By Dr. Mercola
As the opioid epidemic continues to take its toll on Americans, killing 115 every day,1 many are starting to ask the tough questions of how it got this bad. In many cases, drugs that were originally intended only for treating severe pain have become go-to treatments for mild and chronic pain, such as back pain. Subsys, a fentanyl under-the-tongue spray, is among the worst offenders.
Fentanyl is a synthetic opioid that can be 100 times more potent than morphine. The U.S. Food and Drug Administration (FDA) approved the drug for treating breakthrough pain in cancer patients — a type of severe pain that occurs despite the patient being treated with other painkillers. Yet, in a complaint filed by the U.S. government, it's alleged that Insys, which manufactures the drug, focused its marketing campaign on treating pain in general.
The complaint is the result of an investigation into five whistleblower cases filed by former Insys sales representatives as well as workers for a pharmacy benefits manager that processed insurance claims for Subsys.2 The whistleblower lawsuits have recently been unsealed, revealing the many sordid tactics used by drug companies to convince doctors to prescribe their highly addictive drugs to unsuspecting patients.
Drug Sales Reps Use Strip Clubs, Kickbacks and Trips to Shooting Ranges to Drive Prescriptions Up
Subsys was approved in 2012 and approached sales of $500 million just three years later. This dramatic rise in sales was not happenstance but a carefully orchestrated marketing ploy for a highly addictive drug. In May 2015, the U.S. Department of Justice (DOJ) announced it was intervening in the five whistleblower lawsuits, which accuse Insys of paying illegal kickbacks and defrauding federal health programs in the marketing of Subsys. According to a DOJ press release:3
"The government's complaint alleges that Insys paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients. Many of these kickbacks allegedly took the form of sham speaker fees to physicians, jobs for the prescribers' relatives and friends, and lavish meals and entertainment.
The United States also alleges that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and that Insys employees lied to insurers about patients' diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries."
The complaint further reveals some of the tactics Subsys used to get doctors to write more prescriptions. Among them was a pain specialist from Florida who was taken to a strip club and a shooting range by Insys executives.
Medicare has paid more than $3 million for Subsys prescriptions from this one doctor, since 2012. In another case, sales reps offered another Florida pain specialist a full-time job for his girlfriend, if he could increase his prescriptions of Subsys. He wrote prescriptions for 60 units over the course of just two days, and his girlfriend received the job a month or two later.
Many doctors were lavished with fancy dinners and speaker fees, but other even more blatant sales tactics also took place, from telling sales reps to "behave more sexually" and flirt with doctors to reports of sexual relations.
According to Mother Jones, "Insys hired a dental hygienist with no pharmaceutical sales experience, reportedly 'to have sexual relations with doctors in exchange for SUBSYS prescriptions,' … a regional sales manager reported that the new employee was 'dumb as rocks, but that she was sleeping with another doctor and getting a lot of prescriptions out of him.'"4
Meanwhile, the drug was only supposed to be used for cancer patients, Insys sales reps frequently promoted the drug for off-label uses to doctors without cancer patients, for treating chronic pain ranging from back pain to headaches. In fact, up to 90 percent of Subsys prescriptions are for off-label uses. Insys also created the Insys Reimbursement Center to help get insurance companies to cover the prescriptions, which would cost $10,000 for a 30-day supply.
Because insurance companies often required doctors to confirm that patients met the prescribing criteria, Insys employees would claim to be doctors' staff or even falsify patient diagnoses. In the interim, while the insurance companies decided whether or not to cover the prescription, Insys provided the drug free of charge to some patients, which was not done for benevolent reasons, as you may suspect. Mother Jones continued:5
"In the short term, the tactic was expensive for Insys … But in the long term, it paid off: Authorization was much more likely after Insys could tell insurers that the patient was already taking the drug. And by that time, the patient was likely already addicted. As M.S.’s complaint put it, ‘the patient would grow dependent on the medication during that time, ensuring a long prescribing relationship.'"
Doctors Take Industry-Sponsored Opioid Training for Continuing Education
The FDA requires opioid manufacturers to fund continuing medical education (CME) courses about opioids, which doctors take under the guise of education. Since 2013, more than 500,000 doctors have taken part in such programs, which are often required by the state and affiliated with credible institutions like Johns Hopkins University and the American Society of Addiction Medicine. Yet, the courses are backed by opioid makers like Purdue Pharma, Pfizer and Janssen.6
Many doctors are not aware that the courses are funded by the industry, and they give the impression that as long as doctors conduct risk assessments and pain agreements that patients will not be harmed. Meanwhile, some promote questionable practices like switching patients from one opioid to another to avoid tolerance, a tactic that has little evidence of efficacy behind it.
Teachers for the courses may also have their own ties to industry. A Mother Jones investigation found, for instance, seven faculty listed as teachers for FDA-mandated CME courses had received $1.6 million from opioid makers between 2013 and 2016.7 In some of the courses, the slant is decidedly in favor of opioids, with some even claiming that illicit opioids are responsible for most overdose deaths when, in reality, overprescribing of prescription opioids is largely responsible.
As Mother Jones put it, "For opioid-makers, CME 'is one of the most important marketing [tactics] that they have,' says Dr. Adriane Fugh-Berman, a Georgetown pharmacology professor who studies industry influence on medicine. 'It doesn't look like advertising. It doesn't look like promotion. It looks like education, and it's required for most physicians.'"8
Knowing the Damage, Maximizing Profits — Premeditated Murder
Prior to the opioid epidemic, opioids were low-cost and widely available, but carried a reputation for being additive, so many doctors avoided them. The game-changer occurred in 1995, when Purdue Pharma received FDA approval for extended-release oxycodone (Oxycontin) for the management of moderate to severe pain.
Not only could the drug be patented, making it far more profitable than the many generic opioids available on the market, but it was also promoted as being nonaddictive and safe for long-term use, unlike other opioids on the market.
To get this message across, Purdue Pharma launched an extensive marketing blitz surrounding the drug, including doubling its marketing team and paying $40 million in bonuses, offering free initial supply coupons to patients, and hosting "all-expenses-paid pain management and speaker training conferences at lavish resorts" for clinicians.
The drug became a blockbuster, in large part due to nonrigorous patenting standards and lack of policing of fraudulent marketing.9 Unfortunately, the idea that extended-release Oxycontin, which didn't lead to the immediate high drug abusers were presumably looking for, was less addictive was not based on real evidence. And on the contrary, it may actually have been more appealing, New York Magazine reported:10
"Making a long-duration painkiller meant concentrating more narcotic into each individual pill. And since opioid addicts do not typically use pills as directed — but rather, crush them up for snorting or injecting — Purdue’s ‘innovative’ opioid was actually more appealing as a street drug than any of its rivals."
Purdue Pharma claimed they were unaware that Oxycontin was being abused until the 2000s, but a Department of Justice report actually shows they knew the drug was popular with drug addicts in the late 1990s and concealed the information.11
Despite knowing that the drugs were being crushed, snorted and stolen from pharmacies, they continued to market the drug as less addictive or prone to abuse. DOJ prosecutors recommended that three Purdue Pharma executives be indicted on felony charges, which could have sent them to prison, but instead the case was settled.
The Sackler family, owners of Purdue Pharma, were also reportedly sent reports about abuse of OxyContin and another opioid, MS Contin, according to a New York Times report.12 The Sacklers made it onto Forbes' Top 20 billionaires list in 201513 — in large part due to the burgeoning sales of OxyContin. About 80 percent of heroin drug addicts report starting out on painkillers such as OxyContin.14
In 2007, Purdue Pharma pleaded guilty to charges of misbranding "with intent to defraud and mislead the public" and paid $634 million in fines, which did little to dissuade them from continuing to profit off the deadly drugs. A potential part of the problem is the fact that no specific individuals have ever been charged.
None of the members of the Sackler family was ever charged with any kind of misdeed, for example, and owners and corporate leaders of other drug companies have also walked away scot-free. The Sacklers are further unique in that they've been successful in largely separating their name from the deadly product that made them rich.
Too Big to Nail
Reforms for opioid prescribing have been proposed, including a guideline from the U.S. Centers for Disease Control and Prevention (CDC), which would restrict prescriptions of opioids to three-day supplies. The measures, however, have been largely opposed by the American Medical Association (AMA), which spent $21.5 million lobbying Congress in 2017.
"Nearly $6.8 million has been spent in 2018 so far, according to OpenSecrets.com. It gave nearly $2 million to members of Congress in 2016 and has given $519,500 so far this election cycle," the Daily Beast reported.15 AMA has also opposed other restrictive measures for opioids, such as mandating courses about addiction for doctors or requiring them to check the Prescription Drug Monitoring Programs database prior to writing prescriptions.
The database allows doctors to see a person’s prescription drug history, making it easier to spot the potential for abuse. Although many states require this, there is no federal requirement to do so. Sen. Joe Manchin (D-W.Va.) reportedly stated at a meeting to curb opioid abuse that his colleagues would continue to vote down such measures because they were “too scared to take on the AMA."16
Meanwhile, white collar drug dealers like Purdue Pharma are given barely a slap on the wrist for their instrumental role in the opioid epidemic. Even now, as U.S. prescriptions for Oxycontin have dropped close to 40 percent since 2010, they've turned their sights to international pursuits. In Europe and developing countries, Purdue Pharma is working to combat "opiophobia" in doctors, which is reportedly the mistaken belief that opioid painkillers are highly addictive and should be used sparingly.17
Try Other Options for Pain Relief First
It's important to be aware of the money being made by opioid makers even as people are dying as a result. The motivation to sell more of these drugs is not one of altruism but greed. It's also been shown that opioids are not always necessary to treat moderate to severe pain, as ibuprofen and acetaminophen (which admittedly have their own set of risks) may work just as well.18
Pain relievers are clearly valuable medications in many instances, and even opioids have their place (such as for treating severe pain in end of life care), but do use caution, no matter which kind you take. And if you do use an opioid, be aware that there's a high risk for addiction and, with that, overdose death. If you suffer from chronic pain, there are other options for long-term relief.
First, there's a good chance you need to tweak your diet to eliminate grains, sugars and most processed foods while increasing your intake of healthy fats, including animal-based omega-3s. In addition, nondrug remedies and bodywork interventions can often help with pain relief without posing the risks of opioid drugs. You may want to consider one or more of the following for safe pain relief:
Kratom (Mitragyna speciose) is a plant remedy that has become a popular opioid substitute. In August 2016, the DEA issued a notice saying it was planning to ban kratom, listing it as Schedule 1 controlled substance. However, following massive outrage from kratom users who say opioids are their only alternative, the agency reversed its decision. Unfortunately, its legal status is still unstable, as the FDA is on a crusade to eliminate kratom.
Kratom is safer than an opioid for someone in serious and chronic pain. However, it's important to recognize that it is a psychoactive substance and should be used with great care. There's very little research showing how to use it safely and effectively, and it may have a very different effect from one person to the next.
The other issue to address is that there are a number of different strains available with different effects. Also, while it may be useful for weaning people off opioids, kratom is in itself addictive. So, while it appears to be a far safer alternative to opioids, it's still a powerful and potentially addictive substance. So please, do your own research before trying it.
Low-Dose Naltrexone (LDN)
Naltrexone is an opiate antagonist, originally developed in the early 1960s for the treatment of opioid addiction. When taken at very low doses (LDN, available only by prescription), it triggers endorphin production, which can boost your immune function and ease pain.
A primary therapeutic compound identified in the spice turmeric, curcumin has been shown in more than 50 clinical studies to have potent anti-inflammatory activity. Curcumin is hard to absorb, so best results are achieved with preparations designed to improve absorption. It is very safe and you can take two to three every hour if you need to.
One of the most effective oil-soluble antioxidants known, astaxanthin has very potent anti-inflammatory properties. Higher doses are typically required for pain relief, and you may need 8 milligrams or more per day to achieve results.
Also known as boswellin or "Indian frankincense," this herb contains powerful anti-inflammatory properties, which have been prized for thousands of years. This is one of my personal favorites, as it worked well for many of my former rheumatoid arthritis patients.
This protein-digesting enzyme, found in pineapples, is a natural anti-inflammatory. It can be taken in supplement form, but eating fresh pineapple may also be helpful. Keep in mind most of the bromelain is found within the core of the pineapple, so consider eating some of the pulpy core when you consume the fruit.
Also called capsaicin cream, this spice comes from dried hot peppers. It alleviates pain by depleting your body's supply of substance P, a chemical component of nerve cells that transmit pain signals to your brain.
Cetyl myristoleate (CMO)
This oil, found in dairy butter and fish, acts as a joint lubricant and anti-inflammatory. I have used a topical preparation of CMO to relieve ganglion cysts and a mild case of carpal tunnel syndrome.
Evening primrose, black currant and borage oils
These oils contain the fatty acid gamma-linolenic acid, which is useful for treating arthritic pain.
This herb is anti-inflammatory and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea, or incorporated into fresh vegetable juice.
Source: mercola rss