Inspector General reproached the DEA over its prodigious use of civil forfeiture, which let the agency confiscate over $3.2 billion

Posted on April 9, 2019 by Pharmaciststeve

Federal Audit: Secret Surveillance Program Helped DEA Seize Over $50 Million In Cash And Real Estate

https://www.forbes.com/sites/nicksibilla/2019/04/09/federal-audit-secret-surveillance-program-helped-dea-seize-over-50-million-in-cash-and-real-estate/#333d583337de

Under a sweeping surveillance program, the Drug Enforcement Administration secretly spied on Americans who bought money counters, “the vast majority” of whom “were never shown to be connected to illicit drug-related activities.” In an extensive audit, the U.S. Department of Justice Office of Inspector General revealed that between 2008 and 2014, the DEA had collected tens of thousands of records, including the names, addresses, and phone numbers of buyers, though only 131 arrests were made. (The DEA declined to reveal how many convictions were secured following those arrests.) During the same period, however, bulk purchaser data helped the DEA seize $48 million in cash, $4 million in real estate, 88 vehicles, and 179 firearms, as well as nearly 1,500 pounds of cocaine and over 21,300 pounds of marijuana.

Identified only as “Program B” in a heavily redacted report, the Inspector General found that the DEA routinely issued “administrative” subpoenas to companies that sold money counters. Not only were those subpoenas conducted without any court oversight, they were “unrelated to a specific drug trafficking investigation or target.” Once collected, the DEA would then send the raw data from thousands of purchases directly to its field offices, which would cross-reference the data with several law enforcement databases.

The Inspector General also found it “troubling” that the DEA “failed to conduct a comprehensive legal analysis” before starting its bulk data collection. In fact, when asked for a legal review over the subpoena program, one manager in the DEA’s Office of Chief Counsel responded, “Unless a federal court tells us we can’t do this, I think we can continue this project.”

Moreover, the DEA actively worked to keep the program “from becoming publicly known,” telling personnel “not to disclose the source of names…when documenting their investigations.” This stratagem, the Inspector General recounted, was “intended to protect the program’s sources and methods; criminals would obtain money counters by other means if they knew that the DEA collected this data.”

In a dark irony, the DEA’s dragnet collected so many records on money-counter buyers, field offices complained that that they “did not have the time to review it all” and that the bulk data was “too voluminous to use efficiently.” Several field offices griped about “the poor quality of the leads,” with one DEA staff coordinator writing that there were “so many [leads] we put out, we don’t know what’s being done, and why some are better than others.”

After relaying data “indiscriminately” for almost five years, the DEA decided to improve the quality of the leads it sent to field offices; it would first search for hits in other federal databases. In May 2013, the DEA began sending the bulk money-counter data to the Organized Crime Drug Enforcement Task Forces (OCDETF) Fusion Center, which holds over 500 million records from more than 15 different federal agencies, including the ATF, FBI, and ICE.

Yet the fusion center also used the DEA-supplied purchaser data to create “intelligence products” that had “no connection to drug crimes.” Since the DEA’s subpoena power was supposed to aid its ability to investigate drug crimes, the Inspector General argued that transferring bulk data to the fusion center was “tantamount to the DEA lending out its subpoena authority to agencies lacking their own.”

But then the DEA faced objections from a surprising source of civil libertarians: the FBI. Several FBI agents raised concerns about the “legality” of the DEA’s administrative subpoenas with the fusion center’s deputy director. As one FBI agent noted, the DEA issuing blanket subpoenas “wasn’t predicated on individual cases or individual suspicions,” but was “just a general fishing expedition.” “You can’t just take any innocent activity that Americans engage in and go grab all their records knowing that a small percentage of it is potentially connected to illegal activity,” the agent added. “And that sounded exactly like what DEA was looking to do.”

The agents were also worried that the fusion center would be “running all of these names, which had been collected without foundation, through a massive government database and producing comprehensive intelligence products on any ‘hits,’ which included detailed information on family members and pictures.” That type of surveillance “didn’t sit right with any of [them],” they told the Inspector General.

Shortly after they raised their concerns, the FBI announced it wouldn’t participate in the bulk money-counter data program and even barred the DEA from using its fusion-center records. Those decisions, along with Edward Snowden’s blockbuster revelations about the NSA, persuaded the DEA to wind down its dragnet in late 2013.

Although both the Justice Department and the DEA say they have “no plans to reinstate any of the discontinued bulk collection programs,” the Inspector General noted that “there is nothing preventing the DEA or the Department from seeking to start such a program at any time in the future.”

“DEA is committed to ensuring its practices comply with all Department of Justice policies and procedures and continue to be vetted through a rigorous legal review. The DEA agrees with the OIG’s recommendation for further improvement of its administrative subpoenas with respect to data collection, and has already begun enhancing these processes,” Mary Brandenberger, chief of the DEA’s National Media Affairs Section, said in a statement. “As a member of the intelligence community, DEA and other law enforcement entities receive tips and information from a wide array of sources. We take very seriously our responsibility to remain fair and impartial during criminal investigations, and remain closely tethered to the rule of law.”

The DEA is no stranger to withering criticism from federal auditors. Previously, the Inspector General reproached the DEA over its prodigious use of civil forfeiture, which let the agency confiscate over $3.2 billion from 65,000 cash seizures; slammed the DEA for its confidential source program, which rewards informants with money taken through forfeiture; and raised “civil rights concerns” about the agency seizing cash without warrants in its version of stop-and-frisk

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Why Does Medicine Cost So Much? Here’s How Drug Prices Are Set

Posted on April 9, 2019 by Pharmaciststeve

Why Does Medicine Cost So Much? Here’s How Drug Prices Are Set

http://time.com/5564547/drug-prices-medicine/

From 2007 to 2016, Mylan raised the list price of its EpiPen about 500%, from just under $100 to more than $600. From 2002 to 2013, insulin prices more than tripled. From 2012 to 2019, the average price of AbbVie’s rheumatoid-arthritis drug Humira climbed from $19,000 a year to $60,000 a year—and that’s after rebates. These are dramatic examples of a systemwide problem: prices for brand-name drugs are rising at a rate that far outstrips inflation.

What’s behind these rapid price hikes? It’s a simple question with a complicated answer that involves three central entities: drug manufacturers, pharmacy benefit managers (PBMs) and insurers. Together, they create a complicated supply chain that helps drive drug prices aggressively upward. “We have a system that is all engine and no brake,” said Michelle Mello, a professor at Stanford Law School and a professor of health research and policy at Stanford Medicine.

The amount you pay for a brand-name drug will depend on your insurance plan; the plan’s formulary, or list of drugs it prefers and covers; the size of your deductible; and the deal your insurance company has worked out with the drug’s manufacturer, among dozens of other variables. How such discounts are negotiated is proprietary, carefully guarded by the system’s various players.

There’s a lot of finger-pointing over who is to blame for rising prices, particularly between drug companies and PBMs, or the middlemen that negotiate rebates and discounts for health plans.

It all starts with the manufacturers: companies that develop new treatments and conduct clinical trials. There are essentially no regulations governing how drugs are priced. Instead, pharmaceutical companies select a price based on a drug’s estimated value, which typically translates into what they “believe the market will bear,” said Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School. Blockbuster first-in-class treatments, therefore, command stratospheric prices. When Gilead Sciences received Food and Drug Administration (FDA) approval for its hepatitis medication Sovaldi in 2013, the company priced it at $1,000 a pill, or $84,000 for the full course of treatment. The price was possible because the drug worked and, for a time, was the most convenient and effective treatment on the market.

For drugs entering a crowded disease category with multiple other options, the calculus is different. In such cases, a new treatment will typically be priced similarly to its competitors.

The dollar amount a manufacturer assigns a drug is the list price, and functions “like a sticker price on a car,” said Mello. The pharmaceutical company will, depending on the drug and buyer, provide a variety of discounts off the list price.

Rebates for commercial, employer-sponsored or self-insured health plans, negotiated by PBMs on behalf of the insurers, can get confusing, but the process broadly goes like this: Say a manufacturer offers a drug with a list price of $1,000 for a month’s supply. Wholesalers pay the manufacturer the full or close to the full price and make it available to pharmacies. From the manufacturers’ point of view, that’s as far as things would need to go: they’ve put a drug on the market and gotten paid for it. But there would be little demand for the drug if insurance companies didn’t make it available to consumers by listing it on their formularies, and employer-sponsors weren’t making the insurance available to their employees.

It’s the PBMs that negotiate with the manufacturers and insurers to get drugs listed and to establish prices. For that work, the manufacturers pay a fee in the form of a rebate—say, $400 off that $1,000 drug. One of two things then happens to that $400: Either the PBM takes a share of it, say $40, and passes the rest of the savings on to the insurance plan’s employer-sponsor. Or the PBM pays the entire $400 to the sponsor, but raises the fee it charges the insurer to conduct the price negotiations in the first place.

Either way, the drug now has a net price of $600, or the amount the manufacturer actually makes on its sale. The consumer with health insurance pays an amount that ranges from a fixed co-pay to some percentage of the full list price, depending on the terms of the plan and whether deductibles have been met. For many patients, out-of-pocket costs can be cut further by coupons the manufacturer distributes through doctors or online, which can make patients likelier to ask for a certain drug by name.

When the buyer is the government, discounts are typically standardized. The price Medicare pays for a branded drug that is self-administered (taken at home instead of administered in a clinical setting, like chemotherapy) is based on the average sales price of that drug across different health plans, taking into consideration all discounts and rebates. Medicaid gets a better deal: the government insurance program is entitled by law to receive either 23.1% off the manufacturer’s list price or the drug’s largest commercial discount, whichever is lower. In the case of the $1,000 drug, a 23.1% discount would mean a $769 net price, compared with the $600 price negotiated by PBMs and insurers, so Medicaid pays the $600.

This complex system becomes even more so, thanks mostly to the power of the PBMs. Not only do they wrangle rebates and discounts from the manufacturers in exchange for getting their drugs placed on the insurance companies’ formularies, they also help determine where on the formulary hierarchy any drug will be. An insurance plan may cover, for example, three psoriasis drugs, but they are on different tiers. A drug on a preferred tier will have a larger rebate, making it cheaper for patients. Ideally, drugs would be tiered only according to their effectiveness, and there is certainly an element of that in the mix, especially for patients with Medicare. But a lot of it has to do with which manufacturers are willing to offer the greatest discounts.

To force a manufacturer’s hand, PBMs may also practice formulary exclusion, in which they remove one of the medications in a disease category altogether. If a drug is not on a formulary, patients are usually on the hook for the full list price—which most won’t pay if there is a competing drug available. Price pressure intensifies as companies scramble not to get cut.

When the system is working, PBMs do perform a service, getting manufacturers to lower costs. “If you didn’t have an entity called a PBM, you would want to create one,” said Geoffrey Joyce, chair of the department of pharmaceutical and health economics at the University of Southern California School of Pharmacy.

But as it exists today, the system isn’t designed to prioritize savings for patients. A big reason for this is that PBMs are not incentivized to negotiate for lower list prices as much as they are for higher rebates, since the share of those refunds they keep is a part of how they make their money. Manufacturers, competing to secure high formulary tiers, know PBMs want juicy rebates. And so they have two options: offer a larger discount and make less money on the drug, or offer a larger discount while also raising the list price of the drug, therefore keeping the net price level. If you’re a manufacturer, you’re going to pick the latter option. Little of this is evident to the average consumer.

Let’s return to that $1,000 drug. If the manufacturer raises the rebate it is offering the PBM from $400 to $500, it will likely also raise the list price by at least $100 to avoid taking a hit on the drug’s net price. That’s good for the PBM; neutral for patients with good health insurance; and bad for those who pay co-insurance, are on high-deductible plans or are uninsured, as the list price is now $1,100.

“There is a lot of concern that those incentives are somewhat perverse,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis.

Insulin pricing is an especially cautionary example. The drug’s average cost has nearly doubled since 2012. “The increase in the list price has been stunning,” said Karen Van Nuys, a research assistant professor at the USC Price School of Public Policy. Today, insulin is so expensive that some people are rationing their supplies, which comes with serious, potentially deadly risks.

In a 2018 article published in Diabetes Care, Van Nuys and colleagues tracked the list prices for insulin against the net prices, or the amount manufacturers actually received. They found that from 2002 to 2013, list prices for insulin nearly tripled—while increases in net prices during that period were far less significant. (In some cases, those net prices even went down.) The reason: most of the increase went to rebates that the PBMs and plan sponsors got to keep. Many insured patients paying only the net price might not have noticed the difference, but uninsured patients, or those with insurance but with deductibles still to meet, were stuck with the soaring list prices.

On top of secretive agreements with manufacturers, PBMs have separate, confidential contracts with health insurers and employers. Large employer-sponsors, because of their size, can demand favorable terms, said Richard Evans, general manager of SSR’s health practice, such as stipulating that they receive all rebates. But like PBMs, insurers are feeling public heat for holding on to rebates. Last year, Aetna and UnitedHealthcare announced they would start passing rebates down to patients—at least ones in higher-end insurance plans.

Manufacturers argue that the public’s focus on list prices is misplaced, since drug costs are discounted as they move through the supply chain. While this is technically true, the list prices do matter. Not only do uninsured patients and those who haven’t met their deductibles have to pay that amount in full, patients with co-insurance often face out-of-pocket expenses that are based on a percentage of the list price, not on the discounted price.

What can be done to stop or slow the rate at which drug prices are increasing? As of yet, there are virtually no regulations preventing manufacturers from setting and raising prices as high as the market will bear, nor are there policies preventing PBMs from keeping a percentage of the discounts they negotiate.

Public anger, however, is reaching a boiling point. The Trump Administration has floated the idea of eliminating Medicare rebates, essentially forcing PBMs to pass negotiated discounts down to patients. (While this would lower the out-of-pocket expense for patients on high-cost brand drugs, it might increase overall costs in the form of higher premiums.)

In late February, seven pharmaceutical executives testified before Congress about rising drug prices. Their showdown with lawmakers was more muted than expected, but many experts believe the groundwork is being laid for substantive legislative action, if not in the next couple years, then in the next half a dozen.

Changing the system won’t be easy. There’s a lot of money on the line, and the health care industry is preparing for a fight: PhRMA, the pharmaceutical industry’s most powerful influence arm, spent nearly $28 million in lobbying efforts last year, a record-breaking total for the group. (PCMA, the lobbying group for PBMs, spent a far smaller, but not insignificant, amount in the low seven figures.)

Those lobbying efforts are going into overdrive because the drug-supply chain is facing real pressure as health care costs have become a rare bipartisan issue. “Over the last two years there has been increasing recognition by state and federal legislatures that something needs to be done,” Kesselheim said.

Consumers and patients—it’s worth remembering—are also voters. That makes them one link in the supply chain that Washington ignores at its peril.

Contact us at editors@time.com.

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Insurers’ Denials of Opioid Coverage Spurs CDC to Clarify Guidelines

Posted on April 9, 2019 by Pharmaciststeve

Insurers’ Denials of Opioid Coverage Spurs CDC to Clarify Guidelines

https://consumer.healthday.com/bone-and-joint-information-4/opioids-990/insurers-denials-of-opioid-coverage-spurs-cdc-to-clarify-guidelines-744875.html

TUESDAY, April 9, 2019 (HealthDay News) — People with severe pain from cancer or sickle cell anemia should not be denied coverage for opioid painkillers, a new clarification on federal guidelines states.

In the wake of the national opioid epidemic, various medical societies had encouraged doctors to rein in prescriptions for the powerful painkillers.

In 2016, the U.S. Centers for Disease Control and Prevention published guidelines that said for most patients seen by primary care doctors, opioids should be a last resort.

But there has been an unintended consequence: Some insurers have refused to pay for prescriptions for patients with cancer or sickle cell anemia, or for cancer survivors with complicated chronic pain conditions.

The new clarification was issued in a letter from the CDC to three medical societies who’d brought the insurance problem to the agency’s attention — the American Society of Hematology, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network.

The letter, released Tuesday, stresses that the guidelines weren’t intended for patients undergoing cancer treatment.

Beyond that, the letter says, the guidelines weren’t designed to “deny any patients who suffer with chronic pain” the option of opioid medications.

Dr. Deepika Darbari, who is with the hematology society, treats young patients with sickle cell anemia at Children’s National, in Washington, D.C. She said she’s come up against the insurance barrier herself — namely, plans that refused to pay for IV opioids for patients hospitalized with severe pain episodes.

And they’ve cited the CDC guidelines as the reason, Darbari said.

Sickle cell anemia is an inherited disease that causes red blood cells to be crescent-shaped, rather than disc-shaped. The cells also become “sticky” and prone to clotting. Because of poor blood circulation, patients can suffer periodic pain “crises.”

Over time, Darbari explained, sickle cell anemia can cause chronic pain by damaging organs and joints throughout the body.

Patients can first try other pain relievers, like acetaminophen (Tylenol) and ibuprofen (Motrin, Advil), along with nondrug therapies, according to Darbari.

But, she said, some need oral opioids, like Vicodin or OxyContin. And for severe pain episodes, patients may need to be hospitalized and given IV opioids.

The CDC agreed that managing sickle cell pain is complicated. The agency stated in its letter that treatment decisions — and reimbursement — should be based on medical guidelines created specifically for the disease.

Then there is the issue of cancer survivors who suffer lasting pain related to their treatment.

The CDC guidelines specifically said they do not apply to cancer patients undergoing “active treatment.”

“But where does that leave cancer survivors?” said Judith Paice, the lead author of ASCO’s guidelines on treating survivors’ pain.

More and more people are surviving cancer, Paice said — and that means more people living with aftereffects of treatment, which can include chronic pain. Some cancer treatments damage the nerves, for example, leaving people with a form of pain called neuropathy.

Another example, Paice said, relates to the aromatase inhibitors that breast cancer survivors may take for years to cut the risk of recurrence. They can cause chronic joint and muscle pain.

“We have many different options for addressing pain in cancer survivors, and opioids are one,” Paice said.

The CDC guidelines, she noted, were aimed at primary care doctors treating more common problems like lower back pain. Complex pain conditions, like those in cancer survivors, are different, Paice said.

In its letter, the CDC acknowledged that pain in cancer survivors is “unique,” and that guidelines from groups like ASCO offer “useful guidance” on treatment.

Commenting on the letter, the trade group America’s Health Insurance Plans (AHIP) said that health insurance policies have “always” recognized that patients under active cancer treatment do not fall under the CDC guidelines.

Beyond that, the AHIP said, “health insurance providers cover comprehensive, effective approaches to pain management that include evidence-based treatments, more cautious opioid prescribing, and careful patient monitoring.”

The CDC’s letter will be publicly available online, and Darbari said that doctors and patients can cite it if they run into problems with insurance coverage.

Paice called the letter “a beginning.” But she also said the problem is broader: Even when patients are not denied coverage, insurers put up cumbersome prior authorization requirements for opioids — even for refills.

“That can leave chronic pain patients without any medicine,” she said.

Paice said she reminds patients not to wait until their pills are almost gone to get a refill — since they may face delays.

More information

For advice on insurance coverage issues, visit the Patient Advocate Foundation.

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Stories from The Front – What Chronic Pain Patients Are Saying About Suicide

Posted on April 9, 2019 by Pharmaciststeve

Stories from The Front – What Chronic Pain Patients Are Saying About Suicide

www.nationalpainreport.com/stories-from-the-front-what-chronic-pain-patients-are-saying-about-suicide-8839500.html

When our friend, Terri Lewis Ph.D., announced she was looking for data about people with chronic pain who either have considered suicide or whose family member took their own life, we thought we’d help.

She is trying to create a subset of the largest chronic pain survey yet taken to help government regulators and others understand the desperation that the chronic pain community is enduring.

We knew—just knew—that the stories would be painful.

Here are two that we saw:

Kathleen Kaiser

On February 4th, 2019 I attempted suicide by taking a total of 170 opiate tablets. Surprisingly enough I lived. I had my medication reduced from 120 mme to 90 mme about a year ago. During that year I broke a total of eight bones, five of which were vertebrae. The most they would allow me to take while these bones were healing was an extra 15 mme. (two morphine ER and five 10 mg oxycodone) it was all more than I could take and that’s why I finally tried to kill myself. And to be perfectly honest I had been planning this for 6 months. I went through a lot of prep and I did a lot of research.\And I don’t have any opiates now because of what I did.

A reader identified only as Jess: My Brother & I both have/had chronic pain, I guess you could say we have bad genes. After the CDC guidelines was released my brother was abruptly taken off his pain medication in 2016. That same year he tried to commit suicide & was taken to the hospital put in the ICU. Thankfully he didn’t succeed that day. I remember going to the hospital & completely understanding why he wanted so bad not to live anymore. He was alone, abandoned & no Dr or hospital would help his pain. He told me that he felt that there wasn’t a reason to go on, that the pain was just too much. He felt alone! I’m not sure why he was taken off his medications, but I do know that he was doing so much better when he was on his pain medication. My brother was only 35 & he loved helping others, especially the elderly. In fact he would take care of some in his apartment building, that couldn’t help themselves. My brother had a huge heart. On November 2017 the day before Thanksgiving, I got that call. Zack died last night one of my sisters told me, I instantly thought he did it, he committed suicide, but I was wrong. He overdosed on illicit fentanyl & a mix of other drugs were found in his system. This was thus far the worst day of my life! I can’t even imagine what my mom was feeling, having kids myself I just can’t bear to think about losing one of my kids, it’s devastating! I feel my brother would be with us today if he still had his pain medication that gave him a better quality of life. He is missed so very much; my life hasn’t been the same without him. I really hope that something is done to help those of in the chronic pain community & honestly anyone that does have an addiction because they have a illness to it’s just not the same as us chronic pain patients who have been stable for years on pain medication. Who tried every therapy or alternative out there before trying pain medication? Chronic Pain Patients are not the problem!

Editor’s Note: Have you thought about suicide due to chronic pain? Has a loved one? If so, contact Dr. Lewis via email : tal7291@yahoo.com or leave a comment after this story.

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Opioid overdoses: NOT A PRESCRIBING CRISIS – an addiction crisis

Posted on April 9, 2019 by Pharmaciststeve

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An ‘Interview’ With Dr. Andrew Kolodny

Posted on April 9, 2019 by Pharmaciststeve

An ‘Interview’ With Dr. Andrew Kolodny

By Josh Bloom — April 1, 2019

https://www.acsh.org/news/2019/04/01/interview-dr-andrew-kolodny-13921

Dr. Andrew Kolodny, one of the world’s premier experts on addiction and drugs was kind enough to sit down with me to discuss some very tough questions regarding the ongoing opioid crisis in the US. We all owe Dr. Kolodny much gratitude for sharing his wisdom and insight. It is quite revealing.

JB: Good morning, Dr. Kolodny, and thank you so much for finding time in your very busy schedule to speak with me. I’m terribly sorry for being late but some guy pushed me in front of a subway train – again – and I had to stop off at the ER so I could get a Tylenol pill for my crushed femur. I begged for two pills but they called me a junkie and threw me out into the street. Landed on the same leg, which really sucked. Too bad I couldn’t get that second pill. 

AK: You have to be careful with that stuff. Too much Tylenol can give you lung cancer. Or, is it liver damage? Can’t remember. I suppose that if it’s absolutely necessary you could add some acetaminophen to the Tylenol. They work synergistically.

 

JB: But Andrew, Tylenol, and acetaminophen are identical. 

AK: This cannot be true. Look here, I have both. One has a red shiny coating but the other is white.

 

JB: Of course. People make that mistake all the time. But, the active ingredients in the two pills are the same. The company who made the red ones just added the red shell, perhaps to make the pill easier to swallow.

AK: Gee. So *that’s* why they act synergistically. I had no idea.

 

JB: Andrew, that’s not really possible. It takes two different drugs for synergy to be possible. Basic pharmacological principles. 

AK: Pharma… what? I don’t know what that means.

 

JB: It’s OK. No one would expect a psychiatrist to know these things. Pharmacology is the study of the effect of drugs on the body.

AK: Thank you! That is *so* informative. It’s really hard to keep up with all these new technical terms that keep popping up.

 

JB: But the term “pharmacology” was coined in the 19th century.

AK: See what I mean!

 

JB: I apologize in advance because this may be a very sensitive topic, but some people contend that your educational background does not make you qualified to have input into American drug policy. How do you respond to this?

AK: Utter nonsense! I finished in the top 95% of my graduating class at Queens College. My career options were unlimited. To this day I remember exactly what my bocce coach told me at graduation: “It would be a shame if you went into any other field.” I’ll never forget the tears in his eyes when I told him that I’d be going to… what’s that place called?

JB: Do you mean medical school?

AK: Yeah, that’s it. 

 

JB: I don’t need to tell you that you are a very polarizing figure in drug policy today. Some contend that you have stepped up at the perfect time to save America from the ravages of opioid addiction while others criticize your policies as wrong-headed and counterproductive. Putting aside these points of view for a moment, I think it is fair to say that your name and “opioid expert” are almost synonymous. It is nothing short of astonishing that a bocce major from Queens College has become the go-to person on all matters opioid. How did you begin this remarkable journey?

AK: I read an article in TV Guide. It changed my life. 

 

JB: You already have accomplished more in a decade than most of us will ever do in our entire lives. Now that the opioid crisis is over what’s next on the agenda?

AK: That’s a timely question. As we speak, my colleague Jane Ballantyne, who knows almost as much about drugs as I do, and I have begun studying what we believe will trigger the next addiction crisis in the country – Flintstones Vitamins. Another product of big pharma, of course.

 

JB: How’s that going so far?

AK: We’re off to a bit of a rough start. Jane and I both agree that Fred and Wilma are safe enough, provided that they are classified as Schedule II drugs by the DEA. But Jane maintains that Barney, although he should be monitored closely, is safe and effective. To me, Barney is simply a heroin pill. There is no difference. The jury is still out on Dino.

 

JB: Andrew, I can’t thank you enough for allowing me to conduct this fascinating and revealing interview, especially since you undoubtedly headed for the nearest TV camera. I have learned so much and will share your wisdom with all ACSH readers and the pain patients who follow me.

AK: No problem. I sure hope your arm feels better.

JB: Uh, the femur is a bone in the leg.

AK: Whatever. 

 

(HAPPY APRIL FOOL’S DAY!)

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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

Posted on April 9, 2019 by Pharmaciststeve

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm

[4-9-2019] The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our
Disposal of Unused Medicines webpage.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving opioids or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Contact FDA

For More Info
855-543-DRUG (3784)
and press 4
Report a Serious Problem to MedWatch

Complete and submit the report Online.

Download form or call 1-800-332-1088 to

request a reporting form, then complete
and return to the address on the
pre-addressed form, or submit by fax to
1-800-FDA-0178.

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How the CDC Guidelines effected me – Part Two

Posted on April 8, 2019 by Pharmaciststeve

 

This covers how the CDC Guidelines directly effected and further permanently injured me back in 2016 when they were misapplied to Intractable Pain and Chronic Pain Patients across the country. I had been on the same medication at the same dosage for 6 years without them being increased, and was stable with my pain well managed at the time when my doctor was forced to start tapering my dosage down by nearly 50% for NO MEDICAL REASON, And just simply because management was forcing their physicians to adhere to the new CDC Guidelines which were only supposed to be voluntary and not be used as mandatory regulation

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PBM executives are heading to Capitol Hill this week. Here are 4 things to watch

Posted on April 8, 2019 by Pharmaciststeve

PBM executives are heading to Capitol Hill this week. Here are 4 things to watch

https://www.fiercehealthcare.com/payer/pbm-executives-head-to-hill-4-things-to-watch

Pharma CEOs went before the Senate last month, and now it’s PBMs’ turn to be on the hot seat. 

Executives at five pharmacy benefit managers will testify before the Senate Finance Committee on Tuesday in the latest hearing on solutions to drive down drug prices. Express Scripts, CVS Caremark, Humana, Optum and Prime Therapeutics will be represented on the panel. 

Drug rebates—and the Department of Health and Human Services’ plan to eliminate them—are likely to be center stage in the discussion around the role that PBMs play in rising drug prices. PBMs play a shadowy role in the pharmaceutical supply chain and have been a prime target for criticism, especially from drug companies, in the price debate. 

Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., said in a statement upon inviting the PBMs to testify that “middlemen in the healthcare industry owe patients and taxpayers an explanation of their role.” 

RELATED: Pharma CEOs go after familiar target in drug hearings—insurers 

“There’s far too much bureaucracy and too little transparency getting in the way of affordable, quality healthcare,” Grassley and Wyden said. “We’ve heard from pharmaceutical companies, and it’s only fair that the committee has the opportunity to ask questions of other players in the healthcare supply chain.” 

Here are a few things to watch at Tuesday’s hearing: 

1. Breaking into the drug rebate ‘black box’ 

As Grassley and Wyden made clear in their invitation to the PBMs, one of policymakers’ key concerns about drug rebates is the lack of transparency around the negotiations and who gets a cut of the discounts. 

Azar echoed this concern when HHS announced the rebate rule, saying that shining light on this “hidden system of kickbacks to middlemen” is driving up drug costs. 

The central criticism lobbed at PBMs by drug companies is that, because these negotiations happen behind closed doors and are not provided directly to consumers, insurers use the savings to line their own pockets instead of driving down costs for plan members. 

RELATED: Express Scripts hits back at criticisms of PBMs, says it ‘would do just fine’ without drug rebates 

PBMs have hit back at this criticism. The Pharmaceutical Care Management Association launched an ad campaign called #OnYourRxSide to dispute the idea that pharmacy benefit managers are the key driver behind rising drug costs. 

“PBMs have an established and successful track record of implementing consumer-friendly, market-based tools, such as negotiating with drug manufacturers, to lower costs for consumers,” PCMA President J.C. Scott said. 

2. Will eliminating rebates bring down drug costs? Depends on who you ask 

HHS argues that its rule—which would eliminate the anti-kickback protections for rebates and instead provide those legal safeguards to point-of-sale consumer discounts—will drive down drug prices. Drug companies have said the same. 

However, insurers, as one might expect, have disputed that claim. PCMA issued a report on Thursday that analyzes the costs that might be associated with the end of rebates, and it suggests that it could drive up overall drug spending by nearly $200 billion over the next decade. 

RELATED: Winners and losers under bold Trump plan to slash drug rebate deals 

The Centers for Medicare & Medicaid Services Office of Actuary does, to some degree, back up this assertion. An analysis from the actuaries on the rule estimates (PDF) that if the rule were implemented it could drive up overall drug spending by $137 billion by 2029, and Part D spending by $196.1 billion. 

Expect this debate to be a hot topic during the hearing. Coincidentally, the comment period on HHS’ proposed rule ends Monday, so the rule could take effect in short order following the PBMs’ testimony. 

3. The blame game 

Finger-pointing has been the name of the game in this debate, and Tuesday’s hearing is likely to include more of that. At their hearing, drug companies deflected blame for rising drug costs by targeting insurers and PBMs. 

Expect PBMs to return the favor on Tuesday. Industry groups, including PCMA, America’s Health Insurance Plans and the American Hospital Association have had harsh words for drug companies and say that they—not PBMs and payers—are the source of rising costs. 

RELATED: CVS looks to begin rollout of new PBM contracting model in 2019 

“The drugmakers have a long tradition of finger-pointing,” said Erik Rasmussen, AHA’s vice president of advocacy and public policy. “They’ll say it’s everyone’s fault but mine.” 

Of note in this cross-sector blame game is that the hearing panel will be entirely made up of PBM executives, so drug companies will not have the opportunity to respond directly to criticisms of them made at the hearing, paralleling their own hearing where PBMs were unable to counter their claims. 

4. Expect the grilling to be bipartisan

As evidenced by the joint statement, addressing drug prices is of bipartisan interest, and in the Senate Finance Committee’s series of hearings so far, both Democrats and Republicans have been tough on industry players who may have a role in rising costs. 

Though a divided Congress is not likely to undertake a major legislative overhaul, industry experts have noted that action on drug prices is one issue that draws interest from both sides of the aisle. 

It’s an issue that’s also of particular interest to Grassley, who became chairman of the committee this year, as evidenced by the hearings. 

In the statement, the two senators said that “every part of the industry” has a role to play in driving down drug prices, and said they hope PBMs come to the hearing armed with “real information” and will discuss “real solutions.” 

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The Legislature is taking a “ready, fire, aim” approach

Posted on April 8, 2019 by Pharmaciststeve

By CHRIS HOLBROOK
April 05, 2019 – 6:16 PM

A conference committee in the Minnesota Legislature, and/or Gov. Tim Walz, should kill a pair of companion bills on opioid use (SF 751/HF 400) — before the legislation kills victims of chronic pain.

This feels-like-we’re-doing-something-good effort to combat a manufactured crisis will hurt more than it helps. The Legislature is taking a “ready, fire, aim” approach guaranteed to create suffering for Minnesotans who need prescriptions to manage their real pain to sustain a real life.

We are talking about the lives of cancer patients, burn and trauma victims, amputees, and other major surgery patients.

It’s arrogant and ignorant for politicians to say no one needs these pills, they shouldn’t be made, or that one pill is the start of heroin addiction. People turn to street drugs for problems that government ignores, like pain and suffering. Prohibition and taxation do not stop illicit drug use anymore than they stop pain and suffering. Actually, they create it.

Mark Twain popularized the saying that there are “three kinds of lies: lies, damned lies, and statistics.” Quoted numbers from the Centers for Disease Control and Prevention say that 64,000 Americans die annually from drug overdoses. That is all drugs, legal and illegal. Of that, roughly half are by opioids, legal and illegal. Of that 32,000 — close to 90 percent are overdoses of the opioids heroin and fentanyl, leaving around 5,000 deaths per year from solely misusing prescription pills.

By comparison, more than 6,000 people a year commit suicide due to unmanageable pain; 6,000 die riding bicycles; 40,000 in cars; 88,000 from alcohol; and 480,000 from tobacco.

The last report in Minnesota said that 422 state residents died from opioid overdose in a year, legal and illegal. The authorities said that 91 percent of those were fentanyl or heroin. The 38 other deaths were attributed to misused authentic prescriptions.

Is the solution to increase costs on the 99.998 percent who don’t misuse their drugs and who are alive because of these pills?

State Sen. Julie Rosen, R-Vernon Center, authored SF 1098 to force pharmaceutical companies to provide transparency on how they arrive at such high drug prices. Then she authored SF 751 to raise the costs of drugs with $20 million in new annual fees for manufacturers and wholesalers of opioids. This money is slated to create a new government advisory board, with a portion going toward law enforcement. To see how that will work, consider marijuana (which by the way is a gateway off opioids).

No pain patients have been involved in any advisory council or task force making these recommendations. Under the legislation, you would need a state ID to get your prescription (but not for the more dangerous act of voting). Your doctors would be allowed half the number of days to treat pain, or could lose a license and have assets seized, including your private medical records. Several doctors have announced they will no longer treat chronic pain because of the risk of government. In a related story, several heroin dealers have just announced that they will expand their products and services to fill that void.

Let’s use our heads and not just our hearts for once. Urge your legislator and Gov. Walz to stop this illogical, expensive, regressive, misdirected overreaction that will hurt real Minnesotans with real medical pain.

Chris Holbrook is chair of the Libertarian Party of Minnesota.

 

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