State Legal Restrictions and Prescription- Opioid Use among Disabled Adults

Posted on July 5, 2016 by Pharmaciststeve

State Legal Restrictions and Prescription- Opioid Use among Disabled Adults

CONCLUSIONS
Adoption of controlled-substance laws was not associated with reductions in potentially hazardous use of opioids or overdose among disabled Medicare beneficiaries, a population particularly at risk. (Funded by the National Institute on Aging and others.)

The New England Journal of Medicine

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Chronic fatigue syndrome is in your gut, not your head

Posted on July 5, 2016 by Pharmaciststeve

Chronic fatigue syndrome is in your gut, not your head

https://www.sciencedaily.com/releases/2016/06/160627160939.htm

Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn’t alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.

Now, for the first time, Cornell University researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.

In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.

“Our work demonstrates that the gut bacterial microbiome in chronic fatigue syndrome patients isn’t normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease,” said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics at Cornell and the paper’s senior author. “Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin.”

“In the future, we could see this technique as a complement to other noninvasive diagnoses, but if we have a better idea of what is going on with these gut microbes and patients, maybe clinicians could consider changing diets, using prebiotics such as dietary fibers or probiotics to help treat the disease,” said Ludovic Giloteaux, a postdoctoral researcher and first author of the study.

In the study, Ithaca campus researchers collaborated with Dr. Susan Levine, an ME/CFS specialist in New York City, who recruited 48 people diagnosed with ME/CFS and 39 healthy controls to provide stool and blood samples.

The researchers sequenced regions of microbial DNA from the stool samples to identify different types of bacteria. Overall, the diversity of types of bacteria was greatly reduced and there were fewer bacterial species known to be anti-inflammatory in ME/CFS patients compared with healthy people, an observation also seen in people with Crohn’s disease and ulcerative colitis.

At the same time, the researchers discovered specific markers of inflammation in the blood, likely due to a leaky gut from intestinal problems that allow bacteria to enter the blood, Giloteaux said.

Bacteria in the blood will trigger an immune response, which could worsen symptoms.

The researchers have no evidence to distinguish whether the altered gut microbiome is a cause or a whether it is a consequence of disease, Giloteaux added.

In the future, the research team will look for evidence of viruses and fungi in the gut, to see whether one of these or an association of these along with bacteria may be causing or contributing to the illness.

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Lyrica may be linked to Birth Defects

Posted on July 5, 2016 by Pharmaciststeve

Drug Used for Pain, Anxiety May Be Linked to Birth Defects

http://www.painmedicinenews.com/Clinical-Pain-Medicine/Article/07-16/Drug-Used-for-Pain-Anxiety-May-Be-Linked-to-Birth-Defects/36827/ses=ogst

The drug pregabalin (Lyrica, Pfizer), commonly used to treat pain, epilepsy, anxiety and other brain health disorders, may be associated with an increased risk for major birth defects (Neurology 2016 May 18. [Epub ahead of print]).

Pregabalin is approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy and pain after shingles or spinal cord injury. It also is used off-label for generalized anxiety disorder and other mental health issues.

Pregnancies of the women who took pregabalin during the first trimester were three times more likely to result in major birth defects than those of the women who did not take antiseizure drugs. Seven of the 116 pregnancies in women taking antiseizure drugs (6%) had major birth defects, compared with 12 of 580 pregnancies (2%) in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.

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The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the CNS than the women who were not taking the drug, with four CNS defects out of 125 pregnancies (3.2%) compared with three CNS defects out of 570 pregnancies (0.5%).

“Pregabalin should be prescribed for women of childbearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital, in Switzerland.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain; 39 for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis; five for epilepsy; and one was taking it for restless legs syndrome.

A total of 77% of the women started taking pregabalin before they became pregnant. The women in the study stopped taking the drug at an average of six weeks into their pregnancies. Of the women taking pregabalin, 22 (13%) also were taking another antiseizure drug.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects, and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” Dr. Winterfeld said.

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State of denial ?

Posted on July 5, 2016 by Pharmaciststeve

img20160705_0144img20160705_0145

 

 

 

 

 

 

 

 

 

 

 

Click on image to enlarge…

These is two letters that I received today as email attachments about forged Rxs floating around Kentucky. Notice that both letters remind Pharmacists to get ID’s on all controlled Rxs.  Just read all the illegal things that these people did.. from stealing Rx pads, putting phone numbers on the Rx blanks that are not the doc’s number… and on .. and on… but make sure that you get a ID.. what do you think the chances are that their Driver’s license or other ID’s ARE VALID ?  Are they in a state of denial… or just totally CLUELESS ?

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Filling a prescription? You might be better off paying cash

Posted on July 5, 2016 by Pharmaciststeve

Filling a prescription? You might be better off paying cash

http://www.cnn.com/2016/06/23/health/prescription-drug-prices-pbm/

The Health insurance industry seems to playing the same game that house/car insurance companies use.. if you use your insurance.. they raise the price.. but.. unlike the situation with your car/house … they raise your premiums when you have a claim… it now appears that the health insurance companies are charging the pt a fixed copay.. even if the cost of the medication is less – sometimes substantially less  than the copay and the insurance then pockets the difference.  It is sort of like a SURCHARGE for using your prescription insurance.  It would also seem that Pharmacies/Pharmacists are contractually prohibited from telling the pt that they are being overcharged .. with the threat of being thrown out of the network..  Sounds like something you would hear from “THE GODFATHER” movie ? The patient is not prohibited from asking to pay cash for their Rxs.. if the cash price is less than the copay you would have otherwise been charged… To protect yourself… there are websites like www.goodrx.com that will give you the price at specific pharmacies in your area for your prescription.

Some consumers who use health insurance copays to buy prescription drugs are paying far more than they should be and would be better off paying with cash, especially for generics.

The added cost runs as high as $30 or more per prescription, say pharmacists, and the money is largely being pocketed by middlemen who collect the added profit from local pharmacies.
Cash prices started to dip below copays a decade ago when several big box stores started offering dozens of generics for as little as $4 per prescription. But as copays have risen and high-deductible insurance plans become more common, more consumers are now affected.
The phenomenon illustrates the complexity of how drugs are priced in the U.S. and has led to finger-pointing about who is benefiting or who’s to blame.
Pharmacists say large pharmacy benefit management (PBM) firms that handle benefit clams for millions of Americans are pocketing the difference, while those firms say pharmacists themselves are being greedy.
“In some cases, consumers are blaming high drug prices on manufacturers, but really the cause of their costs may be the insurance company or the pharmacy or the pharmacy benefit manager,” said Adam J. Fein, who follows the drug industry for management advisory firm Pembroke Consulting in Philadelphia. “It’s very hard to figure this information out.”

A Bewildering Array Of Factors

How much consumers pay at the pharmacy counter depends on a bewildering array of factors, including health insurance policies that set copayments and deductibles, the pharmacies they choose, and which behind-the-scenes PBM their employer or insurer hires to manage claims and negotiate prices with pharmacies and drug makers.
The back-and-forth between pharmacists and PBMs is part of a long-running feud between the two groups. Not every PBM negotiates prices that allow for these overpayments, the pharmacists say, and not all drugs are affected.
Still, here’s how pharmacists say consumers are getting squeezed. At the pharmacy counter, patients pay their share of the cost — the copay — as set by their PBM and insurance plan.
Medicare change: 'Perverse' incentive or 'perverse' reform?

 
Days or weeks later, the PBM firm takes back a portion of that patient payment from the pharmacy after the PBM determines what it will actually pay for the drug — a practice sometimes called a “clawback.” That money does not go to the consumer, but is generally kept by the PBM.
“It’s a fraudulent misrepresentation to the patient of what is the cost of the drug,” said Susan Hayes, principal with Pharmacy Outcomes Specialists, which audits pharmacy programs on behalf of insurers.
In a survey by the National Community Pharmacists Association taken in early June, members provided examples. None of the pharmacists would talk on the record for fear of being kicked out of the PBM networks, so their responses could not be independently verified.
One told surveyors that a major PBM required the pharmacy to collect a $35 copay for a generic allergy spray, then took $30 back from the pharmacy. Another said a PBM charged a $15 copay for insomnia drug Zolpidem, then took back $13.05. Patients were charged $30 above the cash price for a generic cholesterol medication at another pharmacy.
In effect, the customer has paid more for the drug than the PBM ultimately pays even though “they assume what they are paying is the cost of the drug,” said Susan Pilch, vice president for policy and regulatory affairs with the pharmacists’ group.
In response, the CEO of the benefit managers’ trade association blames pharmacists, whom he says should simply offer customers the cash price of the drugs — if cheaper — bypassing their insurance plans altogether.
Will voters help control the cost of prescription drugs?

 
“Not everything has to go through the plan,” said Mark Merritt, president and CEO of Pharmaceutical Care Management Association. “The only reason [for pharmacies] to process the claim is to keep the copay for themselves.”
While agreeing that in some cases consumers could get their drugs for less if they paid cash, Pilch said pharmacists are specifically barred from discussing the cash price under terms set by contracts between them and the PBMs. Its June survey of 650 pharmacists found that more than 38 percent said they were unable to tell patients about cheaper cash prices 10 to 50 times in the previous month.
“We are required to run it through insurance and we do not have the option of advising the patient regarding matters of the terms of their plan or their options, or we run the risk of being cut from the network,” she said.
For their part, PBMs say patients pay the amounts specified by their insurance plan benefit design. And the amounts they take back, they say, can help hold down cost and slow future premium increases to the insurers and employers who hire them.
Still, Louisiana lawmakers this month passed legislation to rein in the practice by directing pharmacists to tell patients about all their options — including less expensive alternatives.
Arkansas lawmakers last year passed a law that bars PBMs and pharmacies from collecting more from customers for medications than the pharmacy will ultimately be paid.
The laws “should eliminate these consumer clawbacks, which I believe are rare, but are an example of bad behavior by a PBM making a drug more expensive than it should be, said Pembroke’s Fein.

Marketplace Practices

Optum RX, a PBM that is part of UnitedHealth Group, was cited as a firm engaged in such efforts by the national pharmacy association and its affiliates in Arkansas and Louisiana.
UnitedHealth spokesman Matt Wiggin said only a small portion of claims were affected, although he could not give a specific percentage. The firm, he said, is moving to change its contracts to avoid the situation in the future.
At Cigna, another firm called out by the pharmacists, spokeswoman Karen Eldred would not say if it takes back a portion of the customer’s payments from pharmacists. But she said customers “would not pay more than the retail price (cash price) reported to Cigna by the pharmacy.”
A spokesman for Express Scripts, one of the nation’s largest PBMs, said the firm does not engage in the practices which “are not in the best interest of patients or the country,” said spokesman David Whitrap.
Market experts agree that shopping around and doing some leg work are tactics that will help consumers avoid paying too much because of the clawback.
Cigna, Express Scripts and other insurers also have apps and websites where members can check drug prices at multiple pharmacies and decide for themselves how best to proceed. But if a health plan or PBM doesn’t offer an app, consumers can check the cash price for prescriptions through one of the online websites like GoodRX or Blink health before heading to the pharmacy.
Join the conversation
In some cases, it might be less expensive to pay cash. But experts caution that such cash payments don’t always count toward annual drug deductibles. Consumers who expect a lot of drug costs might want to think twice about paying cash. But others may still find it saves them money, even if they never hit their deductible.
“The safest thing to do is always know what the pricing is in the marketplace,” said Mike Miele, an area president who advises employers on benefits for consulting firm Arthur J.Gallagher. “There are literally thousands of generics that are below $10.”

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Senate Easily Passes Bill Addressing Opioid Abuse

Posted on July 5, 2016 by Pharmaciststeve

Senate Easily Passes Bill Addressing Opioid Abuse

http://www.rollcall.com/news/senate_easily_passes_bill_addressing_opioid_abuse-246269-1.html

When  you have a Senate that contains 60 Attorneys… what can you expect except a focus on the Judicial system to handle the mental health disease of addictive personality disorder.

The Senate on Thursday passed 94-1 a bill that aims to combat the nation’s opioid drug and heroin epidemic. The legislation, known as the Comprehensive Addiction Recovery Act, would allow the Department of Justice and the Department of Health and Human Services to provide grants for states to expand treatment efforts and access to overdose-prevention drugs.

The legislation “will help tackle this crisis by expanding education and prevention initiatives, improving treatment programs and bolstering law enforcement efforts,” Majority Leader Mitch McConnell, R-Ky., said on the Senate floor before the vote.

Ben Sasse, R-Neb., was the only no vote.

“I’m distressed by opioid abuse as a dad and citizen,” he said in a statement. “Families, non-profits and government at the state and local level can help. I’m not convinced fighting addiction — as opposed to stopping drug traffickers — is best addressed at the federal level.”

In a press conference after the vote, the bill’s primary backers expressed hope that the overwhelming Senate support would spur the House to quickly pass their own version of the bill.

“I think that gives us the opportunity to get this through the House with the kind of numbers we saw today in the United States Senate,” Sen. Rob Portman, R-Ohio, said.

The Senate spent nearly two weeks debating the legislation (S 524), and on Wednesday reached an agreement on amendments, adopting language intended to strengthen consumer education about opioid abuse and provide follow-up services to people who have received overdose reversal drugs. Last week, senators adopted an amendment that would prevent at-risk patients from getting prescriptions from multiple doctors, and another that would give the Justice Department additional authorities to combat drug trafficking.

After a heated partisan debate over how to fund the new programs, the Senate ultimately rejected a Democratic amendment to include $600 million in emergency funding. Republicans argue that the fiscal 2016 omnibus (PL 114-113) included funding that can be used, and that more will be found during this year’s appropriations process.

“This authorization bill, in addition to the $400 million opioid-specific programs just a few months ago, can make important strides in combating the growing addiction and opioid problem we’ve seen in every one of our states,” McConnell said.

Democrats, including one of the bill’s co-sponsors, Sen. Sheldon Whitehouse, D-R.I., said they would try to hold Republicans to their promises about funding.

“I hope that the Republican leadership, as we move through the appropriations process, will honor some of the statements and commitments that they made on the floor about making sure that CARA does indeed have robust funding,” Whitehouse said at the press conference after the vote.

The bill now awaits action in the House, where companion legislation (HR 953) awaits a hearing by the Judiciary Committee.

At their press conference after the vote, Portman and Whitehouse urged the House to quickly pass the legislation.

“I cannot think of a bill that has been better prepared for House action,” Whitehouse said. “There is unprecedentedly broad support for this bill, and I hope that they don’t stall it and fiddle around with it.”

Portman said that he had reached out to Speaker Paul D. Ryan, R-Wis., on Thursday to convey his hope for House action. But he also hinted that the House may want to take time to deliberate and make tweaks to the legislation.

“Certainly they may want to have some more input and discussion, but this has been a collaborative process from the start,” Portman said.

He also noted that the House legislation has 92 co-sponsors. While only 25 of them are Republicans, he was optimistic that it would gain broad support.

Outside groups praised the bill’s passage, including the “doctor shopping” provision that would allow Medicare to designate single prescribers for at-risk patients.

“This provision will ensure Medicare patients get needed pain relief without being exposed to dangerous amounts of prescription drugs,” said Cynthia Reilly, director of Pew’s prescription drug abuse project.

But others, including the Obama administration, have expressed concern that the legislation focuses too much on conducting studies to compile more information about addiction and treatment, which critics contend is already well-known.

Whitehouse contended that the studies would aid federal agencies as they carry out their new authorities, and that the bill, if funded, would be mostly ready to implement.

“I think, frankly, it’s the money more than the studying that’s going to delay implementation,” he said

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The sharp rise in out-of-pocket healthcare spending

Posted on July 4, 2016 by Pharmaciststeve

screwed1The sharp rise in out-of-pocket healthcare spending

https://drugstorenewsce.com/content/sharp-rise-out-pocket-healthcare-spending

ANN ARBOR, Mich. — Even if you have what you might think of as good health insurance, your next hospital stay could cost you more than $1,000 out of your own pocket.

And that amount has gone up sharply in recent years — a rise of more than 37% just for straightforward hospital stays for common conditions.

Those striking statistics come from the first published analysis of actual out-of-pocket spending by people with private health insurance, most of it provided by employers. It’s appearing today in the JAMA Internal Medicine, and being presented at the AcademyHealth Annual Research Meeting in Boston.

To see the rise in costs paid by privately insured hospital patients, researchers at the University of Michigan’s Institute for Healthcare Policy and Innovation looked at data from more than 50 million Americans in a four-year period.

All of them had insurance plans offered by the four major companies that pool their data via the Health Care Cost Institute, of which IHPI is an academic partner.

The biggest change in out-of-pocket spending came from two types of insurance plan charges: one that patients are familiar with, and the other that is not so familiar.

Deductibles — the amount that patients pay for their care before their insurance kicks in — rose by 86%. Co-insurance — a percentage of the cost of the hospital stay that insurance plans often expect patients to pay, but patients may not even realize they will owe — rose 33%.

“These results open up the ‘black box’ of health care, and show all the costs of hospitalization that are billed to people with private insurance. For many, these may appear to be ‘hidden costs’ that they didn’t realize they would owe,” says first author Emily Adrion, PhD, MSc, a U-M research fellow with the Center for Healthcare Outcomes and Policy. “It shows that even people with the most comprehensive insurance are paying thousands of dollars, at a time when they need hospital care and may not have time to shop around.”

She and her colleagues, including senior author Brahmajee Nallamothu, MD, MPH, note that the growth in out-of-pocket costs was 6.5% a year, compared to a 5.1% growth in health insurance premiums, and a 2.9% growth in overall healthcare spending.

The study looked at costs billed to people between the ages of 18 and 64, from 2009 to 2013. In addition to a broad-based analysis, the researchers took a closer look at those who had heart attacks, pneumonia, appendicitis, heart bypasses, total knee replacement or spinal fusion procedures, and women who gave birth.

It’s different from other studies that have estimated out-of-pocket spending based on the design of insurance plans.

The percentage of patients who were charged deductibles and co-insurance rose by more than five percentage points during the study period.

Co-payments, which are different from co-insurance and are a kind of “entry fee” to a hospitalization, actually fell during this time. But this was due to the fact that fewer insurance plans charged a co-pay for a hospital stay in 2013 than had charged one in 2009 — not to an actual drop in the dollar amount of the co-pays charged to patients who owed one.

The study also reveals sharp differences in out-of-pocket costs for people who chose “consumer-directed” health plans offered by their employers — which often take the smallest bite out of each paycheck — and for people who bought individual private plans during the study period.

For those with consumer-directed plans, the total they’d owe after a straightforward hospital stay topped $1,200 on average. Their employer may have also offered them a way to save pre-tax dollars in a special account to help pay for that, but the study data don’t show that information.

For those with individual private plans, the bite was even harsher: $1,800 on average. Adrion notes that to qualify for an individual private plan during the study period, patients would have to have met standards for good health. A provision mandating that plans cover all adults regardless of pre-existing conditions didn’t take effect until 2014.

“These results show the importance of reading the fine print when you choose a health insurance plan, and being prepared to spend more out of your own pocket after a hospitalization than you might have expected,” says Nallamothu, a professor of internal medicine at U-M and IHPI member.

Patients can also make sure they understand which hospitals and doctors are “in network” for their plan, which might mean lower co-insurance costs. And, for people who can’t pay their entire bill at once, or at all, it means talking to the hospital about a payment plan or even a write-off of some costs under their charity care policy.

The study period didn’t include private individual and family plans bought on the exchanges set up under the Affordable Care Act. Those plans began covering people in January 2014 and are open to anyone regardless of their health status. The study period did include the first years when the ACA mandated that adults up to age 26 could remain on their parents’ private health plans.

Recent estimates by the Kaiser Family Foundation suggest that the trend seen in these data has continued. According to a recent KFF report, 81% of people who get insurance through an employer have an annual deductible of about $1,300, and more than two-thirds of them also have co-insurance as part of their coverage. An even greater percentage of people who bought “silver” plans on an ACA exchange also have co-insurance provisions in their plans.

But plans bought on the ACA exchanges (including healthcare.gov) come with a federal cap on out-of-pocket spending of $6,800. Plans provided by employers, or bought individually outside the exchanges, don’t have such a cap. Adrion and her colleagues plan to study future HCCI data to look at spending trends.

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The personal beliefs of pharmacists cannot outweigh their professional duty — or the law

Posted on July 4, 2016 by Pharmaciststeve

Supreme Court right to not interfere with Wash. state’s pharmacy contraceptive rules

http://www.seattletimes.com/opinion/editorials/supreme-court-right-to-not-interfere-with-wash-states-pharmacy-contraceptive-rules/

I wonder if Judge Susan Graber‘s opinion “Speed is particularly important considering the time-sensitive nature of emergency contraception and of

many other medications…

The personal beliefs of pharmacists cannot outweigh their professional duty — or the law.”

could apply to medications that are used for subjective diseases (pain, anxiety, depression, ADD/ADHD, mental health) that the pt should not be subjected cannot send the woman to another pharmacy miles away… which seems to describe the “Pharmacy crawl “

Does this open a “can of worms” for those Pharmacists who believe that they can reject filling a otherwise legal Rx … for any reason ?

The U.S. Supreme Court was right not to interfere with Washington’s rules regarding a woman’s access to emergency contraception at the pharmacy.

 It took nine years, but the abortion proxy war at the pharmacy counter is finally over.

The U.S. Supreme Court last week declined to consider Washington’s 2007 rules, essentially ensuring women’s access to emergency contraception.

 In taking a pass, the Supreme Court upheld the 9th U.S. Circuit Court of Appeals ruling last year, which found that Washington’s rules struck just the right balance between a pharmacist’s professional duty to fill a lawful prescription and his or her religious-based objection to emergency contraception, such as Plan B, because it can stop conception or terminate a fertilized egg.
 The pharmacy board’s rules were thoughtful back in 2007, when they were acting on reports that some pharmacists were refusing to dispense prescriptions that followed a decision made by a woman and her doctor. And they are particularly good nearly a decade later, when access to a full range of reproductive medicine continues to be under attack.
[Pro/con: Should pharmacists have religious freedom in America?]

In recent weeks, a state judge correctly ruled that public hospital districts must follow state law and provide abortions themselves — and not outsource the duty to Planned Parenthood — if they provide maternity care. And the U.S. Supreme Court turned back Texas’ stealth attempt to shut down abortion clinics with undue medical regulations.

In the pharmacy case, the state rules say a pharmacist can simply hand an objectionable prescription to another non-objecting pharmacist on-site, if one is available, but cannot send the woman to another pharmacy miles away.

“Speed is particularly important considering the time-sensitive nature of emergency contraception and of many other medications,” federal appellate Judge Susan Graber wrote in the 9th Circuit Court of Appeals ruling last year. She also noted that the pass-the-prescription game subjected women to shame for seeking a lawful medicine.

The personal beliefs of pharmacists cannot outweigh their professional duty — or the law.

 
Editorial board members are editorial page editor Kate Riley, Frank A. Blethen, Ryan Blethen, Donna Gordon Blankinship, Brier Dudley, Mark Higgins, Jonathan Martin, William K. Blethen (emeritus) and Robert C. Blethen (emeritus).

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Forgotten news: Bill Clinton was DISBARRED for perjury

Posted on July 4, 2016 by Pharmaciststeve

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Legalized MMJ: Because there’s too much money to be made

Posted on July 3, 2016 by Pharmaciststeve

DEA Source Confirms that Schedule II Marijuana is in the Works.

http://www.smobserved.com/story/2016/07/04/news/dea-source-confirms-that-schedule-ii-marijuana-is-in-the-works/1562.html

“Let me tell you how the big pharma industry works,” said the DEA lawyer, picking up a glass of chardonnay and swirling it around. We were having lunch at Shutters on the Beach, and the wine, which I would pay for, cost $150 a glass. But he had promised to answer some questions from readers of my controversial article entitled “US Gov’t Will Legalize Marijuana August 1.” http://www.smobserved.com/story/2016/06/28/news/us-govt-will-legalize-marijuana-on-august-1/1484.html

“I’ll tell you how this industry works. The big pharma people take the DEA people to dinner to discuss the legalization of Marijuana, how it’s going to really work. They say:

‘Listen, you and I both know that cannabis is much less dangerous, much less addictive than a lot of other schedule II stuff that we already sell, such as Oxycontin. Why don’t we just go ahead and sell a few products, THC extract, TBD oil, so we can all make some money. Instead of all these small time weed clinic guys with their pot clinics banking the cash, let us bank it. The side effects are probably not nearly as bad as other drugs like Oxycontin. It’s not the result of chemists committing unnatural acts with molecules. And a few years from now, when you need a job, you can come work for me.’ I’m sure that’s how it works.”

He’s a tall man, a tall blue eyed DEA lawyer. I’ll call him “Deep Throat.” He met with me on condition I not say anything that might compromise his identity, because he was not authorized to speak to the press. I read him questions from readers, and he answered them over filet mignon and wine.

1. Does this mean insurance companies – including ones with Medicare or Medicaid patients will have access to prescriptions, and having the cost covered by their insurance company at the pharmacy? Like any other drug?

Yes. Under State law, coverage exclusions would run into federal issues. It’s always a plan by plan question, but as a default I would say it would be covered. Why not? As long as prescription medications are covered, under ERISA or other Federal law.

2. Stan, the DEA actually stated in a memo to lawmakers a couple of months back that they would be deciding on marijuana scheduling by the end of June. The Denver Post story talking about July 1 isn’t stating anything new. But THIS story certainly is! Congratulations! I’ve been sharing it all over.

Yes, and did you notice that the June deadline came and went? Just as a matter of logic, the statement that nothing is new is wrong. The decision has already been made, folks. Schedule II marijuana is in the works. We’re just working out the details before we go public with it.

3. This will destroy the existing industry. How about all the people that spent their life savings to get licensed and open up a dispensary? How about all the manufacturers of oils and edibles that won’t be able to conform to FDA regulations? Clinical trials are lengthy and expensive. CVS will be responsible for selecting product for consumers. The black market will explode again.

[Sighs, looks at his salad again]. Yeah, I keep hearing that. Yes, it might destroy the existing industry. Maybe it should. Because the public would be better served by pharmacists. Of course they would be.

The DEA might never squeeze them for it (if they did sell weed), but the Pharmacists can’t fill a marijuana clinic recommendation, or they’re in violation of their licenses. And it’s illogical, they’re exactly the people who should be in. The people that we at the DEA regulate, are exactly the people who should enjoy the legal right to sell marijuana products. That’s fair, and also in the public interest.

If all this state regulation is superceded by General regulation, but I don’t see why that’s a bad thing. Don’t you trust CVS more? This industry as it is now is operating in a grey area. It would be better for patients and society if it were not a public health or safety issue.

4. The problem is allowing the whole MJ plant to be legal. What the layman does NOT understand is there are specific parts of the plant that are harmful, and others that do have very solid evidence-based research to support it. THC is mood altering, and harmful to any human < 25yrs old. Many peer reviewed studies linking THC to schizophrenia, reduced motivation, reduced education, etc. Cannabidiol however is incredible. Proven research for its benefits.

[throws down his fork] Yes yes yes, and moving marijuana to schedule II is all about allowing people to do clinical research. I’m all in favor of that, as are my colleagues at the DEA.

Personally though, I don’t see how you can just wave a magic wand and say all this weed stuff is now Schedule II. This will have to go thru the same trials as anything else on Schedule 4. We parse through what is or is not a drug on the plant.

And that opens the possibility that what is more controversial could survive. But you’re open to some real possibility that some stuff will not survive for having to go thru FDA approval, with FDA saying what they like and don’t like. Exhaustive scientific studies will be performed, including human studies. And again, this is something others would be able to pay for. Describing a side effect would remove credibility from those people on the margins

You couldn’t just say Hemp is good, you could say it’s through the FDA wringer. If parts are good and parts aren’t, we’re gonna find out. And that’s something your local green clinic operator will never do for you, would he?

5. It’s about time… We need to remove marijuana from the DEA drug schedule list. Look at alcohol, it has no more currently accepted medical use than marijuana and has a high potential for abuse. We need to stop destroying lives and regulate marijuana like alcohol. If the legalization of marijuana stops one alcohol overdose, what’s a life worth?

I hear this comparison a lot. It’s fair to raise the argument that alcohol is destructive when abused. In a way that pot isn’t, though marijuana does some stuff alcohol doesn’t. Our current alcohol regime is a result of an historic compromise over decades. The comparison fails because of the different history.

There’s a huge problem with addiction in the US, you can talk about opiods, alcohol, video games (laughs). There’s a big problem with addiction that America doesn’t yet recognize or do anything about.

Does the danger of addiction with marijuana outweigh its therapeutic benefits? Maybe there’s an under investment in addiction in the US, the AMA has resisted spending more money on it. That’s another reason why a lot of this argument has to be looked at with a jaundiced eye, because of all the money being spent on it.

They’re not trained clinicians. How would they know from records? They have no organized system of record keeping. It’s like saying gangsters should still have control over alcohol. It doesn’t mean the dispensaries are evil people, it’s just a lack of record keeping that would give them exp.

An essential element in medical record keeping is the standard of care. It’s frankly a political compromise, and it’s been set up over time.

There may be individual weed clinic people who are awesome at it, but as a group, the pharmacists have it beat. Because they’re heavily regulated and licensed people.

We are living through a time as momentous as the end of Prohibition in 1933. Believe me, we at the DEA are mindful that everything we do, sets an historical precedent.

6. While we are dutifully cognizant that the DEA got their hands slapped and money financing raids and trials, this sounds preposterous. Simply a move to strike against the current industry. If it is moved to a schedule 2 all MMJ clinics will no longer be allowed to operate at all since they are not doctors or pharmaceutical companies. We’re then totally left to rot and the states wouldn’t be able to protect us. So our patient base is totally screwed. If you get cancer in their use to specific strain that has the right cannabinoids in them they won’t be able to get them. And smoking is out now? Really how stupid is that. Lung cancer patients will no longer be able to have treatment to their lungs. Well cannabis is not a miracle for everyone it is a miracle for those who need it and use it. I think them putting it as a schedule2 knocks out the entire cannabis industry.

[Deep Throat freezes in place cutting his meat, while listening to the question] This is jumping to lot of conclusions. Some of your readers obviously smoke too much weed, Stan, and paranoia is a documented side effect of doing that.

I will remind everyone that the DEA has the sole authority to enforce the nation’s drug laws. Don’t even think of challenging our authority, because what you get to take is what we will allow.

If you’re readers really want to be paranoid, they can consider the possibility that there’s a reason I’m talking to you today, and it’s to float a few trial balloons. That’s all I have to say on that subject.

7. So what’s the bottom line? Is medical marijuana legalization really going to happen this year?

[levels his blue eyes at mine]. Yes. Because there’s too much money to be made. And because it’s an important public policy and a lot of people using cannabis. This activity is going to happen on the margins anyway. I can’t believe it’ll just be allowed to continue on the margins, there’s too much money to be made.

There is also the danger. Two people, two medical marijuana clinic employees were shot this month in San Bernardino along. Really, how can we as regulators allow the present system continue?

At that point he stood up and shook hands. I thanked him for his time, paid the bill, and he walked off into the California sun.

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