J&J agrees to settlement with two Ohio counties ahead of opioid trial

Johnson & Johnson (NYSE:JNJ) says it will pay a $20.4M settlement with Cuyahoga and Summit counties in Ohio that accused it of contributing to the U.S. opioid addiction epidemic.

JNJ says the deal resolves all of the counties’ claims with no admission of liability and removes the company from a federal trial scheduled to begin Oct. 21.

Yesterday, Mallinckrodt (NYSE:MNK) announced a $24M settlement with the same two counties, and Endo International (NASDAQ:ENDP) and Allergan (NYSE:AGN) had settled with the counties in August to avoid going to trial.

Remaining defendants in the Oct. 21 trial include McKesson (NYSE:MCK), AmerisourceBergen (NYSE:ABC), Cardinal Health (NYSE:CAH), Teva Pharmaceutical (NYSE:TEVA), Walgreens Boots Alliance (NASDAQ:WBA) and Henry Schein (NASDAQ:HSIC).

JNJ and most of the other companies still face thousands of lawsuits related to the opioid epidemic.

https://seekingalpha.com/news/3503212-j-and-j-agrees-settlement-two-ohio-counties-ahead-opioid-trial

Obama-era officials shut down plan to ban vaping flavors: LA Times

The Food and Drug Administration (FDA) tried to ban child-friendly vaping flavors back in 2015, but heavy lobbying from the vaping industry led top officials in the Obama White House to nix the ban, the Los Angeles Times reported on Tuesday.
The canceling of the proposed ban, officials told the Times, was due to a cost-benefit analysis that indicated the economic hit to the industry was greater than the supposed negative health effects.
Without the ban, the vaping and tobacco industry boomed, as did the number of young people using vaping products, growing from 3.6 million in 2017 to 4.9 million in 2018.
The report comes as health officials nationwide are grappling with a mysterious illness related to e-cigarettes that has sickened hundreds of people and killed at least 14.
The FDA allegedly had reports years ago that showed e-flavor liquids that appealed to children were dangerous. Flavors such as bubble-gum and cotton candy were shown to contain aldehydes, a group of chemicals that restrict the airway.
Cinnamon flavors were reportedly known to have cinnamaldehyde, which was described by scientists as “highly toxic to human cells.”
With widespread approval from the health and science community, an FDA ban headed to the White House for approval in October 2015. The following month, the proposed ban made its way to the Office of Management and Budget (OMB), which is tasked with evaluating the economic impact on major bans or restrictions.
That’s when the lobbyists became involved, the Times reported.
That November, the OMB reportedly met with more than 100 tobacco industry lobbyists and advocates. In early 2016, still more meetings were held between the administration and industry groups.
When the FDA’s final rule on e-cigarette oversight was released in May 2016, the flavor ban was no longer included.
Also allegedly missing were 15 pages of FDA evidence showing flavored tobacco would drive a spike in youth usage.
“You look at these enormous chunks crossed out, and think, ‘How could this possibly have seemed good for public health?'” Eric Lindblom, a former official in the FDA’s Center for Tobacco Products, told the Times.
“It’s as if they looked at each other and said, ‘If we’re not going to do anything about this problem, let’s delete anything that suggests we should.’ It’s a horror story,” Lindblom added.
An FDA spokeswoman told the Times that the agency doesn’t comment on changes makes during the rulemaking process, but added the FDA plans to work “to clear the market of unauthorized, kid-appealing flavored e-cigarette products.”
Within the year after the FDA announced its final rule, Juul reportedly saw its brick-and-mortar sales rise an astonishing 640 percent. Altria, one of the tobacco companies that aggressively lobbied the White House, eventually bought 35 percent of Juul.
Presently, there are reportedly more than 10,000 vaping flavors.
https://thehill.com/policy/healthcare/463892-obama-officials-shut-down-plan-to-ban-vaping-flavors-report

Quick, Noninvasive Approach Promising for Migraine With Vertigo

Noninvasive vagus nerve stimulation (VNS) provides rapid relief of vertigo and headache in patients with acute vestibular migraine (VM), results of a small study suggest.
In the wake of these promising early findings, study investigator Shin C. Beh, MD, assistant professor of neurology, University of Texas, Southwestern Medical Center, Dallas, encourages clinicians to try novel neuromodulatory approaches like vagus nerve stimulation for their VM patients.
“It’s safe, with not much risk to the patient. I’d say go for it; try it out,” he told Medscape Medical News.
The study was published online September 25 in Neurology.

Common Cause of Vertigo

VM is the most common neurologic cause of vertigo. All patients with VM have vertigo as a manifestation of migraine, but they may or may not have headache and, if they do, it is often less severe than pain associated with typical migraine.
The cause of VM, which affects 1% to 2.5% of the population, is primarily linked to genetics. Compared with other migraine types, it is much more common among women than men.

There are no approved treatments for acute VM. Even though headache may not accompany VM attacks, clinicians tend to extrapolate therapeutic approaches from migraine headache guidelines.
Analgesics may not be effective for acute VM. Antiemetics and medications that quiet down the entire vestibular system are sometimes used, said Beh, but these may cause sedation and impair engagement in daily activities. In addition, although triptans may be useful, the evidence for their use in VM is inconclusive.
VNS has been shown to be safe and effective for acute migraine. The US Food and Drug Administration has cleared the hand-held gammaCore (electroCore) for migraine, as well as cluster headache, in adults.
The retrospective study included 18 patients (16 women and two men), with a mean age of 45.7 years, diagnosed with VM. The diagnostic criteria include at least five episodes of moderate or severe vestibular symptoms. Some patients in the study described these episodes as a spinning or rocking sensation.
The criteria also require that 50% or more of these episodes be associated with at least one of three migrainous features. These include migraine headache, photophobia and phonophobia, and visual aura.
Study participants were all patients Beh was seeing in his clinic. Of the 18 participants, 14 were in the midst of an acute VM attack.
“They happened to show up to clinic with an attack and had no medication on hand. The best solution I could come up with was to offer the stimulation,” he said.

Quick, Safe, Noninvasive

Prior to VNS treatment, patients graded the severity of their vertigo/dizziness and headache, if present, using a visual analog scale (VAS) with 0 representing no symptoms and 10 the worst imaginable.
Although some participants were on pharmacologic migraine prevention, none had taken any migraine abortives, antiemetics, or vestibular suppressants within 24 hours of the intervention.

Under supervision, patients used the device to deliver bilateral 120-second electrical stimulations to the right front and then to the left front of the neck.
“It’s quick — 2 minutes on each side,” said Beh. “It doesn’t cause any sedation.”
Patients graded their vertigo/dizziness/headache using the same VAS 15 minutes after VNS treatment.
“The most significant finding was that the vertigo got better,” said Beh.
In the 14 participants who were having a VM attack, 13 reported the vertigo improved and one reported no benefit. Of those who experienced improvement, two had complete resolution and several described at least a 50% improvement in vertigo severity.
The mean vertigo intensity was 5.2 before VNS and 3.1 after treatment. The mean reduction in vertigo intensity was 46.9%.
Only five patients experienced a headache with their VM attack. One experienced complete resolution after stimulation and four reported at least a 50% improvement in headache intensity.

Potential Mechanisms

Mean headache severity was 6 prior to VNS and 2.4 after treatment. Mean reduction in headache intensity was 63.3%.
Four of the 18 participants who just had interictal dizziness reported no benefit from the treatment.
Beh believes that the stimulation may work through nuclei located in the brain stem.
“One of the nuclei, the nucleus tractus solitarius, is of particular interest because the trigeminal system, vestibular system, and vagal system all connect through that nucleus,” he said.
“That nucleus has been found to be responsible for nausea in migraine and for motion sickness, so that may be the most likely candidate,” Beh explained.
But there’s evidence that the effect may not be limited to the brain stem. Beh cited research suggesting that VNS causes changes in multiple areas of the brain, including the thalamus, parietal lobes, and temporal lobes, which are areas involved in the processing of vestibular information.
“I think what’s happening is that by stimulating the vagus nerve, you’re altering the activity within the vestibular system. By doing that, you shut down the spreading processes of a migraine, so whatever electrical dysfunction was causing the migraine, stimulating the vagus nerve somehow manages to shut that down,” he said.
Aside from patients reporting slight discomfort on the neck during the stimulation, there were no side effects of the intervention, said Beh.
“This is very safe and very well tolerated. None of my patients complained about anything negative. The muscles of the face might pull a little bit, but that’s about it.”
Beh hopes to carry out larger studies to test VNS for rescue treatment of vestibular migraine, and possibly for prevention. Such studies would need to have a sham-control design, he said.
Commenting on the findings for Medscape Medical News, Ji-Soo Kim, MD, PhD, professor, department of neurology, Seoul National University College of Medicine, who, along with colleagues, recently identified a new and possibly treatable type of vertigo known as recurrent spontaneous vertigo. This disorder is not accompanied by neurologic symptoms and does not meet diagnostic criteria for vestibular migraine, Ménière disease, or vestibular neuritis.
“Even though I don’t have any experience with VNS, this study may provide a promising opportunity to develop a noninvasive therapy for vestibular migraine,” said Kim.
“This advantage seems to balance the limitation of a retrospective design on a small number of patients,” he added.
Beh and Kim have reported no relevant financial disclosures.
Neurology. Published online September 25, 2019. Abstract
https://www.medscape.com/viewarticle/919203#vp_1

Rule Buried in Proposed Medicare Fee Schedule Could Have ‘Chilling Effect’

Medical groups are trying to thwart Medicare’s bid for authority to revoke billing privileges; the revoking of privileges would be based on actions by state boards that involve clinicians, particularly in connection with cases in which patients were harmed.
The American Medical Association (AMA) was one of many organizations to protest the idea in comments submitted by the September 27 deadline regarding draft revisions to payment policies under the 2020 Medicare physician fee schedule.
While expressing sympathy with federal officials’ stated goal of protecting the public, medical groups say a proposed Medicare policy could frighten physicians and other medical professionals from seeking help for addiction and mental health problems.
The Centers for Medicare & Medicaid Services (CMS) has not defined how its expulsion plan would work. Some medical groups say CMS’ plan could derail the careers of clinicians who admitted to needing help without significantly aiding efforts to identify those posing greater risk to patients.
“We urge CMS to not finalize this ill-defined and overly broad proposal that could have a devastating impact on physicians, and to instead focus on ways to identify and discipline the truly bad actors,” wrote David B. Hoyt, MD, executive director of the American College of Surgeons, in a September 26 comment to CMS.
Several groups, including the AMA, also accused CMS of having buried this controversial plan within a section of the draft 2020 physician payment rule.
CMS tucked the bid for new authority to revoke Medicare billing privileges into a section of the draft rule that deals with opioid treatment, several major associations noted in their comments to the agency.
This gave the appearance that the proposed change would apply only to “high-risk” Medicare-enrolled opioid treatment programs, when in fact it could affect all clinicians, wrote James L. Madara, MD, AMA’s chief executive.

“The CMS proposal is a broad overreach and the lack of deference to state medical boards and other oversight entities is troubling,” he wrote in a September 24 comment to CMS.
In the draft rule, though, CMS says that the agency, “rather than state boards, is ultimately responsible for the administration of the Medicare program and the protection of its beneficiaries.”
CMS said there could be situations “where a state oversight board has chosen to impose a relatively minor sanction on a physician or other eligible professional for conduct that we deem more serious.
“We accordingly believe that we should have the discretion to review such cases to determine whether, in the agency’s view, the physician’s or other eligible professional’s conduct warrants revocation or denial,” CMS said in the draft rule.

“Chilling Effect”

Physicians’ groups argued that CMS does not have the legal grounds for its proposed expansion of revocation authority. They also said CMS’ plan is at odds with efforts underway in many states to overcome stigma associated with the treatment of problems involving mental health and substance abuse.
“The proposal could have a chilling effect on clinician self-reporting behavior such as drug abuse or alcoholism to medical boards and create a disincentive for medical boards to discipline clinicians,” owing to the serious consequences of being kicked out of the Medicare program, wrote Sunny Linnebur, PharmD, president of the American Geriatrics Society (AGS), and Nancy E. Lundebjerg, MPA, AGS’ chief executive, in a comment to CMS.
The CMS proposal is at odds with the agency’s own efforts to address physician burnout and suicide among medical professionals, wrote Hoyt of the American College of Surgeons.

At this time, state boards and medical groups are trying to reduce the hurdles that keep many people, including physicians, from seeking care for problems involving mental health and substance abuse. These groups want clinicians to feel confident about seeking help.
CMS’ proposal could make clinicians feel they are in professional jeopardy if they do so, the groups said. Physicians might face devastating financial losses if they were to agree to abstain from drugs or alcohol and be subject to random drug testing simply to provide evidence that no addiction exists, according to Hoyt.
“CMS does not address the reality of the impact on a physician’s practice of a denial or revocation to participate in Medicare,” Hoyt wrote. “Such a revocation would lead to a mandated cross-termination of participation in Medicaid and most payers will also remove a physician from their provider network when CMS takes this action.”

More Detail Needed

In a comment, the Federation of State Medical Boards (FSMB) pushed CMS for more clarity about its plan. FSMB asked the agency to articulate what specific conduct would be grounds for revocation of Medicare billing privileges or denial of enrollment; such grounds were not spelled out in detail in the draft rule.
Although CMS said it did not intend to act in cases in which a clinician faced a “very modest sanction,” the agency did not explain what would constitute a modest sanction, FSMB said.
FSMB also questioned how CMS would decide which clinicians to expel. In making such decisions, state medical boards undertake detailed investigations, gather evidence, and then decide the outcome of each case. The draft 2020 physician payment rule leaves it unclear as to how CMS would approach this task, FSMB said.
The American Hospital Association (AHA) appeared more open than other groups to CMS’ proposal. But it too raised questions about the broad outline the agency presented. CMS’ draft rule suggests that minor disciplinary actions could lead to the revocation of billing privileges, the AHA said.
“Such revocations have the potential to lead to care access issues. For these reasons, we recommend that the agency further consult state licensure boards, medical professional groups and hospitals before finalizing its criteria to ensure they are applied in a fair, consistent fashion,” the AHA stated.
https://www.medscape.com/viewarticle/919262#vp_1

Ocular Therapeutix’s Dextenza gets permanent J-code from CMS

Ocular Therapeutix (NASDAQ:OCUL) jumps 10% in after-hours trading after getting a permanent J-code for Dextenza 0.4 mg for intracanalicular use from the Centers for Medicare and Medicaid Services.

The J-code becomes effective today and will replace the previously issued C-code, which became effective July 1, 2019. The company will retain transitional pass-through status granted for Dextenza from CMS.

“J-codes are more widely recognized by commercial insurance and Medicare Advantage and Part B plans, and physician familiarity with J-codes should allow for a simpler and more convenient reimbursement process that we believe will further contribute to DEXTENZA’s commercial potential,” said Ocular President and CEO Anthony Mattessich.

https://seekingalpha.com/news/3503121-ocular-therapeutixs-dextenza-gets-permanent-j-code-cms

CymaBay presenting two abstracts at Liver Meeting

CymaBay Therapeutics (NASDAQ:CBAY) will present two abstracts related to its seladelpar program for treating primary biliary cholangitis at The Liver Meeting in November.

Seladelpar is a “potent and selective peroxisome proliferator-activated receptor delta agonist” that’s in a global phase 3 registration study for treating PBC, as well as phase 2 studies for treating nonalcoholic steatohepatitis and primary sclerosing cholangitis.

In a dataset covering PBC patients with cirrhosis, seladelpar exposures were comparable to non-cirrhotic PBC patients over 12 weeks.

The Liver Meeting takes place in Boston from Nov. 8-12.

https://seekingalpha.com/news/3503128-cymabay-presenting-two-abstracts-liver-meeting

Aimmune +11.6% on positive allergist survey

Piper Jaffray says a new proprietary allergist survey shows “massive upside” to sales potential and expectations for Aimmune’s (NASDAQ:AIMT) peanut allergy drug.

Raymond James says the survey showed awareness and willingness to prescribe Palforzia.

Key quote: “While many have equated the opinions of a few high profile critics with the overall market view, bears would do well to pay attention to this feedback.”

AIMT shares are up 11.6% after hours to $22.85.

https://seekingalpha.com/news/3503130-aimmune-plus-11_6-percent-positive-allergist-survey