NYU Langone Health is a “strategic development partner” with Amazon Business, the online marketplace for institutions, said Chris Holt, leader of global health care at Amazon.
Holt spoke Thursday on the NYU Langone campus in Manhattan for the health system’s Health Tech Summit. He described how hospitals must adapt for the digital age and, of course, how Amazon could help them do it.
NYU Langone held the event in part to promote its health-tech hub, which conducts outreach to early stage companies that might partner with the system, said Dr. Christopher Morris, NYU Langone’s associate director for digital health innovation.
An NYU Langone spokeswoman said the health system was “in talks about partnership and participating in some pilot opportunities” with Amazon but declined to elaborate beyond that description.
One of Amazon Business’s major entries into health care has been as a supplier. Holt said that large organizations often spend 80% of their procurement budget with 20% of their suppliers, and the remaining 20% of spending is split between 80% of vendors. Amazon is looking to consolidate that share.
He said that NYU Langone is in “pilot mode” with Amazon Business, which allows organizations’ procurement offices to select certain products for employees to reorder.
Amazon Business said in July 2017 that its platform selling supplies to customers in health care, education, government and other business categories had more than 1 million U.S. customers.
Not all area health systems have jumped at the opportunity to work with Amazon. Northwell Health CEO Michael Dowling told Crain’s in April that Northwell had discussions with the company about its medical-supply business. It ultimately decided to continue using its internal group-purchasing organization and Acurity, the purchasing organization of the Greater New York Hospital Association.
Holt said Amazon’s interest in hospitals goes beyond medical and office supplies. He noted that Amazon’s Alexa device can help patients perform tasks such as adjusting the lights and lowering the shades. NYU Langone has begun using Alexa in some of its recovery rooms, he said. The company is also interested in remaking hospital cafeterias through its Amazon Fresh and Whole Foods brands.
Hospitals need to improve the patient experience if they are going to attract customers as more care moves online, Holt said.
He cited the example of his daughter’s emergency hospital visit. Several months afterward, Holt began receiving bills totaling $130,000. After his insurance company’s share, he was left to pay only about $2,600. But it was the billing experience, not the quality of care his daughter received, that lingered in his memory.
“This experience is unacceptable in any other industry on Earth except for health care,” Holt said.
With the rise in telehealth, proximity and a family’s history with a hospital won’t be enough to attract patients, he said.
“Probably in the next 10 years, I’m only going to interact with a person for the most acute care issues in my life. Everything else will be done digitally,” Holt said. “You’re going to have reinvent your brand in a digital setting with a new type of customer.”
The Trump administration’s request Thursday that a Texas federal court invalidate three key Obamacare mandates for insurance coverage has jolted the healthcare industry as all eyes home in on a case that until now has drawn little national attention or interest.
The U.S. Justice Department on Thursday not only refused to defend the Affordable Care Act against a lawsuit filed by 20 Republican state attorneys general, but echoed the state litigators’ arguments that Congress rendered major provisions of the law invalid when it zeroed out the individual mandate penalty in the 2017 tax bill.
In particular, the Justice Department said the court should overturn the ACA’s individual mandate along with provisions requiring insurers to cover people with pre-existing conditions and to use a community rating to set premiums instead of basing rates on a person’s health condition because they were specifically tied to the mandate’s implementation.
The move shifts the defense of the law to Democratic state attorneys general who have already intervened.
The Justice Department pushed back on the plaintiffs’ request to immediately invalidate the ACA, since the tax penalty is still in effect until January 2019. Instead, the administration asked the court to nix the provisions when the tax cut begins. Paul Larkin of the conservative Heritage Foundation said he believes this request was made to set up the case for a Supreme Court hearing.
Legal scholars largely panned the Justice Department’s argument for lacking merit, but the industry and some analysts are already on alert for what the administration’s stated position on the Affordable Care Act’s most popular aspects could mean.
The legal questions boil down to the point of “severability,” an argument brought in Obama-era litigation against the ACA.
The Justice Department argued in its brief that most of the ACA could stand except the individual mandate, pre-existing conditions and community rating provisions. The Obama administration had said these measures go hand-in-hand and cannot survive without each other and the tax penalty.
“It’s pretty bad,” libertarian law professor Jonathan Adler said of the underlying case merits. “It reflects poor understanding of severability doctrine, you see that in the state’s brief, and you see it implicitly in the DOJ brief insofar as they accept those arguments.”
Abbe Gluck, a Yale University law professor, noted that the doctrine of severability is based on congressional intent, but the legal question in this case shouldn’t focus on Congress’ intent in 2010 when lawmakers passed the ACA. Instead, the court should focus on 2017 when Congress zeroed out the individual mandate penalty but did not touch the pre-existing condition and community rating provisions.
“A court doesn’t now have to guess whether Congress wanted the rest of the statute to remain standing,” Gluck said. “Congress told us that by leaving it intact. The intervening and dispositive action of the 2017 Congress itself is why the whole severability argument has no basis in law and also why the 2012 litigating position isn’t relevant any more.”
Melinda Hutton, general counsel for American Hospital Association, also weighed in on the severability issue, arguing that “as it stands today, the individual mandate is clearly severable from the rest of the (ACA).”
Hatton warned that a legal ruling otherwise “would devastate this nation’s hospitals and health systems and the patients they serve.”
“Nothing requires that catastrophic result,” Hatton said.
America’s Health Insurance Plans, the trade group representing a swath of carriers who offer plans on the exchanges, is planning to file an amicus brief against the plaintiffs’ request for a preliminary injunction—the first signal of stakeholder involvement in the lawsuit.
AHIP also issued a forceful statement against the Justice Department’s petition to invalidate the consumer protection clauses.
“Zeroing out the individual mandate penalty should not result in striking important consumer protections, such as guaranteed issue and community rating rules that help those with pre-existing conditions,” AHIP said Friday in a statement. “Removing those provisions will result in renewed uncertainty in the individual market, create a patchwork of requirements in the states, cause rates to go even higher for older Americans and sicker patients, and make it challenging to introduce products and rates for 2019.”
Ceci Connolly, president of the Alliance of Community Health Plans, called the legal position “troubling” and warned it could spark fresh market instability.
“At the very least it adds uncertainty at exactly the moment when plans are trying to set rates for next year,” Connolly said in a statement. “At the worst, it could strip away guaranteed coverage for those with pre-existing conditions. We don’t want to return to the days when people who needed the care the most could be turned away because of their health status.”
Insurers in Virginia and Maryland have already proposed 2019 rates showing high double-digit spikes, while insurers in Pennsylvania and Maine are showing minimal increases so far.
Jost also worried that as the case gets tangled in court, the Trump administration’s position could reverberate in HHS’ decisions as some states seek greater authority to skirt some ACA regulations.
Although he conceded it is unlikely, Jost wondered whether the Justice Department’s stated belief that the consumer protections are unconstitutional means the executive branch will stop enforcing them. He pointed to at least one outstanding case: HHS’ so-far delayed decision over Idaho’s request to offer exchange plans that don’t comply with the Obamacare requirements. The state is in discussions with the department over its proposal, with a decision expected later this month. Other states, including North Dakota, are watching how HHS responds before proposing their own coverage mandate changes.
For Jost, that leads to more complications for such major issues as setting tax credits that subsidize coverage for people with lower incomes.
“Once you start to invalidate those provisions, the problem is how does the rest of the statute work?” Jost said. “How do you set tax credits if everyone has different rate based on status?”
Gluck said, however, that the Justice Department brief shouldn’t affect HHS’ action.
“The guaranteed issue and community rating provisions are the law of the land until a court or Congress says otherwise,” Gluck said. “And in fact it was Congress that left those provisions on the books. For HHS to try to undermine those provisions before a court rules, which I wouldn’t expect it to do, would be unconstitutional sabotage.”
The case is being heard in a north Texas federal court by U.S. District Judge Reed O’Connor, who was appointed by President George W. Bush. Historically, O’Connor has been an outspoken opponent of Obamacare and observers expect him to skew in favor of the plaintiffs.
If O’Connor rules in Republicans’ favor, the case could move forward to the 5th U.S. Circuit Court of Appeals. Adler predicted the appellate judges won’t accept the merits of the plaintiffs’ case and that the litigation will end there rather than heading to the Supreme Court.
But Larkin, who has not yet studied the Justice Department’s severability argument, said he believes the case will get to the Supreme Court.
Recent progress in the treatment of cancer has not had a major impact on outcomes in advanced forms of cervical cancer.
Increased emphasis on screening for human papillomavirus (HPV) — which causes almost all cervical cancers — has led to diagnosis of most cases of the disease at an early, curable stage. However, the prognosis remains grim for women with recurrent, persistent, or metastatic cervical cancer, associated with a 5-year survival rate of only 5-15%.
Of almost two dozen clinical trials conducted by the Gynecologic Oncology Group (GOG) since 1995, none surpassed a 1-year survival of 30%. The high-water marker occurred in GOG 240, which showed that adding bevacizumab (Avastin) to chemotherapy resulted in an almost 4-month improvement in median overall survival.
“We have an established first-line approach, based on the results of GOG 240,” said Don Dizon, MD, of Brown University and Rhode Island Hospital in Providence. “Every patient should receive either cisplatin or carboplatin, paclitaxel, and bevacizumab. However, for women who progress on that, that’s a real unmet need at this point. We don’t have good data on second-line therapies.”
Beyond GOG 240, the cooperative group trials collectively led to “pretty dismal results,” he said.
The demonstrated efficacy with the addition of bevacizumab to chemotherapy is the single most important development in management of recurrent/metastatic cervical cancer over the past several years, said Stephen C. Rubin, MD, of Fox Chase Cancer Center in Philadelphia. The regimen offers the best balance of efficacy and toxicity among other strategies that have been evaluated.
Several ongoing trials are evaluating vaccines and immunotherapeutic strategies, but none is far enough along to know whether one particular strategy will improve outcomes as compared with the chemotherapy-bevacizumab regimen, Rubin added.
Patients whose disease progresses on first-line chemotherapy-bevacizumab are candidates for clinical trials of novel therapies or combinations, said Charles A. Leith III, MD, of the University of Alabama at Birmingham. However, availability and access to those trials are limited. As a result, more attention should be paid to improved strategies for primary therapy to prevent recurrence.
“Specifically, patients found to have either intermediate- or high-risk pathologic findings following a radical hysterectomy may be eligible for clinical trials sponsored by the National Cancer Institute — GOG 263, or RTOG [Radiation Therapy Oncology Group]/GOG 0724 respectively — which may decrease their risk of cervical cancer recurrence,” said Leith. “In addition an ongoing upfront trial, GY006, is looking at the benefit of adding a ribonucleotide reductase inhibitor to the standard cisplatin chemoradiation backbone and is accruing patients with locally advanced cervical cancer who are not surgical candidates.”
A year ago at the Society of Gynecologic Oncology annual meeting, Leith reported initial results from a trial evaluating an HPV-directed immunotherapy for recurrent/metastatic cervical cancer. The data showed a 12-month survival rate of 38% in 50 heavily pretreated patients, including 44% and 41% in subgroups of patients whose tumors tested positive for HPV-16 and HPV-18. About half the patients in the trial had already received a bevacizumab-containing regimen.
A phase III evaluation of the immunotherapy — axalimogene filolisbac, or AXAL — has begun. The study will evaluate AXAL as consolidation therapy to eliminate residual disease and prevent recurrence in patients who received standard chemoradiation for locally advanced disease.
Evaluation of AXAL had a setback earlier this year when the FDA put a clinical hold on a trial evaluating the agent in combination with the immune checkpoint inhibitor durvalumab (Imfinzi) in patients with HPV-associated cancers. The hold occurred after a patient died of respiratory distress during treatment with the combination. Other clinical trials of AXAL, including the phase III study in cervical cancer, were not affected by the hold.
The 2018 American Society of Clinical Oncology (ASCO) annual meeting included several early-phase studies of candidate therapies for advanced cervical cancer. Key takeaways included:
Neoadjuvant chemotherapyprior to definitive chemoradiation (CRT) led to a lower objective response rate and worse progression-free survival as compared with CRT in patients with locally advanced cervical cancer
The PD-1 inhibitor pembrolizumab (Keytruda) led to objective responses in 12% of 98 patients with advanced cervical cancer, median PFS of 2.1 months, 6-month PFS of 25%, and median overall survival of 9.4 months
A 26-patient cohort with persistent cervical cancer fared even worse with the PD-1 inhibitor nivolumab (Opdivo), producing one objective response and a stable disease rate of 20%
A phase II study of eribulin (Halaven) showed six partial responses in 30 evaluable patients with advanced disease and a median overall survival of 6.6 months
As an invited discussant for several of the presentations, Dizon noted that beyond surgery for low-risk early-stage disease, CRT for high-risk disease, and bevacizumab-containing therapy for advanced/metastatic disease, “there are no standards of care. We are pretty much out of options with known activity that I can cite data for.”
Dizon will chair a treatment planning committee for cervical cancer later this year, and the emphasis will be on strategies to exploit DNA damage-repair pathways. That does not mean that cervical cancer specialists have given up on immunotherapy, he added, noting that “a ton” of ongoing trials are evaluating checkpoint inhibitors and other immunotherapy-based strategies to improve outcomes for patients with advanced disease.
Liu disclosed relevant relationships with Acetylon; Agenus; AstraZeneca; Atara Biotherapeutics; Boston Biomedical; Bristol-Myers Squibb; CytomX Therapeutics; Genentech/Roche; Merrimack and Tesaro.
Hasan disclosed relevant relationships with Inovio Pharmaceuticals.
Tewari disclosed relevant relationships with AstraZeneca; Merck; Roche/Genentech
Antibiotic overuse remains common in the treatment of outpatient acute respiratory infections (ARIs) during flu season, even among patients with laboratory-confirmed influenza, new research suggests.
When researchers reviewed data on patients attending outpatient clinics participating in the Influenza Vaccine Effectiveness Network during the 2013-2014 and 2014-2015 influenza seasons, they found that 41% of patients prescribed an antibiotic had diagnoses for which antibiotics were not indicated.
Just under one-third of patients with influenza confirmed through research testing were prescribed antibiotics, Fiona Havers, MD, of the CDC’s Division of Bacterial Diseases, and colleagues wrote in the online journal JAMA Network Open.
“Antibiotics don’t treat viruses, but many, many patients are still receiving antibiotics inappropriately for common things like sore throats and sinusitis,” Havers told MedPage Today. “There are pretty strict clinical criteria for when it is appropriate to treat people with sore throats with an antibiotic, but doctors in this study weren’t necessarily following those criteria.”
ARIs remain the conditions for which antibiotics are most often prescribed, even though these infections are most often viral, Havers explained.
Most previous studies examining antibiotic overuse have relied on national survey data, which often lacks clinical and laboratory testing results, Havers said.
The newly published study included detailed patient data, such as illness onset date, laboratory testing for influenza self-reported fever and results of clinician-ordered group A streptococcal (GAS) testing.
The researchers also used three approaches to assess antibiotic prescribing among outpatients: they examined antibiotic prescribing by age group, antibiotic type and diagnosis; they characterized antibiotic prescribing among patients with laboratory-confirmed influenza, excluding syndromes for which antibiotics are indicated, such as pneumonia; and they examined appropriateness of antibiotic prescribing for those with pharyngitis, sinusitis, and otitis media diagnoses based on symptom duration, presence of fever, prescription of recommended first-line antibiotics, and GAS testing results.
The study included outpatients 6 months of age or older with ARIs evaluated at outpatient clinics associated with five US Influenza Vaccine Effectiveness Network sites during the 2013-2014 and 2014-2015 influenza seasons.
All patients received influenza testing by real-time reverse transcriptase–polymerase chain reaction for research purposes only.
Antibiotic prescriptions, medical history, and ICD-9 diagnosis codes were collected from medical and pharmacy records, as were GAS testing results in a patient subset.
Antibiotic prescription within seven days of enrollment was the main outcome, and appropriateness of antibiotic prescribing was based on diagnosis codes, clinical information, and influenza and GAS testing results.
Some 15,000 patients with ARIs were included in the analysis. Mean age was 32 (SD 24); about 60% were women and 80% were white. Abpout 40% received an antibiotic.
The analysis revealed that:
Of the 2,522 with diagnoses for which antibiotics are not indicated, 2,106 (84%) were diagnosed with viral upper respiratory tract infection or bronchitis (acute or not otherwise specified).
Among the 3,306 patients (22%) not diagnosed as having pneumonia and who had laboratory confirmed influenza, 945 (29%) were prescribed an antibiotic, accounting for 17% of all antibiotic prescriptions among patients with non-pneumonia ARI.
Among 1,248 patients with pharyngitis, 1,137 (91%) had GAS testing; 440 of the 1,248 patients (35%) were prescribed antibiotics, among whom 168 (38%) had negative results on GAS testing.
Of 1,200 patients with sinusitis and no other indication for antibiotic treatment who received an antibiotic, 454 (38%) had symptoms for 3 days or less prior to the outpatient visit, suggesting acute viral sinusitis not requiring antibiotics.
“Our study adds to evidence that misuse of antibiotics, characterized by antibiotic overuse and inappropriate antibiotic selection, is widespread in the treatment of outpatient ARIs,” the researchers wrote. “The study indicates a number of potential targets to achieve the goal of the National Action Plan for Combating Antibiotic-Resistant Bacteria of reducing inappropriate outpatient antibiotic use by 50% by 2020.”
Havers and colleagues called for the strengthening of outpatient antibiotic stewardship efforts aimed at eliminating antibiotic treatment for viral upper respiratory infections and acute bronchitis and improving adherence to guidelines for antibiotic prescribing.
“In addition, our findings indicate that improved point-of-care influenza diagnostics and increased recognition and appropriate treatment of influenza virus infection may also aid in decreasing unnecessary antibiotic use for ARIs,” they wrote.
This research was funded by the CDC.
Reviewed by F. Perry Wilson, MD, MSCEAssistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Upfront use of biparametric magnetic resonance imaging (bpMRI), a more rapid and lower-cost version of multiparametric MRI, rules out almost all significant disease in men with suspected prostate cancer and thus would spare many from invasive biopsy, a new study indicated.
Among 1,020 men who underwent both bpMRI and standardized transrectal (TRUS) biopsy, low-suspicion bpMRI had a negative predictive value of 97% in ruling out significant prostate cancer (95% CI 95%-99%), reported Lars Boesen, MD, PhD, of Herlev Gentofte University Hospital in Denmark, and colleagues.
“The results suggest that bpMRI may be used as a triage test to exclude the presence of aggressive disease and avoid unnecessary biopsies with its inherent complications,” the investigators explained in JAMA Network Open.
Boesen’s group also found that restricting combined biopsies just to those with suspicious bpMRI findings meant 30% of men could avoid a TRUS biopsy. “Most of these men had low-risk disease qualifying for surveillance,” the authors noted.
Use of bpMRI also improved diagnoses of significant prostate cancer by 11% while insignificant prostate cancer diagnoses were reduced by 40% (P<0.001 for both endpoints). And this was done using fewer biopsy cores compared with standard TRUS biopsy alone. “If combined biopsies were restricted solely to patients with suspicious bpMRIs, only 8 men with significant prostate cancer would have been missed and significantly fewer men … with insignificant prostate cancer would have been diagnosed,” the authors observed.
The 715 men with suspicious bpMRI lesions underwent a targeted biopsy, and prostate cancer was detected in 67%, with clinically significant cancer found in 47% of the biopsied group. Standard TRUS biopsy detected prostate cancer in 63% of the men, and in 34% of them the cancer was significant.
Commenting on the study, Timothy Wilt, MD, MPH, and Philipp Dahm, MD, both of the University of Minnesota School of Medicine in Minneapolis, said that while the authors emphasized the sensitivity (98%) and negative predictive value (97%) of bpMRI, specificity (48%) and positive predictive values (56%) were less impressive.
They also point out that the rate of prostate cancer in the study seemed to be “extraordinarily high,” with a 40% rate of clinically significant disease. A more typical scenario in a standard U.S. practice would likely peg that risk at roughly 9% based on a standardized risk calculator, they said.
“For MRI-based triaging strategies to be cost-effective, patients and physicians must be willing to change management based on MRI findings,” Wilt and Dahm wrote. “The use of MRI will result in low-value rather than high-value care if patients with negative MRI findings … still undergo a biopsy or active surveillance imaging and if all men with MRI-defined clinically significant disease undergo radical interventions.”
The BIDOC (Biparametric MRI for Detection of Prostate Cancer) study required a clinical suspicion of prostate cancer in all participants as evidenced by either a prostatic-specific antigen (PSA) of 4.0 ng/mL or greater or an abnormal digital rectal exam that necessitated a diagnostic prostate biopsy. The median PSA level of the cohort was 8.0 ng/mL.
Clinically significant prostate cancer was defined as any high-grade prostate cancer (Gleason score 4+3 or maximum cancerous core length greater than 50% for Gleason 3+4). Prior to undergoing standard TRUS biopsy, men underwent bpMRI using a 3-T MRI magnet with a pelvic-phase-array coil positioned over the pelvis. All bpMRI images were reviewed by the same experienced radiologist, who was blinded to the clinical findings.
Patients also underwent standard 10-core extended sextant biopsies, and then any suspicious lesion detected by TRUS was sampled by a standard biopsy scheme. This was followed by targeted biopsies of any bpMRI suspicious lesions. Overall, 64% of the men had prostate cancer and 40% of them had significant prostate cancer.
Limitations of the study include the fact that it was carried out at a single center with a single dedicated radiologist reading the bpMRIs and two TRUS operators performing the biopsies.
The study was funded by the Beckett Foundation.
Boesen has received grants from the Beckett Foundation and fees from Sanofi-Aventis. Co-authors also reported relationships with industry.
Wilt and Dahm had no financial disclosures to make.
Rates of suicide rose by about 25% in the U.S. from 1999 to 2016, according to a new report from the CDC.
Additionally, over half of states saw an increase of over 30% over the past two decades — accounting for around 45,000 deaths in 2016 alone — according to a “Vital Signs” report.
The extent of this increase varied from state to state, with suicide rates rising across the country in all states except Nevada. North Dakota and and Vermont saw increases approaching or topping 50%. Not counting Nevada, Delaware saw the smallest increase at 5.9%.
“We don’t know for sure why the rates of suicide are increasing essentially across the board — across virtually all states and for both females and males,” Nadine Kaslow, PhD, of Emory University School of Medicine in Atlanta, explained to MedPage Today.
“Some reasons that people have concerned include the lack of adequate and accessible mental health services for everyone who is experiencing mental health problems and the limited social services for people with financial and employment challenges,” said Kaslow, who was not involved with the study.
“The CDC correctly points out that the suicide is multifactorial in its cause,” commented John Walkup, MD, of Ann and Robert H. Lurie Children’s Hospital of Chicago.
Although a public health approach to solving this is warranted, he explained to MedPage Today how tackling this issue is particularly difficult.
“Do you target suicide specifically or target the larger issues that contribute to suicide risk,” he questioned, suggesting how the greatest benefit will probably be seen by targeting those with risk factors for suicide in order to reduce suicide risk and morbidity on a larger scale due to reduction in risk factors. “For example, educating the public and screening teens for depression and engaging them in treatment will lower suicide risk and may be more universally beneficial than only referring for treatment those with positive suicide screens.”
CDC’s Findings
In their analysis, led by Deborah M. Stone, ScD, of the Division of Violence Prevention at the National Center for Injury Prevention and Control, and colleagues assessed suicide trends in all 50 states and Washington, D.C., from 1999 to 2016 among individuals 10 years and older.
Firearms were used in about half of suicides, making it by far the most common method. But increases were seen across all methods.
Notably, the report also found that 54% of people who died from suicide had no known mental condition, making it even more important for people to recognize the warning signs.
“What was striking to me as an anxiety disorder expert is the very low rate of reported anxiety disorders in the population of the deceased,” commented Walkup.
“This is especially important as untreated anxiety disorders are associated with suicidal behavior, poor educational outcome and problems transitioning to adulthood and substance use disorders. I think we are just beginning to understand the pathway from anxiety to suicide and much can be done to raise awareness that anxiety and depression contribute to suicide risk.”
Circumstances surrounding suicides were generally common among decedents with and without mental health conditions, the researchers found. The most common contributing factor being relationship problems, followed by life stressors, recent or impending crises, physical health problems, and substance abuse.
“While the CDC is correct to focus on known triggering events for a specific suicide it is important to note that those triggering events are ubiquitous in the US and not everyone who experiences economic duress, or relationship problems etc. is at risk for suicide,” Walkup warned. “Addressing those factors is important as it is directly relevant to the person in distress and the right thing to do.”
He continued, adding: “The flip side is the observation that is common in the suicide prevention literature. When common everyday events are linked to suicide in a causative way there are individuals who perceive such a link as “support or permission” for them to consider suicide. One of the problems with media portrayals of suicide is that it can support a person’s belief that suicide is logical outcome of economic distress or relationship problems. It is the reason people are concerned about media portrayals of suicide.”
Although methods of suicide were also generally similar between those with and without mental health conditions, those without any known mental health conditions were slightly more likely to die by a firearm (55% versus 41%). Among both groups, suffocation was the second most likely cause of death, followed by poisoning.
What Healthcare Providers Can Do
From a healthcare providers perspective, Daniel Dickstein, MD, of Bradley Hospital in Rhode Island, told MedPage Today it’s key that providers not be afraid to ask patients about suicide.
“It is really important for healthcare workers to try to encourage families to consider being part of a research study — because just as with cancer — such partnerships are the only way that the future will be brighter,” he encouraged. Dickstein also added when dealing with pediatric patients, it’s important to include parents in on the conversation, highlighting how suicide is the second leading killer of kids starting at age 10, all the way through young adulthood.
Men in particular may fall under the radar, warned Eric Caine, MD, of the University of Rochester Medical Center in New York, who said it’s men who typically don’t seek help, are less likely to share thoughts and feelings with others, and are also less prone to visits healthcare providers routinely.
“There is a substantial amount of work within healthcare systems, but it is most important to remember that most suicides occur in communities and most deaths happen with the first attempt,” he told MedPage Today.
Kaslow also suggested several steps to clinicians should bear in mind when talking with patients.
“First and foremost, [providers] should routinely ask people if they are feeling depressed, anxious, and or like hurting themselves. They also need to ask about substance use,” she explained. If patients respond affirmatively, providers should dive deeper and connect the patient with appropriate services.
She also recommended more integrated primary and specialty care, achieved by integrating behavioral health professions into various medical services. Providers should also readily have resources available for their patients who report mental health problem, such as crisis hotlines, mental health facilities and providers, apps and websites.
Dickstein agreed with this point, expressing that “more than ever, our healthcare system is fragmented,” adding that we all must work to improve access to mental healthcare, including tackling barriers such as lack of providers and lack of insurance coverage.
“All health professionals need to be trained in suicide assessment and prevention. This will enable them to be more comfortable talking to their patients about suicide and related topics,” Kaslow recommended.
None of the authors reported any conflicts of interest.
Just six weeks after taking the helm of biotech Advaxis, CEO Ken Berlin has launched a search for a partner for its stalled lead axalimogene filolisbac (AXAL) and will scale back trials of the immunotherapy in order to bring earlier stage programs forward. It will also eliminate almost a quarter of its workforce.
Berlin joined the company from Rosetta Genomics in April shortly after the FDA placed a clinical hold on a phase 1/2 study of AXAL in human papillomavirus-associated cancers—in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab)—after a patient fatality. The trial was enrolling patients with both cervical and head-and-neck cancers, and the death was in a cervical cancer patient.
Advaxis says it will spend “a limited period of time” looking for a U.S. or European partner but, if it can’t find one, it will wind down an ongoing study in high-risk, locally advanced cervical cancer patients as well as a second planned trial in metastatic cervical cancer.
It will press ahead with head-and-neck cancer studies if it can find a cost-effective way to do so, but the net effect will be “a significant reduction in our spend on the HPV program,” according to Berlin. Advaxis will respond to the FDA’s concerns about the HPV trial shortly, he added.
That reduction means the company can accelerate plans to start clinical testing for two earlier-stage immunotherapies—ADXS-HOT and Amgen-partnered ADXS-NEO—which both target cancer neoantigens and are designed to stimulate T cells to attack tumor cells. Advaxis reckons they have potential applications across multiple tumor types, but the first ADXS-HOT candidate will be tested in non-small cell lung cancer. Trials of both will get underway this year and will generate data beginning in 2019.
“It is important that we allocate capital to invest in these programs in order to realize their potential, but this also requires us to reduce investments in other programs,” said Berlin on a conference call. “The HPV program is important to us, but we must be realistic about what we can and cannot develop on our own.”
Advaxis reported data from another immunotherapy candidate, ADXS-PSA, in prostate cancer at ASCO this year and says that the combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) is worthy of “further evaluation.” It will follow patients for another six to nine months before deciding on a path forward.
The ASCO trial showed evidence of “an early clinical signal in extending survival among patients,” according to Advaxis new chief medical officer Andres Gutierrez, M.D., Ph.D., who joined the firm at the same time as Berlin.
Shares in the company rose 11% in the wake of the announcement, which coincided with Advaxis’ second-quarter results statement, suggesting investors were happy with Berlin’s decisions. The company posted a net loss of just over $13 million in the three-month period, ending it with cash reserves of around $59 million.
The headcount reduction and rejigged R&D portfolio means that Advaxis has operating funds for at least one year, according to the company.
