’ll give you an example, Bill. This is my bottle of doxycycline. It is a common antibiotic that I take every day for a skin condition. And there is a conspiracy around doxycycline. And so sitting here today as the attorney general of the state of Connecticut, I’m one of the victims.
Between 2013 and 2014, a bottle of doxycycline shot up 8,281 percent from $20 to more than $1800. A bottle of asthma medication, albuterol sulfate, jumped more than 4000 percent, from $11 to $434. Pravastatin, a cholesterol drug, up more than 500 percent, from $27 a bottle to $196.
The sudden price spikes caught the attention of Congress, which called a hearing; the Department of Justice, which launched an investigation; and the state of Connecticut, which now has filed two lawsuits.
William Tong: This is a phased approach And we’re focusing on all the major players.
Bill Whitaker: So is it your contention that these companies are putting Americans’ lives at risk?
William Tong: Yes, you know, it’s $100 billion market. We’re talking about the drugs that America takes every day to live. And they’re profiteering off of that in a highly illegal way. They’re just taking advantage.
Bill Whitaker: The industry says that the prices went up because of market forces and because of drug shortages. These explanations don’t wash with you?
William Tong: No. I mean they’ve said this to me to my face. And—
Bill Whitaker: Why don’t you believe that?
William Tong: Because we have evidence, hard evidence, in the form of text messages, emails, documents, witnesses that demonstrate clearly that it wasn’t about product shortages. It was about profit. It was about cold, hard greed.
Correspondent Bill Whitaker with Joe Nielsen and Mike Cole
How can he say that? Because of what these two sleuth attorneys uncovered. Mike Cole heads the antitrust division in the Connecticut Attorney General’s office. Joe Nielsen is his lead prosecutor on this case. They’ve worked together for more than a decade reaching multi-million dollar settlements with big names like Apple and Bank of America. This, they say, is their biggest case yet.
Michael Cole: This particular industry — the generic drug industry — touches everybody.
Joe Nielsen: 90 percent of all prescriptions filled in this country are filled with generic drugs.
In the summer of 2014, Cole and Nielsen spotted a newspaper article about a sharp rise in the price of a decades-old generic heart medication called digoxin.
Bill Whitaker: So you read the article and something just didn’t smell right?
Michael Cole: I guess you could say you get a little bit of a sixth sense after you do this type of work for a long period of time which we both have. So we did a little bit more due diligence. And we sent out three subpoenas.
Bill Whitaker: What did you think you would find?
Michael Cole: We were looking for communications amongst competitors. When you do this kind of work it’s really not one hot document, as they say, that’s gonna prove a case. It’s kind of like putting together a puzzle, a piece at a time.
The puzzle grew into a monster. Three subpoenas turned into more than 300 to major generic drug companies, dozens of employees and phone companies. Over the course of the investigation, the subpoenas generated almost 19 million internal documents and phone records. There were so many pieces, Joe Nielsen couldn’t make out the big picture at first. For more than two years, he was the only one working the case. He spent days at his office desk and many nights at his dining room table looking for patterns. He eventually bought software used by law enforcement to investigate drug cartels, so he could analyze nearly 12 million phone logs.
Bill Whitaker: And this allowed you to do what?
Joe Nielsen: Well, this allows you within five minutes to look at someone’s entire phone records and see the history of who they communicated with, when.
Nielsen saw a picture emerge of a cozy relationship among industry competitors with lots of phone chatter right before they increased prices apparently in lock step.
Joe Nielsen: You know, we can see that competitor A is talking to competitor B five times on one day. And what that allows us to do is to go into our document database and look on that day at what they were saying.
It all snapped into sharp focus when he matched phone logs to thousands of text messages from Heritage Pharmaceuticals. Nielsen says this exchange, with competitor Citron Pharma, showed collusion to increase the price of a diabetes medication. The text messages implicate two other companies: Aurobindo and Teva, the world’s largest generic drug maker. The national accounts manager at Heritage wrote:
A.S.: “We are raising the price right now — just letting you know, Teva says they will follow” A.S.: “Aurobindo agrees too”
A corporate account representative from Citron answered:
KA: “…we are def [initely] in to raise pricing … are doing this immediately”
The Heritage executive responded:
AS: “We are raising our customers 200% over current market price.”
Bill Whitaker: So what’s wrong with these companies talking to each other?
Joe Nielsen: If they were talking about— their families or, you know, a barbecue that they went to, there would be nothing wrong with it. But when they talk about raising prices and they agree to do that then it’s completely and totally illegal.
Take the case of the antifungal drug Nystatin. As you can see with this graph, the price held steady at $68 a bottle for years, but in April 2013 Sun Pharmaceuticals almost doubled the price to $131. Right after the increase there was this flurry of phone calls between Sun and competitors, Heritage and Teva.
Joe Nielsen: So you see a phone call between Heritage and Sun pharmaceuticals lasting over 45 minutes.
After dozens of calls like this, first Teva, then Heritage followed Sun’s lead and jacked up the price of Nystatin to $142 a bottle. Joe Nielsen also found messages that seemed to show companies, including Pfizer, conspiring to divvy up the market for other drugs. The lawsuit filed Friday states: “Pfizer, acting through its wholly-owned subsidiary and alter ego… Greenstone, entered into agreements with Teva and… other competitors to allocate and divide customers and markets… and to fix and raise prices.” It refers to this email from Teva as evidence.
“[T]ell Greenstone we are playing nice in the sandbox and we will let them have [the … customer].”
Bill Whitaker: Play nice in the sandbox. What does that mean?
Joe Nielsen: Avoid competing with each other, take your fair share and don’t go after anything more than that. Keep the prices as high as you can.
Bill Whitaker: But I thought the whole point of generic drugs was to have competition and keep the price down?
Joe Nielsen: That’s the point for us, but that’s what the companies who are selling the generic drugs want to avoid.
William Tong: I think what we’ve come upon is that the generic drug industry is the largest private sector corporate cartel in history.
Bill Whitaker: What is the effect of that on you? Me? Average consumer?
William Tong: It’s devastating. it affects health insurance premiums and health insurance plans. It impacts Medicare and Medicaid. And it is a chain reaction that drives up the price of American healthcare to unnatural heights.
We reached out to the companies mentioned in our report for comment. Pfizer, which advertises on this broadcast, denies any wrongdoing and says it has cooperated with the Connecticut Attorney General. It says its subsidiary, Greenstone, intends to vigorously fight the claims. Sun issued this statement: “Sun Pharma is committed to the highest level of ethics and integrity… We believe the allegations made in these lawsuits are without merit and we will continue to vigorously defend against them.”
In court filings Sun and other drug makers have argued there’s no proof of an overarching conspiracy. The industry trade group told us generic prices declined three straight years from 2016.
William Tong: There has been some leveling off. But I don’t think that means that the conspiracy has ended. They’re still unnaturally high. What we haven’t seen is if they stopped colluding you would expect prices to go down dramatically. You would expect competition to ensue and one competitor would go after another. And they’d start undercutting each other on price. That hasn’t happened.
Dr. Thomas Pliura
Bill Whitaker: Are you seeing patients today?
Dr. Thomas Pliura: I am.
Dr. Tom Pliura is feeling the impact of rising generic drug prices. He runs a clinic that serves 14,000 people in rural, southern Illinois. This is a federally designated, “health care shortage area,” which is a bureaucratic way of saying there aren’t enough doctors around here.
Three quarters of his patients are on Medicare or Medicaid. Both government programs set limits on reimbursements for drugs. The rising generic prices have created a medical emergency for him. Since the government won’t cover the increased costs, his patients or his clinic must.
Dr. Thomas Pliura: We’ve been able to— to keep the doors open. But it’s getting harder and harder. And with these tremendous— spikes— it’s a problem.
Bill Whitaker: The impact of the rising prices is so great that it might put you out of business?
Dr. Thomas Pliura: No question about it. We’ve had that discussion right here in this building.
He worries his patients will suffer. So, Dr. Pliura has joined unions, pharmacies, school employees and other plaintiffs that have filed dozens of class action lawsuits in the wake of Connecticut’s investigation, all accusing generic drug makers of fixing prices.
Bill Whitaker: That’s a big fight for a small clinic in rural Illinois to pick.
Dr. Thomas Pliura: I think somebody has to raise their hand. Somebody has to say, “You know— it’s wrong, what’s going on.” you can’t put people in a position where they’re forced to either pay their rent or buy food and forego their medication.” And that’s what’s — that’s what’s happening all over the U.S.
William Tong: As an attorney general, I look at that and I say, “How can they do that?” And I think what we’ve concluded is they know it’s illegal. And— and it’s not that they’re too big to fail. It’s that they’re just too big to care.
Bill Whitaker: That sounds harsh. Too big to care.
William Tong: That’s the only conclusion I think anyone can draw when they see this evidence. And so then you start wondering why would they do this? Because there’s just too much money to be made.
Connecticut Attorney General Tong told us he and the other state attorneys general are continuing to investigate the generic drug industry and plan to file more lawsuits.
William Tong: This conspiracy has caused billions and billions of dollars in damages to the people of Connecticut and states across the country. And we’re gonna take them on in court and hold them accountable. And they’re gonna pay for the money they stole from the American people.
They mention in this video that the price increases started back in 2006… and do you know what else started in 2006.. Jan 1, 2006 all Medicare folks and a lot of Medicaid folks first became eligible for Medicare Part D. That also means that the PBM’s in this country picked up a lot of new pts and moved their percentage of the PBM’s control over to be much larger.. .maybe as much as 70%+ of all prescriptions filled in the USA. This also gave the PBM industry a much bigger leverage over the discounts/rebates/kickbacks that they were demanding out of the Pharmas. The Pharmas were forced to hand over all of those $$$ or the PBM’s would not include the Pharma’s meds on their formulary and that means that they automatically become a PRIOR AUTHORIZATION med. What is surprising is that all of these Attorney Generals seems to be oblivious to this fact.
These AG’s claim that they are going after all the money that these generic companies “over charged pts”, but I wonder where the money is going to go if they get some money out of the generic companies – My money is that it will be put into the state’s coffers.
The price-gouger-driven skyrocketing prices for insulin have endangered the lives of Americans with diabetes, who are rationing their supplies and trying not to die.
The latest expression of this desperation is the “Caravan to Canada,” groups of Americans with diabetes who form caravans of automobiles and buy insulin at Canadian pharmacies (Canadian insulin costs 90% less than the clinically identical US version, because Canadian pharmaceutical prices are fixed by a government agency called the Patented Medicine Prices Review Board).
America has about ten times as many people as Canada, a fact that worries some pharamceutical industry figures; the CBC quotes Barry Power, director of therapeutic content with the Canadian Pharmacists Association, saying “If you look at the disparity in the populations, a small percentage of Americans coming to Canada is a disproportionate increase for services and supplies that are earmarked for Canada.”
Lija Greenseid, who organized the Caravan to Canada, lives in St. Paul, Minn. Her 13-year-old daughter has Type 1 diabetes and she and her husband buy insurance through the Affordable Care Act.
Last year, she said they spent $13,000 US just to obtain health insurance — and then $14,000 US out of pocket before her daughter’s insulin was covered.
“It’s a huge amount of money for us. Because of that, we didn’t put any money into our kids’ college savings accounts or put anything into retirement for the year. We really just had to pay our health-care bills,” Greenseid said.
“So now you can see why we do crazy things like go across the border and buy insulin.”
Use of prescription opioids such as OxyContin or Vicodin fell at a record rate last year as the U.S. government cracks down on pharmacists and drugmakers that dispense the sometimes lethal painkillers, according to a report published Thursday.
Prescription opioid use in the U.S. was down 17% in 2018, marking the largest annual decline ever recorded, research firm IQVIA Institute for Human Data Science said. In 1992, prescription opioid use was at roughly 22 pain pills per U.S. adult per year and rose to a peak level of 72 pills per U.S. adult in 2011, IQVIA said. Since 2011, use has declined by 43% to 34 pills per adult.
The new data, unveiled in IQVIA’s 2019 report on health-care trends, provides some hope for combating the nationwide opioid epidemic, which kills roughly 130 Americans every day. Just last month, a new study provided troubling news that the opioid crisis has led to a sharp increase in the death rate for overdoses by teens and young adults.
The Justice Department and U.S. lawmakers have been working to combat the epidemic, such as limiting painkiller prescriptions and punishing those seen as responsible for the epidemic.
On Wednesday, Sen. Elizabeth Warren, D-Mass., and House Oversight Committee Chairman Elijah Cummings, D-Md., unveiled a $100 billion proposal that would fund prevention services and provide resources to programs for those battling addiction and in recovery.
Last month, a former CEO of Rochester Drug Cooperative, one of the nation’s largest drug distributors, was indicted on what prosecutors say are the first criminal charges against an executive of a drug company to stem from the opioid epidemic. In addition, the federal government reached a $20 million settlement with the company over its alleged role in the crisis.
Separately, federal prosecutors charged 60 doctors, pharmacists and other licensed medical professionals across five states in connection with illegally prescribing more than 32 million pain pills.
The indictments came as some 1,600 cases against OxyContin-maker Purdue Pharma and other opioid manufacturers are being consolidated and transferred before a judge in the Northern District of Ohio, and New York and other states begin their own massive legal fights.
The report Thursday showed prescriptions for lower-dose opioids remained stable, possibly because such painkillers are still perceived by physicians and patients as relatively safe, IQVIA said.
The DEA seems to like to make (fabricate) cases based on LARGE NUMBERS.. that in reality has nothing to do with the REAL FACTS..
According to a web search there are 248 million adults in the USA.
From the article we are dispensing 34 doses/adult/yr or 8.4 billion doses (248,000,000 X 34)
It is estimated that there are 25 -35 million pts that could be labeled as having/dealing with INTRACTABLE CHRONIC PAIN.. meaning that they need opiate medication 24/7.
At a minimum each of those intractable chronic pain pts would require 2 long acting doses/day – 730 doses/yr
25 million pts X 730 doses/yr = 18.25 billion. So according to those numbers we are dispensing only 46% of what is minimally needed for the 25 million intractable chronic pain pts.
That only means that we have a short fall of dosing the pts dealing with intractable chronic pain pts.. there are no doses left to treat the other 75 + million chronic pain pts and none left to treat those with acute pain from accidents , surgery or other situation where acute pain would/should be treated with opiates.
If we got back to the number of opiate doses that were being dispensed back in 2011 – 72 doses/yr/adult… we would still only have 17.9 billion doses – and still not having enough to provide minimal pain management therapy for those 25 million intractable chronic pain pts.
Does anyone really NOT UNDERSTAND why suicides by chronic pain pts are increasing dramatically ?
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
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.
“…[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.”
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.
“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.
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.”
We know that both the FDA and Pfizer does not approve – or discourages – the use of Methylprednisolone and similar cortisteroids to be administered as epidural spinal injections (ESI).
Pain Patients Like Me Are Rising Up Against Discrimination and Suffering
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