“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
Vice News from the TV Channel Viceland has reported some stories that are on our side as far as the “opioid epidemic.” I would love to see them do a full show on our cause. This is where you come in! They have a phone number where you can call and leave a message, essentially about anything…this is what we would like you to do.
Call 646-851-0347 and leave a message. Please choose option 1. I suggest you write down what you want to say instead of winging it, that way you know you cover the information that is important. Below is a suggestion of what you should include in your message.
1. Your name and number number (if you are not comfortable leaving your number that is okay, but hopefully they will contact some of us back.
2. State that you are calling as a chronic pain patient and want to dispute the false narrative that the mainstream media is propagating about opioids in America.
3. Explain why you need opioids and how the current hysteria over opioids is affecting your life and report if you have had your meds cut or discontinued. Be specific but do not ramble. try to be concise.
4. Ask them to please do a show sharing the plight of chronic pain patients because no one is telling our side of the story.
This is an easy call to action and imagine the impact if they get 500 calls from us……or 1000. PLEASE participate. No one has the right to complain about the situation if they are not actively trying to change it. No one will fight for us, WE have to fight for ourselves. Please try to do this within the next two weeks. It will make a stronger impression if all the calls come at once. Help make our voices heard!
As the opioid epidemic rages on, many still have misconceptions about what heroin really does – and how we can end the crisis
The War on Drugs Expanded the Ways People Use Heroin – and Set the Stage for the Opioid Crisis
Spencer Platt/Getty Images
There is nothing new about heroin: What has changed is the way that we consume, dispense and talk about it. Despite the rising rate of opioid abuse and overdose in this country, we continue to mischaracterize heroin, thereby neglecting to understand the indelible hold it has on users. Here’s an attempt to clear up some of the most common misconceptions.
Heroin Isn’t Always White Powder
Heroin generally comes in three different forms in the United States: powder heroin – which falls into two subcategories, brown and off-white – tar heroin and heroin pills. Historically, the Mississippi River has been the line of demarcation between the tar and powder markets. Off-white powder heroin, which originates in Southeast and Southwest Asia, is generally considered the most desirable kind. Powder, with its origins in Mexico, often carries a deeper, browner hue, and is usually less powerful. On the West Coast, heroin comes almost exclusively from Mexico and South America and is most often sold in tar form; little balls of goo that look like black earwax. The third, least common form of heroin is “pill” form. “Pills” refer to heroin often sold in gel capsules and mixed with other powders – be it cocaine, methamphetamine or the more common heroin adulterants like powdered lactose, quinine and baby laxative. Pills are usually the cheapest and lowest-quality form of the drug.
What Might Look Like an Opioid High Is Actually the Symptoms of Withdrawal
Outsiders often confuse withdrawal symptoms for the effects of the drug, because the effects of withdrawal are far more noticeable than the euphoria the drug produces. Dilated pupils, sweating, shaking, slurring and vomiting aren’t signs of being high; they’re signs of opioid withdrawal. Quitting heroin is often called “kicking” in reference to the tendency to kick out one’s legs in attempt to stretch away the discomfort.
The War on Drugs Expanded the Ways People Use Heroin – and Set the Stage for the Opioid Crisis
In the Sixties and Seventies, just about all heroin addicts were intravenous users, but as the purity of the drug increased, so did potential methods for use.
During the 1960s, heroin use rose, in part, due to soldiers returning from Vietnam who were exposed to the drug overseas, and drug dealers in urban centers seized on this opportunity. Then, in the summer of 1969, when Nixon declared his war on drugs, he cited New York City’s heroin trade as the core of the problem. The speech apparently roused the NYPD, who proceeded to arrest some of the city’s biggest dealers.
Meanwhile, suppliers in Asia became concerned that they would lose their distribution. In response, they began setting up their own networks in America’s cities to establish a more discrete trade. Heroin sold in the U.S. saw a bump in purity around this time as a result of this more direct supply line. However, purity levels would soon skyrocket as the heroin market was about to become competitive.
Though Nixon targeted heroin in his speech, in practice the drug war mainly targeted toward marijuana.
With cocaine, heroin and marijuana all categorized as Schedule I drugs, DEA agents opted to pursue the smelliest, bulkiest and most conspicuous of those three substances.
Colombian and Mexican drug cartels, who had previously trafficked mainly in marijuana, switched to a product that was less noticeable and carried more value by weight. Ironically, it was the drug war itself that pushed the cartels into the heroin business.
Additionally, in the Eighties, crack appeared almost overnight – and authorities suddenly deprioritized heroin. Meanwhile, as a result of the tenfold rise in heroin purity between 1970 and 1990, nasal administration became a viable option for users. Mexican and Colombian cartels introduced the drug to suppliers and users who previously had only dealt with cocaine. The new, more socially acceptable method of use endeared the drug to an entirely new demographic of trendy, wealthy and often white cocaine users.
The demographic that had previously been most afflicted by heroin addiction took a deliberate step away from the drug. In low-income urban centers, the fallout of the 1970s heroin explosion became a cautionary tale. A generation came up witnessing the long-term effects of the drug, which had hardly existed as a threat in rural and suburban America. “Young African Americans and young Latinos were not going into heroin because they saw the destruction that occurred in their families and in their neighborhoods and they didn’t want to go down that road,” says Philippe Bourgois, a cultural anthropologist and author of the book Righteous Dope Fiend. “It was seen as a loserly thing to do.”
Meanwhile, he says, working-class white people in rural areas – which in the past had not been as affected by drug epidemics – found themselves beset by poverty due to the shifting nature of the American economy. The groundwork was laid for a potential drug crisis.
The Pharmaceutical Companies Made it Worse
For a true public health crisis to occur, there first had to be an influx of opioids into the country, the likes of which no drug cartel could muster. Enter the major American pharmaceutical companies. In the late 1990s, the pharmaceutical companies successfully lobbied the Joint Commission, an organization responsible for accrediting American health care programs thereby essentially setting the standard for American health care programs, to accept the concept of pain as a vital sign. Before that, pain was a secondary consideration. But now, physicians would be required to ask about and treat their patients’ pain. In the decade that followed, sales of prescription opioids in the U.S. quadrupled. Roughly during the same time period, the overdose rates quadrupled as well.
And as they made public attempts to reform, it only took the crisis in new directions. Take “abuse-proof” OxyContin. In 2010, OxyContin producer Purdue Pharma introduced a new version of the pill that they claimed was “crush-proof,” turning into a jelly if you tried to crush it into a powder, therefore making it impossible to inject or snort. Almost immediately, though, Internet forums lit up with collective solutions for overcoming the newly implemented safeguards. Meanwhile, anecdotes of addicts visiting the emergency room as a result of injecting the binders contained within the abuse-proof pills began to spread. Other users opted for a better workaround: switching to heroin.
Naloxone Is No Party
The existence of more opioid-dependent citizens continues to benefit the pharmaceutical industry. Naloxone, often sold under the brand name Narcan, counteracts the effects of an opioid overdose. Since 2014, there’s been a near 500 percent increase in sales of the drug. Meanwhile, over the last three years, pharmaceutical companies have steadily raised the price by as much as 50 percent. Now, with first responders throughout the country needing a steady supply of naloxone on hand, Big Pharma doesn’t only see several billion dollars per year off opioids themselves, but they see a growing profit from the sale of anti-opioids.
Thus far, 46 U.S. states have opted to make naloxone available over the counter. Despite this progress, a vocal minority has expressed concern that increased access to naloxone might have dangerous repercussions. The hysteria generated by those who oppose naloxone access may be responsible for the creation of a relatively new heroin myth.
In August 2017, a report from Boston’s Fox News 25 claimed to have identified a new trend where partygoers were intentionally overdosing on opioids so they could take Naloxone, thereby “giving the drug user a rush.” Several similar reports described the practice, dubbed “Narcan Parties.” The supposed trend was touted by Pennsylvania State Senator Lisa Boscola and State Representative Dan McNeil as a reason not to expand access to naloxone in the state. However, there’s no evidence that these parties are actually happening. “I have not been able to verify a single case of this,” Bill Stauffer, Executive Director at the Pennsylvania Recovery Organization, told The Outline. “I suspect it to be an urban legend.”
Replacement and Maintenance Therapies Gets Results Maintenance therapies like methadone and subutex have shown better results than non-medication-assisted treatments, both in cases of addicts seeking abstinence from opioids, and for those seeking simply to carry on living relatively normal lives. Replacement therapy with drugs like methadone, subutex, kratom and even cannabis have also shown major promise in helping addicts get clean.
The success rate of addicts getting clean without the help of replacement therapies has been stated to be as low as 3 to 5 percent and as high as 20 to 30 percent. Success rates amongst those using drugs like methadone and buprenorphine to help them taper off opioids have been cited as high as 60 to 90 percent. According to the California Society of Addiction Medicine, addicts who go cold turkey are significantly more likely to relapse than those who taper off with drugs like methadone or Suboxone.
Though Attorney General Jeff Sessions recently shared his opinion that most heroin addiction starts with marijuana “and other drugs too,” the benefits of marijuana as a potential treatment for opioid addiction have become the cornerstone of several controversial treatment modalities. Researchers also believe that painkillers derived from chemicals found in marijuana such as CBD could provide an effective and far less dangerous alternative to prescription opioids.
Safe-injection Sites Reduce Risk, Too
A 2005 study in Switzerland found greater reductions in opioid use and greater rates of complete abstinence among subjects who were given injectable heroin while supervised, over those who were given methadone over the same 12-month period. With the number of supervised injection sites around the world nearing 100, and showing promise in major cities like Sydney, Vancouver and Amsterdam, activists in major cities like New York have begun the fight to bring supervised injection sites to the U.S.
The Cure Could be in Hallucinogens
If anything like a “cure” for opioid addiction ever emerges, it will likely come from outside the medical establishment. For example, many consider Ibogaine, a hallucinogenic plant, to be one of the most promising opioid-dependence treatments on the horizon. The anti-addictive potential of the drug was discovered in the 1960s by Howard Lotsoff, an opioid-addicted beatnik who would spend the rest of his life championing the drug as a treatment for addiction.
The mantle for Ibogaine advocacy has since been taken up by people like Dimitri Mugianis, who after getting clean with Ibogaine put his life and freedom on the line to help suffering addicts with guerilla-style treatments in hotels across New York City. After a DEA sting landed Mugianis in jail in 2011, he became an icon of the harm reduction movement, a movement many consider integral to improving the state of addiction in this country. (After a years-long court battle, he was eventually convicted of a misdemeanor drug charge and served 45 days house arrest.)
While scientists see promise in drugs like 18MC, a new chemical compound that attempts to make use of the anti-addictive properties of Ibogaine without the hallucinogenic effects, Mugianis believes that too much emphasis is put on chemical solutions.
Mugiainis insists that the only way forward is to begin changing our outlook on those addicted to opioids. “We need to start treating drug users well, like human beings,” he tells Rolling Stone. “We must offer a menu of choices as varied and complex as humans are, and addiction is.”
Addicts Aren’t So Easily Pegged
Mugianis believes that the biggest misconception about heroin addicts is that they are non-functional. During his time treating addicts, Mugianis says he’s seen heroin users with careers and families living what many would consider successful, fulfilling lives. The harm for them mainly came when they didn’t have access to the drug. “To say that people are totally dysfunctional on opiates as Americans, we’d have to discount all that active users have given to this culture, from Billie Holliday to Edgar Allan Poe to Jimi Hendrix; people who not only functioned but excelled and enriched our culture,” he says. “The people who made our culture were high.”
HAMILTON, Mont. — The Florence doctor convicted last year of 22 felony drug counts including two negligent homicides is back in jail.
Dr. Chris Christensen had been free pending his appeal with the Montana Supreme Court. He was sentenced to 10 years in prison. But his bail has been revoked.
According to court documents, Christensen failed to file a timely appeal with the state Supreme Court.
Christensen has been arrested and is currently in the Ravalli County Detention Center.
The report said that it is the court’s judgment that Christensen’s stay should be “lifted immediately” and that he should begin serving his sentence “without further delay.”
A whistleblower with Aetna who accused CVS Caremark of gouging Medicaid and Medicare customers with high prescription-drug costs has been placed on paid administrative leave by the insurance company.
The move comes after the whistleblower’s lawsuit was unsealed in federal court in early April. It also comes as CVS Caremark, one of the country’s largest pharmacy benefit managers, pursues the acquisition of Aetna for a reported $69 billion.
Sarah Behnke, at the time the chief Medicare actuary for Aetna, filed the whistleblower lawsuit, which is pending. Her attorney told The Dispatch that the decision by Aetna to send her home is “retaliatory and inappropriate.”
Behnke said her internal investigation found that CVS Caremark was billing the federal government significantly higher prices for seniors’ drugs than was appropriate.
The scheme has been used by CVS Caremark since 2007, Behnke said, and has cost the federal government more than $1 billion in fraudulent charges, according to her lawsuit.
Some pharmacists say the same practice is happening in Ohio. CVS Caremark is the pharmacy benefit manager for four of Ohio Medicaid’s five managed-care companies.
A pharmacy benefit manager, or PBM, is the middleman entity that negotiates with drug manufacturers and then sets the prices for insurance companies and pharmacies. Those prices are what the public pays for prescription drugs.
State legislators in Ohio have requested that CVS provide pricing lists to see whether so-called “spread pricing” is happening in Ohio. Spread pricing is when the PDM negotiates a lower or discounted price with a drug manufacturer and then negotiates another price with the pharmacy. PBMs also negotiate different payments to pharmacies to make money. Those discounts typically are not passed on to the health-insurance provider.
CVS Caremark officials, who have rejected allegations of spread pricing or wrongdoing, say they will turn over documents by June 1. They say they were not aware of who filed the lawsuit until after announcing the plan to buy Aetna.
“We believe this complaint is without merit, and we intend to vigorously defend ourselves against these allegations,” CVS Health spokesman Michael DeAngelis said in an email response. Should CVS Caremark acquire Aetna, he said, “CVS Health policy prohibits the taking of punitive action against a whistleblower.”
Aetna officials declined to comment.
The lawsuit and CVS Caremark’s planned acquisition of Aetna both have significant implications for taxpayers, who fund Medicare and Medicaid programs.
Aetna would be the first health-care provider owned by CVS. If the purchase is approved by the U.S. Department of Justice, it would give the pharmacy giant a health-care conglomerate of managed-care and pharmacy benefit management operations.
That control of the entire chain of health care by CVS would, in effect, create a vertical monopoly and directly affect how much customers end up paying for health care, including prescription drugs.
The Trump administration has heavily criticized these types of conglomerations as being “monopolies” that allow companies in the prescription-drug chain to conceal prices. Last week, President Donald Trump’s Food and Drug Administration chief called it a “rigged system” against the public.
PBMs such as CVS Caremark were created to lower prescription-drug costs in the marketplace. During the past five years, prescription-drug costs have been the fastest growing facet of the health care chain, according to a recent study by U.S. News and World Report.
Three PBMs control between 80 and 90 percent of the prescription drugs in the marketplace, with an estimated $400 billion in gross sales, according to the IMS Institute for Healthcare Informatics. PBMs conceal how they affect drug prices from insurance providers and the public.
Behnke filed a federal False Claims Act lawsuit in 2014 under seal. Whistleblower lawsuits are sometimes filed under seal to allow federal prosecutors time to review the allegations and get involved.
Behnke’s attorney, Susan Schneider Thomas, said the government deferred participation for now. That allowed the judge to unseal the lawsuit in April.
That meant that CVS officials didn’t formally know the allegations or who filed the lawsuit until April.
Whistleblower advocates expressed concern that the acquisition by CVS could be bad for Behnke and affect the lawsuit. They said it’s unlikely, though, that CVS pursued the acquisition to choke off the lawsuit.
“I think if there is an acquisition by CVS, she has a reason to be concerned,” said James Mowery Jr., a Dublin-based lawyer whose firm specializes in whistleblower lawsuits. “She needs to be sure that her employer will always be Aetna, and she needs to be keeping a diary of everything that happens up until the acquisition.”
Mowery said the proposed acquisition makes the lawsuit a “significantly complex piece of litigation.”
Whistleblower Advocates, a whistleblower-lawyers firm based in Chicago, said that until the federal government demands to be a party in the suit, CVS will not feel pressure to address Behnke or her accusations.
Behnke said she took her concerns to corporate executives for Aetna and CVS Caremark in 2013, according to court records. Nothing happened.
Thomas said in the complaint she filed against CVS Caremark that the company was charging Aetna 25 to 40 percent more for drugs than its competitors.
Behnke also said that during meetings in February of 2013 with CVS officials to present her findings, CVS Vice President Allison Brown said Caremark had negotiated lower prices for those drugs but was not contractually obligated to show Aetna those prices.
Thomas called the exchange a “virtual admission of liability,” according to court records.
attrib? CVS Caremark officials also confirmed at those meetings that they had re-created Behnke’s analysis of drug prices and confirmed that she was accurate, according to court records. Behnke asked whether CVS Caremark could use the information to negotiate better prices for Aetna’s policyholders.
“Caremark defendants … stated that improving or increasing the discounts Aetna received would adversely impact” CVS Caremark’s profits due to “retail contracting methodology,” according to court records.
In an email sent in July of 2013, Aetna’s head of its Medicare division marveled at how much money CVS Caremark was making on the “hidden spread.”
By September of 2013, Aetna indicated it would shop around for another PBM to see whether it could find better rates, according to the lawsuit.
CVS Caremark officials immediately offered to lower the costs of drugs for Aetna. When Aetna started shopping for a better deal, CVS Caremark offered an even steeper discount, according to the lawsuit.
Attorneys for CVS Caremark filed a motion April 20 to permanently seal the case again, saying the lawsuit would cause significant financial harm. The company’s attorney said Behnke provided sensitive information.
“These details concern the financial guarantees and pricing terms to which Caremark and Aetna agreed as well as financial terms allegedly offered during negotiations and data allegedly revealing specific prices paid by Aetna as well as Caremark’s performance on financial guarantees,” the motion read.
Behnke’s attorneys have until Friday to respond to the request to seal the case.
The PBM’s are forcing me to rant on Facebook, which I thought I would never do! Please, band together with me, watch, educate, share and help stop these BULLIES!!
Here is a recent article from the State of Arkansas discovered that the PBM Caremark – part of CVS – is paying themselves (CVS Pharmacies) – on average – $60.00 MORE PER PRESCRIPTION than when a pt had the very same prescription filled at one of CVS’ competitors.
Here is another article from the state of Illinois where the same PMB (Caremark) has cut reimbursement on prescriptions paid for by Medicaid and handled by Caremark has been reduced to a level that is BELOW THE COST OF DOING BUSINESS
DUE TO THE GROWING NUMBER OF PAIN PATIENTS LOSING THEIR ACCESS TO PAIN MEDICATION & DOCTORS UNWILLINGNESS TO PRESCRIBE, WE HAVE BEEN INUNDATED WITH MESSAGES, AND THERE’S A HIGH DEMAND FOR INFORMATION ABOUT HOW TO GET PROPER TREATMENT.
WE NEED HIGHLY EXPERIENCED TECH SAVVY INTERNS (YOUR HIGH SCHOOL KIDS, GRANDKIDS, NEIGHBORHOOD KIDS, ETC.) TO VOLUNTEER TO HELP US CONTINUE TO SPREAD OUR MESSAGE ACROSS FACEBOOK, TWITTER, YOUTUBE, INSTAGRAM, ETC. AS OUR MOVEMENT IS IMMENSELY GROWING DAY BY DAY. THE CLOCK IS TICKING & TIME IS OF THE ESSENCE SINCE OUR GOVERNMENT IS RUSHING TO PASS MORE RESTRICTIONS WHICH WILL FURTHER IMPACT THE PAIN COMMUNITY.
IF YOU WOULD LIKE TO HELP MAKE A DIFFERENCE, PLEASE REPLY EMAIL PAINWARRIOR55@GMAIL.COM – REMEMBER, OUR LIVES DEPEND ON IT AND SADLY, FOR MANY IT’S ALREADY TOO LATE! THANK YOU!
Three sponsors of Medicare Part D plans—UnitedHealth Group, Humana and CVS Health—account for more than half the program’s total enrollment. If proposed mergers involving smaller players like Aetna, Express Scripts and Cigna move ahead, the market would become even more concentrated.
The study, led by Juliette Cubanski, PhD, MPP, MPH, the associate director of the program on Medicare policy at the Kaiser Family Foundation, looked at CMS data on Medicare Part D for 2018—43.4 million of Medicare’s 60 million beneficiaries have prescription drug coverage under the program, with 58 percent covered by a stand-alone prescription drug plan (PDP) and 42 percent in Medicare Advantage drug plans (MA-PDs).
UnitedHealth Group is the market leader, covering 23 percent of all PDP and MA-PD enrollees, followed by Humana (18 percent) and CVS Health (14 percent). The 10 largest Plan D plan sponsors account for nearly 90 percent of enrollment.
Humana and UnitedHealth’s positions could be threatened by pending mergers between some of the biggest Plan D players. CVS would take over the No. 2 spot by combining its market share with Aetna while Cigna and Express Scripts would separate itself from the bottom of the Top 10 with its proposed merger.
“If these mergers go through, four firms—the two merged firms plus UnitedHealth and Humana—would cover 71 percent of all Part D enrollees and 86 percent of stand-alone drug plan enrollees, based on 2018 enrollment,” Cubanski and her coauthors wrote.
Despite the dominance of a few companies, average monthly premiums for Part D plans haven’t increased at the same rates seen among commercial insurance or on the Affordable Care Act exchanges. PDP enrollees are paying only 2 percent more in 2018, an average of $41 per month, though that represents an 11 percent hike since 2015. The average MA-PD premium is $34 this year.
Among the top five PDPs, the study found an inverse relationship between year-to-year premium hikes and changes in voluntary enrollment among beneficiaries who aren’t receiving low-income subsidies. If premiums go down, enrollment goes up—such as when Aetna’s Medicare Rx Saver plan dropped premiums by $2 and saw enrollment increase by 13 percent.
GW Pharmaceuticals executives give the scoop on the anticipated upcoming launch of the first cannabinoid drug with blockbuster potential.
Only three drugs based on marijuana have ever been approved by the U.S. Food and Drug Administration (FDA). None of those drugs were actually made from marijuana plants, but were instead created using synthetic versions of cannabinoids. None of them have been huge commercial successes, either. But a cannabinoid drug that’s actually made from marijuana plants and has blockbuster sales potential could soon win approval including CBD products as kushiebites which you can get online.The FDA is scheduled to make a decision by June 27, 2018, on GW Pharmaceuticals’ (NASDAQ:GWPH) cannabidiol (CBD) drug Epidiolex as a treatment for Dravet syndrome and Lennox-Gastaut syndrome (LGS). An FDA advisory committee already unanimously recommended approval for the cannabinoid drug.
Epidiolex is widely expected to be a big seller. Market research firm Evaluate Pharma projects that it will be one of the 10 biggest new drugs launched in 2018, with sales around $1 billion by 2022.
With the countdown on for the anticipated approval and commercial launch of Epidiolex, GW Pharmaceuticals executives fielded questions on Wednesday at the Bank of America Merrill Lynch 2018 Health Care Conference. Here are five things you’ll want to know about what could be the biggest medical marijuana drug ever.
Image source: Getty Images.
1. When could Epidiolex be available to patients?
There’s no guarantee that the FDA will approve Epidiolex. The agency doesn’t have to go along with the recommendation of the advisory committee. But the odds of approval appear to be really good. In most cases, the FDA does approve a drug when it’s been recommended by an advisory committee.
While an approval decision should be made within the next month or so, GW Pharmaceuticals CEO Justin Gover said that Epidiolex won’t be launched in the U.S. until early fall. That’s because the drug must be scheduled by the Drug Enforcement Administration (DEA) after it’s approved by the FDA. This process can take up to 90 days.
Gover stated that GW continues to believe that Epidiolex will receive no worse than a schedule IV. Drugs under this schedule have a low potential for abuse and low risk of dependence. He mentioned that the FDA advisory committee examined the clinical data for Epidiolex in detail and concluded, like GW’s team did, that CBD has a low potential for abuse.
2. What are payers saying?
FDA approval and DEA scheduling are just the first hurdles for GW Pharmaceuticals. The company must also secure payer coverage for Epidiolex. Julian Gangolli, president of GW’s North American operations, said that there has been “a lot of discussion with payers going back to 2017.”
Gangolli thinks that payers understand the unmet medical need in treating epilepsy. How do they feel about Epidiolex, though? His view is that payers “get the science” and “understand the value” of the drug.
He noted that the three well-controlled phase 3 clinical studies supporting Epidiolex are different than what payers are accustomed to in the orphan drug market. (Orphan drugs treat diseases that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but aren’t expected to recover the costs of developing and marketing the drug.) Other orphan drug studies are usually smaller and “not quite as well controlled” as the ones that GW conducted, according to Gangolli.
3. Will GW be able to keep up with demand?
There aren’t any FDA-approved treatments for Dravet syndrome. And while there are approved drugs for treating LGS, many patients develop resistance to these drugs. Epidiolex could enjoy strong demand right out of the gate if it’s approved, especially if physicians also prescribe the drug for other types of epilepsy that aren’t on the product label.
Justin Gover was clear about GW Pharmaceuticals’ intention to promote Epidiolex only for the two approved indications. However, he added that the company “is mindful of the level of unmet need.” Gover said that GW should be in good shape to meet projected demand for the first two years with its current production facilities, which have already been inspected by the FDA. After the second year following anticipated approval, the company will have added capacity.
4. How much will patients have to pay out of pocket?
GW Pharmaceuticals hasn’t announced the pricing for Epidiolex. However, Gangolli noted the price tags for two current LGS drugs on the market. Onfi costs roughly $21,000 to $22,000 per year on a weighted average basis, while Banzel costs around $32,000 per year. It seems likely that GW will price Epidiolex competitively with these two other products.
What about how much patients will have to pay out of pocket? That depends on the type of coverage. Gangolli stated that around 55% of Epidiolex patients would likely be on Medicaid or Medicare. These patients usually have drug copays between $5 and $10. Gangolli acknowledged that Medicaid and Medicare copays can sometimes be more, but that they should “be affordable.”
As for the patients on private insurance, the out-of-pocket costs will be specific to each plan. Gangolli mentioned, though, that copays for Banzel and Onfi could be as high as the $180-$200 range, but that many were between $50 and $80.
5. Could many patients choose medical marijuana instead of Epidiolex?
Is it possible that medical marijuana could be more popular with patients than Epidiolex? Justin Gover’s immediate response was that “first and foremost, this [epilepsy] is not a trivial disease” and that patients “should be under appropriate medical care.”
Perhaps the most important reason why Epidiolex shouldn’t be threatened by medical marijuana too much, though, is the financial consideration. Gover noted that non-FDA-approved CBD oils aren’t cheap. He also stressed that the “therapeutic dosage required is pretty sizable.” The costs to patients to try to replicate the dosage of Epidiolex with other CBD oils would be very high.
At the same time, GW Pharmaceuticals fully expects to secure payer coverage for Epidiolex. Patients would only need to pay copays for the drug, which would make it much more cost-effective than buying CBD products that insurers don’t cover.
Looking ahead
GW Pharmaceuticals stock will likely enjoy a boost if the FDA approves Epidiolex as expected. The key thing to watch immediately following this anticipated approval is the DEA classification of the drug. Should Epidiolex win a less restrictive classification than schedule IV, GW would probably have another positive catalyst.
The most important thing for investors, though, is how well the expected commercial launch of Epidiolex goes. GW Pharmaceuticals appears to be in good position to quickly hire and train a sales team. The big question will be how favorably payers view Epidiolex. Their reactions will have a significant impact on Epidiolex sales — and on GW Pharmaceuticals stock.
President Trump’s pick for CIA director Gina Haspel was confirmed Thursday by the Senate, with help from several Democrats who backed the nomination despite concerns over her role in post-9/11-era interrogation and detention practices.
The Senate voted 54-45 to confirm Haspel, with a handful of Democrats voting in support. The vote came a day after Haspel was recommended in a 10-5 vote by the Senate Intelligence Committee. Haspel will be the first woman to lead the agency.
Haspel, who will replace now-Secretary of State Mike Pompeo, served as the base chief at a black-site prison in Thailand in 2002, where techniques such as waterboarding were used on terror suspects. But Republican supporters accused Democrats of politicizing her nomination, and initially trying to derail an otherwise highly qualified nominee.
At her confirmation hearing last week, Democrats grilled her on her views on what they deemed torture, as well as objecting to what they saw as the CIA’s selective declassification about information on her. She was also questioned at length about the 2005 destruction of more than 92 interrogation tapes — a move she said she supported to ensure the safety of CIA agents.
Haspel refused to criticize her colleagues and superiors for their conduct during what she called a “tumultuous time,” but said the CIA under her watch would not resume such techniques. She also defended her own conduct.
“After 9/11 … I stepped up. I was not on the sidelines, I was on the frontlines in the Cold War and I was on the frontlines in the fight against Al Qaeda,” she said in response to a question from Sen. Ron Wyden, D-Ore.
Haspel’s confirmation had been in question after Sen. Rand Paul, R-Ky., later joined by Sen. Jeff Flake, R-Ariz., said he would not vote for her.
“While I thank Ms. Haspel for her long and dedicated service to the CIA, as a country we need to turn the page on the unfortunate chapter in the agency’s history having to do with torture,” Flake said in a statement Wednesday.
Along with the absence of Sen. John McCain, R-Ariz., it meant that Haspel needed Democratic votes to assure her confirmation.
But in the days leading up to Thursday’s vote, she picked up Democratic support, particularly from those in tough midterm re-election fights. Sen. Joe Donnelly, D-Ind., and Sen. Joe Manchin, D-W.Va., came out to back her last week, and others followed.
A key factor may have been a letter she wrote to Sen. Mark Warner, D-Va., vice chairman of the intelligence committee, on Tuesday, saying: “With the benefit of hindsight and my experience as a senior agency leader, the enhanced interrogation program is not one the CIA should have undertaken.”
Warner subsequently said in a statement that he believes she “is someone who can and will stand up to the president if ordered to do something illegal or immoral — like a return to torture.”
Amazing, Democrats have stuck together over the last 18 months voting against anything and everything that came up for a vote – INCLUDING lowering income taxes.. estimating that the average family would be getting $2000 more in their pocket…
Now that we are getting close to the Nov election… a handful of Senators up for re-election have decided to vote for what is in the best interest of the public in general…
It will be interesting if they are re-elected in Nov… what their voting record will be after Nov 2018. Will they get back in “lock-step” with the rest of the Democratic party – because they won’t have to run for re-election for 6 yrs and the voter’s memory is not that long ?
For those chronic painers out there… Manchin last year floated a “opiate tax” on prescription opiates to help pay for the cost of dealing with addicts. It will be the first time – I think – where one group of people with a particular health issues would be required to pay for the treatment of another group of people with a different health issues .
