“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
The latest quarterly watch list from the US Food and Drug Administration (FDA) includes 15 drugs or drug classes for which there is new safety information or possible signs of serious risk.
The watch list, updated January 12 on the FDA website, is created from the FDA Adverse Event Reporting System (FAERS).
Placement on this list does not mean the FDA has found that a drug is associated with the listed risk, only that the FDA has identified a potential safety problem. If a further review concludes that the drug is associated with the risk or causes a problem, the FDA has many options for further action, including requiring changes to labeling, restricting use of the drug, or, in rare cases, pulling a product from the market. Follow us for more details salbreux-pesage .
The current list, which is from the third quarter of 2017 (July-September), includes 11 antibiotics for which the FDA saw signs of potential risk for hypoglycemic coma and nine antidepressants the FDA flagged because of a potential risk for DRESS (drug reaction with eosinophilia and systemic symptoms).
For two drugs on the list, potential risk has resulted in changes to labels. Ibrutinib capsules (Imbruvica, Pharmacyclis Inc) were listed because of signs of potential risk for ventricular arrhythmia. The Warnings and Precautions section of the labeling for the drug has since been updated to include ventricular arrhythmia. For selexipag tablets (Uptravi, Actelion Phamaceuticals Ltd), the Adverse Reactions: Postmarketing Experience section of the labeling was updated to include hypotension. songsforromance provides you more details.
For all but one of the other drugs listed, the FDA is evaluating whether regulatory action is needed. The exception is rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), for which the FDA has determined there is no need for action at this time.
Table.
Active Ingredient (Trade Name) or Product Class
Potential Signal of a Serious Risk/New Safety Information
Additional Information (as of January 12, 2018)
Tocilizumab injection (Actemra), for intravenous or subcutaneous use.
Ciprofloxacin injection (Cipro IV), for intravenous use
Ciprofloxacin hydrochloride tablets (Cipro)
Ciprofloxacin extended-release tablets (Cipro XR)
Gemifloxacin mesylate tablets (Factive)
Levofloxacin injection (Levaquin), solution for intravenous use
Levofloxacin (Levaquin), solution for oral use
Levofloxacin tablets (Levaquin), film coated for oral use
Moxifloxacin injection, for intravenous use
Hypoglycemic coma
FDA is evaluating the need for regulatory action.
Cetirizine hydrochloride
Levocetirizine dihydrochloride
Pseudoephedrine hydrochloride
Rebound pruritis
FDA is evaluating the need for regulatory action.
Pseudoephedrine
Acute generalized exanthematous pustulosis
FDA is evaluating the need for regulatory action.
Ibrutinib capsules (Imbruvica)
Hepatotoxicity and ventricular arrhythmia
Regarding hepatotoxicity, FDA is evaluating the need for regulatory action. Regarding ventricular arrhythmia, the Warnings and Precautions section of the labeling was updated to include ventricular arrhythmia.
Methotrexate injection, USP
Methotrexate oral solution (Xatmep)
Drug interaction with nitrous oxide, potentiated effect of methotrexate on folate metabolism, resulting in increased toxicity (severe myelosuppression, stomatitis, and neurotoxicity)
FDA is evaluating the need for regulatory action.
Nafcillin injection, USP, for intravenous use
Acute renal failure
FDA is evaluating the need for regulatory action.
Obeticholic acid tablets (Ocaliva), for oral use
Liver injury
FDA is evaluating the need for regulatory action.
Rheumatrex (methotrexate sodium) tablets
Methotrexate tablets, USP
Wrong dosing frequency errors (once-daily administration instead of intended once-weekly administration)
FDA is evaluating the need for regulatory action.
Eculizumab injection (Soliris), for intravenous use
Nongroupable meningitis infections and Neisseria (other than N. meningitides) infections
FDA is evaluating the need for regulatory action.
Selexipag tablets (Uptravi)
Hypotension
The Adverse Reactions: Postmarketing Experience section of the labeling was updated to include hypotension.
Cariprazine capsules (Vraylar)
Stevens-Johnson syndrome
FDA is evaluating the need for regulatory action.
Rivaroxaban tablets (Xarelto)
Liver injury
FDA decided on the basis of available information that no action is necessary at this time.
Source: FDA
More information about FAERS and its quarterly watch lists is available on the FDA website.
BAY COUNTY, Fla. – Ryan Torrens is a democratic candidate from Tampa, where he owns a small law firm. He says his experiences in law and as a regular citizen are what drives his campaign.
Some of his top priorities are crime in Florida and drug addiction, which he said is something that hits close to home.
“I call it the crisis of addiction instead of the opioid crisis because it includes cocaine, it includes other drugs as well as opioids,” he said. “A record number of Floridians are dying because of this crisis,
I myself am someone who is in recovery and I’ve come out publicly with that so that gives me a unique perspective.”
The state will vote for a new attorney general will be November 6.
Those of us who live in FL, know the impact that the current AG – Pam Bondi – had on the chronic pain community in Florida over the last 7 yrs of her being in office. She help create the “pharmacy crawl”, where pts would have to go to up to a couple of dozen pharmacies to get a single controlled prescription filled. Florida became the home of infamous phrase used by way to many pharmacists “I’m not comfortable” as the only justification they had for refusing to fill a pt’s prescription(s)… even for those pts in late stage cancer.
Torrens’ perspective on addiction could just become a “new nightmare” for chronic pain and other pts dealing with subjective diseases and have a legit medical need for controlled substances.
A top-level advisor to Attorney General Jeff Sessions wants doctors to drug test all their patients, and to force users, they suspect of addiction into rehabilitation against their will. If Robert DuPont gets his way, drug testing could become a required part of your visit to the doctor.DuPont, 81, is one of a small group of drug-policy “experts” Sessions invited to a closed meeting last month to discuss federal response to marijuana legalization. He is one of the most hardline and influential architects of the Drug War, having started out in the 1970s as a liberal on the drug control issue. But by the 1980s DuPont had taken a hard right turn, popularizing the long-debunked claim that cannabis is a “gateway drug.”
DuPont wants to force people into treatment for up to 5 years.
In an interview last year, DuPont pushed for expanding drug testing. His idea includes having physicians force patients whom they believe to have substance abuse problems to submit to drug tests, or lengthy stays in treatment facilities reports Newsweek.
“Among other things, he proposed giving doctors the authority to compel suspected substance abusers into treatment against their will,” reports The Daily Beast. “Once in treatment, patients could face up to five years of monitoring, including random drug tests.”
“We want [drug screens] to be routine in all medicine,” DuPont said. “Doctors already check for things like cholesterol and blood sugar, why not test for illicit drugs? Right now the public thinks that if we provide treatment the addicts will come and get well … that’s not true. So let’s use the leverage of the criminal justice system.”
DuPont was invited to the meeting to speak on “the effects of marijuana on drugged driving.” He has some pretty radical ideas on that subject, too.
A national model bill he helped write in 2010 called on cops to test anyone stopped for suspicion of driving under the influence for all controlled substances, and arresting them on the spot if the slightest trace showed up — regardless of the amount. While the bill includes an exemption for drivers with prescriptions, cannabis users would still get busted. Medical-marijuana patients don’t have prescriptions (due to federal law), just doctor recommendations.
WASHINGTON – NOVEMBER 29: The President of the Institute for Behavior and Health doctor Robert L. DuPont, an opponent of medical marijuana, speaks to the media outside of the U.S. Supreme Court November 29, 2004, in Washington, D.C. The court heard arguments from last years 9th Circuit Court of Appeals ruling in Ascroft v Raich to decide whether the Controlled Substance Act of 1970 is unconstitutional as it applies to the right to cultivate and possess cannabis to treat medical conditions as recommended by a medical doctor. (Photo by Mannie Garcia/Getty Images)
That bill’s language makes it specifically clear that people will still be punished even if they are legal medical marijuana patients in states which permit its use. “[The] fact that any person charged with violating this subsection is or was legally entitled to consume alcohol or to use a controlled substance, medication, drug, or other impairing substance, shall not constitute a defense against any charge,” the bill reads.
Even more ominously, the bill includes a section, “prohibiting the internal possession of chemical or controlled substances,” which means you can be arrested for failing a drug test.
“Any person who provides a bodily fluid sample containing any amount of a chemical or controlled substance … commits an offense punishable in the same manner as if the person otherwise possessed that substance.”
This means you could face federal criminal charges for failing a drug test. Of course, the fact that all of this flies in the face of the Fourth Amendment can’t be overlooked. Mandatory drug testing and involuntary detention are radical and according to many legal scholars, unconstitutional..
DuPont’s views on cannabis became increasingly conservative as his career in drug policy flourished. In 1978, after serving as President Richard Nixon’s drug czar, he warned The Washington Post the marijuana would have “horrendous” effects on society.
“I get a very sick feeling in the pit of my stomach when I hear talk about marijuana being safe,” DuPont said. “I have no doubt there are going to be horrendous [effects].” The quote was later used in a 1981 report, “The Marijuana Epidemic,” by far-right think tank The Heritage Foundation.
DuPont proposed that all welfare recipients — and their children — should be forced to submit to drug testing in a policy The Heritage Foundation also published. This created controversy, because DuPont, after a four-year stint at the National Institute on Drug Abuse (NIDA) had ventured into the drug-testing industry, reports Rewire. Suddenly, it had become financially beneficial for DuPont to oppose cannabis legalization and support widespread drug testing.
In 2000, he appeared before the federal Food and Drug Administration, pushing for expanded hair follicle testing. DuPont claimed there was no conflict of interest, even though at the time was also a paid consultant and shareholder in Psychemedics, which offered costly hair testing analysis.
The ACLU took them to court and the mandatory urine testing was declared a VIOLATION OF THE 4TH AMENDMENT… and the rule was declared UNCONSTITUTIONAL.
If Session remains in office and continues on the current path of taking us back to the 70’s in fighting the war on drugs… will almost assure that President Trump has ZERO CHANCE of getting elected for a second term. This 81 y/o advisor needs to RETIRE… obviously his “medical expertise” is grossly out of step with the wants/opinions of the majority of the citizens of the country.
Walmart is the latest national company joining in the fight to try to help curb America’s harrowing opioid epidemic, which now kills more people than breast cancer.
On Wednesday the chain rolled out a pharmacy product it says provides a safe way to get rid of extra prescription opioid drugs. It’s called DisposeRx and when mixed with warm water it turns any form of opioid drug — including powders, pills, tablets, capsules, liquids or patches — into a biodegradable gel that can’t be separated or converted back into a usable drug.
Walmart touted it as the first of its kind in a statement, and said the ingredients are FDA approved.
“The health and safety of our patients is a critical priority; that’s why we’re taking an active role in fighting our nation’s opioid issue – an issue that has affected so many families and communities across America,” Marybeth Hays, executive vice president of Consumables and Health and Wellness at Walmart U.S., said in the statement.
In 2016 more than 42,000 Americans died of an opioid overdose — including prescription opioids, heroin and fentanyl. That is more than any year on record and 40 percent of all overdose deaths involved a prescription.
Walmart explained patients filling new opioid prescriptions at any of its 4,700 pharmacies will receive a free DisposeRx packet starting immediately, while existing customers can ask for one at any time. Patients with chronic pain prescriptions will be offered packets every six months.
Republican Sen. John Boozman from Arkansas praised Walmart for helping “to keep unused prescription drugs out of the wrong hands.”
“About one-third of medications sold go unused. Too often, these dangerous narcotics remain unsecured where children, teens or visitors may have access,” he said in the statement Walmart released.
A CDC study found Arkansas’ prescription drugs are so ubiquitous there are enough pills on the black market that every single citizen — nearly 3 million in the state — could have a full bottle, reported Talk Business & Politics.
Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University, agrees that leftover pills do contribute to the spread of addiction but he says products like DisposeRx are unnecessary because the CDC already encourages anyone who’s at the end of a prescription opioid treatment to “flush them down the toilet.” No special ingredients necessary.
“The problem is the general public just doesn’t know that,” he said.
“Think about it,” he continued, “every time someone taking an opioid medication urinates or defecates, it gets into the water supply. So that’s not the real problem.”
Kolodny is also conducting a long-term study on the impact of numerous legislative and private company-led efforts to stem the epidemic. His conclusion on Walmart’s DisposeRx? “It’s nice that they’re trying but it will have little impact.”
The root of the explosion in the addiction crisis, he says, is rampant over-prescribing by doctors and dentists. Through his research, which is ongoing, Kolodny has found that policies limiting prescriptions are most effective, like the one imposed by CVS. In September the drug-store chain began limiting opioid painkillers to seven-day supplies for new patients.
But even that falls short of what is required, Kolodny said.
A better strategy is the one undertaken by the Vermont Department of Health. New rules established in April limit the quantity of a “morphine milligram equivalent” in prescriptions. They lay out specific dosages of drugs containing oxycodone, hydrocodone and acetaminophen-oxycodone (found in Percocet) that doctors should prescribe.
Kaiser Health News reported 22 states either adopted or toughened their prescription size limits in 2016.
Chronic pain physicians had them. So did emergency room doctors. Now outpatient physicians have clear guidelines for managing acute pain without quickly resorting to opioids.
“I believe these guidelines are a critical tool for both healthcare providers and for patients and will allow them to work together to identify the safest and most effective tools to treat their acute pain,” said Dr. Kristina Box, Indiana State Health Commissioner.
The new guidelines recommend that for patients with acute pain — pain defined as being related to damaged tissue and that will resolve with healing in a matter of days and weeks — doctors first consider non-pharmacologic treatment, such as ice, acupuncture, chiropracty and massage. If those are not strong enough, doctors should then consider non-opioid pharmacologic treatment, the guidelines say.
Only the most severe injuries warrant opioids, the guidelines say. In those instances, doctors should take several steps to ensure that the drugs are not misused, using opioids only in concert with other therapies, putting patients on the lowest dose possible and offering no refills.
An Indiana law that went into effect in July prohibits doctors from prescribing more than a seven-day supply to patients under 18 or to adults for whom that is their first prescription from that provider. Within the first few months of the law going into effect, there were 100,000 fewer prescriptions written, said Dr. John McGoff, president of the Indiana State Medical Association.
While many doctors shy away from practicing what McGoff called “cookbook medicine,” he added that the guidelines aim to raise awareness among doctors about the problem and serve as a document that doctors can consult for best practices on how to address a patient’s acute pain.
The stunning statistics associated with the opioid epidemic prompted the experts to devise ways to decrease doctors’ reliance on opioids. Excessive prescribing in the early part of this century helped stoke the epidemic, many experts believe.
Since 1999, Indiana has seen death by drug overdose increase by 500 percent.
Nationally accidents have become the third leading cause of death in the United States for the first time ever, according to the National Safety Council.
In 2016, preventable deaths increased by 10 percent over the previous year, largely due to a rise in deaths due to drug overdoses and motor vehicle crashes. Previously chronic respiratory diseases were responsible for the most deaths after heart disease and cancer, according to the Centers for Disease Control and Prevention.
While the experts who wrote the guidelines hope doctors find them useful, the final decision of whether to prescribe an opioid still rests with the doctor, said Julie Reed, executive vice president of the Indiana State Medical Association of the guidelines. Doctors will be able to tailor their decisions to fit their patients’ needs.
“They don’t stand to replace professional judgment or clinical judgment,” said Julie Reed, executive vice president of the Indiana State Medical Association of the guidelines. “That’s really an important thing that needs to be balanced, that is to make sure that the needs and unique characteristics and judgment that healthcare providers have learned through their training over the years can really serve to complement these guidelines.”
IndyStar’s “State of Addiction: Confronting Indiana’s Opioid Crisis” series is made possible through the support of the Richard M. Fairbanks Foundation, a nonprofit foundation working to advance the vitality of Indianapolis and the well-being of its people.
Call IndyStar staff reporter Shari Rudavsky at (317) 444-6354. Follow her on Twitter and on Facebook.
SHAWANO, Wis. (WBAY) – At least a dozen local pharmacy across Wisconsin are scrambling after a large company recently sent an accidental letter to its customers which claims they needed to switch to big-box pharmacies if they want lower prices.
Express Scripts is a Fortune 100 company that handles the benefits between clients and their pharmacies all across the U.S. The company is now apologizing after its erroneous letter led many of those clients to turn their backs on locally-owned pharmacies.
Sent in December to about 2,600 people, the note claims customers will pay a higher price if they don’t switch to big box stores nearby, or else use Express Scripts’ own home-delivery service.
Tim Dreier’s family has owned a pharmacy in downtown Shawano for fifty years. When his longtime clients came in and said they had to switch, he knew there had been a mistake.
“It’s consumed over a week of my time. Pretty much everyone that comes in here asks about it. Some still aren’t aware that this is not the case,” said Dreier, who also informed pharmacists in other towns after Express Scripts admitted to the mistake.
The uncertainty hit the family hard. “I really didn’t sleep much that night knowing how this would affect us, and it was serious,” said Jana Dreier.
Tim Dreier took action as soon as the transfer calls came. “One pharmacy called me with a couple transfers, and I called these people back. I said, ‘Are you transferring because of this letter?’ And they said yes.”
“We don’t want to lose any of our faithful customers who have been coming here for decades,” said Dreier.
Target 2 found pharmacies affected by the error all across the state. We even broke the news that the letter wasn’t true to one pharmacist over the phone.
Others have been fighting to keep their customers for a week.
“What we’re trying to do is be proactive and give our patients phone calls, but we don’t know the number of patients or customers that have actually received the letter. We won’t know until they don’t come in or they call us,” said Diane Collier, owner of Erickson Pharmacy in Clintonville.
Collier wants a better, immediate response from Express Scripts. “Very frustrated,” she said. “They’ve basically admitted making a mistake and that they were going to give the patients phone calls to let them know. But it’s a robo call. So they hang up, they don’t listen to it. It needs to be handled with another letter. They had no problem sending letters out to begin with!”
Pharmacists tell us they’re already losing money.
“They are going to come back, but we’ve lost that business for this month,” said Collier.
In a statement to Target 2, Express Scripts says it will mail a letter of apology to all clients affected.
PhRMA, the powerful Washington-based advocacy group that represents pharmaceutical companies, blasted a proposal by New York Gov. Andrew Cuomo to levy a 2-cents-per-milligram surtax on opioid prescription medication sold in the state to help fund measures against the drug epidemic.
ALBANY—A national trade group representing the pharmaceutical industry is vehemently opposed to a proposal by New York Gov. Andrew Cuomo to levy a tax on opioids.
On Tuesday, during his annual budgetary address to the Legislature, Cuomo unveiled an “Opioid Epidemic Surcharge,” a 2-cent-per-morphine-milligram tax on opioids pharmaceutical companies sell in the state. The surcharge on opioids is expected to “provide a financial disincentive for the use of these drugs and generate roughly $125 million to support ongoing efforts to address the opioid crisis,” according to Cuomo’s budget briefing book.
“Opioid manufacturers have created an epidemic. We would have an opioid surcharge—2 cents per milligram [that] will be paid by the manufacturer and would go to offset the costs that we’re spending to fight opioid abuse,” Cuomo said during his Tuesday speech.
PhRMA, the powerful Washington-based advocacy group that represents pharmaceutical companies, blasted Cuomo’s proposal, arguing that the narrowed focus doesn’t take into consideration many other factors that have contributed to the spike of opioid use in the country.
“We are opposed to the proposed tax because it ignores all of the factors that resulted in the current crisis and unfairly penalizes and ostracizes vulnerable patients who legitimately rely on these medicines to treat serious, debilitating and sometimes fatal conditions,” said PhRMA spokeswoman Priscilla VanderVeer.
“The proposed tax also ignores the fact that this crisis is the result of a number of factors, including a deeply troubling influx of counterfeit fentanyl and other illegal drugs coming into the U.S. through drug trafficking organizations the DEA [Drug Enforcement Administration] is monitoring, which is contributing to an increase in overdose deaths.”
Cuomo spokesman Rich Azzopardi countered PhRMA’s remarks, charging that the industry fueled the opioid epidemic.
“Big Pharma and the health insurance companies just got a big federal tax break while at the same time created the machine that fueled the opioid crisis. Spare me the song and dance about corporations crying poverty, like the tobacco companies, this money is going to help fight the problem they created,” Azzopardi said in an email.
Azzopardi did not immediately say whether the 2-cent surtax would apply to opioid medications used to treat addiction, such as methadone or buprenorphine.
Earlier this month, during his State of the State address to the Legislature, Cuomo announced plans to sue pharmaceutical companies for “perpetuating the opioid epidemic.” The Democratic governor’s remarks come as a growing number of counties in New York and across the United States have sued the makers of opioid medications.
“[Pharmaceutical companies] were conveniently blind to the consequences of their action. They pumped these pills into society and created addiction. Like the tobacco industry they killed thousands. … We will make them pay,” Cuomo said earlier this month.
Since it is commonly believed that addictions are a mental health disease and not a moral failing… So Gov Cuomo apparently believes that it constitutional, moral and rational to charge a certain segment of people with a chronic condition – requiring the use of opiates – to pay a tax on their medically necessary therapy to help pay for the therapy for another segment of our population suffering from a different chronic health issue. Gov Cuomo tries to “pass the buck” that it will be paid for by the manufacturer.. Apparently Gov Cuomo has never heard the fact that corporations DON’T PAY TAXES.. PEOPLE PAY TAXES… whatever costs a bureaucracy imposes on a corporation.. it will be passed along to final purchaser of the product/service the corporation provides.
A 12-year-old suing the federal government may have a whiff of adorableness. But for Alexis Bortell, who filed a lawsuit against Attorney General Jeff Sessions last fall, it’s a choice she had to make to save her life. Alexis has epilepsy, and Sessions has made it his mission to make it impossible for her to access the only drug that has kept her seizures at bay: cannabis.
A Scream of Terror
Alexis doesn’t remember her first seizure. But her father, Dean Bortell, does.
“We were literally folding clothes, and Alexis was sleeping on the couch,” Bortell told Newsweek. “All of a sudden, I heard her make this shriek—I mean, it was a scream of terror,” he said. “I look over, and Alexis is stiff as a board, on her back, spasming.”
At first, Bortell suspected his daughter had a brain-eating amoeba on account of headlines about them that summer and took her to the hospital. Within hours, it became clear something else was wrong. Alexis was diagnosed with epilepsy in 2013.
Three years ago, Alexis began taking medical marijuana, and her seizures disappeared. But that treatment option is threatened by an aggressive federal crackdown on medicinal cannabis led by Sessions, who is also the acting director of the Drug Enforcement Administration.
Her day in court—February 14, at a New York City federal courthouse—is fast approaching. Alexis won’t be there in person, but her lawyer, Michael Hiller, thinks the ruling will go their way.
“We are very optimistic that the case is going to come out the way it should, which is that the Controlled Substances Act is going to be found unconstitutional,” Hiller said. Several other plaintiffs—a former professional football player, a veteran and another child—are also included.
Alexis Bortell stands in a field in this undated photo. Courtesy of the Bortell Family
Out of Options
The basic outline of Alexis’s story has been well reported: Horrible seizures forced her family to move to Colorado from Texas, where she could use products with compounds derived from marijuana. But due to the concentration of THC, also known as tetrahydrocannabinol, in one of the products she uses, Alexis is unable to cross state lines, board an airplane or set foot on a military base or in other federal buildings and lands.
Biologically, Alexis’s problem begins in the left frontal lobe of her brain. Normally, brain cells communicate with one another using electrical and chemical signals. Epileptic seizures happen when those signals go haywire.
Anyone familiar with epilepsy knows that’s a fairly muted description. These rogue cells can create something terrifying to experience or watch, and you can’t know when the next seizure will strike. It can be “frustratingly random,” Bortell said.
These brain signals can also spark a long-term relationship with one’s local neurologist or hospital as patients and doctors figure out what is happening. But that’s only half the battle; controlling the seizures is the other. For many people with epilepsy, one of the various kinds of prescription drugs available will work. But finding the right one or the right combination can take time. “They try to go mild to wild,” Bortell said.
At home in Texas, none of the mild stuff worked for Alexis. Giving two medications a real shot and having them both fail is usually enough for doctors to call a person’s epilepsy intractable; in other words, unresponsive to drugs. Alexis tried at least 20 different doses or combinations, her father said. She also experienced some extreme side effects from conventional medications.
She had two final options in Texas: See if she was a candidate for surgery to remove the brain tissue where the seizures began or try one last medication, Felbatol. This drug carries a “black box warning,” the most serious kind the U.S. Food and Drug Administration will put on a label to flag extremely dangerous side effects. In this case, Felbatol has been associated with a serious bone marrow disorder and liver failure.
The family decided on Felbatol. But on the way to fill the prescription, their pediatrician called them and suggested they try something else. Weeks later, the Bortells packed their bags and drove to Colorado, ready to try a different course of treatment: a tincture of cannabidiol (a compound found in marijuana that isn’t responsible for a high) and a spray with THC (the compound that is). The CBD tincture tastes “bad and earthy,” Alexis told Newsweek, but it’s been working. She still gets auras, the warning signs that a seizure is about to hit, but she hasn’t had a full-blown episode in the past three years. Her father says the only side effect is the constant threat of federal law enforcement.
Alexis Bortell, left, and her mother stand in a hemp greenhouse in this undated photo. Courtesy of the Bortell Family
Safer Than Seizures
Some science backs up Alexis’s treatment plan. Clinical trialshave shown that CBD can be useful to treat seizure disorders, but we’re still learning why it works. CBD could be working along about a dozen different pathways and receptors, said Dr. Jerzy Szaflarski, the director of the epilepsy center at the University of Alabama at Birmingham. (Coincidentally, that’s the same state university system from which Sessions earned his law degree.) Exactly how many might be related to epilepsy isn’t entirely clear. “The evidence for each and every one of those pathways is there but it’s relatively weak,” Szaflarski said. “It’s going to take a while before we sort this out.”
The evidence is stronger for CBD as an anti-seizure medication than for THC, he noted. “It doesn’t mean that THC doesn’t work for seizures,” said Szaflarski. “It just means that we have much less data because we’ve been studying this much less.”
Despite their utility, these products aren’t without risk, Szaflarski noted. The concentration of CBD in some products available on store shelves can vary from batch to batch. These drugs may interact with traditional anti-seizure medications, changing the amount of the drug found in a person’s blood. And some studies have linked early THC exposure to lower IQs and behavioral problems.
But, Szaflarski noted, “the question is, Do these problems that we see that develop through the use of cannabis outweigh the risk of epilepsy?” For Alexis, the answer is clear: Her drugs are safer than having continued seizures.
A Violation of the Constitution
The government disagrees. It says marijuana has no medical applications whatsoever and is accordingly listed by the DEA as a Schedule 1 drug under the Controlled Substances Act, first passed in 1970.
That entire act is what Alexis, her co-plaintiffs and Hiller, her lawyer, are challenging. Hiller took the case pro-bono and has written a brief that, at 98 pages, is the longest of his career. The document lays out the basic reasons why he believes the act is unconstitutional. Specifically, the case claims the act violates Americans’ fundamental right to travel, as well as the Commerce Clause of the Constitution and the First, Fifth, Ninth and 14th amendments.
Hiller believes the case could end up in the U.S. Supreme Court. It’s impossible to say what the outcome of the case will actually be until a judge hears the arguments and makes a ruling. But while Alexis and her family wait for that outcome, they are on increasingly uncertain ground.
On January 4, Sessions rescinded the Cole memorandum, an Obama-era directive to U.S. attorneys ordering them to focus on prosecuting major distributors and more serious marijuana-related offenses, such as selling to minors. The Rohrabacher-Blumenauer amendment, renewed in December, is also set to expire on January 19. That amendment prevents the Justice Department from using its funding to keep states from implementing medical marijuana laws.
That amendment is likely to be renewed, Hiller said. Senator Elizabeth Warren has also announced plans to introduce legislation that could have the same effect as the Cole memo. But that’s little comfort to the Bortells—a family that just wants to help their child use the one thing that’s worked for her epilepsy.
“No one else is living memo to memo or administration to administration,” Bortell said. “I don’t think asking for my daughter to have that long-term plan for her life—I don’t think that’s asking too much.”
This article has been updated to clarify the medical treatment Alexis received after her first seizure.
Citing waste of taxpayer dollars, shifting public opinion, and constitutional concerns, Reps. Ted Lieu (D-Calif.) and Justin Amash (R-Mich.) have introduced a bill in Congress that would block funds from the federal government’s controversial asset forfeiture fund from being used for the Drug Enforcement Administration (DEA) marijuana eradication program.
The Stop Civil Asset Forfeiture Funding for Marijuana Suppression Act, first introduced in 2015, would use Congress’ power of the purse to block money from the Justice Department’s Asset Forfeiture Fund from being used to support the DEA’s Domestic Cannabis Suppression/Eradication Program.
According to the DEA, the program was responsible in 2016 for the eradication of more than 5 million marijuana plants, more than 5,000 arrests, and the seizure of more than of $51 million from marijuana cultivators.
For example, in 2009 federal prosecutors unsuccessfully fought to seize a farm from an Alabama woman after her husband was caught growing marijuana on the property. Her husband, who said he used the marijuana to manage chronic pain, committed suicide during his trial in a last-ditch attempt to keep the farm in family hands, as it had been for generations. His wife was never charged with a crime.
“Civil asset forfeiture is an unconstitutional practice whereby the government takes people’s property without due process,” Amash, one of the more libertarian members of Congress, said in a joint statement with Lieu. “The DEA’s use of proceeds acquired through civil asset forfeiture to expand marijuana enforcement—a state-level issue—makes the already unacceptable practice even worse.”
Lieu called the DEA eradication program “a waste of time and money and runs contrary to the will of the people.”
“The Federal Government has a responsibility to spend taxpayer money wisely,” he said. “Instead, A.G. Jeff Sessions would rather waste federal dollars by attacking marijuana, which has been legalized either for medical or recreational use in the majority of states in the U.S.”
Attorney General Jeff Sessions, a longtime supporter of the drug war, recently rescinded Obama-era guidance to U.S Attorneys on marijuana enforcement, sparking fears of a federal crackdown on the drug, which is now legal at the state level for recreational use in eight states and the District of Columbia.
A new poll conducted by Mason-Dixon Polling and Strategy and released by Smart Approaches to Marijuana (SAM), an anti-legalization group, found that only 16 percent of Americans support keeping the current federal policy on marijuana, while 49 percent favor full legalization for recreational use.
The bill also has the support of marijuana legalization groups.
“Never in modern history has there existed greater public support for ending the nation’s nearly century-long experiment with marijuana prohibition,” Justin Strekal, the political director of the National Organization for the Reform of Marijuana Laws, said in a statement. “With eight states and the District of Columbia now having legalized its personal use and 30 states having legalized medical marijuana, it is time that the DEA cease interfering with state-legal programs and stop wasting taxpayer dollars that would be better directed at going after the pill-mills contributing to the nations opioid crisis.”
