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Limiting opioid prescriptions will do little to reduce overdose deaths, study says

https://www.bostonglobe.com/metro/2019/02/01/limiting-opioid-prescriptions-will-little-reduce-overdose-deaths-study-says/DX9nHWdUWaLcP4DjdgLafJ/story.html

When the death toll from opioid overdoses began to soar a few years ago, the evidence was clear how it all started: Painkiller prescriptions had tripled in a decade, exposing millions of people to the risk of addiction. Policy makers naturally sought to put a lid on opioid prescribing.

But a study published Friday in JAMA Network Open finds that reducing opioid prescriptions will have little effect on the death rate over the next few years, now that the epidemic is dominated by heroin and illicit fentanyl.

The study offers a countervailing view at a time when authorities are warning or even prosecuting high-prescribing doctors and numerous state and local governments are suing over the conduct of opioid manufacturers, including whether Purdue Pharma deceptively marketed the popular painkiller, OxyContin.

A team that included researchers from Massachusetts General Hospital and Boston Medical Center employed mathematical modeling to project what could happen over the next several years. They predicted that opioid-related mortality nationwide would double or triple from 2015 levels, reaching around 82,000 a year in 2025.

The projections showed that restrictions on prescription opioids — such as a Massachusetts law requiring prescribers to consult a database that can flag doctor-shopping, and another that limits the length of new prescriptions — would reduce opioid deaths by only 3 percent to 5 percent in the near future.

“You can’t just cut off the spigot and expect things to get better,” said Dr. Marc R. Larochelle, a Boston Medical Center addiction researcher and one of the study’s authors. “The nature of the threat has changed and we haven’t caught up with it.”

In many states, the vast majority of opioid-related deaths involve heroin or fentanyl, and prescription drugs account for only a small number. In Massachusetts in 2018, fentanyl was found in 90 percent of people who overdosed, while prescription opioids are present in only 17 percent of cases.

And opioid prescribing, although still high, has been decreasing since 2010. Larochelle said that restricting access to pills can drive people to more dangerous street drugs.

The research, however, failed to persuade two prominent advocates of limiting opioid prescribing. One said it contained errors and the other said it overlooked the fact that taking prescribed opioids can lead to heroin use.

Dr. Andrew Kolodny, a Brandeis University researcher and executive director of Physicians for Responsible Opioid Prescribing, said the study contained errors and he was surprised JAMA published it.

“The projections have already been disproven,” he said, pointing to federal data that show the number of opioid-related deaths leveling off nationwide in 2018. The JAMA Network Open study instead projects the death toll to continue rising. Kolodny also said the researchers based their work in part on a “misleading” study that suggested an increase in the number of people whose first opioid is heroin. In fact, the number is decreasing, he said.

The research team gathered data on the trajectory of the opioid crisis from 2002 to 2015, and used that data to project numerous scenarios for the years 2016 to 2025. No matter how the epidemic played out in the different projections, including an optimistic scenario where deaths leveled off, reducing the misuse of prescription opioids still showed minimal impact, they said.

“Our study does not devalue the efforts to reduce misuse of prescription opioids, [but] these efforts in isolation will not bend the overdose death curve,” said Jagpreet Chhatwal, senior scientist at MGH’s Institute for Technology Assessment and the study’s co-lead author.

The researchers acknowledge imperfections in their models.

“It’s really hard to predict the future,” Larochelle said. But they say none of the limitations undercut the study’s fundamental conclusion that lowering the misuse of prescriptions won’t make much of a difference.

The authors argue that policy makers need to focus on increasing access to effective treatment, especially with medications such as buprenorphine and methadone, and reducing deaths among those not in treatment, by expanding the use of the overdose drug naloxone, needle exchanges, and creating safe places to use drugs.

Dr. Adriane Fugh-Berman, professor of pharmacology and physiology at Georgetown University Medical Center, agreed that such measures are critical. But the study, she said, doesn’t address the fact that prescription opioids “can start people down the path to heroin.”

“Overprescription of opioids continues to feed this epidemic,” said Fugh-Berman, who directs PharmedOut, a Georgetown-based project that promotes evidence-based prescribing. “Opioids are still being prescribed at too high a rate to patients for whom the risks outweigh the benefits.”

Dr. Scott Hadland, a Boston Medical Center addiction specialist who was not involved in the study, agreed with the study authors that “limiting the supply of prescription opioids is not going to be the primary answer” to reduce deaths in the short term.

But Hadland, a pediatrician who recently published a study showing a connection between marketing efforts by opioid maker and fatal opioid overdoses, added that opioid prescribing still requires attention for the long term.

In national surveys, about 4 percent of high school seniors report using opioids without a medical reason, and high schoolers are 10 times less likely to use heroin, he said. Looking ahead to these teens’ lives after 2025, Hadland said, it remains important to prevent young people from misusing prescription opioids.

Felice J. Freyer can be reached at felice.freyer@globe.com. Follow her on Twitter @felicejfreyer.

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Retail-induced panic attack?!!

https://www.reddit.com/r/pharmacy/comments/alyudx/retailinduced_panic_attack/

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Combating the opioid crisis one doctor at a time

https://www.washingtonpost.com/national/health-science/combating-the-opioid-crisis-one-doctor-at-a-time/2019/02/01/9d11c1a0-1a71-11e9-8813-cb9dec761e73_story.html

GLENSIDE, Pa. — Sandeep “Sonny” Bains pulled up to Lyons Family Medicine in the pre-dawn dark armed with coffee, doughnuts and glossy brochures about pain treatments.

“What can I help you with for acute pain?” he inquired of ­father-and-son primary-care doctors Michael and Zachary Lyons as he was ushered into a wood-paneled back office.

Bains’s quick drop-ins are modeled on those used by pharmaceutical sales reps to pump up sales. The similarity ends there, though: Bains, a pharmacist, is part of a fledgling movement co-opting the drug industry’s tactics to deliver a different message to doctors — that narcotics are not only addictive but also often no better at managing pain than safer, over-the-counter medicines.

“I’m cold-calling them, picking up the phone: ‘I’m Sonny . . . a pharmacist providing free education,’” Bains said. “It does sound like a drug rep’s pitch.”

The opioid crisis and a series of high-profile lawsuits against drugmakers, including Purdue Pharma and Insys, have put a national spotlight on aggressive pharmaceutical marketing campaigns to persuade doctors to prescribe their drugs, sometimes with scant attention to safety issues — a $20 billion-a-year effort for all drugs sold in the United States, according to a recent study. It has also given new energy to a countermovement that borrows the style, if not the substance, of that outreach.

Late last year, Aetna invested nearly $7 million in the counterprogramming strategy, partnering with a nonprofit, Alosa Health, to bring its pain treatment education to doctors in Pennsylvania, Maine, Illinois, Ohio and West Virginia — states hit hard by opioid overdose deaths. The health system Kaiser Permanente and the Department of Veterans Affairs also use the approach.

Bains is one of about 30 trained academic detailers, as they call themselves, who will be knocking on doctors’ doors for the next year, deploying their knowledge about drugs and their people skills to provide the best evidence about how to treat pain. Aetna will measure how well the intervention works and could expand it to other states — or to other health problems, such as overuse of antibiotics.

“What’s fascinating about this program is that . . . the cause of the opioid epidemic was inappropriate and aggressive marketing of opioids by these sales reps,” said Daniel Knecht, vice president of clinical strategy and policy at Aetna.

Holly Campbell, a spokeswoman for PhRMA, a lobby for the drug industry, said that ethical relationships between drugmakers and health care professionals were beneficial for patients and aided in the development of new medicines.

“An important part of achieving this mission is ensuring that health care professionals have the latest, most accurate information available regarding medicines,” Campbell said.

Policymakers often favor top-down approaches to change how doctors practice: Some states, for instance, set limits on pain prescriptions, or send doctors report cards on their prescribing habits in hopes of quelling a crisis that now kills more Americans each year than AIDS at the height of the HIV epidemic.

Bains’s approach, in contrast, adopts the very method of building relationships with doctors that helped seed the opioid crisis.

“The message is not: ‘Don’t use opioids,’ ” Bains said, after quizzing Michael Lyons on when he would consider using narcotics to treat pain. “It’s . . . be cautious. Use immediate-release and not necessarily long-acting drugs. Short course of treatment.”

He sees himself as peddling evidence, often championing treatments that may be too old or too unconventional, like Advil and Tylenol or acupuncture, to have a sales force dropping by to remind doctors to use them.

“The drug company is frankly much smarter about how to get into people’s heads,” said Jerry Avorn, a Harvard Medical School professor and critic of the drug industry’s influence. As a primary-care doctor, “I would definitely have sales reps trying to get to see me to talk about this amazing medication, [to] tell me that pain is undertreated, it’s the fifth vital sign and every patient should be asked if they are in pain.”

The idea of using the drug companies’ own playbook is familiar to Avorn, who first showed the strategy could work nearly four decades ago in a research project. But only recently has Avorn seen broader embrace of the idea that the drug industry’s outreach may drive up the use of expensive medicines and push physicians to use them inappropriately.

Bains makes these visits not just for opioids, but also to help physicians manage dementia, lung diseases, diabetes and other conditions, through an Alosa Health program supported by the Pennsylvania Department of Aging. In brief meetings that often take place off-hours, he builds relationships with doctors, listening to their questions and challenges.

The interactions are collaborative and respectful, even if doctors practice in ways that don’t conform with evidence. Bains said doctors are often dismissive when confronted with a new idea or evidence, but then they bring it up with greater interest next time he sees them.

These unconventional education efforts have often started as one-off contracts or experiments, but they are growing as studies show they work. Michael Courtney, director of physician engagement at the Capital District Physicians’ Health Plan, now deploys his experience as a pharmaceutical sales rep for companies such as Pfizer and Johnson & Johnson to dissuade doctors from unnecessary use of expensive drugs, drawing on relationships built over time.

“Even in the pharmaceutical industry, it wasn’t a one-time call,” Courtney said. “You were going in there because the data said you have to hear something six to eight times to make it change or resonate.”

A recent study in JAMA Network Open found a possible link between the number of office visits that drug reps made, building trust over time, and the number of overdose deaths — although the research couldn’t show that the visits caused the deaths.

For doctors, these visits amount to a different way to stay abreast of research in their fields. Normally, physicians learn about new findings piecemeal, at best, when they have time to read medical journals or to sit in darkened hotel rooms watching slides flash by. Or they get a highly selective version of the data from drug company representatives, along with free samples.

Bains, by contrast, comes with prescription pads already filled out for treatments like Tylenol or rest, ice and compression — and with warnings about risks and side effects of opioids.

“Being in primary practice, it would be very easy to be in isolation — to take the medical knowledge from the time you finish residency, really not bulk it up, or update it, and really veer off of what is the current evidence-based medicine,” said Zachary Lyons, the son.

The Lyonses, trained three decades apart, were both aware of the risks of opioids, but they debated with Bains about when to turn to steroids, which are not recommended for short-term pain relief for acute low-back pain.

“The wonderful thing about doing what we do is — you and I can disagree, but we’re all on the same side. We all want the patient to get better,” Michael Lyons said of their chats with Bains. “Drug salesmen come, but they have motivation — they’re trying to sell.”

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Trump Targets Drug Middlemen With ‘Devastating’ Rebate Plan

https://www.bloomberg.com/news/articles/2019-01-31/trump-to-curb-protections-for-drug-rebates-blamed-for-high-costs

The Trump administration proposed ending a complex system of drug rebates that influence tens of billions of dollars in U.S. pharmaceutical spending, a move that could upend the relationship between drugmakers and pharmacy benefits middlemen.

The proposal, a long-awaited part of the administration’s plan to target high list prices of drugs, would ban rebates paid by drugmakers to pharmacy benefit managers, or PBMs, in government programs like Medicare.

Those rebates have been called anticompetitive by critics, who blame them for forcing many patients to pay more out of pocket. Under the administration proposal, rebates would instead be passed along directly to customers.

The proposal comes ahead of President Donald Trump’s State of the Union address scheduled for Tuesday, handing him a potential win on drug pricing — a major issue for both parties. The measure, released by the Department of Health and Human Services Thursday, would roll back so-called safe-harbor protections for such rebates, which kept them from running afoul of federal antikickback laws. The plan isn’t final and will be subject to a 60-day period for public comment.

The changes are “potentially devastating to the current pharma ecosystem,” said Eric Coldwell, an analyst with Baird Equity Research. “The U.S. health-care system is a sandcastle and the tide is coming in.”

Shares of major drug-plan providers fell. CVS Health Corp., which oversees drug benefits for more than 90 million Americans, fell 2.4 percent in late trading in New York, and Cigna Corp., which last year bought PBM giant Express Scripts, declined 1.4 percent.

Drugmakers pay rebates to insurers and PBMs in exchange for preferred status with those plans’ customers. Some of those rebates go toward insurance premiums, while the middlemen keep some for themselves. The pharmaceutical industry has said PBMs prefer higher-priced drugs so they can negotiate bigger rebates and pocket more of the money.

In a statement announcing the proposal, HHS Secretary Alex Azar blasted PBM rebates as “a hidden system of kickbacks to middlemen” that increases drug costs for Americans every day.

“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” Azar said in a statement.

Reporting by Bloomberg News over the past three years has examined a variety of pricing practices at PBMs that have been criticized by politicians and others for making it hard to tell where the money is going. In addition to the debate over rebates, PBMs also are under scrutiny over a practice known as spread pricing, a contractual arrangement that allows PBMs to pay pharmacies one price for a generic drug while charging higher prices to their health plan customers.

CVS said drugmakers were to blame for drug costs. “While PBMs have become a convenient target in the fight against skyrocketing drug costs, in reality they serve as a last line of defense for the consumer,” the company said in a statement.

Brian Henry, a spokesman for Cigna, said that rebates had helped keep premiums down overall. “It is short-sighted to look at one component of our offering as having a disproportionate impact on our business model,” Henry said in an email.

Under the proposal, safe-harbor protection would be eliminated for rebates drugmakers pay to pharmacy-benefit managers, Medicare Part D plans and Medicaid managed-care organizations. A new safe harbor would be created for rebates on drug discounts offered directly to patients, as well as fixed-fee service arrangements between drugmakers and PBMs. Without safe-harbor protections, rebate money pocketed by PBMs could be considered an illegal kickback.

Congress

While the out-of-pocket cost for many people picking up drugs at the pharmacy would decline, the premiums they pay for coverage would rise. Premiums for Medicare drug plans under the proposal could increase anywhere from 8 percent to 22 percent while average costs patients pay out of pocket would fall 9 percent to 14 percent, according to the Department of Health and Human Services.

It would be up to Congress to write new laws banning rebates in commercial plans that cover most working-age Americans, and the reception on Capitol Hill was mixed. In the Democrat-controlled House of Representatives, the chairmen of two key committees overseeing health care criticized the proposal.

“The majority of Medicare beneficiaries will see their premiums and total out-of-pocket costs increase if this proposal is finalized,” Ways & Means Committee Chairman Richard Neal of Massachusetts and Energy and Commerce Committee Chairman Frank Pallone of New Jersey said in a joint statement. “We are concerned that this is not the right approach.”

House Speaker Nancy Pelosi likewise urged Trump to work with lawmakers on drug costs.

“President Trump must work with Congress to deliver the real, tough legislation needed to actually drive down the price of prescription drugs for seniors and families across America.” she said in a statement criticizing the plan.

The Pharmaceutical Care Management Association, an industry group for PBMs, said it was reviewing the proposed rule.

“We stand ready to work with the administration to achieve our shared goal to reduce high drug costs,” PCMA Chief Executive Officer JC Scott said in a statement.

The Pharmaceutical Research and Manufacturers of America, the main drug industry trade group, applauded the move. The proposal would “fix the misaligned incentives in the system” that now result in insurers and PBMs favoring medicines with high list prices, PhRMA CEO Stephen Ubl said in a statement.

A few days ago I made this post Saving Money For Medicaid in WV      where WV got rid of their middlemen on their state Medicaid program in 2017  and saved 30 million dollars. WV is not all that large a state ..population about 1.8 million.

The PBM industry started when I was in my last year of Pharmacy school and have watched the industry grow from a nuisance to Pharmacists to a entity that is controlling of the price and approval to pay about 80%-90% of all the prescriptions filled in the country.

They have gained so much control from their beginning that they can now demand discounts/rebates/kickbacks from the pharmas in exchange for the PBM’s to put their medications of the PBM’s approved list of “paid medications”

We have had for years Silver Scripts which is part of CVS Health and last year they started charging higher copays for having prescriptions filled at non-preferred pharmacies and last year there was only two independent pharmacies that were preferred pharmacies.  As of Jan 2019, in three adjacent counties the only PREFERRED PHARMACIES are CVS pharmacies and if a pt with Silver Scripts uses a non-preferred pharmacy the copays they are charged will be 50%-100% higher.

All of these PBM’s are licensed insurance companies and they have fought every attempt to regulate how they run their business by parts of our bureaucracy.  Basically they have fought not to be forced to operate in a TRANSPARENT WAY.  Also the insurance industry has one of the top funded lobbyist funds.  If this gets much traction in Congress i suspect that there will be a whole herd of lobbyists descending on Congress to see if they can get this proposal greatly modified to cause less financial harm to the PBM industry.

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5 police officers injured in Houston shooting, 2 suspects dead, officials say

https://www.foxnews.com/us/5-police-officers-injured-in-houston-shooting-officials-say

Did anyone pay attention to this raid on a suspected drug house in Houston…  Apparently all the police involved in this raid was from the city of Houston and/or Harris county.

Does it seem strange to anyone but me, but the DEA has a district office in Houston , TX but apparently they were no where to be found or involved in this raid.

Maybe because there were probably no real assets to seize/confiscate and/or there was a high probability of a fire fight… ?

If this had been a prescriber’s office… where there is little/no change of getting shot and high probability of sizeable assets to be seized and a high profile court case to be sending out endless stream of press releases on their BUSTING A PILL MILL DOC ?

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