NC hemp commission considers joining lawsuit against DEA

http://www.newsobserver.com/news/business/article142568559.html

RALEIGH

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Donald Trump’s Pick to Oversee Big Pharma Is Addicted to Opioid-Industry Cash

https://theintercept.com/2017/04/04/scott-gottlieb-opioid/#comment-381880

Newly-released financial disclosure documents show that Dr. Scott Gottlieb, President Trump’s nominee to the lead the Food and Drug Administration, has received significant payments from the opioid industry — while attacking attempts to deter the explosion of opioid pill mills.

The FDA has some of the most significant authority in the federal government to oversee manufacturers of prescription painkillers. Gottlieb is set to appear for his confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee at 10 a.m. tomorrow.

Gottlieb’s disclosure statements, required under federal law, show that since the beginning of 2016 he has received almost $45,000 in speaking fees from firms involved in the manufacture and distribution of opioids.

“Our country is in desperate need of an FDA commissioner who will take on the opioid lobby, not one who has a track record of working for it,” said Dr. Andrew Kolodny, the co-director of Opioid Policy Research at Brandeis University, reacting to this information.

Mallinckrodt Pharmaceuticals, the maker of a highly addictive generic oxycodone pill, paid Gottlieb $22,500 for a speech in London last November shortly after the U.S. presidential election. Prosecutors have charged that the firm ignored red flags and supplied as many as 500 million suspicious orders in Florida for its oxycodone product between 2008 and 2012. Mallinckrodt reached a tentative settlement this week, agreeing to pay $35 million while admitting no wrongdoing.

The Healthcare Distributors Alliance, a trade group for the largest opioid wholesale distributors in America, also retained Gottlieb as a speaker last September.

Dr. Scott Gottlieb, left, is seen on Capitol Hill in Washington in 2009.

Photo: Harry Hamburg/AP

Among the distributors represented on the HDA executive committee are AmerisourceBergen Drug Corp., McKesson Corporation and Cardinal Health. Cardinal’s CEO, Jon Giacomin, is chairman of HDA.

Cardinal Health also temporarily lost its license to distribute opioids from its Florida warehouse in 2012 after the Drug Enforcement Administration found that the firm supplied several pharmacies known to act as so-called pill mills that routinely filled inappropriate prescriptions for oxycodone.

Gottlieb swiftly condemned the DEA’s action at the time, writing in the Wall Street Journal that the agency had overstepped its bounds, and that it should lose its authority to police the opioid market.

Gottlieb argued that the DEA should not treat corporate pharmaceutical firms like street drug dealers. “So Cardinal isn’t a Colombian drug ring. Its CEO isn’t Pablo Escobar. Like other large distributors, Cardinal has invested heavily in systems to track unusual narcotics-sales patterns,” said Gottlieb.

Gottlieb was also paid as a speaker by Johnson & Johnson, which owns a subsidiary that produces the opioid painkiller Nucynta, in January of last year. The federal drug payment disclosure database shows that Gottlieb received payments from Pfizer, the manufacturer of several opioid products, in 2015.

On a call with reporters on Tuesday, Sens. Ed. Markey, D-Mass., and Sherrod Brown, D-Ohio, announced their opposition to Gottlieb’s nomination, citing his opioid industry ties.

“People die because of the opioid epidemic,” said Brown. “We need all hands on deck to fight this crisis, including and especially the FDA. Unfortunately Dr. Gottlieb’s record indicates that as commissioner he wouldn’t take the epidemic and the FDA’s authority to rein in prescription painkillers and other drugs seriously enough.”

Markey, who opposed President Barack Obama’s last FDA commissioner, Dr. Robert Califf, on grounds that the agency was moving too fast to approve dangerous new prescription painkillers, voiced similar concerns over Trump’s nominee.

“Dr. Gottlieb has also said he wants the FDA approval process to move faster, and that FDA has too high of a standard for safety. I strongly disagree with that,” said Markey during the call.

The opioid crisis claims more than 16,000 lives from overdose deaths every year. The crisis stems in large part to the over-prescribing phenomenon, which has been fueled by deceptive marketing practices and efforts by industry to court doctors. As we’ve reported, Americans consume about 81 percent of the global supply of oxycodone products (the active ingredient in OxyContin) and almost 100 percent of hydrocodone (the active ingredient used in brands such as Vicodin).

The painkiller crisis is closely linked to heroin addiction, with many heroin users embracing the drug after first using opioids that were prescribed to them.

Gottlieb’s financial disclosure form further shows that he made more than $3 million throughout 2016 and the first three months of this year, through a combination of speaking fees, consulting arrangements with drug companies in general, board memberships, and his work at several healthcare-focused investment firms. Gottlieb is well-known as a critic of the FDA approval process and regulations, and has called for revamping agency rules to bring new drugs to market. In sharp contrast to Trump’s rhetoric on the campaign trail, Gottlieb has also criticized a range of proposals to bring down drug costs through government intervention in the market.

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The maker of the EpiPen is being sued under a law that’s typically used to take on organized crime

http://www.businessinsider.com/mylan-class-action-lawsuit-over-epipen-2017-4

Christina Kollmeyer’s son has a allergy that requires him to carry an EpiPen, the emergency auto-injecting devices available that can be used to treat severe allergic reactions.

When Kollmeyer, who has a high-deductible health plan, picked up her son’s prescription in January, she paid $735.09 for two two-packs of the devices.

That’s up from the $313.38 she paid for the same amount in October 2016. 

Now, Kollmeyer is one of three women taking the fight to the company that makes the EpiPen: Mylan. 

Kollmeyer, along with Amber Rainey and Lisa Vogel, filed a class-action lawsuit on Monday in Tacoma, Washington that claims EpiPen-maker Mylan engaged in a scheme with pharmacy benefit managers, or PBMs — companies that act as intermediaries between pharmacies, insurers and drug companies — to dominate the market and overcharge consumers.

“As a result of Defendant’s scheme, Ms. Kollmeyer overpaid for EpiPens,” the complaint said. The women involved in the suit paid anywhere from $53.94 to $453.49 for two-packs of the EpiPen and EpiPen Jr. 

This isn’t the first time a citizen has filed a lawsuit over the price of the EpiPen. In September, an Ohio woman filed a case against Mylan claiming the price increases violated Ohio’s consumer protection law. 

Monday’s, however, is the first to focus on the role of PBMs and to bring claims under the Racketeer Influenced and Corrupt Organizations Act, a federal law historically used against organized crime. 

Mylan spokeswoman Nina Devlin declined to comment.

Mylan was called out in August 2016 for raising the price of the EpiPento $608.61 from $93.88 over the past decade. It caught the nation’s attention because parents were refilling their kids’ prescriptions, and some found that they were on the hook for hundreds of dollars for the device. The company now sells a $300 generic version.

The plaintiffs in Monday’s lawsuit say Mylan paid large rebates to PBMs so they would favor EpiPen over competitors. In helping Mylan control 95 percent of the epinephrine auto-injector market, the rebates artificially inflated EpiPen’s sticker price, resulting in higher costs for many patients, the suit said.

The lawsuit says the three largest U.S. pharmacy benefits managers – CVS Caremark, part of CVS Health; Express Scripts Holding Co and OptumRX, part of UnitedHealth Group Inc – aided Mylan’s alleged scheme. PBMs may later be added as defendants on the lawsuit, The Wall Street Journal reports. 

Pharmacy benefit managers are the companies responsible for negotiating rebates to the prices drugmakers set, and are meant to favor the most effective drug. This is meant to help keep prices low. Many question how effective they are at doing that, however and some have said they could be part of the reasonwhy prices are skyrocketing.

The plaintiffs are seeking damages to represent a nationwide class of EpiPen purchasers.

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Hint of a Trump Marijuana Crackdown? DEA Probes Colorado Cannabis Cases

www.medicalmarijuana.com/hint-of-a-trump-marijuana-crackdown-dea-probes-colorado-cannabis-cases/

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Levaquin Lawsuit In Minnesota Moves Forward

http://www.digitaljournal.com/pr/3292665

A number of lawsuits are currently running that involve Avelox, Cipro, and Levaquin, in which the plaintiffs all claim that the drugs contributed to the development of peripheral neuropathy. The U.S. District Court, District of Minnesota, has recently moved forward another Levaquin lawsuit and provided an update on the state of affairs. Specifically, it has been reported that 738 individual lawsuits are currently pending in relation to fluoroquinolone, most of which are against Janssen Pharmaceutical, which produces Levaquin.

Plaintiffs’ attorneys are currently conferring and meeting with the defense on bellwether trial proposals. These involve 14 individual lawsuits in Pennsylvania’s Court of Common Pleas. It is believed that the counsel will ask the federal court to liaise with state court in order to schedule the cases.

Levaquin is a type of antibiotic with fluoroquinolone as its active ingredient. This is one of the most commonly prescribed antibiotics in this country, with millions of Americans using it, particularly for the treatment of bacterial infections, STDs, and pneumonia. However, recently, there have been concerns about the side effects of these types of drugs, suggesting that they outweigh the potential benefits.

The FDA stated in 2016 that fluoroquinolone should not be prescribe to anyone who has uncomplicated UTIs, acute bronchitis, or acute sinusitis, particularly when other options are available. The FDA has stated that the drug’s potential side effects, which affect the central nervous system, nerves, joints, muscles, and tendons, are unacceptable. Several patients claim that these side effects have proven to be permanent. The FDA has instructed drug manufacturers, including Janssen Pharmaceutical, to update their black box warning to reflect this.

In 2013, the FDA also ordered pharmaceutical companies to make the warnings about peripheral neuropathy more visible on their labels. This was after it was found that the original description did not indicate how quickly neuropathy can start, nor that it could be permanent. Manufacturers were also ordered to no longer classify it as a “rare” side effect. Additionally, patients often wonder why is peripheral neuropathy worse at night, which underscores the importance of clear and thorough warnings about the condition.

In the various lawsuits that Janssen Pharmaceutical is facing, the plaintiffs claim that the manufacturer knew of the potential risks associated with taking Levaquin, with knowledge existing since the 1990s. They also state that, despite orders from the FDA, current warnings remain confusing and inadequate.

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Contact Drug-Lawsuits.org:

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me.me/i/drug-war-hidden-history-the-dea-nixons-pills-black-12367494

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The DEA’s case against Mallinckrodt has odd parallels to the gun industry

http://hotair.com/archives/2017/04/03/the-deas-case-against-mallinckrodt-has-odd-parallels-to-the-gun-industry/

This is one of those stories which has been percolating on the back burner of national news coverage for years and may now be coming to a close. Beginning early in the Obama administration, the Drug Enforcement Agency (DEA) began pursuing possible charges against pharmaceutical giant Mallinckrodt, the major producer of oxycodone. In response to an epidemic of these pills mysteriously showing up on the black market for illegal sale (what the industry refers to as “diversion”) and subsequently leading to high numbers of overdose deaths, the DEA sought to find out if the manufacturer was somehow responsible. Now, as detailed in this special report at the Washington Post, there’s apparently going to be an unofficial but extremely expensive “settlement” which will make the whole thing go away.

To combat an escalating opioid epidemic, the Drug Enforcement Administration trained its sights in 2011 on Mallinckrodt Pharmaceuticals, one of the nation’s largest manufacturers of the highly addictive generic painkiller oxycodone.

It was the first time the DEA had targeted a manufacturer of opioids for alleged violations of laws designed to prevent diversion of legal narcotics to the black market. And it would become the largest prescription-drug case the agency has pursued…

But six years later, after four investigations that spanned five states, the government has taken no legal action against Mallinckrodt. Instead, the company has reached a tentative settlement with federal prosecutors, according to sources familiar with the discussions. Under the proposal, which remains confidential, Mallinckrodt would agree to pay a $35 million fine and admit no wrongdoing.

The opioid epidemic is nothing to joke about, so the initial investigation clearly had merit. But all along there seemed to be an obvious question hanging over the investigation. If Mallinckrodt was producing a legal product (which they were) and it was winding up on the streets in the hands of drug dealers, how did the pills get “diverted” from the normal delivery process? If it could be shown that Mallinckrodt executives or sales people were shipping tons of the drugs to some gang lords outside of Miami then the case would be pretty clear. Lock ’em up! But if they were following the rules, how were they responsible?

It all seems to boil down to some rather vague instructions from the FDA which require manufacturers to report instances where there are “unusual” ordering patterns from customers. The customers in this case are legally authorized distributors who purchase the medicine in bulk and then market the pills to doctors, hospitals, pharmacies, etc. In the case of the oxycodone, some big orders were coming in from Florida and eventually winding up on the streets. But at the same time, it was being reported years ago that doctors were writing alarming numbers of prescriptions for the drug. It was a booming business and the distributors were obviously ordering record amounts of the pills. What qualifies as “unusual” under those circumstances?

This sounds suspiciously similar to efforts to impose massive fines and penalties on firearms manufacturers when they produce a legal product which winds up in the wrong hands. (See the Newtown lawsuit for only one of many examples.) If the firearm was legally allowed under the law but someone else then either sold it to a criminal or a person legally purchased it and committed a crime, that’s not the fault of the manufacturer. Why would we be applying a different standard to a drug manufacturer? This might be a sign that we need something along the lines of a Protection of Lawful Commerce in Pharmaceuticals Act.

Instead, we wind up with the odious resolution which the Mallinckrodt investigation is set to produce. They end up in a situation where they “admit no wrongdoing” but still have to shell out tens of millions of dollars to the DEA. If they didn’t do anything wrong, why are they paying all that money? And if they actually did break the law, shouldn’t the government have to prove that in court? The entire thing stinks on ice if you ask me.

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Woman’s online journal of disorder paves way for new medical courses

http://www.kpaddock.org/

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“Opioid painkillers cause chronic pain” stories leave physician reader in agony

www.healthnewsreview.org/2016/06/opioid-painkillers-cause-chronic-pain-stories-leave-physician-reader-in-agony/

When writing in 1953 of the structure of deoxyribonucleic acid (DNA), Watson and Crick concluded: “It has not escaped our notice that the specific pairing that we have postulated immediately suggests a possible copying mechanism for the genetic material.”

Words like “postulated,” “suggests,” and “possible” seem quaint in 2016.  Instead, we have researchers and their accomplices in the news media who trumpet “game-changing” “breakthroughs” on daily basis – often with the flimsiest of scientific support.

The latest example: opioids causing pain

Consider the headlines generated this week by a study which documented a phenomenon known as opioid-induced hyperalgesia. This is the idea that opioid medication, instead of calming pain, might actually make pain worse.

Denver Post: CU Boulder study: Narcotic painkillers cause chronic pain

FOX News: Opioids may prolong chronic pain, study suggests

Washington Post: Opioid paradox: Could morphine use hurt as much as it helps by prolonging chronic pain?

Forbes: Prescription painkillers may worsen and lengthen chronic pain

Much has been made of opioid-induced hyperalgesia. Whether it is clinically important for patients with chronic pain on standard opioid medication is unclear. Even the most recent reviews of this phenomenon are unable to determine its prevalence (see here and here), and studies have generally been experimental in nature or with unusual administration of opioids (for example, the drugs have been administered intrathecally; that is, via direct injection close to the spinal cord).

A closer look at the study

As it so happens, the new Proceedings of the National Academy of Sciences study being reported on also involved intrathecal administration of medication.

Not only that, but the study also involved rats who had sutures tied around their sciatic nerves.

The sciatic nerve was tied and the animals were left in pain for 10 days. Then, the researchers administered morphine directly to spinal cords of these rodents for 5 days.

Their conclusion? “That morphine increased the vigor and speed of hindpaw withdrawal to the von Frey filaments in SD rats was supported by increased startle (converted to force; N) to a 0.2-mA shock.”

In other words, the rats that received the morphine showed increased sensitivity to a plastic “hair” and an electric shock.

Use of rat models to help elucidate human disease is nothing new. But use of rats to claim that the study’s “implications for people taking opioids like morphine, oxycodone and methadone are great, since we show the short-term decision to take such opioids can have devastating consequences of making pain worse and longer lasting” is nothing short of ridiculous and harmful.

A PR news release drives the narrative

That sensational quote, originating in the University of Colorado Boulder news release, was subsequently picked up by the Denver Post and a variety of other outlets that covered the story. While most of this coverage did acknowledge (in the body text of the story) that the study involved rodents, few stories pushed back against the researchers’ attempts to draw a straight line from this animal study to humans. Readers drew the same straight line: Of the over 300 reader comments on the Denver Post article alone, almost all are about humans, not rats.

Science magazine was one of those rare outlets that provided the perspective of an independent expert, who offered the following indispensable context:

The finding certainly shouldn’t be the basis for withholding opioids from people in pain, says Catherine Cahill, a neuroscientist at the University of California, Irvine. These drugs also work to block the emotional component of pain in the brain, she notes—a form of relief this study doesn’t account for. And opioids might not prolong pain in humans the way they did in these rats, she says, because the dosing of morphine and its quick cessation likely caused repeated withdrawal that can increase stress and inflammation. Humans usually don’t experience the same withdrawal because they take sustained-release formulations and taper off opioids gradually.

What’s more, none of the coverage that I saw tried to put this 5-day rat study into any appropriate historical perspective. Opium-derived products have been used to relieve pain since ancient times. Opium was one of the only medications not consigned to the bottom of the sea by Oliver Wendell Holmes in 1860. Morphine has been on the World Health Organization’s list of essential medicines since its inception. Yet opioids are not available to 5 billion people with consequent unmitigated pain and suffering. The American Geriatrics Society has determined opioids to be a potentially “indispensable” treatment for selected patients. British geriatric guidelines are similar. While advocating their judicious use, Canadian guidelines note that “opioids can be an effective treatment for chronic non-cancer pain (CNCP) and should be considered.”

Consider the CDC context

This rat study and the related coverage aren’t taking place in a vacuum. They’re taking place amid the CDC’s recent recommendations for the use of opioids in chronic pain — guidelines that excluded a Cochrane review showing effectiveness. The CDC took the acknowledged limited study in this area and interpreted it as evidence only of harm. Can harms happen with chronic opioid use? Yes. Can benefits also happen? Yes. By not acknowledging this dual truth, the CDC recommendations – and especially the rhetoric that has surrounded them (e.g. “prescription opioids are just as addictive as heroin”) – risk creating more heat than light.

This is in contrast to the National Institutes of Health 2014 report “Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain.” The report found that:

Patients, providers, and advocates all agree that there is a subset of patients for whom opioids are an effective treatment method for their chronic pain, and that limiting or denying access to opioids for these patients can be harmful.

… Biased media reports on opioids also affect patients. Stories that focus on opioid misuse and fatalities related to opioid overdose may increase anxiety and fear among some stable, treated patients that their medications could be tapered or discontinued to “prevent addiction.”

The CDC guidelines also excluded acute pain. I’m not sure how 10 days of sudden unrelieved pain is considered by a rat, but it sounds acute to me.

Here we see in miniature the flaws of basic science and public health policy alike in their promulgation of questionable “evidence.”  A rat study headlined “Narcotic painkillers cause chronic pain” – that  doesn’t mention the rat subjects – is the latest example of the pendulum being pulled back so far it is straining credulity as well as contributing to people’s suffering.

The next time a patient of mine becomes a rat, has its sciatic nerve constricted with sutures, and asks for 5 days of morphine near its spinal cord 10 days later, maybe I’ll take another look at this study. In the meantime, I’ll tell my patients to ignore the unbalanced news coverage that the research spawned. I’ll also follow universal precautions in prescribing opioids, listen carefully to my patients and their context, work to find the best approach for mitigating their pain, limit side effects and untoward outcomes, respond effectively should they occur, and practice with a compassion not shown to these rats.

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