Applied DNA Sciences
APDN 104.93% shares are trading higher after the company published a press release highlighting the FDA's findings on sensitivities in specific COVID-19 tests. The company says its' Linea COVID-19 Assay Kit is '1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7).'Search This Blog
Friday, January 8, 2021
Why Applied DNA Sciences Is Up 80% Today
1 in 5 Cancer Patients on Long-Term Opioids Misuse Them
Among cancer patients receiving long-term opioid treatment for pain, 19% developed behaviors of nonmedical opioid use (NMOU), researchers reported.
In a study of more than 1,500 patients being treated at a comprehensive cancer center's supportive care clinic, the most common NMOU behavior was an early refill request, in 29%, followed by self-directed dose escalation in 15%, co-use of illicit or non-prescribed drugs in 13%, and impaired daily function due to opioids in 11%, among others, according to a team led by Sriram Yennurajalingam, MD, MS, of MD Anderson Cancer Center in Houston.
"This finding highlights the need for continuous vigilance and careful use of these opioids in this population," the authors wrote in JAMA Oncology.
On multivariate analysis, several factors were independently associated with an increased risk of NMOU behaviors, including single (HR 1.58, 95% CI 1.15-2.18, P=0.005) or divorced marital status (HR 1.43, 95% CI 1.01-2.03, P=0.04), Edmonton Symptom Assessment Scale (ESAS) pain level (HR 1.11, 95% CI 1.06-1.16, P<0.001), Screener and Opioid Assessment for Patients with Pain (SOAPP) score (positive vs negative HR 1.35, 95% CI 1.04-1.74, P=0.02), and morphine equivalent daily dose (HR 1.003, 95% CI 1.002-1.004, P<0.001).
In a recursive partition analysis, a morphine equivalent daily dose >50 mg, being single, and a SOAPP score of 7 or higher were associated with a 56% higher risk for NMOU behavior.
"Based on these findings, a universal screening, setting limits on opioid use by limiting supply, more intense follow-up with an interdisciplinary team to provide optimal use of medications for pain and symptom management, and the provision of counseling and support to patients and their family members may help prevent the development of these NMOU behaviors," wrote Yennurajalingam and co-authors.
The study examined NMOU behaviors in 1,554 consecutive cancer patients on opioids for their pain who were referred to MD Anderson Cancer Center's supportive care clinic from 2016 to 2018. Patients were assessed using SOAPP score; the Cut Down, Annoyed, Guilty, Eye Opener-Adapted to Include Drugs (CAGE-AID) survey; and ESAS pain level.
In all, 29.4% of patients had a SOAPP score of 7 or above. On the CAGE-AID survey, 16.6% scored at least 2 of 4 points. Median age in the cohort was 61 years, 52.5% were women, 72.3% were white, and 19.2% had one or more NMOU behaviors, with 745 behaviors recorded among these 299 patients.
Other NMOU behaviors included resistance to change in an opioid prescription (7%), request for a specific opioid (6%), doctor shopping (6%), reports of lost medication (4%), frequent emergency department visits for opioids (3%), a concerned family member (3%), requesting opioids for reasons other than pain (2%), and obtaining opioids from nonmedical sources (1%).
Disclosures
Yennurajalingam reported grants from the Helsinn Healthcare Fatigue and Cachexia Study and the Genentech Patient Experience Study. Co-authors reported grants from or relationships with Teva Pharmaceutical, Insys Therapeutics, and Helsinn Healthcare.
Primary Source
JAMA Oncology
Post-vax covid infection a reminder to keep on masking and distancing
Some healthcare workers have reported falling ill with COVID-19 after getting their first vaccine dose -- but that's not a surprise, as protection can take as long as 2 weeks to kick in, researchers said.
A nurse from California made headlines last week after getting sick 6 days after he received his first shot. Since then, other healthcare workers have shared similar experiences on social media.
Trauma surgeon Qaali Hussein, MD, for example, developed COVID-19 12 days after her first COVID-19 injection.
"I'm 12 days post 1st dose of the vaccine so I do not have full protection yet," Hussein wrote on Twitter, stating that she should have at least some protection from severe illness. "I think we definitely need to ramp up vaccinations and would highly recommend getting vaccinated as soon as you are able to."
Emily Porter, MD, a physician in Austin (and sister of California Rep. Katie Porter [D]), also got sick with COVID-19 a few days after getting immunized. Josh Mugele, MD, an emergency physician in Georgia, reported mild symptoms 8 days after his first dose.
"The vaccine is still the best weapon we have, but we still need to mask up, wash our hands and isolate," Mugele wrote on Twitter.
Despite reports of illness onset after vaccination, experts say there is no cause for concern. The number of doses received, how long it takes to develop an immune response, and the time of viral exposure all play a role in whether or not people who have received the vaccine will still get sick.
Both the Pfizer/BioNTech and Moderna mRNA shots require two doses to provide maximum protection. Gregory Poland, MD, a spokesperson for the Infectious Diseases Society of America and an internal medicine physician at the Mayo Clinic who studies vaccines, said it can take up to 2 weeks after the first dose to develop a sufficient antibody response.
"When you get your first dose of vaccine, you will develop an immune response from that. But it takes time -- in the neighborhood of 7 to 14 days -- for that antibody response to develop, much less be at a level that's protective," he said.
Three to four weeks after the first injection, a second shot boosts the immune response, cementing antibody production into cell memory. "Giving a second dose is important to pushing that antibody level up as high as you can go to give the maximum amount of time before it wanes below a protective threshold," Poland added.
Peter Katona, MD, an infectious diseases physician at the University of California Los Angeles, agreed that the simple answer to why people are getting sick after vaccination is that not enough immunity has been built up yet.
Results from Pfizer/BioNTech's late-stage clinical trial suggest one dose of the vaccine might confer some level of immunity, with an efficacy rate around 52%. But the one-dose regimen has not received any sort of government approval, as vaccine efficacy jumps to 95% after the second dose.
Aside from the number of doses taken and the time it takes to develop immunity, Poland said distribution logistics for the vaccines might also impact efficacy.
Both have specific guidelines and need to be stored at extremely cold temperatures. "Once the vaccines exceed the time they can be at refrigerator or room temperature, they begin to rapidly degrade in quality," Poland stated.
Amid a slower-than-expected vaccine rollout, experts said it is critical for people who have been immunized to continue infection control methods.
"Even though you received the vaccine, you still have to do all the steps that we're doing right now," said Deepak Aggarwal, MD, chief of medical staff at the Northeast Georgia Medical Center in Gainesville, including hand-washing, mask-wearing, and physical distancing.
https://www.medpagetoday.com/infectiousdisease/covid19/90584
No surveillance cameras in nursing home rooms after Whitmer pocket veto
Michigan Gov. Gretchen Whitmer opted not to sign a bill allowing nursing home residents to install surveillance cameras in their own rooms.
Senate Bill 77, sponsored by Sen. Jim Runestad, R-White Lake, would have allowed electronic monitoring in a residents’ room with their permission, or shared permission if the room is shared. Runestad and other Republican co-sponsors pushed the bill so residents could have a check against potential abuse.
The resident would have been on the hook for the installation costs of the camera, and the facility would have had to put into effect an “electronic monitoring” consent form within 60 days of the bill.
In a statement opposing Whitmer’s pocket veto, Runestad mentioned the story of 75-year-old Norman Bledsoe, who was severely beaten in May by a 20-year-old patient receiving COVID-19 treatment. Bledsoe suffered four broken fingers, broken ribs, and a broken jaw after the attack.
“Without the benefit of video, no one would have known the truth of how Mr. Bledsoe was injured,” Runestad said in a statement. “The governor had a chance to sign this bill and help stop the type of abuse we’ve seen in nursing homes for years. Instead she chose to turn a blind eye, and now seniors pay the price.”
Despite Runestad claiming bipartisan support for the bill, it passed on partisan lines 22-15 in the Senate and 64-41 in the House during last month’s lame-duck session.
Whitmer did not release a statement explaining her pocket veto. Despite concerns over privacy when Runestad introduced the bill, the Health Care Association of Michigan supported the final product for addressing those issues.
“As passed by the legislature, Senate Bill 77 was able to strike the balance of connecting residents with loved ones, while protecting their privacy and dignity rights,” said Melissa Samuel, president and CEO of the association. “While we are disappointed the bill was not signed into law, we will continue to work with Senator Runestad, his colleagues, and the administration to ensure privacy rights of those in nursing facilities will continue to be protected while connecting families and loved ones.”
For much of last year, Michigan Republicans have taken aim at nursing home policies enacted by the Governor and the Department of Health and Human Services, particularly orders that allowed for patients with COVID-19 to transfer into long-term care facilities.
“In the last year we’ve seen the appalling policy from Gov. Whitmer of placing COVID-19-infected patients in nursing homes with uninfected patients,” Runestad said. “Our seniors have been suffering in isolation, and many have continued to be physically abused, and now with this pocket veto, the governor has chosen to continue playing politics with our vulnerable citizens.”
While some health experts found that Michigan’s nursing home strategy was appropriate, the state’s Nursing Homes COVID-19 Preparedness Task Force recommended that transfers should be done away with compared facilities that specifically treat the disease. Whitmer signed a bill in November banning most COVID-19 patient transfers into nursing homes.
As of Jan. 6, Michiganders who live in nursing homes have been the group hardest hit by the virus at nearly 5,000 total deaths in long-term care facilities. That includes 3,683 skilled-nursing residents, 826 who lived in other senior citizen facilities and 390 residents of group homes for adults with disabilities.
In all, residents and staff of long-term care facilities comprise 39% of all Michigan deaths from coronavirus.
“Whatever her reasoning, I will not be detoured from working to protect our most vulnerable,” Runestad said. “Nursing home residents should be allowed to install their own video cameras. They deserve to be able to communicate with their loved ones and be protected from abuse.”
Chimerix Acquires Oncoceutics to Expand Pipeline with Late-Stage Oncology Program
ONC201 Registrational Trial for Recurrent H3 K27M-mutant Glioma
Compelling Response Rates to Date; Defined Regulatory Path to Registration
Pivotal Data Anticipated in 2021 to Support Potential Registration, Addressing an Estimated Market Opportunity of Greater than $500 Million
Management to Host Conference Call at 8:30 a.m. ET Today
https://finance.yahoo.com/news/chimerix-acquires-oncoceutics-expand-pipeline-110000574.html
Iran leader bans import of US, UK COVID-19 vaccines, demands sanctions end
Iran's Supreme Leader on Friday banned the government from importing COVID-19 vaccines from the United States and Britain, labelling the Western powers "untrustworthy", as the infection spreads in the Middle East’s hardest-hit country.
In a live televised speech, Ayatollah Ali Khamenei raised the prospect of the two Western countries, long-time adversaries of the Islamic Republic, possibly seeking to spread the infection to other countries.
He added however that Iran could obtain vaccines "from other reliable places". He gave no details, but China and Russia are both allies of Iran.
"Imports of U.S. and British vaccines into the country are forbidden ... They're completely untrustworthy. It's not unlikely they would want to contaminate other nations," said Khamenei, the country's highest authority.
"Given our experience with France's HIV-tainted blood supplies, French vaccines aren't trustworthy either," Khamenei said, referring to the country's contaminated blood scandal of the 1980s and 1990s.
Iran launched human trials of its first domestic COVID-19 vaccine candidate late last month, saying it could help Iran defeat the pandemic despite U.S. sanctions that affect its ability to import vaccines.
Tensions between Washington and Tehran have risen since 2018, when President Donald Trump abandoned Iran's 2015 nuclear deal and reimposed sanctions to pressure Tehran into negotiating stricter curbs on its nuclear program, ballistic missile development and support for regional proxy forces.
In retaliation for U.S. sanctions, which were lifted under the nuclear deal, Tehran has gradually violated the accord. U.S. President-elect Joe Biden, who takes office on Jan. 20, has pledged to rejoin the agreement, if Tehran also returns to full compliance.
Khamenei said Tehran was in no rush for the United States to re-enter the deal, but that sanctions on the Islamic Republic must be lifted immediately.
Iran's utmost authority, Khamenei ruled out any talks over Tehran's missile programme and Iran's involvement in the Middle East, as demanded by the United States and some other major powers.
"Contrary to the U.S., Iran's involvement in the region creates stability and is aimed at preventing instability ... Iran’s involvement in the region is definite and will continue."
Shortly before Khamenei's speech, Iran's elite Revolutionary Guards unveiled an underground missile base at an undisclosed Gulf location.
The West sees Iran’s missiles both as a conventional military threat to regional stability and a possible delivery mechanism for nuclear weapons should Tehran develop them.
But Iran, which has one of the biggest missile programmes in the Middle East, regards the programme as an important deterrent and retaliatory force against U.S. and other adversaries - primarily Gulf Arabs - in the region in the event of war.
DERMAPHARM Receives a Buy rating from Jefferies
In a research note published by Alexander Thiel, Jefferies advises its customers to buy the stock. The target price is still set at EUR 60.