Johnson & Johnson warns of insulin pump hack risk

http://www.usatoday.com/story/tech/news/2016/10/04/johnson-johnson-warns-insulin-pump-hack-risk-animas/91542522/

SAN FRANCISCO — A major maker of medical devices has for the first time issued a warning about a potential computer security flaw in a consumer product, but cautions that the danger to patients is extremely low.

Johnson & Johnson on Tuesday issued a warning about a possible cybersecurity issue with its Animas OneTouch Ping Insulin Infusion Pump. The problem was first reported by Reuters.

Computer security firm Rapid 7 discovered that it might be possible to take control of the pump via its an unencrypted radio frequency communication system that allows it to send commands and information via a wireless remote control. The company alerted Johnson & Johnson, which issued the warning.

Getting too high or too low a dose of insulin could severely sicken or even kill.

There have been no instances of the pumps being hacked, Johnson & Johnson said.

Insulin pumps are used to control diabetes. They are worn on the body and deliver insulin into the body via a catheter placed under the skin. They are overwhelmingly used by patients with Type 1 diabetes, the least common type in the United States.

In the OneTouch Ping device, the user can order the pump to give them a dose of insulin via a wireless remote control which talks to the insulin pump via an unencrypted radio frequency communication system.

An entire community of hackers has arisen in recent years that focuses on diabetes hacking, though generally to tweak their own devices or to better understand how they work. This appears to be the first instance where a company has taken direct action due to external research on them, however.

To hack into the OneTouch Ping system, someone would need to use a radio frequency monitor to detect that the person had this particular insulin pump and then which of 16 possible channels it was transmitting on. They could then record a command to deliver more insulin and the repeat that command over and over, potentially resulting in a very high dosage of insulin, said Jay Radcliffe, the senior security researcher with Rapid 7 who found the flaw.

“Someone would have to have malicious intent, they would have to want to harm another human being. And they’ve have to have technical expertise, they’ve have to have radio antennas and they’d have to be within 25 feet, unobstructed,” said Marene Allison, the company’s chief information security officer.

However to do so would require that the potential hacker were within 25 feet of the device and would require technical expertise and sophisticated equipment, Animas said in a statement Tuesday. Animas is owned by Johnson & Johnson.

While there are many diabetics in the United States, 29.1 million according to the American Diabetes Association, the vast majority of them have Type 2 diabetes. Just 4%, or 1.25 million Americans, have Type 1 diabetes, which is caused by an autoimmune disorder that destroys the cells that release insulin.

There are 114,000 OneTouch Ping insulin delivery systems in circulation in the United States and Canada, according to Johnson and Johnson.

Type 2 diabetics don’t typically need the sophisticated and frequent insulin delivery that an insulin pump offers, said Sarah Kim, who directs the diabetes clinic at Zuckerberg San Francisco General Hospital.

“Someone would have to go to extreme measures to hack in and command the insulin pump without the person’s knowledge. At this point it seems like an unnecessary worry,” she said.

In its release, Animas said that users of its insulin pump can turn off the radio frequency feature. They can also set the pump to vibrate when an insulin dose begins to be delivered, giving them time to cancel the order if they themselves did not give it.

Radcliffe said it’s important to note that insulin pumps and in fact all medical devices operate on a much longer development cycle than say cell phones. “This pump was probably designed ten or 15 years ago, when no one was thinking about security around communications protocols,” he said.

He said Johnson & Johnson “has done a great job” responding to the issue. “If my child were diagnosed with diabetes today, I would have no problem putting them on an Animas pump,” he said.

Johnson & Johnson has actually been working with the Food and Drug Administration on guidelines for medical device cybersecurity for the past 18 months. Those guidelines were published in January, said Allison.

Future Johnson and Johnson insulin delivery pumps will incorporate security measures, she said.

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DEA Reduces Opioid Manufacturing for 2017

http://www.pharmacytimes.com/news/dea-reduces-opioid-manufacturing-for-2017

While the DEA claims that they are “NOT DOCTORS” … theirs – and other parts of the Federal government’s alphabetic soup of agencies … actions… have apparently caused a reduced prescribing of opiates…  This suggests two things…. more and more chronic pain pts with a medical necessity of taking opiates… are getting FEWER prescriptions and could suggest why there are more people are ODing from purchasing opiates on  “the street” to help them deal with their relentless chronic pain… or those suffering from the mental health disease of addictive personality disorder and – for whatever reason – have chose to try and deal with the monkeys on their backs and/or demons in their heads.. because our judicial system has declared that certain addictions is a CRIME and not a DISEASE… prohibiting them from seeking appropriate medical care from a licensed healthcare prescriber.

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Maternal marijuana use not significantly linked to adverse neonatal outcomes

http://www.clinicaladvisor.com/obgyn-information-center/maternal-marijuana-use-may-not-be-linked-to-adverse-neonatal-outcomes/article/522493/

(HealthDay News) — Maternal marijuana use is not independently associated with adverse neonatal outcomes, according to a review published in the October issue of Obstetrics & Gynecology.

Shayna N. Conner, MD, from Washington University in St. Louis, and colleagues extracted data from studies that compared rates of prespecified adverse neonatal outcomes in women who used marijuana during pregnancy and women who did not. The primary outcomes were low birth weight and preterm delivery at less than 37 weeks of gestation. Data were included from 31 studies that assessed the effects of marijuana use during pregnancy.

The researchers found that marijuana use during pregnancy was associated with an elevated risk of low birth weight (15.4% vs 10.4%; pooled relative risk, 1.43; 95% confidence interval [CI], 1.27 to 1.62) and with preterm delivery (15.3% vs 9.6%; pooled relative risk, 1.32; 95% CI, 1.14 to 1.54) based on pooled unadjusted data. After adjustment for tobacco use and other confounding factors, pooled data showed no statistically significant risk for low birth weight (pooled relative risk, 1.16; 95% CI, 0.98 to 1.37) or for preterm delivery (pooled relative risk, 1.08; 95% CI, 0.82 to 1.43).

“The association between maternal marijuana use and adverse outcomes appears attributable to concomitant tobacco use and other confounding factors,” the authors write.

Reference

1. Conner, SN, Bedell V, Lipsey K, et al. Maternal marijuana use and adverse neonatal outcomes: A systematic review and meta-analysis. Obstet Gynecol. 2016;128(4):713-723. doi:10.1097/AOG.0000000000001649.

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DEA Officials Complain That Synthetic Drug Ban Is Too Narrow

http://www.huffingtonpost.com/entry/senate-kratom-dea_us_57ed85fde4b0c2407cdcf0a4

This is supposedly the law that the DEA used to reschedule KRATOM on an emergency basis.  KRATOM is not a SYNTHETIC DRUG… it is a NATURAL SUBSTANCE/HERB… part of the COFFEE plant family, and has been labeled/sold as a SUPPLEMENT for DECADES/CENTURIES, not a NEW DRUG .  So did the DEA exceed its legal authority in its action of rescheduling KRATOM.  Could this be the issue to go to court to legal challenge the emergency rescheduling of KRATOM and seek a INJUNCTION until the issue works its way thru our legal/court system ?

DEA officials are complaining (anonymously) that the synthetic drug ban approved by a congressional conference committee last week does not cover all of the stimulants they thought it should. The Synthetic Drug Abuse Prevention Act of 2012, Part D of the Food and Drug Administration Safety and Innovation Act, covers two chemicals used in the quasi-legal speed substitutes sold as “bath salts”: mephedrone and methylenedioxypyrovalerone (MDPV), both of which are already illegal under an “emergency” ban announced by the DEA last year. Fifteen other stimulants flagged by the DEA were included in a stand-alone bill approved by the House last December, but they did not make it into the FDA bill, apparently due to resistance from Patrick Leahy (D-Vt.), chairman of the Senate Judiciary Committee. Astounded that Leahy would not do whatever the DEA asked in the name of protecting Americans from “a deadly array of toxic drugs,” ABC correspondent Russell Goldman takes up the agency’s cause (emphasis added):

When asked why not criminalize drugs that the DEA says it needs listed to help keep the streets safe, the committee staffer said, “Sen. Leahy has been clear that scheduling controlled substances is not something to be taken lightly.”

“It is not without implication to put a whole lot of chemicals on the federal drug schedule,” he said. “It means putting more people in jail and makes it harder to seek legitimate uses for these drugs. Leahy is most comfortable sticking with what has been carefully considered.”

Wait. Prohibition entails costs? The DEA never mentioned that. Goldman nevertheless seems convinced that banning “bath salts” (every last one of them) is necessary, because they are “believed to have played a role in a spate of grisly incidents, including a May assault in Florida in which an attacker allegedly high on the drug chewed off a homeless man’s face.” Believed by whom? On what basis? Who, exactly, alleged that Rudy Eugene was under the influence of “bath salts” when he attacked Ronald Poppo, and what was the evidence for that claim? Should we maybe wait for the results of toxicological tests on Eugene’s body before rushing to ban chemicals he may never have consumed? Even if Eugene did take one of the drugs on the DEA’s list, does that mean the drug made him eat Poppo’s face? Should we apply a similar kind of reasoning to, say, alcohol?

The alleged link between “bath salts” and cannibalism is not the the only questionable claim that Goldman endorses. Judging from this article, he also believes that cocaine and methamphetamine, both of which are legal for medical use, are “on the ‘Schedule I’ list of federally criminalized drugs,” and that “synthetic marijuana” (also targeted by the synthetic drug ban) is distinct from “the street drugs ‘K2’ and ‘Spice,'” which are brands of fake pot.

Goldman does correctly note that the FDA bill strengthens the DEA’s authority to quickly impose a temporary ban on drugs it considers an “imminent hazard” to public safety (as it has already done with mephedrone, MDPV, and a third stimulant, methylone, along with five compounds used in fake pot). The bill lengthens the duration of such “emergency” bans from one year to two years, and the DEA will have the discretion to extend that period for an additional year (rather than the six months allowed by current law). The DEA also has the authority, using a more elaborate process, to permanently ban drugs without congressional action, as it did with MDMA, which it temporarily banned in 1985 and permanently placed on Schedule I the following year. In February the agency announced its intention to make its temporary ban on fake pot ingredients permanent, and it is expected to do the same with its “bath salt” ban. So a good question for Goldman to ask in response to DEA bellyaching about the limited scope of the stimulant ban would have been: Why don’t you guys just ban these drugs on your own? 

Quoting an unidentified DEA official, Goldman says the agency is “playing a ‘game of whack-a-mole,’ discovering new drugs and trying to classify them fast enough to prosecute offenders.” There are indeed many possible stimulants, THC substitutes, and psychedelics out there, but that is a challenge for legislators as well as DEA bureaucrats. Perhaps prohibitionists should pause to consider how this game increases drug-related harms by encouraging people to mess around with novel substances that could prove more dangerous than the ones Congress and the DEA have managed to ban so far.

In addition to mephedrone, MDPV, and “cannabimimetic agents” (including 15 that are named specifically), the Synthetic Drug Abuse Prevention Act of 2012 bans nine synthetic psychedelics in the “2C” family.  

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In a campaign appearance Saturday in Youngstown, Ohio Chelsea Clinton suggested that marijuana has the ability to kill.

http://www.breitbart.com/big-government/2016/09/29/chelsea-clinton-suggested-that-marijuana-has-the-ability-to-kill/

So now ANECDOTAL EVIDENCE is enough to declare that MJ can KILL ?… but anecdotal evidence is INSUFFICIENT to prove that long term use of opiates in treating chronic pain is beneficial for pts.

There are all sorts of  legal substances  that can interact with other medications and can be lethal…  Anything from GRAPEFRUIT with certain medications… ALCOHOL with many medications… ASPIRIN/NSAID with Warfarin (Coumadin) can cause a pt to hemorrhage and bleed out or have irreversible brain damage. 

I wonder where Chelsea Clinton came up with the  FACTOID about  how lethal MJ can be.  Could it have been that actually the “other things” that the people were taking… were what was actually LETHAL ?

During her speech, Clinton said, “We also have anecdotal now from Colorado, where some of the people who were taking marijuana for those purposes, the coroner believed after they died that there were drug interactions with other things they were taking.”

One of the most progressive rulings in the past ten years has been the legalization of marijuana that is now sweeping the nation. What started in states like Colorado, Washington, and Oregon, and the District of Columbia has now exploded across the country. Nine states will decide in November if they will join the growing list of states that have legalized marijuana.

Colorado, in particular, has seen many benefits since the legalization of marijuana. According to the Boston Globe, “Legalization has ushered in thousands of new jobs in the burgeoning industry, brought $135 million into state coffers last year, and ended the prohibition of a widely used substance.”

The state has also seen a drop in highway deaths as well as a drop in overdose death of harder illegal drugs such as heroin. The DEA acknowledges that there has never been a reported death from an overdose of marijuana. According to the Washington Post, “On its own, marijuana is not known to have any fatal dosage level. The DEA itself acknowledges that nobody has ever died from marijuana alone.”

A Breitbart/ Gravis poll released late last week shows “In Colorado, a swing state with nine electoral votes, Trump leads Democratic nominee Hillary Rodham Clinton by four points—outside the survey’s 3.5 percent margin of error. Trump, at 41 percent, leads Clinton—who has just 37 percent. Libertarian Gary Johnson takes six percent and Dr. Jill Stein of the Green Party takes six percent, and 10 percent of the voters polled are undecided. The poll, conducted from Sept. 22 to Sept. 23, surveyed 799 registered voters in Colorado.”

As Trump surges in the all-important battleground state of Colorado, Clinton’s comments could hinder her mother’s ability to reach out to a large group of voters who support the legalization of the same “drug” that Clinton lied about. The most current Colorado poll shows Trump and Clinton in a dead heat. Only one point separates the two candidates. According to a CNN/ORC poll, “In Colorado, likely voters break 42% for Trump, 41% for Clinton, 13% for Libertarian Gary Johnson and 3% for Green Party candidate Jill Stein.”

In a statement to the Washington Post Wednesday, a spokeswoman for Clinton stated, “While discussing her [Chealsea Clinton] and her mother’s support for rescheduling marijuana to allow for further study of both its medical benefits and possible interactions with other medications, Chelsea misspoke about marijuana’s interaction with other drugs contributing to specific deaths.” She went on to say, “Hillary Clinton has said we should allow states that have reformed their marijuana laws to act as laboratories for our democracy and we should reschedule marijuana from a Schedule I to a Schedule II substance.”

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17. Opioids

There is a growing opioid problem in the United States, with tragic costs to lives, families and society. How would your administration enlist researchers, medical doctors and pharmaceutical companies in addressing this issue?

Hillary Clinton (D): Our country is in the grips of a quiet epidemic of drug and alcohol addiction. Twenty-three million Americans suffer from addiction, and 52 million Americans over the age of 12 have misused prescription drugs, including one in four teenagers. We must work with medical doctors and nurses across the country to treat this issue on the ground, from how patients are accessing these medications to how we are supporting them in recovery.

To combat America’s deadly epidemic of drug and alcohol addiction, I have proposed a $10 billion initiative, and laid out a series of goals to help communities across the country. We need to expand the Substance Abuse Prevention and Treatment block grant and support new federal-state partnerships targeting prevention, treatment, recovery, and other areas of reform. We must empower communities to implement preventive programming for teenagers; help individuals suffering from addiction receive ongoing, comprehensive treatment; and provide first responders with naloxone, which prevents overdoses from becoming fatal. We must also work with those individuals prescribing controlled medications, and ensure they are getting the proper training in providing these prescriptions.

Finally, we must prioritize rehabilitation and treatment over prison for low-level and non-violent offenders. Currently, 65 percent of inmates in our prison system meet medical criteria for substance use disorders and over half of inmates suffer from a mental health problem. Jail time should not be a substitute for treatment. Working together, we can combat this epidemic and ensure that people across the country are getting the care they need to live long and healthy lives.

Donald Trump: We first should stop the inflow of opioids into the United States.  We can do that and we will in the Trump administration.  As this is a national problem that costs America billions of dollars in productivity, we should apply the resources necessary to mitigate this problem.  Dollars invested in taking care of this problem will be more than paid for with recovered lives and productivity that adds to the wealth and health of the nation.

Gary Johnson (L): Opioid addiction is, indeed, a crisis, and one that can largely be attributed to the insanity of our drug laws. A major reason opioids are overprescribed is that patients don’t have access to other safer pain management alternatives – such as cannabis. It is absurd that thousands of people are dying each year from ‘legal’ opioids, while the Federal Government still treats medical cannabis as criminal. One of my first acts as President would be to direct the rescheduling of cannabis to allow more research and prescription.

And in all due respect, with regard to doctors and pharmaceutical companies, the reality is that opioid prescription and subsequent abuse is a product of crony capitalism. In state after state, legislation to allow the prescription of medical cannabis and related products has been stymied largely by doctors, pharmacists and those who profit from the sale of legal opioids.

Jill Stein (G): We will end the “war on drugs” and redirect funds presently budgeted for the “war on drugs” toward expanded research, education, counseling and treatment.

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Insider Q&A: A front-row seat for the drug pricing battle

http://www.charlotteobserver.com/news/article105514881.html

I have blogged about MIDDLEMEN in the prescription distribution system. There has been recent information that these PBM’s – Like Express Scripts – are “demanding” rebates/kickbacks from the manufacturers of up to 70% to keep the manufacturer’s product(s) on the PBM’s formulary…   What is not clear is where the monies from that 70% goes… Over the last four years, Express Scripts’ net profits – based on Earnings Per Share (EPS) is UP > 50%.  It is also claimed that some of this money goes back to the insurance company and or the company that pays the insurance premiums or if the company is self insured… funds the employee’s health costs.

What few seems to know if the insurance company and or self funded employer calculate premiums or the employee’s share of premiums based on “rack rate” of all medical costs charges… does not include all discounts/rebates/kickbacks.  So an employee whose “share” of the employer’s health insurance cost is say – 30% –  but if the employer did the calculation on net costs.. the employee may be actually paying 60% or more of the net health insurance premium costs.

So if anyone wonders why prescription medication costs have “gone thru the roof”… it would appear that the for-profit motive of all these middlemen that has entered the market place since 1970… could share the blame for the”lion’s share” of the all the soaring price increases in prescription medications.

In the late 60’s, when there was few generics and no middlemen… the average prescription price was in the $4 -$5 range.  Since 1970… I can identify three different categories of  for profit middlemen in the prescription distribution system… there could be more …that are not so obvious ?

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https://www.prevagen.com/blog/faq/what-are-the-most-commonly-reported-benefits-of-prevagen/

Review the short advertising video on this SUPPLEMENT… they claim that it has been “CLINICALLY PROVEN” to improve you memory and yet on both the video and their website – briefly displays the statement:

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Which is required for SUPPLEMENTS that DO NOT have clinical trials that back up their statements…  but the FDA/FTC continue to allow these SUPPLEMENTS to be advertise that “SUGGESTS” MAY provide some medical benefit. 

Until Oct 1, 2016 Kratom… has been classified as a supplement until the head of the DME ( Rosenberg) decided that it was DANGEROUS… without any substantial/verifiable  facts that support the re-scheduling because it is a DANGEROUS DRUG.
What is the most commonly reported benefit of Prevagen?

Improves short term memory*

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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Medical students need exposure to chronic pain patients

www.kevinmd.com/blog/2016/09/medical-students-need-exposure-chronic-pain-patients.html

Pain. It permeates every aspect of medicine, crawls into the deepest corners of our practices, sinks its claws in and stays put. Opiates are at the center of a vicious national debate, and our patients are trapped in its clutches. But my thoughts are less on medications, protocols, and procedures and more on how we approach the patient who cries pain. Through everything I have observed, as a caretaker and student physician, I have come to a concerning conclusion: The burden is on the patient to prove his or her pain.

A patient recently repeated a remark made by her previous doctor, who had declared she was not in “that much” pain. My patient’s response was simple: “How do they know how much pain I am in? Only I know how much pain I am in!”

She was right. When a patient has any sort of pain, our question is always, “On a scale of one to ten, how bad is it?” They answer, and we immediately judge whether the number fits the presentation. Does the patient really look like an eight out of ten? Are they writhing in enough pain to satisfy us?

This is a ridiculous routine. Do not ask and then ignore what they say. Obviously, clinical judgment is an indispensable tool, so if a patient comes in with 10/10 pain but they are resting at ease on the emergency room stretcher, you can likely delay the exploratory laparotomy. But consider assessing their pain in context.

I recently saw a young lady who called her abdominal pain 10/10, but was interacting pleasantly, with no grimacing nor guarding, and only occasionally rubbing her right flank and flinching when the pain periodically recurred. On further exploration, she had never in her life experienced any significant pain – not even a sprained ankle for comparison. For her, this was the worst pain she could imagine.

Conversely, the judgment that follows mention of 12/10 pain is always the same: “There is no twelve,” we say out in the hallway, “they are just being dramatic.” But if we already ignore 8/10 pain, it follows that a patient may declare twelve out of ten pain to get our attention.

My sister demonstrates a useful paradigm. She is in chronic, bone-deep pain at all times. Her joints ache, her muscles spasm, her head pounds… daily. She suffers from Ehlers-Danlos syndrome and is in constant agony, but was blessed with a spirit that keeps her motivated and enables her to present a deceptively happy face. When she submits to going to the emergency room, we know she must be in unimaginable pain: pain bad enough that it is worth the mistreatment she will endure. Why? Because she internalizes her agony and thus she does not fit the stereotypical picture of a person in pain. So doctors write her off as exaggerating when she quietly uses her words. She does not appear worthy of their time.

I recently cared for a cranky elderly patient who had been reporting pain for days. At first, every question was met with a glare and a growl, but I was determined to be thorough and tried my hardest to coax out the quality of the pain. After several days of this, we had a breakthrough: the patient began to cry while describing shooting, burning pain, plus aches and cramps that made physical therapy too daunting. I returned to my chief and asked to change the patient’s orders: in addition to the typical opiates, I added gabapentin for neuropathic pain, muscle relaxants and heating pads for the cramps, and a B12 titer to address the paresthesias and fissures at the corners of my patient’s mouth. Impressed with my initiative, the chief agreed. When I arrived the next day, the labs showed a B12 level just below normal limits; I had been right. I went to see the patient and was met with a hesitant smile. The new regimen was beginning to work.

“That is what is missing in medicine these days,” my patient explained, “no one takes the time to listen, and no one took my pain seriously, until you did.”

So what is the “right” kind of pain? I once witnessed a resident describing an ER patient with pelvic pain as “actually not that crazy looking,” as if her presentation automatically implied mental instability. When my team told her the “good news,” that she could go home because we had not found any pathology, the patient, with a tortured expression, I will never forget, explained that it was not good news because we had not given her any help, any answers, or any hope. I trailed after my team as they left the room, embarrassed to be associated with them.

These attitudes are not universal, although it can feel that way to the patient. I strive to emulate physicians who approach patients with respect and an open mind. One such attending once explained how everyone has his or her own way of coping. “Some patients shout about it, some get very quiet, others look distracted, and still others joke about it, so you cannot take anything at face value.” It was some of the most important advice I ever received.

The best-case scenario is when pain has an obvious source and will resolve naturally, as with fractures and post-operative pain. But when patients start to complain disproportionately, or when no clear cause exists, we start to write the patient off in our minds. We run our battery of tests, while rolling our eyes.

What is it about pain that makes us want to judge patients, accuse them, and abandon them? Why do we go into medicine and then find ourselves surprised when our patients report pain? Pain is the body’s way of telling us that something is amiss, even if it is the pain receptors themselves! This does not mean such pain is a figment of the patient’s imagination, and it does not mean everyone must react identically. There is no available method to compare pain, and yet we still try to do so, because nuance is too hard to document, and too scary to treat. We do not understand pain well enough to treat it adequately, and we have no way of quantifying it other than asking “well, is it really bad? Or really bad? Or just … bad?”

I believe the solution starts at the foundation, as soon as we begin medical school. We need exposure to these patients, to understand what we are facing, so we are not surprised when we reach intern year. We must hear their stories, of mistreatment and misjudgment. Treatments are limited and outcomes are often poor; thus, our burden is enormous. We must stop the cycle, and we must remove the burden of “being believed” from the patient. We are the providers, and it is time to change how we understand and treat pain.

Sarah Cohen is a medical student.

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DEA defies senators’ appeal to reconsider ‘unprecedented’ kratom ban

https://www.washingtonpost.com/news/wonk/wp/2016/09/30/dea-defies-senators-appeal-to-reconsider-unprecedented-kratom-ban/#comments

Chuck Rosenberg – head of the DEA… with the following educational background…

He attended Tufts University, graduating in 1982 with a B.A., and Harvard, earning a Master’s in public policy.

https://news.vice.com/article/the-dea-chief-just-called-medical-marijuana-a-joke

Declared MJ “a joke” and the White House got a petition with 100,000 + signatures calling for replacing Rosenberg as head of the DEA… Does this demonstrate how useful/practical the White House petition system works ?

It is also the same person that had “determined” that Kratom represents an imminent hazard to public safety.

So we have someone with NO MEDICAL BACKGROUND… using a law that was specifically to be used  interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death… which Kratom does not fit into.  Used “emergency regulation” to avoid a public comment period and has now admitted that there MAY HAVE BEEN A SINGLE DEATH SOLELY FROM THE USE/ABUSE OF KRATOM.  If these actions do not produce the “final straw” for Congress to at least muzzle the DEA or curtail their budget and/or dramatically narrow their scope of authority.  Is it just me, or does it seem that the DEA has ILLEGALLY expanded it statue of authority to exceed the intend of the laws that they are charged with enforcing ?

A bipartisan group of nine senators is calling on the Drug Enforcement Administration to delay its “unprecedented” decision to ban kratom, a plant that researchers say holds great potential for mitigating the effects of the opioid epidemic.

The DEA recently decided to place kratom into Schedule 1 of the Controlled Substances Act, the most restrictive regulatory category, on a temporary, emergency basis “to avoid an imminent hazard to the public safety.”

The Senate letter, spearheaded by Orrin G. Hatch (R-Utah) says: “Congress granted emergency scheduling authority to the DEA based on the need for law enforcement interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death. The use of this emergency authority for a natural substance is unprecedented, so it is important to determine whether the circumstances here necessitate a jump to Schedule I.”

“Given the long reported history of Kratom use,” the letter continues, “coupled with the public’s sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders.”

The DEA announced its plan to place kratom in Schedule 1 only one month ago, using an emergency authority that does not require it to solicit public feedback on the decision. Blowback from pain patients was swift and furious and appears to have caught the DEA off-guard.

People who take the plant have shared their stories on how kratom helped them overcome addiction to opiates or alcohol, or how it has helped them treat otherwise intractable pain. Researchers say that their work with the kratom plant could eventually lead to the development of nonaddictive alternatives to powerful opiate painkillers, and that by placing kratom in Schedule 1, the government is effectively crippling their ability to carry out that research.

Over 140,000 people have signed a White House petition asking the Obama administration to reconsider the move.

The DEA cites 600-plus poison-control center calls involving kratom between 2010 and 2015 in its justification for banning the plant, and notes that 15 deaths were linked to the use of the plant between 2014 and 2016. In an interview with The Washington Post, a DEA spokesman later clarified that all but one of those fatalities involved the use of other substances.

Earlier this week 51 U.S. representatives similarly called on the DEA and the White House to reconsider or at least delay the ban, which was slated to go into effect as early as Friday.

In an interview, DEA spokesman Russell Baer confirmed that the ban was not yet in place. “We have not yet determined a date when we will publish that final order” putting the ban into effect, he said.

Because of the uncertainty surrounding the final date of the ban, many online businesses selling the plant have already shuttered or got rid of their supplies for fear of running afoul of the DEA’s stringent Schedule 1 rules.

“Given the extremely short timeframe for the implementation of the proposed DEA scheduling order, we urge you to take appropriate steps to delay the order to allow both for a public comment period and sufficient time for the DEA to outline its evidentiary standards to Congress regarding the justification for this proposed action,” the letter from Hatch and colleagues concludes.

Baer said the DEA would respond to the senators’ and congressmen’s concerns, but could not say whether the ban would go into force before that correspondence happens.

“It’s not a matter of if. It’s simply a matter of when, in terms of DEA publishing the final order to temporarily schedule kratom,” Baer said. “Our administrator [Chuck Rosenberg] has determined that kratom represents an imminent hazard to public safety. So I have a sense that publishing our final order will be sooner as opposed to later.”

The text of the full letter is available here. The list of Senate signatories, sent by a spokesman for Hatch, is below:

Orrin G. Hatch (R-Utah)

Mike Lee (R-Utah)

Mark Kirk (R-Ill.)

Angus King (I-Maine)

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