“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
This video is not only about the appalling coverage by CBS News but all major news outlets. I could just as easily of named Fox News, the Washington Post or even Andrea McCarren of WUSA Channel 9, Washington DC (another CBS affiliate) who has now blocked me on Tweeter for requesting her assistance in exposing these genocidal policies. Sadly they all REFUSE to contact me even after hundreds of emails, Tweets & even phone calls. America needs to know the truth. President Trump needs to know before he can help. Who among you are willing to spread the horror stories from coast to coast? Remember; just one second! One accident. One diagnosis. In just one second any of you can join us as the 100 million forgotten Americans left to suffer cruel and inhumane torture daily. Robert D. Rose Jr. BSW, MEd. USMC Semper Fidelis
A long-awaited report from the President’s Commission on Combating Drug Addiction and the Opioid Crisis, with strategies to combat it, was just issued by The White House. The document is over 130 pages long and consists of 56 recommendations designed to get a handle on what should more accurately be called “the fentanyl crisis.”
Some of the recommendations are no-brainers, such as better training of emergency personnel in the use of Narcan (Naloxone) to block the effects of opioids, expansion of electronic record keeping, and fast-tracking technological alternatives that would treat pain without the downside of opioids.
But some of the recommendations are controversial; some are good and others are terrible. Let’s grade a few of the recommendations that may have the greatest impact – good or bad – on pain patients and addicts, the groups with the most to gain or lose. If you have read it as well, you can add your own in the comments section.
RECOMMENDATION # 7 – ONE-SIZE-FITS-NONE
“The Commission recommends that HHS coordinate the development of a national curriculum and standard of care for opioid prescribers. An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices to supplement the CDC guideline that is specifically targeted to primary care physicians.”
As I have written before, it is impossible to establish standards of care that will apply to the general population, especially with regard to opioid drugs. Standardized doses will fail because they do not account for two critical variables. One is the large variation in patient weight. A 100-pound woman will have a very different response to set opioid dose than that of a 350-pound man, based on size alone. But size is only one variable. Metabolism is another. This already-impossible job of determining a standard drug dose or regimen for the public becomes even “more impossible” when the difference in opioid metabolism is included.
Some people, independent of weight, are much more efficient in metabolizing opioids because of their liver oxidase enzymes. Can government identify a “standard dose” that provides the same pharmacological response in a 350-pound man who is a slow metabolizer, as it does in a 100-pound woman who is fast metabolizer? No, it can’t because the differences in metabolism between two people can be as large as 15-times.
When both these factors are taken together it becomes obvious why a fixed-dose approach to a diverse will fail. It may be easy for the government to establish a maximum dose of a drug, but this number is not only a guess but a poor one at that.
Grade: F
RECOMMENDATION # 10- EDUCATING DOCTORS WHO DON’T NEED TO BE EDUCATED
“Recommends the Administration work with Congress to amend the Controlled Substances Act to allow the DEA to require that all prescribers desiring to be relicensed to prescribe opioids show participation in an approved continuing medical education program on opioid prescribing.”
On the surface, this may seem like a fine idea, but it is really a mixed bag. While a few physicians may benefit from more training in opioid prescribing, this recommendation suggests that doctors were to blame for today’s crisis and that “educating” them (1) will help reverse the harm done. This is false. Although there are pill mill doctors who did enormous damage, the overwhelming majority of doctors have not. The fact that pain patients become addicted only a very small percentage of the time (about 1%) clearly demonstrates that physicians who were caring for their patients ethically and responsibly were helping patients, not harming them.
There is a “blame the doctor” mentality built into this recommendation, which is unfair. Ethical doctors did not create today’s fentanyl epidemic. A few unethical doctors, and people who use opioids to get high did.
GRADE: C
RECOMMENDATION # 11- PHARMACISTS CAN OVERRULE DOCTORS
“The Commission recommends that HHS, DOJ/DEA, ONDCP, and pharmacy associations train pharmacists on best practices to evaluate the legitimacy of opioid prescriptions, and not penalize pharmacists for denying inappropriate prescriptions.”
Recently, CVS took a “bold,” but atrocious step of establishing restrictions that limit the dose, number of days of the prescription, and even the type of drug (time release vs immediate release). (See: CVS’s Transparent Opioid PR Stunt). This will mean that the pharmacist will have the power to overrule a physician.
This is wrong on many levels. Pharmacists should (and do) consult with physicians when there is a question about a drug or its dose, or when it might be dangerous when taken with another drug, but pharmacists cannot be permitted to unilaterally overrule the wishes of the physician. It is not their job to do so.
Grade: F
RECOMMENDATION # 17- DISPOSING OF UNUSED OPIOIDS
“The Commission recommends community-based stakeholders utilize Take Back Day to inform the public about drug screening and treatment services. The Commission encourages more hospitals/clinics and retail pharmacies to become year-round authorized collectors and explore the use of drug deactivation bags.”
In a perfect world (even sane) world, disposing of unused opioids would be entirely appropriate. Whenever excess pills are kept around there is always a chance that children or (more likely teens) will get their hands on them, so it is better not to have them lying around.
GRADE (in a perfect world): A
But, we are not in a perfect world; we are in the middle of a war on pain medications, which is really a war on pain patients. If you are counting on getting some Vicodin when you really need it, for example, a toothache or a migraine headache, you will probably be seriously disappointed. The opioid jihad, which is aimed at persecuting pain patients will touch all of us at some point in our lives. It is inevitable.
My personal opinion: You have to be out of your mind to give back a single pill. Instead store them safely, because at some point they will come in mighty handy. (See the article that my colleague Alex Berezow and I wrote for the Boston Globe website STAT: “Why we are hoarding our opioid pills.”) You may be less likely to return them.
GRADE (in the real world): D
RECOMMENDATION # 23- ENHANCED CRIMINAL PENALTIES FOR FENTANYL TRAFFICKING AND SALE
The harsh enforcement of drug laws, (e.g.’ The Rockefeller Laws’) which have resulted in absurdly lengthy prison sentences for people who were caught selling marijuana and other illegal drugs, has now been recognized as an abject failure. Prisons are full of non-violent offenders, while the flow of drugs continued unabated.
Except it is different this time. Fentanyl is both a drug and a murder weapon; there has never been a drug like it. As it continues to replace heroin (2), it is almost inevitable that “heroin” addicts will eventually die from an accidental fentanyl overdose. It is perfectly reasonable to apply severe penalties to people who knowingly are involved in trafficking fentanyl.
That said, it is unlikely that even the most fervent prosecution of dealers or traffickers will stop the deaths from overdoses. At best it will slow them.
GRADE: B
RECOMMENDATION # 19: FINANCIAL INCENTIVES TO DISCOURAGE PROPER MEDICAL CARE
“The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain.”
Of the 56 recommendations, this one may be the worst. If doctors and hospitals are incentivized to avoid giving patients the opioid pain medications that they need after surgery, be prepared for a world of suffering. This is not to say that viable alternatives are not sometimes available, such as nerve blocks or the use of long-acting local anesthetics in repaired wounds. (See: Surviving Post-Op Pain Without Opioids, Thanks To Chemistry). But the assumption that a few days of morphine or Percocet for post-surgical pain will lead to addiction is ludicrous. If hospitals will make more money giving post-op patients Tylenol (which doesn’t even work, See: Tylenol Isn’t So Safe, But At Least It Works, Right?) instead of something stronger, surgical wards are going to become very noisy places. From patients screaming in pain because the Tylenol did nothing.
GRADE: F-
RECOMMENDATION: KEEP FENTANYL OUT OF THE US
“Fentanyl defies detection at our borders, as the small quantities involved for psychoactivity of fentanyl and fentanyl analogs challenge Customs and Border Protection, USPS, and express consignment carriers’ ability to detect and interdict. We are miserably losing this fight to prevent fentanyl from entering our country and killing our citizens. We are losing this fight predominately through China. This must become a top-tier diplomatic issue with the Chinese.”
Of all the recommendations in the Commission’s report, this may be the most important, but it won’t be easy. By being less than vigilant about illegal fentanyl manufacturing, the Chinese government has been, in effect, waging a pharmacological war against the US. But there are signs that this may be changing. As I wrote last month, two large fentanyl factories in China were shut down and the owners indicted. (See: How Chinese Organic Chemists Get Away With Murder – Literally). The Chinese must understand that it is in their best interest to put a stop to this one-sided war.
GRADE: A
CONCLUSION:
The Commission’s report is a mixed bag. Many of the recommendations deal with funding initiatives, a topic I have not included. Many are common sense and noncontroversial. But the recommendations I have covered are controversial and will have a great impact on pain patients. Some are harmful in that they reinforce the false narrative about pain patients becoming addicted, further inserting government into the already-growing gap between patients and physicians, and creating financial incentives that will result in bad medicine and more suffering. On the other hand, the report does show a glimmer of understanding about what the real problem is (and has always been)—heroin and fentanyl—and concrete steps have been proposed to address this. Because without identifying the real problem, all “solutions” will be misguided and ultimately harmful. This is a good start.
NOTES:
(1) Why is the Orwellian-sounding “re-education” limited to doctors who prescribe opioids? Why not antidepressants, antibiotics, ADHD drugs, or sedatives?
(2) There is no longer any doubt what is killing Americans. It’s fentanyl, not pills. A recent DEA report revealed that of the drugs seized and analyzed by the agency, fentanyl was identified 65% of the time and furanyl fentanyl (even worse) 9% of the time.
Yes, three-quarters of the drugs accounted for by the agency were deadly poisons, yet we worry about how many days of pain medication can be prescribed to surgical patients. Insane.
HARRISBURG, Pa. (WHTM) – Susquehanna Township EMS responds to a handful of medical calls every day.
First responders are often responding to pain related issues, which has become a difficult condition to treat because of the opioid crisis. Now they have a new pain reliever that’s less harmful than opioids.
“What we’re used to using is an opioid, a morphine or fentanyl. What that does is it helps reduce the messages for pain sent to the brain. And what this drug is going to do is actually treat at the site of the pain,” Capt. Daniel Tempel said.
The drug is called ketorolac, also known as Toradol. The state Department of Health recently approved EMS agencies to carry the non-addictive pain drug.
First responders say ketorolac is the better option for responding to certain types of pain; it’s more effective with fewer side effects.
“It gives us the option to provide someone that does have an opioid addiction some type of pain management. It also prevents getting someone started on that opioid,” Tempel said.
EMTs across the state can begin using ketorolac on July 1.
Ketorolac is classified as a NSAID.. .like Aspirin, Aleve, Motrin…BUT… has a VERY LARGE FDA BLACK BOX WARNING attached to this medication… and now they are allowing EMT to administer this medication to people in which they have a very limited medical background and the most they know about the pt is that they are in PAIN. This may end up being a situation where the CURE IS WORSE THAN THE DISEASE.
Politicians and journalists often tell a story about greedy pharmaceutical companies that turned doctors into dealers and patients into addicts. And now, we’re told, tens of thousands of Americans are dying of overdoses every year because of government inaction.
If this is truly an epidemic, the diagnosis is wrong in a few major ways. And the cure prescribed by the government is making the disease worse.
Pain and Suffering
Dr. Forest Tennant is one of the last doctors in America willing to treat pain patients using high doses of opioid painkillers. He operates out of a strip mall in West Covina, California. And he’s contacted by patients from all over the country on a daily basis, pleading with him to treat them because nobody else will.
But in a matter of months, thanks in part to increased pressure in the government’s war on opioids, he may be closing his clinic’s doors, which have been open since 1975.
When Reason did a story on Tennant’s clinic in 2017, his patients spoke of how government restrictions on opioid use were causing legitimate pain patients to suffer needlessly. Four months after we ran that story, the DEA raided Tennant’s clinic and home. The search warrant accused him of overprescribing medication and accepting payoffs from the pharmaceutical company INSYS. Tennant has earned speaking fees from the company as recently as 2015, which he says is standard practice. And his nonprofit clinic regularly operates at a loss, according to financial statements submitted to the Department of Justice.
“I think the government is trying to kill me and every one of [Tennant’s] patients,” said Gary Snook, a resident of Montana, when asked about the raid on Tennant’s clinic. Snook, who suffers from chronic pain resulting from back surgery complications, turned to Tennant when he couldn’t find adequate pain treatment from a local physician.
“We have no place to run,” says Snook.
Last year, the Centers for Disease Control recommended new opioid prescription guidelines, with a maximum dosage of 90 morphine-milligram equivalents (MME) a day. Although the guidelines were supposed to be voluntary, Tennant says most physicians have begun to treat them as mandatory. Several states have adopted legislation that mirrors the federal recommendations.
“I do not know of physicians who will be willing to prescribe high-dose opioids anymore,” says Tennant.
This situation has put a target on the back of doctors who don’t follow the guidelines, and Tennant says the pressure that the guidelines have put on him are a major reason that he’s decided to wind down his practice and focus on tapering his patients down below 90 MME so that they can find other doctors to treat them once he retires.
But he maintains that some patients exhibit genetic variations that require them to take unusually high doses of opioids to achieve pain relief.
“I don’t know how those people are going to get down to 90,” says Tennant. “There has been propaganda—and it’s pure propaganda—that you can just stop opioids. No need to taper them. Just stop. And we’re going to have some patients commit suicide.”
Prohibition, Then and Now
Government officials like Attorney General Jeff Sessions and former New Jersey governor Chris Christie, who heads the President’s Commission on Combating Drug Addiction and the Opioid Crisis, have repeatedly blamed the problem on doctors overprescribing opioids to their patients and turning them into addicts.
“It’s not starting on our street corners. It’s starting in our doctors’ offices and hospitals,” Christie told CNN’s Jake Tapper in July 2017.
But the story isn’t quite so straightforward. Several studies, including a recent one out of Harvard, pegs opioid abuse among postsurgical patients at less than one percent. Estimates about abuse among chronic pain patients vary, with the high end being a little less than eight percent.
“Most policy makers have bought into this idea that we doctors prescribe opioids to our patients, who then rapidly become drug addicts,” says Jeffrey Singer, a Phoenix-based general surgeon and policy analyst (and a donor to Reason Foundation, the nonprofit that publishes this website). “All of the evidence suggests that this is not the case.
Singer says it’s a myth that most nonmedical users start on pills prescribed to them by a doctor. Instead, they more often borrow, buy, or take them from a friend or family member with leftover pills. The DEA calls it “diversion.” A 2014 analysis of data from the National Survey on Drug Use and Health (NSDUH) confirms that most nonmedical pain pill users obtain their pills via diversion, not directly from a physician.
In many ways, the story of the opioid overdose crisis begins with the introduction of OxyContin to the US market in 1995. It promptly became the pill of choice for nonmedical street users of opioids.
Purdue Pharma, the manufacturer of OxyContin, was aware of its popularity as a street drug, which it allegedly worked to conceal. Yet the company also created abuse-resistant formulations (ADFs), which are uncrushable and can’t be liquefied. By doing so, the company was able to extend the drug’s patent. With encouragement from the Food and Drug Administration, Purdue soon made all OxyContin pills uncrushable. Singer says policies of this sort have profound unintended consequences.
“The only thing [ADFs] have done is to make nonmedical users switch over to something other than [pain pills], and most of the time it’s been heroin,” says Singer.
Singer compares ADFs to attempts by the federal government to control alcohol consumption during Prohibition. The government ordered the “denaturing” of industrial alcohol through the addition of unpalatable chemicals. But it’s hard to stop determined consumers from getting what they want, and people kept drinking the denatured alcohol. So the government went a step further by adding poison to the alcohol, a move that likely resulted in thousands of deaths.
Seymour Lowman, the assistant U.S. treasury secretary partially responsible for overseeing alcohol prohibition, even said that if drunks were “dying off fast from poison ‘hooch'” then “a good job will have been done” if it meant a more sober America. Singer doesn’t think that modern government officials have the same attitude but argues that the effects are quite similar.
“If [policy makers] step back and think about what they’re doing by promoting abuse-deterrent formulations of opioids, they’re in effect doing to same thing that alcohol prohibition people did. They’re driving people to much more deadly, dangerous substances,” says Singer.
A June 2017 National Bureau of Economic Research paper found that “there appears to have been one-for-one substitution of heroin deaths for opioid deaths. Thus it appears that the intent behind the abuse-deterrent reformulation of OxyContin was completely undone by changes in consumer behavior.”
The Nature of Addiction
“The focus on prescription pain killers is especially misguided now that the vast majority of opioid-related deaths actually involve illegally produced drugs,” says Reason’s Jacob Sullum.
Sullum been writing about the suffering caused by restricting access to pain medication for 21 years. His April cover feature for Reason magazine examines the myths underlying the government’s response to the opioid overdose problem. He says the misguided focus on the supply of opioids is a proven failure but that politicians continue to do it because it’s much simpler than dealing with the complicated nature of addiction.
Jillian Monda is an Ohio-based bartender and photographer who struggled with and overcame an addiction to heroin several years ago. She says her boyfriend introduced her to heroin and that she took to it because it allowed her to turn off her mind and forget about a recent sexual assault she experienced and keep her obsessive-compulsive disorder under control.
“Heroin is really good at making you not feel anything at all,” says Monda. “The big unifying factor [among users I knew] was that everyone had some kind of mental problem or thing they were trying to avoid…and rather than getting proper psychiatric care for that, they were doing heroin.”
Victims of trauma like Monda, or people with mental illnesses who are self-medicating, are far more likely to develop an opioid addiction than are pain patients. To deal with these complex psychological and social problems, Sullum says a more nuanced approach than supply-side prohibition is needed.
Harm Reduction
Cities like San Francisco and Oakland, California are at the forefront of what’s called the “harm reduction” movement in America.
“Harm reduction is, at its core, a pragmatic way of looking at all risk-taking behavior,” says Eliza Wheeler of the Harm Reduction Coalition, a policy organization that advocates for harm reduction measures such as needle exchanges, many of which operate in the Bay Area. These exchanges allow heroin users to turn in dirty needles and obtain clean ones to prevent the spread of diseases. They also offer medications like naloxone, which can save lives by reversing the effects of an opioid overdose.
And now San Francisco’s Department of Public Health is preparing to convert some needle exchanges into “safe consumption sites,” where drug users can shoot up, snort, or smoke their drugs under supervision.
San Francisco would be the first American city to allow safe consumption sites, but Vancouver has already allowed the practice for years and the U.S. Surgeon General recently announced support for the idea in the United States.
“The problem with implementation [of harm reduction measures] is not lack of evidence that it works,” says Wheeler. “What we’re battling is a moral discomfort.”
There’s an even more radical approach than harm reduction. In response to its own overdose crisis, Portugal decriminalized all drugs in 2001. The country saw rates of overdose deaths, disease transmission, and overall use fall. Portugal’s drug overdose rates are now approximately six deaths per million people. In the U.S., it’s 312 per million.
Meanwhile, the DEA investigation of Dr. Tennant is still ongoing. He hopes to find another doctor to take over his clinic. If not, he’ll close its doors by the end of June, and his patients—already turned away by their hometown doctors—will need to find someone else to care for them.
“When people get hopeless is when they think about suicide,” says Tennant. “And so we need to give people some hope. If nothing else, let them know that somebody cares.”
Sullum says that if the government doesn’t change its approach to opioids soon, we can expect more of the same results.
“The strategy the government seems to be pursuing is one of harm maximization,” says Sullum. “If it continues to do that, at the expense of harm reduction policies, you’re not going to see a decrease in opioid-related deaths—and in fact, they may continue to go up.”
CORRECTION: This story originally stated that the Harm Reduction Coalition “funds and oversees” needle exchanges. Though the Harm Reduction Coalition does provide support in the form of coordinating the distribution of naloxone, it is a policy organization and doesn’t directly fund or oversee the operation of exchanges. The text has been edited to correct the error.
Doctors have reduced their prescribing of opioid painkillers for the fifth year in a row, the nation’s largest physician group announced.
The American Medical Association found that between 2013 and 2017, the number of opioid prescriptions fell by more than 55 million, a 22.2 percent decrease.
Doctors also became more likely to use a state database that tracks when patients previously have been prescribed opioids, called the prescription drug monitoring program. The database allows doctors to make sure that their patients aren’t getting multiple prescriptions from different doctors to sell or abuse them and to decline the prescription when they suspect abuse.
The findings were detailed in a report from the AMA, showing that in 2017 doctors and other medical providers used the databases more than 300.4 million times, a 121 percent increase from 2016.
More than 42,000 people died of opioid overdoses in 2016. That includes prescription painkillers, but more often the overdoses are the result of cheaper and more easily available alternatives such as heroin and fentanyl. Many of the addictions to illegal opioids begin after an initial doctor prescription to painkillers such as OxyContin or Vicodin.
The new report also shows that doctor involvement in drug treatment and overdose reversals increased as well.
Doctors increased their prescriptions of naloxone, a drug used to reverse an opioid overdose, from 3,500 to 8,000 a week. The upward trend appears to be continuing in 2018, with weekly prescriptions at 11,600. A growing number of states require doctors to prescribe naloxone if their patients have a history of drug abuse or if they provide patients with a high amount of prescription painkillers.
More than 50,000 doctors as of May 2018 have become certified to prescribe buprenorphine, a drug that helps reduce withdrawal symptoms for people with addictions. That marks a 42.4 percent increase from a year ago.
Doctors need a special certification by law because the drug can also be abused, though lawmakers and advocacy groups hope to loosen restrictions so that more healthcare providers will be able to give the drug to patients. The AMA made the recommendation as a way to continue progress against the opioid crisis.
“What is needed now is a concerted effort to greatly expand access to high-quality care for pain and for substance use disorders,”
said Dr. Patrice Harris, chairwoman of the AMA’s Opioid Task Force. “Unless and until we do that, this epidemic will not end.”
The number of people killed by drug overdoses in Maine during the first three months of the year fell slightly from last year, state authorities said Friday, although deaths caused by Maine’s ongoing opioid crisis are still near all-time highs.
Between January and March, 86 people died of overdoses, down from 89 such deaths during the same time period in 2017, according to the offices of the Maine Attorney General and the Chief Medical Examiner. A record 418 people died of drug overdoses in 2017. More people now die from drug overdoses than motor vehicle accidents, according to federal statistics.
Although the total number of deaths declined during the first three months of 2018, more people who die from overdoses were killed by illegal substances, including fentanyl, as opposed to pharmaceutical opioids.
About 65 percent of the deaths recorded in the first quarter were due to fentanyl or fentanyl analogues, up from 52 percent in 2016 and 59 percent in 2017. Fentanyl is a cheaper, more powerful alternative to heroin, and many users who believe they are taking heroin are actually using fentanyl.
“The shift we are seeing from heroin to cheap, deadly fentanyl is deeply troubling,” Attorney General Janet Mills said in a statement. Mills, one of seven Democratic candidates for governor, oversees the medical examiner’s office.
“We must break the stranglehold that opioid use has on our state,” she said. “The figures released today demonstrate dramatically that we have not yet turned the tide against opioids and there is still much work to be done.”
Addiction experts denounced the state’s anemic response to the opioid crisis.
“This is sad, sad, sad,” said Dr. Lisa Letourneau, associate medical director of Maine Quality Counts, a health advocacy nonprofit and a former member of the state’s opioid task force. “The state is failing to respond appropriately to this epidemic. We need doubly accelerated strategies. We are not doing enough.”
One proven tool for reducing overdose deaths is finally becoming more widely available in Maine. The Board of Pharmacy last week published new rules for making naloxone, a lifesaving drug that reverses the effects of an overdose, available without a prescription. Republican Gov. Paul LePage had repeatedly vetoed bills to expand access to naloxone, sold under the brand name Narcan, and slowed down the administrative rulemaking process. But the Legislature finally mustered the votes needed to override his opposition and provide access to naloxone for anyone.
A bill that would provide $6.6 million to help about 500 uninsured Mainers gain access to substance use disorder treatment is in limbo, as the Legislature adjourned this spring before deciding whether to fund that bill and others. The Legislature may return in a special session, but the fate of the bill is unclear.
Meanwhile, expanding Medicaid would provide access to treatment for about 70,000 Mainers, although it’s unclear how many of those newly eligible for coverage would need treatment. Maine voters approved Medicaid expansion 59 percent to 41 percent in 2017, but implementing the expansion is on hold.
LePage and House Republicans have been refusing to expand Medicaid, arguing that the Legislature needs to appropriate money for it, while Democrats say there doesn’t need to be a specific appropriation. An advocacy group is suing the LePage administration, saying Mainers should be able to sign up by July 1.
Malory Shaughnessy, executive director of the Alliance for Addiction and Mental Health Services, said that while efforts to help alleviate the opioid crisis stall, Mainers are dying.
“Things have not gotten any better,” she said. “It’s a travesty.”
The Legislature did approve a bill in 2016 that placed more restrictions on prescribing opioids, and opioid prescribing dropped 32 percent from 2013 to 2017, in part because of the new law and also because of changes in prescribing practices and Medicaid rules in Maine that also constricted opioid prescribing.
Dr. Mark Publicker, an addiction treatment specialist and past president of the Northern New England Society of Addiction Medicine, said the state has had limited success in increasing the number of doctors who are certified to prescribe Suboxone, a leading medication used to treat opioid use disorder. But Publicker said demand for treatment still far outstrips the supply, and the new prescribing law may be having the unintended consequence of pushing more people into illicit drug use. The law sets caps on dosage and length of opioid prescriptions, although there are many exceptions, such as end-of-life care.
“There’s lots of people dying still. It’s a tragic and terrible situation,” Publicker said.
Mills urged more treatment, education and prevention efforts, and called on the Legislature to act on the issues.
According to Maine DHHS, 8,627 Mainers received medication-assisted treatment, including methadone and Suboxone, in 2016, the latest year figures were available.
While there’s no estimate of how many Mainers lack access to opioid treatment, a U.S. Substance Abuse and Mental Health Services Administration survey estimates about 25,000 Mainers struggling with all forms of drug addictions believe they don’t have access to treatment programs.
The figures released were compiled by Dr. Marcella Sorg of the University of Maine’s Margaret Chase Smith Policy Center.
In all of 2017, 418 people died of drug-related causes. In 2016, that figure was 376 deaths—many of which were chronicled in a Portland Press Herald/Maine Sunday Telegram series, Lost: Heroin’s Killer Grip on Maine’s People.
Senator Ron Johnson (R-Wis.) isn’t mincing words about his so-called “right to try” bill, signed into law by President Trump on Wednesday. In a feisty letter to Food and Drug Administration Commissioner Scott Gottlieb Thursday, Johnson put things bluntly: “this law intends to diminish the FDA’s power.”
The revelation substantiates a leading criticism of the law, which was otherwise pitched as a compassionate measure to help people suffering from life-threatening illnesses obtain easier access to experimental therapies. Critics feared it would simply undercut the agency’s regulatory power to ensure experimental treatments are used safely, while offering little aid to patients. After all, the FDA already has a prompt and lenient system for providing such patients access to experimental treatments, and 38 states already have similar “right to try” laws. Proponents, meanwhile, said the new federal law would give desperate patients hope and dismissed concerns that it would weaken the FDA.
But Johnson laid bare his regulatory intentions after being apparently infuriated by some of Gottlieb’s recent comments to reporters and on Twitter. Specifically, in a May 22 tweet, Gottlieb wrote, “When the House passes #RightToTry legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients; and build on #FDA’s longstanding commitment to these important goals #RTT.”
And in news articles, Gottlieb was quoted as saying he would work to “build in additional patient protections” alongside the law to ensure access but also safety.
Johnson is having none of that, according to his letter. “[This law] is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments.”
Johnson went on to request a meeting with Gottlieb as soon as possible in which he can further “discuss the law’s intent and FDA’s plans to implement the law consistent with that intent.”
Right to do what now?
As it stands, the right to try bill signed into law, which Johnson sponsored, will cut out the FDA’s role in approving and overseeing the use of experimental drugs in patients with life-threatening diseases. Such patients will be able to work directly with a doctor and a drug company to gain access—outside of a clinical trial—to an experimental therapy that has only made it through early clinical trials and not obtained FDA approval.
Prior to the new law, such patients in all states could do the same thing, but if their state didn’t have its own “right to try” law, they had an added step of getting the FDA’s approval. That said, through the agency’s “expanded access” pathway, the FDA granted 99 percent of those requests and usually processed them in mere days. In emergency situations, the FDA granted them “immediately over the phone.”
In a recent commentary piece in the New England Journal of Medicine, medical ethicists raised concerns about cutting the FDA from the process. Namely, they noted that FDA sometimes gives guidance on how patients and doctors should go about their experimental treatment safely—and that guidance is sometimes based on undisclosed data to which the FDA has access.
Thus, the law “would cause patients to lose the benefit of meaningful safety-oriented changes that the agency recommends in 10 percent of expanded access approvals on the basis of confidential information that is often unavailable to treating physicians,” they wrote.
Other opponents fear that the law would leave patients vulnerable to less-than-scrupulous doctors or predatory drug developers, such as the hundreds of shady stem cell clinics that have popped up around the country.
“The agency has made substantial progress in balancing the needs of desperate patients and the principle that all patients deserve evidence that the benefits of medical products justify their risks,” the commentary authors conclude. “We upset that balance, and diminish the FDA’s public health mission, at our peril.”
Johnson, meanwhile, touts the new law as being “fundamentally about empowering patients.”
what exactly is a pt with a “life-threatening disease”… and just what is an “experimental therapy”… could many of the substances that the DEA has designated as having “no valid medicinal value” could be now eligible as “experimental therapy” ?
After all each of us is basically terminal… no one is going to live forever… it is just trying to figure out … when the end is going to come and just exactly how that is going to happen.
Vague laws… often end up with some/many unintended consequences …just a matter of time…
A Massachusetts skilled nursing facility reached a settlement recently with a U.S. attorney’s office in a pivotal discrimination case. It’s the first known case involving a patient being refused admission based on the patient’s use of buprenorphine for opioid use disorder.
Perhaps more significant is the prevailing position of skilled nursing facilities nationwide refusing buprenorphine patients. Under the Americans with Disabilities Act (ADA), such a patient is considered disabled.
Experts say the settlement provides a practical caution for healthcare providers, indicating that refusing to treat individuals solely based on their addiction disorders will be considered discrimination under ADA.
Sally Friedman, legal director of the Legal Action Center, who has worked with the Department of Justice on ADA violations, says the law doesn’t expect healthcare providers to offer care beyond their expertise or scope of practice. However, it also won’t allow them to discriminate against patients because of their disability.
“Here, the skilled nursing facility refused admission to someone with opioid use disorder because they were receiving treatment with buprenorphine,” Friedman tells Behavioral Healthcare Executive. “The person was otherwise qualified for the service. It was just that one discriminatory variable.”
The Charlwell House facility will pay a civil penalty of $5,000 and agreed to implement non-discrimination training programs. But the settlement could represent larger implications by setting a precedent for all healthcare providers—including those in behavioral health.
Abstinence programs vulnerable
Philosophical clashes in the behavioral health specialty have long pitted abstinence programs against programs using medication assisted treatment (MAT). However, there are no major rulings to provide legal guidance for abstinence programs that systematically refuse treatment for individuals using medications for addiction.
“You could make the argument that that violates ADA, but it’s trickier,” Friedman says. “It’s not the same as the skilled nursing case.”
She believes that depending on the circumstances, there might be room for a discrimination claim if a patient using MAT is refused treatment in a program in which abstinence is a core philosophy, but there’s no indication of how a court might ultimately rule.
Legal risks are a different proposition for recovery homes where the Fair Housing Act might also apply in addition to ADA, Friedman says. Many operators are concerned about diversion and expect individuals living there to remain drug-free as a condition of residency.
“I have not heard a legitimate reason for a recovery home not allowing medication,” she says. “I think they’re vulnerable under law.”
For example, she says, residences could offer reasonable accommodation to store take-home doses of methadone or buprenorphine securely in the home under lock and key. And ADA requires that states, cities and homeowner associations provide “reasonable accommodations” to individuals with disabilities, including those in recovery.
Industry leaders are more vocal now than ever before about the efficacy of MAT, and their influence is having some effect in communities. Just recently, Caron Treatment Centers introduced a stand-alone treatment unit exclusively for patients with opioid use disorders. Leaders informed local recovery residences that if they want to continue to receive referrals from Caron, they must accept and allow the patients to use anti-craving medication post-discharge
A huge whistleblower lawsuit has been filed against CVS Caremark, alleging it over billed the Government by hundreds of millions of dollars in an elaborate pricing scheme.
And that the money lost, impacted millions of Ohioans on Medicare. But if the allegations are true, the fraud could impact many more.
The case centers around accusations from a specialist in drug costs who worked at Aetna, which happens to be one of the largest Medicare Drug clients of CVS Caremark.
She claims Caremark did a great job of negotiating prices with manufacturers to provide drugs, but did not pass those savings on to insurers like Aetna, that contract with the state.
“There is a tremendous amount of fraud going on here because there is no transparency,” says Antonio Ciaccia from the Ohio Pharmacists Association.
And it’s a bombshell. Blowing open, what he calls a shell game, by companies like CVS Caremark which are hired to help keep costs down
“So, CVS Caremark is essentially being trusted to pay for your prescription drugs through the Medicare program. And the allegation is they’re billing a much higher amount than they’re actually paying,” says Ciaccia.
In the lawsuit, which both Aetna and CVS fought to keep private, but we were able to obtain, CVS is accused of submitting false Medicare Part D drug costs for at least the past ten years.
That those false drug costs, caused Aetna, which is one of CVS’ biggest Medicare Drug Clients, to pay as much as 25% to 40% more than its competitors
And as a result, Federal and State health insurance programs that contracted with them also had to pay more
Ciaccia says, if you’re a patient, this could impact the amount that you’re paying at the pharmacy counter. It could over inflate your co-pay. But as a taxpayer this ends up impacting everybody because the cost of prescription drugs is going up and thus the bill to the Federal government is going up.
CVS issued this statement in response to the suit: We believe this complaint is without merit and we intend to vigorously defend ourselves against these allegations. CVS Health complies with all applicable laws and CMS regulations related to the Medicare Part D program, and the government filed a notice of declination with regard to this complaint. Also, contrary to these false allegations, CVS Health is committed to helping both patients and payors with solutions to lower their prescription drug costs.
In fact, we announced in March (https://cvshealth.com/newsroom/press-releases/cvs-health-kept-drug-price-growth-nearly-flat-and-improved-medication) that in 2017, we kept drug price growth nearly flat for our PBM clients, despite manufacturer price inflation near 10 percent. Annual out-of-pocket costs for PBM members also declined, with three out of four members spending less than $100 out of pocket for their prescriptions, and nearly 90 percent spending less than $300.
But here’s where this really hits home, while this suit involves Medicare patients, the Ohio House is now looking to see if this is also going on in the State’s three billion dollar Medicaid program.
It recently introduced two bills looking into prescription drug pricing. As CVS also oversees the pharmacy benefits for four of the state’s five Medicaid managed care plans.
“This is really just the tip of the iceberg,” says Ciaccia
What’s interesting, especially considering Aetna did not want details of the lawsuit released, and they were ostensibly harmed by this, is that the Aetna and CVS are trying to get approval for a merger.
