20 percent of patients with serious conditions are first misdiagnosed, study says

20 percent of patients with serious conditions are first misdiagnosed, study says

https://www.washingtonpost.com/national/health-science/20-percent-of-patients-with-serious-conditions-are-first-misdiagnosed-study-says/2017/04/03/e386982a-189f-11e7-9887-1a5314b56a08_story.html

More than 20 percent of patients who sought a second opinion at one of the nation’s premier medical institutions had been misdiagnosed by their primary care providers, according to new research published Tuesday.

Twelve percent of the people who asked specialists at the Mayo Clinic in Rochester, Minn., to review their cases had received correct diagnoses, the study found. The rest were given diagnoses that were partly in line with the conclusions of the Mayo doctors who evaluated their conditions.

The results are generally similar to other research on diagnostic error but provide additional evidence for advocates who say such findings show that the health-care system still has room for improvement.

“Diagnosis is extremely hard,” said Mark L. Graber, a senior fellow at the research institute RTI International and founder of the Society to Improve Diagnosis in Medicine. “There are 10,000 diseases and only 200 to 300 symptoms.”

Graber was not involved in the Mayo Clinic research, which appears in the Journal of Evaluation in Clinical Practice.

In 2015, the National Academy of Medicine reported that most people will receive an incorrect or late diagnosis at least once in their lives, sometimes with serious consequences. It cited one estimate that 12 million people — about 5 percent of adults who seek outpatient care — are misdiagnosed annually. The report also noted that diagnostic error is a relatively under-measured and understudied aspect of patient safety.

According to previous research cited in the new study, diagnostic errors “contribute to approximately 10 percent of patient deaths” and “account for 6 to 17 percent of adverse events in hospitals.” Graber estimates that the rate of misdiagnosis, although difficult to determine, occurs in 10 percent to 20 percent of cases.

“Diagnostic error is an area where we need more research, more study and more information,” said James M. Naessens, a professor of health services research at the Mayo Clinic, who led its study. “The second opinion is a good approach for certain patients to figure out what’s there and to keep costs down.”

The researchers looked retrospectively at 286 patients who had seen primary-care physicians, physician assistants and nurse practitioners in 2009 and 2010. Nearly two-thirds were younger than 64, and most were female.

With or without the help of their initial provider, those people sought additional advice from the Mayo Clinic’s internal medicine department. That makes the group somewhat different from the general population, Naessens said, because their conditions were serious enough to merit another look by some of the best physicians in the country.

 

“It’s not going to be 20 percent wrong every time” a patient goes to see a doctor, Naessens said.

In 62 cases (21 percent), the second diagnosis was “distinctly different” from the first, the researchers reported. In 36 cases (12 percent), the diagnoses were the same. In the remaining 188 cases, the diagnoses were at least partly correct but were “better defined/refined” by the second opinion, according to the study.

Naessens and Graber said a second opinion is valuable any time a patient is told he or she has a serious condition, such as cancer, or needs surgery — even if an extra visit initially means more expense. In the long run, additional advice can save lives and money, they said.

“Doctors are humans, and they make the same cognitive mistakes we all make,” Graber said. “If you are given a serious diagnosis, or you’re not responding the way you should [to medication], a second opinion is a very good idea. Fresh eyes catch mistakes.”

 

Dealing with the CMS’ FIVE STAR RATING SYSTEM

CMS (Centers for Medicare and Medicaid Services) has implemented a FIVE STAR RATING SYSTEM for all those providing care to those pts covered by Medicare/Medicaid/Medicare Advantage.

More STARTS means that the vendor GETS HIGHER REIMBURSEMENTS. Pts file GRIEVANCES to CMS ( www.cms.gov or 800-MEDICARE) about poor/unacceptable service will lower the vendor’s star rating… They get LESS MONEY !

There are a few disease states that CMS is focused on “helping” pts manage and part of that “management” is to make sure that you regularly take your medication.  http://pqaalliance.org/measures/cms.asp

Barb was getting supper ready and HER CELL PHONE RANG and so I answered it… the woman on the other end ask to speak to me… and identified herself as working for our Part D provider.

All she asked for ID verification from me was the YEAR I was born in…  not exactly EXTREME VETTING .. since she was going to discuss medication that I was taking.

She asked me if the number she called was a good number.. I told her NO.. since it was my wife’s cell phone .. which she seldom answers… you would think that she would then ask me a BEST NUMBER… but NOT HER…

She proceeded to inform me that one particular medications was DUE FOR A REFILL and named the pharmacy that we use.  I knew that I had a few weeks worth of medication on hand and told her such… We normally get 90 days supply of chronic medication and the rules of this part D provider is that you can refill a prescription when 80% of the previous fill would have been taken… meaning that you can refill a prescription 18 days early.

It is normal for me if Barb has some refills… if I have some medications within the 18 day window… I will go ahead and refill them..  I did however look at the prescription bottle that they were referring to and technically I would not be out of medication for ANOTHER WEEK…

I find it hard to believe that this Part D provider really cares about my health, but more interested in their FIVE STAR RATING and their bottom line… since I have used this Part D provider for nearly FIVE YEARS and this is the first time that I have received a call from them about getting my prescription(s) refill on time.

My money is on that it would have to snow in July before they called me about refilling a controlled substance.

To me, this demonstrates how important it is for pt with Medicare/Medicaid/Medicare Advantage that they should file GRIEVANCES with CMS when they do not receive proper care from a hospital, prescription, Part D insurance, pharmacies and others.  Remember healthcare is nothing more than a FOR PROFIT BUSINESS and putting “dings” on their FIVE STAR RATING … that will lower their reimbursements… is the only leverage a pt has.

 

DEA’s position is an example of bureaucracy that clearly thwarts the will of Congress and disadvantages American farmers

NC hemp commission considers joining lawsuit against DEA

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

The state commission charged with fostering an industrial hemp industry in North Carolina is considering joining a lawsuit against a government agency that it agrees is making things difficult: the U.S. Drug Enforcement Administration

The N.C. Industrial Hemp Commission, which was created by the General Assembly in 2015, gave its verbal support to the lawsuit last week and plans to announce Thursday whether it will become a party to it.

The lawsuit would be filed by Founder’s Hemp of Asheboro – the first company to register in North Carolina as an industrial hemp producer. The company says it intends to sue the DEA over its ruling that products made with CBD or cannabidiol hemp, which are in the same cannabis family as marijuana, are illegal and cannot be transported across state lines.

“We cannot let this stand as an industry,” Bob Crumley, president of Founder’s Hemp, said during a meeting of the Industrial Hemp Commission last week. “If we let what the DEA is currently doing stand, we need to fold our tents and give everybody their money back.”

The federal government outlawed the growing of hemp in 1937. But with the 2014 Farm Bill, Congress allowed universities and state departments of agriculture to grow industrial hemp for research, and more than 30 states, including North Carolina, have passed laws allowing hemp research and pilot programs.

But the DEA has maintained that the transportation of hemp seeds across state lines is illegal, and that it is illegal for farmers to sell their finished hemp products in other states within the U.S.

Crumley said the DEA’s position is based on the antiquated idea that “all cannabis is bad.” He noted that hemp contains negligible amounts of THC, the psychoactive chemical that provides the “high” associated with marijuana use; industrial hemp has less than 0.3 percent of THC, compared to 3 to 15 percent or higher in marijuana.

Crumley said that the DEA’s position is an example of bureaucracy that clearly thwarts the will of Congress and disadvantages American farmers.

“To say that a Canadian farmer has more rights in this market than a farmer from North Carolina or Kentucky does – it’s ridiculous,” Crumley said. “It’s abhorrent.”

The DEA did not respond to multiple requests for comment.

Talk of the lawsuit comes as farmers are lining up to grow and sell hemp under North Carolina’s test program. Last week, the Industrial Hemp Commission approved applications from 16 growers who said they would import hemp seeds from outside of the U.S., which the DEA has ruled is legal. The commission delayed the approval of the six applicants that listed their seed source as within the U.S. and said it will decide what to do with those applications at its meeting Thursday.

Hemp is a versatile plant used in the manufacture of fabrics, fuels, plastics and construction materials, among others products. CBD hemp oil is a nutritional supplement with anti-inflammatory properties that been marketed as having the potential to soothe chronic pain.

Vernon Cox, director of the plant industry division at the N.C. Department of Agriculture and Consumer Services, said grower interest in hemp has been high. The agriculture department, which is charged with serving as staff for the Industrial Hemp Commission, has reviewed 40 to 50 applications from farmers hoping to grow it.

Cox said the “safest option” for growers at this point is to import seed from Europe or Canada.

Meanwhile, Tom Melton, the chairman of the commission, said it would need to consult its lawyers to determine whether it could join the Founder’s Hemp suit as a complainant, as Crumley requested.

“We’re just not quite sure where we fall in being able to support them in litigation, so we had a motion and voted to support them verbally – to let everyone know that we support where they stand,” said Melton, deputy director of N.C. Cooperative Extension at N.C. State University. “But whether or not we can actually be part of litigation, we have to find out from our state attorneys really how that falls out.”

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

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.

FILE - In this June 11, 2009 file photo, Dr. Scott Gottlieb, left, is seen on Capitol Hill in Washington. A White House official says President Donald Trump is choosing Gottlieb, a conservative doctor-turned-pundit with deep ties to Wall Street and the pharmaceutical industry to lead the powerful Food and Drug Administration (FDA).  (AP Photo/Harry Hamburg, File)

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.

A 2016 investigation by the Charleston Gazette-Mail found that these three companies supplied unusually large shipments of prescription painkillers in West Virginia, and provided the bulk of 780 million prescription pills sent to pharmacies in the state, a key factor in the fatal overdose epidemic.

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.

Class action RICO lawsuit filed against Mylan and PBM’s

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.

 

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

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/

While Attorney General Jeff Sessions was busy publicly reminding America just how much he hates marijuana legalization—facts, data and public sentiment be damnedfederal law enforcement officials with Sessions’s Justice Department were probing pending marijuana-related court cases in Colorado, the International Business Times is reporting.

This revelation came Friday courtesy of the IBT’s David Sirota, who obtained an email exchange between one of Sessions’s people and Colorado officials. The one-page email is brief and is only an information request, but it’s one of the first concrete signs of federal interest in state-level cannabis under the Trump era. Which means it’s guaranteed to make marijuana industry types worried about a job-killing federal crackdown a little more nervous.

“Are you able to provide me the state docket numbers for the following cases?” a Denver-based DEA agent asked a Colorado state prosecutor on March 6, according to the email exchange, obtained via a public-records request. “Some of our intel people are trying to track down info regarding some of DEA’s better marijuana investigations for the new administration. Hopefully it will lead to some positive changes .”

 As IBT noted, the exchange came about two weeks after White House press secretary Sean Spicer first raised the specter of “greater enforcement” around legal marijuana on Feb. 23. The next several weeks were full of public sabre-rattling from Sessions, who sought counsel from the attorney general of nearby Oklahoma—one of the litigants of a (failed) lawsuit filed against Colorado for the purposes of shutting its marijuana industry down—before comparing marijuana unfavorably to heroin.

So what does this mean—and is it a sign of impending cannabis armageddon, preparation for the first shots in an all-out federal marijuana war? If you allow us to speculate (and you have no choice in the matter), we believe this email is fairly innocuous, and the answer to our rhetorical question is no.

The cases referenced by the DEA are ongoing prosecutions. These are situations in which the state of Colorado, where marijuana is legal, has identified illegal activity pertaining to marijuana. We don’t know what cases the DEA agent is asking about—Sirota and IBT do not say—but we suspect it stems from one of the many multi-agency raids from last year.

The DEA was a partner agency on at least a few of them, but all of them targeted illegal cultivation and interstate marijuana trafficking. Twenty more sites were raided by DEA agents working with local law enforcement in mid-March, 10 days after the email, but a DEA spokesman told the AP at the time that those raids were in the works for “months” and did not have anything to do with a Trump-era directive

However, the DEA agent is asking for publicly available information—which is exactly what a DEA agents did in San Francisco in 2011-2013. In California, DEA agents requested public records about city-licensed marijuana dispensaries; in some cases, a few months later, the landlords of those dispensaries received letters from the local U.S. attorney, informing them that the marijuana stores needed to be closed, otherwise the landlords’ property could be seized and the landlords thrown in jail.

Many did close, though no operators were arrested. But that was about the worst it ever got for legal marijuana under the Obama administration, which largely gave up on state-licensed cannabis dispensaries after Colorado and Washington legalized adult-use marijuana in November 2012.

But back to the present. Sessions also allowed himself a candid slip when he admitted that neither he nor all the 4,000 DEA agents in the world are enough to stop legal cannabis.

Seven states have legalized adult-use marijuana, and more than 40 allow some form of medical cannabis. It’s too little, too late—but as we’ve said before, this doesn’t mean that there won’t be a few more drug war casualties just before the eleventh hour. Or merely plenty Sessions-induced paranoia, which—for now—this email exchange is a part.

You can keep up with all of HIGH TIMES’ marijuana news right here.

Source: hightimes.com

 

Attorneys will sue for causing peripheral neuropathy but not for refusing to treat it ?

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.

###

Contact Drug-Lawsuits.org:

info@drug-lawsuits.org

Drug War Hidden History

Arthur, Drugs, and Drunk: DRUG WAR HIDDEN HISTORY
 The DEA, Nixon's Pills, & Black People
 In 1973 President Richard Nixon created the DEA claiming there
 was a junkie explosion with 8x as many heroin addicts as 2 years
 earlier (a complete lie), and that drugs were "decimating a
 generation of Americans." (At the time, far more Americans
 were dying from choking on food or falling down stairs.)
 In reality, Nixon saw the DEA as a jurisdiction-free police force
 that would indirectly target blacks saying, You have to face the
 fact that the whole problem is really the blacks. The Key is to
 devise a system that recognizes this all while not appearing to.
 While
 President
 Nixon would
 get drunk and
 Pop pills from his
 private stash. He never
 had himself arrested
 Brought to you by You
 Die The Burden of Modern Taboos
 by Robert Arthur
 Narco Polo (blog suburta.com)
EndAllWars

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

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

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.

The painful truth