In an interview on CNBC’s Mad Money, Evolus CEO David Moatazedi said, “Our product and company was designed to compete with the market leader… We’ve branded the company around Millenials… The synthetic market is being powered by Millenial growth… Jeuveau is manufactured out of a new facility.”
Thursday, February 7, 2019
Push Is On to Reclassify Schizophrenia as a Neurologic Disease
A mental health advocacy group has spearheaded a new initiative to reclassify schizophrenia as a neurologic, rather than a psychiatric, disease. The action is designed to reduce stigma and ultimately obtain more research funding from the Centers for Disease Control and Prevention (CDC).
In May 2018, the Schizophrenia and Related Disorders Alliance of America (SRDAA) submitted a request to have schizophrenia included in the implementation of the National Neurological Conditions Surveillance System (NNCSS) with the 21st Century Cures Act — a new CDC program that was allotted $5 million by Congress to collect data on the prevalence of and risk factors for neurologic conditions in the US population.
“At a basic level, the distinction between neurological and psychiatric conditions is artificial,” Raymond Cho, MD, professor of psychiatry, Baylor College of Medicine, Houston, Texas, and chairman of the SRDAA, told Medscape Medical News.
“It’s a ‘no-brainer’ that neurological and psychiatric disorders should be considered under the same umbrella, since everything is mediated by the brain, neural systems, and neurochemistry, but the problem is convincing the rest of society, lawmakers, insurance providers, family members, and patients of this,” he said.
The “paradigm shift we seek will be treatment-focused and not finger-pointing, hopefully translating into how healthcare is delivered and paid for, because right now, despite mental health parity laws, how ‘mental health’ treatment is practiced and paid for is very different from the ideal,” he added.
Curbing Stigma
“The term ‘mental illness’ carries discrimination and stigma and is often associated with the misperception that this [illness] is the fault of the patient or perhaps the family — such as the older description of the schizophrenogenic mother,” Linda Stalters, MSN, APRN (ret), chief executive officer and founder of the SRDAA, told Medscape Medical News.
Cho described treating people with early psychosis and meeting first-episode schizophrenia patients and their families “who were trying to deal with the hardship and trauma that came along with that, wondering what they did wrong, so I had to do a lot of education about the brain and genetic nature of the disorder.”
Stalters, who is as an intensive care nurse practitioner and a psychotherapist with a private practice, founded the SRDAA almost 11 years ago “to focus on the most seriously ill, who are the most underserved and misunderstood of our people and are maligned and maliciously treated,” she said.
The organization, which takes a “biopsychosocial perspective,” consists of clinicians, caregivers, and patients. Its reach extends beyond the United States; it provides support and resources in countries as far as the United Kingdom, Russia, Uruguay, India, Hungary, and Japan, said Stalters.
On board with the initiative is the Treatment Advocacy Center, a nonprofit organization that seeks to eliminate barriers to the treatment of mental illness, and the National Alliance on Mental Illness.
“We have created a movement. We have the support of other organizations, family members, and patients, and there are multiple private Facebook pages supportive of caregivers and patients — for example, one has over 7000 participants, including people who hadn’t originally been supportive of this movement but are now,” Stalters said.
“Mental Health Czar” Weighs In
In an interview with Medscape Medical News, Elinore McCance-Katz, MD, assistant secretary for mental health and substance use, Interdepartmental Serious Mental Health Illness Coordinating Committee, Substance Abuse and Mental Health Services Administration, agreed that schizophrenia is a “neurobiologically based disease, a brain disease, as are many mental illnesses, although they are called ‘psychiatric.’ ”
Dubbed the “mental health czar,” McCance-Katz, who was a practicing psychiatrist before assuming her current position, suggests there is “an artificial abyss between what’s considered a physical disease or condition and what is a mental or substance use disorder.”
This leads to a “wide chasm, so that people who have real diseases, real illnesses that are physically based but happen to manifest in behavior, are not actually treated in a manner that is at parity with individuals with recognized physical health conditions, which is very unfortunate,” said McCance-Katz, who was copied on the SRDAA’s request to the CDC.
The proposed reclassification of schizophrenia may “help to raise awareness that these illnesses are physiologically based, not just aberrant or bad behaviors, but with physical underpinnings.”
Despite increasing recognition of the neurologic underpinnings of schizophrenia, many psychiatrists as well as the American Psychiatric Association (APA) are reluctant to support its reclassification as a neurologic disorder.
“Schizophrenia is and should continue to be treated as a mental disorder,” the APA said in a statement to Medscape Medical News,
“Patients diagnosed with schizophrenia should be in the care of a psychiatrist, who is medically trained in the treatment of complex mental, emotional, and behavioral problems. Changes to its classification could inhibit access to care for this important population of patients,” it added.
Straw Man?
Christoph Correll, MD, professor, Center for Psychiatric Neuroscience, the Feinstein Institute for Medical Research, Manhasset, New York, agrees.
“While I clearly welcome the public education efforts to point out that mental disorders also have biological underpinnings and causes, which is hoped to ultimately reduce the stigma of mental disorders, I see this discussion as another example of a well meaning but still somewhat unfortunately perpetuated mind-body dualism,” said Correll, who is also the medical director of the Recognition and Prevention Program, Department of Psychiatry, the Zucker Hillside Hospital, Manhassett, New York.
Correll said “groups’ lobbying for reclassification and inclusion of schizophrenia in the CDC surveillance…is like setting up a straw man.”
Although “all mental disorders, like most neurological disorders that are not limited to peripheral nerve pathology, are brain-based,” the “symptomatic expression of mental disorders is not predominantly via motor or sensory disturbances that are relatively unidimensional and that can be measured relatively easily,” he said.
He noted that, “clearly, many neurological conditions of the central nervous system are also associated with emotional, cognitive, and behavioral disturbances, as some psychiatric disorders are associated with motor and sensory disturbances.”
There is therefore “overlap from both ends, and that is why in my opinion simply reclassifying a mental disorder as a neurological disorder does not do justice to either or both.”
He suggested instead reclassifying both neurologic and mental disorders as “disorders of the brain or the central nervous system, with varying dimensionally different symptom expressions across sensory, motor, affective/emotional, cognitive, and behavioral domains.”
Stalters acknowledged that their request to the CDC was “a long shot, because there are at least 40 other organizations for different diagnoses that want to be in this very limited number of initially included diseases that will be covered in the neurological disease surveillance system.”
Focus on MS, Parkinson’s
Indeed, at present, schizophrenia will not be included in the NNCSS, William R. Mac Kenzie, MD, deputy director for science, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, told Medscape Medical News.
Instead, the CDC will “begin planning and developing demonstration projects for two neurological conditions — multiple sclerosis (MS) and Parkinson’s disease.”
It will be a three-stage process, he said, and will be carried out “in association with partners and stakeholders, as resources allow.”
The two neurologic conditions will be used to determine “how we can have the biggest impact by exploring innovative methods and complex data sources and capturing lessons learned to determine which approaches will help efficiently extend the NNCSS to other neurological conditions,” said Kenzie.
The second step will be to “build out the NNCSS” for both conditions, using successful approaches from the demonstration projects and “checking methods, costs, and opportunities, as resources allow,” he said.
The lessons learned from these demonstrations will be used “to extend the NNCSS to other neurological conditions, as resources allow,” he said.
Kenzie noted that the “legislation surrounding the NNCSS does not reference any disease, disorders, or conditions by name.”
However, he added, “As we move ahead with the surveillance system, CDC will engage multiple federal agencies, external subject matter experts, professional organizations, and other interested parties in determining specific conditions to include in the NNCSS.”
He emphasized that “at this time, CDC understands reclassification of diseases as outside the scope of NNCSS work.” It relies on the International Classification of Diseases, which is maintained by the World Health Organization (WHO), as the “international standard diagnostic tool for epidemiology, health management, and clinical purposes.”
Stalters acknowledged that the SRDAA is aware that the CDC is now conducting a pilot study of MS and Parkinson’s disease.
However, “we are gathering support from other advocacy, provider, professional, and government agencies for inclusion of schizophrenia in the extension of the NNCSS” and “we will continue our work so when the NNCSS has the funding, schizophrenia will be included in the system,” she said.
“We understand that the CDC does not have the purview to reclassify, and we have submitted a request to the WHO regarding reclassification [of schizophrenia],” she added.
Lannett Making Progress With Pipeline, Cost Savings: BMO
Lannett Company, Inc. LCI 0.35% reported solid second-quarter results Wednesday and raised its 2019 guidance.
The pharma company is making good progress in preparing for the loss of levothyroxine with new launches and cost-cutting initiatives, according to BMO Capital Markets.
The Analyst
BMO Capital Markets’ Gary Nachman maintained a Market Perform rating on Lannett and raised the price target from $7 to $10.
The Thesis
Lannett reported Q2 revenue of $194 million, convincingly beating the consensus expectation of $161 million. The company’s EPS came in at 86 cents, significantly higher than the 67-cent Street estimate.
The upside was driven by levothyroxine, as the company recorded a part of the $50-million margin pre-payment from Amneal Pharmaceuticals Inc AMRX 2.1% in the quarter, Nachmansaid in a Wednesday note.
Lannett is preparing for levothyroxine’s transition and is executing well on new launches, the analyst said. The company already announced 17 launches in 2018 that generated $40 million in the first half of fiscal 2019. These should contribute $75 million for the full year, he said.
Another 20 launches are being targeted annually, with a pipeline of 60 products at different stages of development, Nachman said.
Lannett expects 10 launches in the first half of 2019 to contribute $10 million for the second half, and a total of 20 launches in 2019 to contribute $75 million in the full year, according to BMO.
The company has made good progress on cost curtailment, with annualized net savings of $33 million expected by the close of 2020, Nachman said. This gives the company more flexibility to take care of debt while pursuing various business development opportunities, he said.
‘Good’ response rates for next antibody-drug conjugate for Seattle Genetics
In August 2017, Seattle Genetics opted into a development partnership for an antibody-drug conjugate developed by Genmab as part of a collaboration seven years in the making. A year and a half later, researchers have pulled the curtain on some early results that might justify their enthusiasm for tisotumab vedotin.
In a Phase I/II trial involving 147 patients — spanning 6 different cancer types — who have become resistant to an average of three types of prior treatments, the ADC is found to yield responses in a “significant minority,” meaning their tumors either shrank or stopped growing. The responses lasted an average of 5.7 months, with the top of the range reaching 9.5 months, according to the research team at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust.
Described as a “Trojan horse,” the ADC works by binding to a receptor that’s abundant on the surface of cancer cells called tissue factor (the antibody’s job) then releasing a cytotoxic payload (the drug part) to kill the cancer cells from within.
Described as a “Trojan horse,” the ADC works by binding to a receptor that’s abundant on the surface of cancer cells called tissue factor (the antibody’s job) then releasing a cytotoxic payload (the drug part) to kill the cancer cells from within.
Investigators reported “good responses” and “manageable side effects” for heavily pre-treated patients in the study — with the exception of prostate cancer, where there were none.
Bladder cancer: 27%
Cervical cancer: 26.5%
Ovarian cancer: 14%
Esophageal cancer: 13%
Non-small cell lung cancer: 13%
Endometrial cancer: 7%
“We have already begun additional trials of this new drug in different tumour types and as a second-line treatment for cervical cancer, where response rates were particularly high,” said professor Johann de Bono, head of clinical studies at ICR. “We are also developing a test to pick out the patients most likely to respond.”
Cervical cancer: 26.5%
Ovarian cancer: 14%
Esophageal cancer: 13%
Non-small cell lung cancer: 13%
Endometrial cancer: 7%
“We have already begun additional trials of this new drug in different tumour types and as a second-line treatment for cervical cancer, where response rates were particularly high,” said professor Johann de Bono, head of clinical studies at ICR. “We are also developing a test to pick out the patients most likely to respond.”
Tisotumab vedotin adds to the slate of ADCs on offer at Seattle Genetics, including its blockbuster franchise drug Adcestris as well as enfortumab vedotin, which is going through a pivotal Phase II with a “breakthrough” badge bestowed by the FDA.
Seattle Genetics and Genmab sponsored the study, which was published today in The Lancet Oncology.
‘Euthanasia Could Save Canada Millions in Healthcare Costs’
Perhaps it’s all that New World fresh air and pioneering spirit, but Canada is taking to its new euthanasia legislation like a duck to water. It only became legal in June and already about 800 people have received a lethal injection at the hands of a doctor.
Where it is beating the Old World euthanasia regimes is in its frank, open and creative ideas for integrating euthanasia into Canadian life. In December two Quebec bioethicists argued in the Journal of Medical Ethics that combining euthanasia with organ donation would be an excellent idea which could yield top-quality organs for needy patients.
And last week researchers from the University of Calgary calculated that when euthanasia reaches the level of Belgium and the Netherlands, the country’s health system could save up to up to C$139 million every year. “Medical assistance in dying could reduce annual health care spending across Canada by between $34.7 million and $138.8 million, exceeding the $1.5–$14.8 million in direct costs associated with its implementation,” they wrote in the Canadian Medical Association Journal.
The logic behind their figures is as follows. End-of-life care rises steeply in the last six months of life. In the province of Manitoba, for instance, more than 20 percent of health care costs are incurred by patients who die within six months even though they are only 1 percent of the population. Such people are typical candidates for euthanasia in Europe. But, as the Calgary bean-counters delicately point out, “patients who choose medical assistance in dying may forego this resource-intensive period”.
Not only are relatives spared the pain of looking after the elderly, but the government reaps rich rewards as well! A win-win all around!
Of course, say the researchers piously, “We are not suggesting medical assistance in dying as a measure to cut costs. At an individual level, neither patients nor physicians should consider costs when making the very personal decision to request, or provide, this intervention.”
Even if this is true, though, hospitals and relatives might consider the cost savings of early departures from the transit lounge. In 1998, a major article in the New England Journal of Medicine estimated that the cost savings from euthanasia or assisted suicide would not be substantial — less than 0.07 percent of total health care costs, or about US$627 million in 1998 dollars.
However, the authors pointed out, “it is important to recognize that the savings to specific terminally ill patients and their families could be substantial. For many patients and their families, especially but not exclusively those without health insurance, the costs of terminal care may result in large out-of-pocket expenses.” The average saving for a family if an uninsured loved one died six months early might be as much as $20,000. In a dysfunctional setting, immense pressure might be exerted to urge the sick family member to make a quick get-away.
“What savings level, if any, would motivate families to pressure patients into requesting a physician’s assistance with suicide is a matter of speculation but one that cannot be ignored,” they observed drily.
If Canadian trends track Belgium and the Netherlands where between 1 and 4 percent of all deaths are due to euthanasia, eventually Canada will have about 8000 euthanasia deaths a year.
In an accompanying editorial in the CMAJ, Peter Tanuseputro, of the Bruyère Research Institute in Ottawa, argued that last six months of life were expensive because Canada has an “inadequate and haphazard” palliative care system. The proportion of Canadians with cancer who die in hospital is more than twice as high as the United States. “Whereas some patients who seek medical aid in dying are resolute in their choice, the choices of others may reflect the failure of our health care system to provide effective palliative care,” he writes.
When the Supreme Court decreed that euthanasia was permitted by Canada’s charter of human rights, it launched the country into deep waters. If medical journals are already advertising how much money could be saved if people choose euthanasia, how much incentive will the government have to create a better palliative care system?
Harpoon Therapeutics Announces Pricing of Initial Public Offering
Harpoon Therapeutics, Inc. (“Harpoon”), a clinical-stage immunotherapy company developing a novel class of T cell engagers, announced today the pricing of its initial public offering of 5,400,000 shares of its common stock at a price to the public of $14.00 per share. The gross proceeds to Harpoon from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Harpoon, are expected to be $75.6 million. The shares are expected to begin trading on the Nasdaq Global Select Market on February 8, 2019 under the symbol “HARP.” The offering is expected to close on February 12, 2019, subject to customary closing conditions. In addition, Harpoon has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock. Citigroup and SVB Leerink are acting as joint book-running managers for the offering. Canaccord Genuity and Wedbush PacGrow are acting as co-managers for the offering.
Ziopharm falls, rebounds in after-hours
After the market close, shares of Ziopharm (ZIOP) fell after a regulatory filing from the company was misinterpreted as a new sale of shares. David Connolly, Ziopharm VP of corporate communications and investor relations, noted in a statement that Ziopharm “did not register to sell, the company registered shares as common that were already sold in a private placement.” At their lows, shares traded down to $2.15 per share, but have since come back and are trading at $2.29 per share.
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