Another front in war on opioids: Criminal charges for Big Pharma execs, MDs

https://www.jdsupra.com/legalnews/another-front-in-war-on-opioids-66941/

An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths. Prosecutors now are saying  that at least some of the causes of this crisis are nothing less than criminal behavior by people wearing white coats and ties.

Federal and state prosecutors are bringing felony charges against doctors and Big Pharma executives as if they were street drug dealers and crime bosses.

This formal faulting for the nation’s opioid crisis hasn’t yet spread widely among drug makers, those at the pinnacle of the pharma pipeline. The legal war, however, has resulted in aggressive steps by federal prosecutors accusing not only scores of doctors across seven states with improperly prescribing painkillers for cash and sex, but also with officials filing for the first time drug-trafficking charges against a major pharmaceutical distributor and two of its former executives.

The criminal cases will combine with an avalanche of civil lawsuits to break down the wall of denial that key players — Big Pharma, doctors, nurses, insurers, and others — have tried to construct about their roles in creating the nation’s opioid and overdose crisis, which has become a leading killer of Americans younger than 55.

In the U.S. criminal justice system, of course, the accused are entitled to a presumption of innocence. But the scope and scale of the wrongs that prosecutors blame on drug case defendants may make it difficult for them to assert their ignorance about widespread, destructive, debilitating, and addictive products and practices they promoted.

Executives at the Rochester Drug Cooperative — one of the nation’s leading pharma distributors — for example, ignored “red flags and shipped tens of millions of oxycodone pills and fentanyl products to pharmacies they knew were distributing drugs illegally,” the New York Times reported, adding of the firm, its ”sales soared, as did the compensation of the chief executive.”

The newspaper elaborated:

[RDC execs] Laurence F. Doud III and William Pietruszewski, were also charged with conspiring to distribute drugs and defrauding the government … Mr. Pietruszewski, 53, of Oak Ridge, N.J., who was the chief compliance officer, was also charged with failing to file reports to the authorities about suspicious orders for controlled substances. He pleaded guilty last week and is cooperating with prosecutors … Mr. Doud, 75, the former chief executive officer, pleaded not guilty … and was released on a $500,000 bond. If convicted, Mr. Doud faces a mandatory 10-year minimum sentence and a maximum of life in prison. The charging documents portray a company largely animated by Mr. Doud’s greed. As chief executive, he drove up the sales of oxycodone pills up nine-fold over four years, from 4.7 million in 2012 to 42.2 million in 2016. Fentanyl sales shot up even more over the same period, to 1.3 million doses from 63,000 doses, the documents said. And Mr. Doud’s compensation, tied to the sales, more than doubled, climbing to over $1.5 million.

Doud has proclaimed his innocence, claiming that colleagues at the No. 6 drug distributing firm in the country are trying to make him the scapegoat for shameful practices that RDC has acknowledged in a separate, civil consent decree with federal officials. The New York Times says the company “admitted in court papers that it intentionally violated federal narcotics laws by shipping dangerous, highly addictive opioids to pharmacies, knowing that the prescription medicines were being sold and used illicitly.” RDC will pay a $20 million fine, agree to abide by drug laws now, and submit to independent monitoring for five years.

The Washington Post reported that the criminal prosecution of RDC may provide a template for officials to pursue actions against major firms like McKesson, Cardinal Health and AmerisourceBergen. The three control 90% of drugs in this country, taking them from makers and shipping them to pharmacies nationwide. The companies have rare insight into the process, including what individual pharmacies order, where their customers come from, and how they pay. Federal law requires them to flag suspicious transactions, including surges in orders, out-of-proportion volumes, and big cash payments.

All three firms, the Washington Post reported, have settled civil cases with the federal government for failing to crackdown on opioid sales, including instances where small drug stores were inundated with painkilling pills far in excess of common-sense sales.

Some in the federal Drug Enforcement Administration earlier wanted criminal charges brought against the distributors. But a Washington Post-60 Minutes investigation found that the corporations waged a legal battle to prevent stiffer actions, including criminal charges or the yanking of the firms’ required drug licenses. Big Pharma also hired away key government agency staff in moves that undercut attempts at tougher opioid oversight.

For now, though, Uncle Sam is talking tough, with Geoffrey S. Berman, the U.S. Attorney for the Southern District of New York, saying in statement:

This prosecution is the first of its kind:  executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country.  Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms.

Similar tough talk came from officials in a federal task force that took aim at “corrupt medical professionals” who inundated the nation’s Appalachian region with painkiller prescriptions and made the area one of the worst ravaged by the opioid crisis, the New York Times reported. The newspaper described some of the physicians’ tawdry behavior, thusly:

Some doctors performed unneeded medical procedures to justify the pills they prescribed, prosecutors said, while others simply passed out prescriptions without going to the trouble of disguising their purpose. One of the doctors facing charges in Ohio had at one time prescribed more controlled substances than anyone else in the state, prosecutors said. A pharmacy in Dayton, Ohio, was accused of dispensing more than 1.75 million pills. And a nurse practitioner in Tennessee who called himself the Rock Doc was accused of prescribing hundreds of thousands of pills in exchange for sex.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be wreaked on them by dangerous drugs, notably opioids. It took time and bad actions by an array of parties — Big Pharma, doctors, nurses, hospitals, insurers, and others — to create this drug epidemic, which will take considerable, sustained effort to reverse.

It may seem extreme to some to charge executives for crimes associated with their corporate activities. Not so. The public won’t be fooled, as a new survey found, with respondents saying Big Pharma must be held accountable for the opioid crisis. As prosecutors told Washington Post reporter Lenny Bernstein about their new charges with Big Pharma execs, “guys in expensive suits don’t do well in jail.” That message, they hope, will ring alarm bells, not only for drug distributors but also those who are directors and C-suite execs for drug makers, too. Jurors are deliberating still a complex criminal case against John Kapoor, the founder of Insys pharmaceuticals and aggressive promoter of the fentanyl product Subsys. The wealthy and philanthropic Sacklers have found themselves under such fire for harms tied to the painkiller OxyContin from their family firm Purdue that they now want a “global resolution” of more than 2,000 civil suits in which their entangled.

It may be satisfying to see those who can be proven to have harmed others brought to justice, whether street drug dealers or boardroom bad actors. That’s only a part of what needs to occur. President Trump and his administration can’t jaw away this nightmare and they can’t rely on excellent prosecutors alone to deal with the opioid crisis. The nation needs, too, a comprehensive plan to assist the millions who have been hooked on and debilitated by opioids and the illicit drugs for which the painkillers have served as a gateway. Opponents need to think hard about their resistance to opioid treatment that, yes, may require patients to receive other drugs, including widespread availability of the antidote naloxone. And individuals with chronic, proven pain should get thoughtful, considered medical services — not just an abrupt shutoff of medications that may help them when administered appropriately. We’ve got a lot of work to do.

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Another Lawmaker Overlooks Pain Management in Bill to Fight Opioid Crisis

www.rewire.news/article/2019/03/28/another-lawmaker-overlooks-pain-management-in-bill-to-fight-opioid-crisis/

Hardly a day goes by when the discussion of opioids and their misuse is not on the front page of local or national newspapers. However, the flipside of the issue, pain management, is barely, if ever, centered in the conversation.

This came up most recently with Republican Sen. Rob Portman of Ohio, who seeks to advance a bill he previously introduced called the Comprehensive Addiction and Recovery Act 2.0, which would, among other things, establish a three-day limit for opioid prescriptions.

This lack of focus on disabled and chronically ill patients has inadvertently pitted doctors against their own patients, who are framed as going down the rabbit hole of dependency following a sprained ankle or routine dental surgery. But this overly simplistic framing erases people with long-term disabilities and chronic health conditions who are struggling to live their lives while being punished for using the best tools we have available to enable their full participation in society.

The Centers for Disease Control and Prevention (CDC) in 2016 offered strategies to taper patients off opioids, but left doctors and patients with their decision-making authority, as it should. However, while the CDC clearly intended the guidelines to be just that—recommendations—that’s not how they’ve been interpreted.

As of last fall, 33 states have put policies in place that limit a person’s access to pain medication, in some cases to three to seven days of medication with no available refills. In some states, this means that patients are forced to go back to the doctor, enduring the burdens of medically unnecessary appointments just to get a new prescription, in order to get the medication they need every seven days.

These are people for whom opioids allow them to go to school, work a job, and manage their home life. In the words of Maelee Johnson, a disability advocate, in an interview for this piece: “Dependence isn’t addiction, and that is continually left out of the discussion and the policies being made.”

This costs lives, Johnson added. “Since the opioid crisis became a political issue, I’ve lost access to all my medication, and I dread having to convince doctors that I need these meds to survive again. The consequences of this are very far reaching.”

It’s not a legislator’s job to diagnose a patient’s ailment or prescribe relief. That responsibility falls to clinicians, who go to school for years for this specialty. And yet, time after time, lawmakers in Congress think they are equipped to address the complex needs of millions of individual patients with their policymaking. In the case of Sen. Portman’s bill, this is especially concerning in light of data pointing to the disastrous impact of arbitrary day-centered limits on pain treatment.

While this bill and similar efforts—including one by Democratic Sen. Kirsten Gillibrand of New York, whose recent policy announcement ended in her pledging to work more closely with the disability and chronic health communities to fix her bill—have an exemption for “people with chronic pain,” this approach fails to take into account what that will mean in practice for actual patients.

Research shows that even when there are exemptions, the patients’ needs are overridden as physicians fear being punished for over-prescribing medication. “Despite exemptions for [chronic pain] patients in the CDC Guideline and Tennessee state law, [a nurse practitioner at Vanderbilt University’s hematology department] had seen a major push from state regulators and insurers to get [sickle cell disease] patients down to lower doses,” noted a 2018 report from Human Rights Watch.

The report showed that legislative interventions such as these do have an impact on the quality of care doctors can provide to their patients who live with chronic pain. Doctors are interpreting the CDC guidelines and congressional action as broad, iron-clad requirements, and patients and people with chronic illnesses are the ones struggling.

Every person experiences pain differently, and legislation addressing this issue needs to take that into account.

Evidence shows that policies inserting the government into the doctor-patient relationship don’t work. For one thing, the majority of people with addiction issues tied to opioids do not receive them from a medical professional. Rather, they receive them from a friend, colleague, or they purchase them on the black market, according to data from the Substance Abuse and Mental Health Services Administration. Furthermore, the U.S. Department of Veterans Affairs, when working on limiting access to opioids among its community, issued a report in 2018 that clearly showed how restrictions did not result in fewer veterans overdosing. It resulted in more veterans dying by suicide, according to the research.

If you enact a policy and it results in constituents dying, it’s a bad policy.

This is what happens time and time again when policymakers craft legislation based on “good intentions” versus tapping into the deep expertise and “lived experience” of the disability community.

Inconsistent enforcement by the Drug Enforcement Administration has also led physicians to be concerned about the prescriptions they’re writing for patients. But it isn’t just the DEA pressuring and arresting physicians; when government intervention is not successful, insurance companies may meddle in complex patient care decisions. The America’s Health Insurance Plans (AHIP) has announced it will begin to track how physicians are complying with these new policies. Though this surveillance data will not be released to the public initially, there is little doubt it will be used to track the preponderance of opioid prescriptions.

This will compound the pressure already on doctors to not diagnose people with chronic pain and will lead to a decrease in access to pain management.

Additionally, there is a concern we will see an expanded list of drugs under restriction; we have already seen anti-seizure and anti-anxiety drugs like gabapentin included in recent state regulations. Broadening what drugs are included will undoubtedly expand who is affected. As we saw when allergy medications became restricted due to their use in manufacturing crystal meth, many times a medication that could be used to combat one symptom could be used for a nefarious purpose.

Instead of trying to force a flawed, one-size-fits-all policy onto hundreds of millions of people in the United States, legislators in Congress should support the dissemination of unbiased, science-based information about appropriate opioid use. Part of the current challenge is that so much of that information is produced by the pharmaceutical industry.

The marketing of OxyContin by Purdue Pharma is a great example of how this can be a conflict of interest. Purdue flew doctors on all-expenses-paid trips to resorts around the country to “educate” them about the merits of the drug. At the same time, the Food and Drug Administration was concluding that OxyContin was not any more effective than any other drug on the market. In 2007, the manufacturer pled guilty to misrepresenting how addictive the drug was and received a significant fine.

Rather than letting pharmaceutical companies run roughshod over clinicians, doctors need education about impacts of over-prescribing, and continuing medical education (CME) requirements should focus on responsible and careful pain management and the consequences of over-prescribing opioids.

Arbitrary limits on the days of medicine a person can receive is not good policy. Nor does it help people. And isn’t that gist of the Hippocratic oath?

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Bedford Police Department. The Bedford Police Department works day in and day out to keep our Bedford community safe. To address the drug epidemic that neighborhoods across Indiana continue to face, officers are working with our local schools to teach all students to have drug-free futures. I’m honored to fight for our law enforcement officers and first responders in Congress to keep them safe.

Trey Hollingsworth  Indiana 9th District House Member

Various entities have been trying to “teach all students to have a drug-free future” for over FOUR DECADES.  That is TWO GENERATIONS that we have tried to “educate on not smart to abuse drugs”.  So since we have as many or more people abusing controlled substance now as back them… Is this a FAILURE of all those various entities who have tried to reach kids ?

OR Is this a issue that our country has a substantial and/or growing number of people who are dealing with mental health issues for various reasons ?

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Editorial: Why is the Florida Senate helping drug companies in opioid lawsuit?

Attorney General Ashley Moody wants access to the state’s prescription database to build her case. The Senate’s concerns about patient privacy are unfounded.

www.tampabay.com/opinion/editorials/editorial-why-is-the-florida-senate-helping-drug-companies-in-opioid-lawsuit-20190501/

Don’t be fooled: The “privacy” concern that state senators are using to hinder Florida’s lawsuit over the opioid epidemic benefits only big corporations that need to be held accountable for the public health crisis. In the final days of the legislative session, the Senate should follow the House’s lead and give Attorney General Ashley Moody a legitimate tool to pursue the state’s claim in a timely manner. Any legitimate privacy issues can be addressed without undermining or delaying the state’s pursuit of justice.

Moody wants access to the state’s prescription drug database to bolster Florida’s lawsuit against the nation’s largest drug makers, distributors and pharmacies, which the state reasonably accuses of recklessly supplying Floridians with drugs. On Monday, the House unanimously passed legislation, HB 1253, granting Moody access to the Florida Department of Health’s data. But the Senate has refused to take up the issue, which would hand a big win to the pharmacy giants and a big loss for public health and safety.

The database tracks all monitored drugs, from oxycodone to sleeping pills. But Moody can’t use it for the state’s civil lawsuit, which is filed in Pasco County. By law, the use of the database is restricted to criminal cases and administrative actions against physicians. Moody needs the database to show specific examples that Walgreens, along with its rival CVS, “raced to sell as many opioids as possible” while failing to stop suspicious shipments of drugs, as the lawsuit alleges.

But the Senate bill stalled in the committee of Sen. Lizbeth Benacquisto, a Fort Myers Republican, who said she won’t hear the measure because of concerns it could invade the privacy of patients. Other opponents contend that allowing access would be a misuse of personal information and an invitation to hacking. These are the same hollow arguments that lawmakers voiced for years before the drug database was finally created in 2009. “They use the word ‘privacy,’ which gets people’s attention,” said former Sen. Mike Fasano, who was instrumental in getting the database created and is now the Pasco County tax collector. “What this comes down to is protecting the corporations that need to be held accountable for helping to create this epidemic.”

If Moody’s lawyers got access to the data, they would not see patients’ names. There would be a unique identifying number for each patient, along with the patient’s year of birth and their city, county, and zip code. Dates of birth and sex would also be removed, and the attorney general could use the information only as evidence in a civil, criminal or administrative suit against a pharmacy or dispenser. Experts have assured the attorney general that the risk of re-identification is nearly impossible, calling the concerns “conspiracy theories” with “no basis in reality.”

Moody still could get the information from the companies through the lawsuit’s discovery process. But that would be expensive and the companies could drag out the process for years. There is no justifiable reason for denying the state a narrow, practical path for presenting its case.

The human and public health costs of the opioid epidemic are staggering; between 1999 and 2016, more than 200,000 people nationwide have died from overdoses related to prescription opioids, including thousands of Floridians. Opioids killed nearly 6,000 people in the state in 2016 alone. It’s beyond time to hold those responsible accountable, and the Senate should allow the state to gather all of the facts for its lawsuit in the most effective manner.

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Amid Opioid Crisis, Walgreens Adds Mental Health Training For Pharmacists

https://www.forbes.com/sites/brucejapsen/2019/05/01/amid-opioid-crisis-walgreens-adds-mental-health-training-for-pharmacists/#2f041e427b68

Walgreens plans to increase mental health and substance abuse training for hundreds of pharmacists and staff at its drugstores amid the U.S. opioid epidemic.

Walgreens has partnered with the National Council for Behavioral Health and the American Pharmacists Association to make training available to Walgreens pharmacy staffers in “mental health first aid,” which those involved say will help assist patients suffering from mental health conditions or substance abuse.

“With the growing need for services and resources to help those living with mental health conditions, as well as substance use and addiction, we can play an important role by giving our pharmacists and certain team members the training to help those in crisis,” Walgreens Boots Alliance co-chief operating officer Alex Gourlay said in a statement.

The strategy is the latest from big healthcare companies to ratchet up screening for patients with substance abuse and mental health conditions in the wake of the deadly opioid epidemic. Major health insurers like Anthem, Cigna and UnitedHealth Group are closely monitoring prescriptions and making sure physicians in their networks adhere to certain protocols and recommended dosages.

By improving mental health education, screening and literacy, companies could also be engaging in risk management.

Drug makers and other healthcare companies like Walgreens that have been involved in the production, sale and distribution of opioids may have reason to fear “a tobacco-style master settlement agreement,” a report last year from Fitch Ratings said. Other companies that distributed or sold opioids also face some risk, including drugstore chains like CVS Health, which is also at some financial risk because it owns the pharmacy benefit manager (PBM) Caremark, Fitch said. Other PBMs, including Express Scripts now owned by Cigna and UnitedHealth Group’s OptumRx, could also face some risk.

Walgreens has increased mental health services in recent years as the company has added more medical treatments and wellness services to become a retail health destination for consumers. Three years ago, Walgreens expanded mental health services to include access to behavioral health treatment via Breakthrough, a unit of telemedicine firm MDLive. Walgreens also expanded customer options for treatment, screenings and awareness through its mental health platform, Walgreens.com/mentalhealth, which was launched in May of 2016.

The additional “mental health first aid” training administered by the National Council, trains “participants in mental health literacy, understanding risk factors and warning signs for mental health and addiction concerns, and strategies for how to help someone in both crisis and non-crisis situations,” Walgreens and the council said. “One in five people experiences a mental health or substance use issue in a given year and it’s likely that most of those individuals use a pharmacy’s services during that year,” the National Council for Behavioral Health’s CEO Linda Rosenberg said.

If you are a chronic pain pts or a pt that has a medical necessity for controlled substances and you patronize Walgreens.. you may soon start receiving the recommendation to seek out mental health services – for your opiate use disorder…  you see that they have changed or in the processing of changing the nomenclature…  There seems to no more addiction or dependency but anyone using a opiate (legally/Illegally) > 90 days.. is now being diagnosed with a “opiate use disorder” diagnosis.

You see, the Tobacco Settlement money ..it has been paid out on a annual basis from the tobacco companies and that will be drying up in another 4-5 yrs and a lot of bureaucracies have become “financially dependent/addicted” on this money and they face the possibility when the money dries up to raise taxes, cut budgets or find another source of revenue… and now everyone and their brother is filing suits against the major pharmas, wholesalers, and major chain pharmacies… but there is more deep pockets within the Insurance industry- which includes the PBM’s.  So all of those within these industries are trying to CYA there “deep pockets” from all the law firms that are working on a contingency basis with suing everyone that is involved with the controlled substance distribution system.  These bureaucracies are “hiring” all of these law firms on a contingency basis… so they have nothing to lose.. since the law firms only get paid if they win a settlement.

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International GUIDELINESon HUMAN RIGHTSand DRUG POLICY

29 pages click link to upload *.PDF

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Movement to reform pharmacy middlemen reaches a boiling point nationwide

https://www.dispatch.com/news/20190429/movement-to-reform-pharmacy-middlemen-reaches-boiling-point-nationwide

They once were the obscure middlemen reaping billions off prescription-drug transactions as they worked behind a veil of secrecy. But a wave of reforms to the $400 billion-a-year industry of pharmacy benefit management is cresting across the United States.

According to the National Academy for State Health Policy, 101 PBM reform bills are being considered in 41 states this year.

PBMs, such as CVS Caremark, OptumRx and Express Scripts, act as the middlemen between health insurers, drug manufacturers and pharmacies. Their contracts typically keep pricing and rebate data secret, leading many people to conclude that they’re partly to blame for the rising price of drugs, which itself is the fastest-rising part of the health-care sector.

Following a Dispatch analysis last year of confidential pharmacy-reimbursement data, the Ohio Department of Medicaid released its own analysis showing that in 2017, CVS Caremark and OptumRx charged taxpayers $224 million more for drugs than they reimbursed pharmacists. That was three to six times the going rate, according to the analyst who did the report, which didn’t look at whether the PBMs were pocketing portions of rebates and other fees they were collecting.

“Unfortunately, things were really, really bad in Ohio,” said Anne Cassity, vice president of federal and state affairs for the National Community Pharmacists Association, an industry group representing independent pharmacies.

But things also were bad elsewhere, such as in Kentucky, where a state report determined that the “spread” between what PBMs billed taxpayers for Medicaid drugs and what they paid pharmacies was $123.5 million in 2018, prompting Kentucky Attorney General Andy Beshear to launch an investigation.

Louisiana, New York, and Arkansas each has either passed or is considering measures that would ban such spread pricing. Other states are considering various types of bills, such as ones in California and Oregon intended to increase transparency, while still other states are considering bills that would require PBMs to provide pharmacists with minimum reimbursements.

In West Virginia, rising drug costs in the Medicaid program prompted officials there to carve Medicaid drugs out of its managed-care system. State Medicaid officials have broken up PBM functions, leading to an increased transparency that they say saved $54.4 million a year.

Cassity, of the national association of pharmacists, praised that approach and said that states are leading the way in approaches to reform.

Pharmacy benefit managers defend their role, saying that they save money for consumers and arguing that many of the recent legislative initiatives would increase costs.

“Pharmacy benefit managers (PBMs) serve as the only check in the prescription-drug supply chain against drug-makers’ sole power to set and raise prices,” said Greg Lopes, spokesman for the Pharmaceutical Care Management Association, a national organization representing PBMs. “Any new state legislative mandates that undermine PBMs’ cost-savings tools would not reduce prescription-drug prices for consumers; rather they would reduce access and increase prescription-drug costs.”

Lopes cited a 2017 study by the University of Southern California that found that for every $100 spent on branded drugs, PBMs retain about $2, compared with $58 for manufacturers. For generic drugs, PBMs retain $7, compared with $18 for manufacturers.

However, Neeraj Sood, who conducted the study, told The Dispatch in January that it’s incorrect to use his work to evaluate whether that’s a fair split between manufacturers, which develop and produce medicines, and PBMs, which facilitate sales.

“You and I ask, ‘Is (the amount PBMs are getting) a reasonable number, or should PBMs be making less than that?’ My research didn’t address that question,” Sood said. He added that he is working on a study to try to find an answer.

The Montana legislature recently passed a bill meant to attack the PBM problem. Senate Bill 71 would require the Montana Securities & Insurance Commissioner to regulate PBMs that serve private health plans on the individual market. Similar reforms already have been made for state employees through the companies that administer the state’s self-funded insurance plan. The change is intended to require insurers to look out for taxpayer interests and to give state regulators the power to effectively check insurers’ math.

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The bill would allow the insurance commissioner access to PBM contracts and require insurers to use a list of drug prices that would be disclosed to regulators, secret, PBM-generated cost lists that prevail in the industry. It would outlaw spread pricing by requiring PBMs to pay pharmacists their costs plus a dispensing fee. It would eliminate after-the-fact fees that PBMs charge to take back part of the reimbursements they’ve already paid pharmacists.

SB71 also would take away health plans’ incentive to steer patients to expensive drugs with big rebates by mandating that all money collected by PBMs from manufacturers be returned to the state, and by forcing open contracts and other records to ensure that happens.

That provision would prevent insurers from boosting profits by classifying some portion of rebates as a medical expense, said Derek Oestreicher, an attorney for the Montana insurance commissioner who was involved in developing the measure.

“It’s ultimately important that insurers take back the reins from pharmacy benefit managers,” he said, explaining that he’d seen crazy things as he worked on the bill. One PBM contract he saw defined “rebate” as a number of things — “rebates” not among them.

Marilyn Bartlett was recently named 13th on Fortune magazine’s list of the World’s Greatest Leaders for her work reforming how Montana does business with hospitals, managed-care companies and PBMs. She said it took a hard political fight to pass SB71 over the objections of insurers and PBMs. It remains to be seen whether Democratic Gov. Steve Bullock will sign the bill. His office didn’t respond to a call last week for comment.

Maine lawmakers began hearings this month on a sweeping package of five bills broadly modeled on the Montana legislation.

The role of PBMs “is supposed to be about working on behalf of patients to drive down the cost of prescription drugs and serve as a check against the power of pharmaceutical companies,” said state Sen. Heather Sanborn, D-Portland. “However, more and more evidence has emerged that PBMs have taken advantage of their secrecy and used their position to pad their own investors’ pockets rather than drive down costs for consumers.”

In Ohio, Medicaid managed-care company CareSource earlier this month touted a new contract with Express Scripts that it says will bring new transparency to the system. The contract will be available to state officials, but not the public, however.

Company officials say making the contract public would give an unfair advantage to its competitors.

Montana’s Oestreicher isn’t buying that.

“Let’s be clear, we’re not dealing with the Coca-Cola recipe here,” he said. PBMs “are always coming up with more algorithms to become more profitable and more secretive.”

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DOJ Declines to Prosecute DEA Agent Who ‘Provided False Statements Under Oath’ About Subordinate Who ‘Apparently’ Had Sex in Park

https://www.cnsnews.com/news/article/cnsnewscom-staff/doj-declines-prosecute-dea-agent-who-provided-false-statements-under

(CNSNews.com) – The Department of Justice has declined to prosecute a Drug Enforcement Agency special agent who “provided false statements under oath” to the Office of the Inspector General of the Department of Justice about a subordinate who “apparently engaged in sexual activity in a public park,” according to a summary of the case released by the IG.

“The Department of Justice Office (DOJ) of Inspector General (OIG) initiated this investigation upon the receipt of information alleging that a Drug Enforcement Administration (DEA) Assistant Special Agent in Charge (ASAC), since retired, had contact with a local police officer after the officer observed the ASAC apparently engaged in sexual activity in a public park,” said the IG’s summary.

“The ASAC was on annual leave on that date,” said the summary.

“During the course of the investigation, the OIG found indications that the ASA’s immediate supervisor, the Special Agent in Charge (SAC), failed to properly report the ASAC’s contact with the local police to the DEA Office of Professional Responsibility (OPR), and provided false statements during his OIG interview concerning the ASAC’s conduct.

“The OIG investigation found that by apparently engaging in sexual activity in a public park, the ASAC failed to act in a professional manner as a DEA employee, in violation of federal regulation and DEA policy,” said the summary.

“The OIG investigation further found that the SAC failed to properly report to DEA OPR the ASAC’s contact with local police; showed favoritism to the ASAC by not reporting the incident to DEA OPR, which would have allowed for an impartial review of the incident; and provided false statement under oath to the OIG concerning his knowledge of the allegations involving the ASAC, all in violation of federal regulations and policies,” said the IG’s summary.

“Prosecution of the SAC was declined,” said the IG’s summary.

“The OIG has completed its investigation and provided its report to the DEA for appropriate action,” said the summary.

So when you work for law enforcement and you commit a crime and then another person in law enforcement LIES ABOUT WHAT WENT ON…  and everyone goes on with their life without any consequences.  Laws apparently are only meant to apply to those outside of law enforcement ?

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Kolodny: Opioid Makers’ Deception Merits Dramatic Responses

https://www.addictionpro.com/article/kolodny-opioid-makers-deception-merits-dramatic-responses

In a workshop talk on preventing future public health catastrophes at the Rx Drug Abuse & Heroin Summit, Andrew Kolodny, MD, opened with the comment, “I’m not playing the blame game.” Still, the co-director of the Opioid Policy Research Collaborative at Brandeis University delivered blistering criticisms for many contributors to the opioid epidemic.

Makers of powerful opioids clearly headed the list, but government regulators, state medical boards and accrediting agencies all were targeted during Kolodny’s talk. At the heart of his concern is the role that pharmaceutical industry money has historically played in compromising the mission of these other entities.

“A big problem, I believe, is the revolving door,” said Kolodny, referring to the common practice of drug regulators leaving government to take jobs in the industry they had been overseeing. Kolodny, who disclosed he is assisting states in lawsuits against opioid manufacturers, placed atop his list of solutions the imposition of limits on the revolving-door practices.

He also advocates campaign finance law reform. “Congress failed in its oversight,” he said, as the Food and Drug Administration recklessly allowed opioid manufacturers, absent research evidence, to promote the idea that opioid painkillers were safe for long-term use.

Questioning accepted wisdom

Kolodny questions the general explanation for how the opioid crisis has evolved in the U.S. The account goes that a first wave of overprescribing of prescription painkillers led to a crackdown that forced addicted individuals to heroin, which then became a more deadly trend when fentanyl infiltrated the supply. Kolodny believes this explanation oversimplifies the issue somewhat. First, “We really haven’t had a crackdown—we’re still massively overprescribing opioids,” he said.

Also, the three-wave construct ignores that heroin use was steadily increasing in many places at early stages of the prescription opioid crisis, Kolodny said. Young, mainly white, adults started with prescription opioid use and moved to heroin because doctors grew more uncomfortable writing multiple prescriptions for younger patients, a concern they didn’t apply to older patients who were able to stay on prescription opioids, he said. Another cohort that is ignored in the conventional wisdom, he said, are older inner-city adults, mostly non-white, who had a longtime heroin addiction but now faced deadly consequences of their use. In Washington, DC in particular, “Fentanyl was killing men who had survived 40 to 50 years with a heroin addiction,” Kolodny said.

He outlined the well-financed marketing efforts of Purdue Pharma and other drugmakers in assisting prescribers to grow more comfortable with opioids as a class, as they characterized any resistance to prescribe as “opiphobia” that would result in patients suffering needlessly. Helping the effort, however, were also entities such as the Federation of State Medical Boards, which sent the message that physicians would be sanctioned for undertreating pain, and the Accreditation Council for Continuing Medical Education, which failed to enforce its standard that continuing medical education be free from commercial bias, Kolodny said.

Outcome-focused sessions

Another workshop on the second day of the conference discussed a University of Kentucky team-based initiative to link emergency medical patients with opioid use disorders to ongoing care. The First Bridge Clinic was launched in early 2018 and involves the cooperation of a multidisciplinary team that includes waivered doctors and nurse practitioners, a nurse navigator, a licensed therapist and a certified peer support panelist.

Among the panelists, and Bridge Clinic leaders, was cardiac anesthesiologist J. Thomas Murphy, MD, who said he became board certified in addiction medicine and waivered to prescribe buprenorphine after seeing an increase in patients needing surgery for complications of endocarditis.

Another outcome-focused session at the conference featured two physicians who discussed improving services for pregnant women with opioid use disorder and their families. Mishka Terplan, MD, MPH, professor of obstetrics and gynecology and medical director of the MOTIVATE Clinic at Virginia Commonwealth University, lamented the lack of evidence-based care for pregnant women, even though it has been known since the 1970s that methadone is compatible with an uneventful pregnancy and the birth of a child with manageable symptoms. From 2002 to 2009, the percentage of addiction treatment centers offering services for pregnant and postpartum women actually declined from 19% to 13%, Terplan said.

Stephen Patrick, MD, MPH, director of the Vanderbilt Center for Child Health Policy, discussed the successes of an interdisciplinary Team Hope project at Vanderbilt that has been able to reduce lengths of stay for newborns who have been exposed in utero to opioids. The effort has emphasized standardizing protocols and taking a more compassionate approach that seeks not to routinely separate the baby from the mother.

I remember AK stating that he has never said that opiates SHOULD NOT BE USED FOR TREATING LONG TERM CHRONIC PAIN LONG TERM

but in this article AK is quoted:   He also advocates campaign finance law reform. “Congress failed in its oversight,” he said, as the Food and Drug Administration recklessly allowed opioid manufacturers, absent research evidence, to promote the idea that opioid painkillers were safe for long-term use.

AK seems to vision himself as a “knight on a white horse” that save our country from continued opiate crisis… but is he more like Don Quixote

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Munster doctor sentenced for over-prescribing pain pills

https://www.nwitimes.com/news/local/crime-and-courts/munster-doctor-sentenced-for-over-prescribing-pain-pills/article_31c9fcad-d45b-5ef5-b493-777b0439c2f6.html

Filed under: General Problems | 4 Comments »