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Monday, March 2, 2020

Chinese biotech censured for misleading coronavirus drug claims

China’s BrightGene Bio-Medical Technology has been censured by the Shanghai Stock Exchange for wrongly claiming it is able to manufacture Gilead’s experimental drug remdesivir – scientists’ best hope of a treatment for the novel coronavirus.
Shares in BrightGene tanked after the announcement from the stock exchange that the biotech has not gained approval from China’s drug regulator to make remdesivir.
BrightGene has not been licensed by Gilead, which owns the drug’s patent, to make the drug and it has not received clearance to mass produce it.
The announcement wiped 20% off the company’s share price in intraday trading, the daily limit of the stock exchange.
Remdesivir is an antiviral drug that is not approved to treat any disease, although it has shown promise in preclinical trials and late-stage trials have just begun against the coronavirus that causes the disease known as COVID-19.
It is being tested in hospitals in Wuhan, the centre of the coronavirus outbreak, as well as in the US.
BrightGene said on February 12th that it had managed to manufacture remdesivir in large quantities, sending its stock up 60% to a record high.
In a separate development, US biotech Moderna said it had shipped its first vaccine against coronavirus ready for a phase 1 study.
Vials of the vaccine dubbed mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) to be used in the planned US-based study.
Moderna’s vaccine is mRNA-based and targets the spike (S) protein necessary for membrane fusion and host cell infection.
This protein has been the target of vaccines against the related coronaviruses that cause Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
Moderna is one of several companies working on vaccines, including the US drugs giant Johnson & Johnson and its Janssen pharmaceuticals unit, as well as Sanofi and GlaxoSmithKline.
Chinese biotech censured for misleading coronavirus drug claims

Novel Treatment Offers New Hope for Peripheral Neuropathy

Combined electrochemical treatment (CET), a technique that uses local nerve blocks in conjunction with electric cell signaling, regenerates nerve fibers and significantly reduces pain for patients with peripheral neuropathy, early research suggests.
Five of six patients with objectively diagnosed painful peripheral neuropathy (PPN) who were treated with CET over a 6- to 12-week period experienced a 100% increase in nerve density. Pain scores were reduced by 90%, and the treatment was also associated with a 74% improvement in physical function.
Dr Peter Carney
“When I see patients with peripheral neuropathy, I tell them there are three treatments,” study investigator and neurologist Peter M. Carney, MD, who is in private practice in Elkhart, Indiana, told Medscape Medical News.
“You can take medication, which has about a 35% to 40% chance of helping you and a 60% chance of giving you side effects, or, if you don’t respond to drugs, the second option is to just learn to live with it. Now we have treatment number three, where we are using physics, not pharmacology, to regenerate the nerves, reduce pain, and improve function,” Carney said.
The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.

“Revolutionary Concept”

CET involves the use of local anesthesia to block pain and other nerve function in the distal lower extremities. Electric cell signaling treatment (EST) is then applied to both lower extremities to promote blood flow, which is essential to healing, said Carney.
“It’s a totally different, revolutionary concept of how you treat pain. It uses the principles of physics, rather than pharmacology,” said Carney, who became interested in the use of the principles of quantum mechanics to treat patients with PPN about 5 years ago.
“The principles of quantum mechanics not only treat PPN more effectively and more safely than pharmacological methods but also demonstrate that these principles help to regenerate nerves destroyed by PPN,” he said.
The six patients in this series had pain that varied in intensity from 4/10 to 9/10 on a visual analogue scale (VAS). The patients had been experiencing pain for a period ranging from 6 months to 20 years.
Before treatment with CET, all patients underwent epidermal nerve fiber density (ENFD) biopsy to confirm the diagnosis of peripheral neuropathy.
They received an average of 21.5 CET treatments. Each treatment lasted from 15 to 30 minutes; treatments were administered twice a week.
Patients were followed for an average of 26 months (range, 4 to 40 months) after their last treatment. Another ENFD biopsy was performed 6 months after treatment ended.
In addition to the VAS, other measures of treatment efficacy included the Neuropathy Functioning Index (NFI) and assessments of the degree to which medications were used.
These were recorded during treatment, at the last treatment, and on average 26 months after the last treatment.

Objective Evidence of Efficacy

Five of the six patients experienced 100% regeneration of nerve fibers, as documented by ENFD. At the start of treatment, the average nerve density was 2.77 nerve fibers per millimeter. Six months later, it was 5.54 nerve fibers per millimeter.
“That’s objective evidence that this works,” said Carney.
The average pain score dropped from 6.8 during treatment to 1 at the end of treatment. This reduction in pain continued, further diminishing to 0.7, for a 90% reduction at 30 months.
There was a 67% improvement in physical functioning by the end of treatment, with NFI scores going from 57.2 to 18.6. At 30 months, there was a 74% improvement; the average NFI score was 14.6.
In addition, there were no short- or long-term side effects.
Of the five patients who were taking medication for PPN before starting CET therapy, four stopped taking one or more of these medications.
The single patient who did not experience nerve fiber regrowth still experienced a 44% reduction in pain and a 34% improvement in function. He was lost to follow-up 4 months after finishing treatment, Carney reported.
“These results demonstrate the effectiveness of CET. You regenerate the nerves, you reduce the pain, restore the function. When the world understands that by using physics, you can regenerate nerves, reduce pain, and restore function, we will have totally revolutionized how we treat pain,” Carney said.

Report Stimulates Further Study

Dr Jianguo Cheng
Commenting on the findings for Medscape Medical News, Jianguo Cheng, MD, PhD, president of the American Academy of Pain Medicine and professor and director of the Pain Fellowship Program at Cleveland Clinic, Ohio, said the findings warrant further study.
“Because of the lack of effective treatment for painful peripheral neuropathy, novel approaches to this common clinical problem are highly needed. Carney’s report stimulates further study, ideally through randomized and controlled clinical trials, to demonstrate efficacy, safety, and generalizability.”
Carney and Cheng have disclosed no relevant financial relationships.
American Academy of Pain Medicine (AAPM) 2020 Annual Meeting: Abstract 421. Presented February 29, 2020.
https://www.medscape.com/viewarticle/926002#vp_1

USPSTF Recommends Hep C Screening for All US Adults Ages 18-79

The US Preventive Services Task Force (USPSTF) today expanded its recommendation for one-time hepatitis C virus (HCV) screening to include all asymptomatic US adults ages 18-79 years, including pregnant women, who do not have known liver disease.
It is a B-level recommendation, indicating that the USPSTF “concludes with moderate certainty” that screening for HCV will have a substantial net benefit. The B level is also important because the Affordable Care Act requires that private insurers and Medicaid cover preventive services recommended at an A or B level by the USPSTF with no deductibles or copayments.

Guidance Expands 2013 Recommendation

The recommendation updates and expands the Task Force’s 2013 guidance, which stated that one-time screening should include adults born between 1945 and 1965, with periodic screening of those at continued risk.
“HCV is associated with more deaths than the top 60 other reportable infectious diseases combined, including HIV,” the group, led by Douglas K. Owens, MD, Stanford University, California, stated.
Among reasons for the change, authors cite the almost 3.8-fold increase in cases in the last decade, largely because of more injection drug use and better monitoring.
The recommendation was published online March 2 in JAMA.
Owens and colleagues note that research indicates the most important risk factor for HCV is injection drug use.
“In the United States, recent increases in HCV incidence have predominantly been among young persons who inject drugs (PWID). Approximately one third of PWID aged 18 to 30 years are infected with HCV, and 70% to 90% of older PWID are infected,” they write.

Patients Should Know Test Is Voluntary

The authors point out it is important for clinicians to let patients know that screening is voluntary and to communicate what HCV is, how it is acquired, what a positive or negative test means, and potential harms and benefits of treatment.
The USPSTF also suggests that clinicians consider screening patients considered high risk (past or current injection drug users even if they fall outside the recommended age range).
The recommendations come in light of several developments over the past decade.
One is the convincing evidence that the newer direct-acting antiviral (DAA) regimens result in cure rates above 95% for adults ages 18-79 years, and the “adequate evidence of sustained virologic response in adolescents.”
In addition, the duration of treatment has declined. Whereas older, interferon-based regimens required as long as 48 weeks of treatment, DAA-based regimens require just 8 to 12 weeks of therapy.
Additionally, screening and treatment rates have varied widely. Screening rates have been high in healthcare systems serving insured people, some academic medical centers, and Veterans Health Administration centers.
However, the authors write, “national HCV screening rates in community health centers and from the National Health Interview Study were 8.3% and 17.3%, respectively; one study of four safety-net primary care practices serving low-income and uninsured or underserved populations found that only 0.8% of persons born in 1945 through 1965 were screened over a 1-year period.”
The USPSTF did not find evidence of harm in screening in any new studies.

Test Can Give Results Quickly

Kalyan R. Bhamidimarri, MD, MPH, chief of the division of hepatology at the University of Miami in Florida, told Medscape Medical News that although much of the testing will fall on primary care physicians, rapid testing with a swab or finger stick can mean results are quickly available.
At their facility, they give patients a fingerstick test in the waiting room so results are ready to discuss during appointments, he said.
Even if rapid testing is not available and the blood sample needs to be sent out, he said, testing is able to capture “more than 98% of HCV infection” and false-positives are “very, very low.”
He pointed out that primary care offices are already on alert to watch for signs of fatty liver disease, which has become an epidemic.
Bhamidimarri said the USPSTF move was important because while hepatitis C infections have decreased in the baby boomer group covered by the previous recommendations, they have increased in other groups as opioid use has increased, particularly in young people.
“The biggest challenge with hepatitis C is underscreening and undiagnosis,” said Bhamidimarri, an associate professor of clinical medicine at the university.
He said acute infections have risen sharply in recent years and warns that without screening and treatment they will become chronic.
“So we are going to see another peak where individuals will have cirrhosis and will need a liver transplant sometime in the future,” he said. “If this goes untreated we will see a major public health burden later on. In all these years they are untreated, they are going to horizontally spread the infection to others.”
The broad screening that the USPSTF recommends is also important because it gets around possible stigma. Just asking people if they have risk factors won’t work because people may come to appointments with a significant other and don’t want to admit behaviors or talk about them with physicians, Bhamidimarri said.

Consistent With Other Recommendations

The USPSTF recommendation is very similar to the draft update of guidelines by the Centers for Disease Control and Prevention (CDC), which recommends screening for HCV at least once in a lifetime for all adults 18 years old and over, “except in settings where the prevalence is less than 0.1%.”
The CDC’s draft guidelines continue, “All persons with risk factors (eg, persons with HIV, prior recipients of blood transfusions, persons who ever injected drugs and shared needles, and persons who are born to an HCV-infected mother) should be tested for HCV, with periodic testing while risk factors persist.”
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommends one-time, opt-out HCV screening for everyone at least 18 years old and one-time testing for all people younger than 18 years at increased risk of exposure. They also recommend periodic screening for people with increased risk of exposure as well as yearly HCV tests for all people who inject drugs and HIV-infected men who have unprotected sex with men.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. A coauthor has reported receiving grants and personal fees from Healthwise. The US Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF. Bhamidimarri has declared no relevant financial relationships.
JAMA. Published online March 2, 2020. Full text
https://www.medscape.com/viewarticle/926057#vp_1

Supreme Court to hear ObamaCare appeal

The Supreme Court on Monday announced it will take up a case seeking to overturn the Affordable Care Act, returning the health care law’s fate to the high court.
The major announcement means that the case will loom over the November elections and could make the Affordable Care Act an even bigger issue in the presidential race.
The case will be heard during the court’s next term, which starts in October, meaning that a decision is not expected until after the elections. It is unclear when the court will hear arguments, but those could come in October, before the election.
The case threatens to blow a major hole in the health care system and overturn coverage for roughly 20 million people if the Supreme Court overturns ObamaCare.
But legal experts in both parties say the challengers’ legal arguments are weak and view it as unlikely that the high court will strike down the law.
The case was brought by a group of GOP-led states and is supported by the Trump administration.

Democrats immediately seized on the decision with a flurry of press releases to highlight the stakes for the election, while Republicans were mostly silent.
“This case is a stark, life-and-death reminder how much is at stake this fall and what’s on the ballot right now: Democrats must nominate the candidate whom they know can beat Trump and bring along the Senate, to ensure we can protect our health care for generations to come,” former Vice President Joe Biden said in a statement.
A spokesman for the Democratic Senatorial Campaign Committee called the lawsuit the “single most important issue in Senate battlegrounds across the country.”
The GOP challengers in the case argue that the health law’s mandate for everyone to have coverage is now unconstitutional, because Congress repealed the financial penalty associated with it in the 2017 tax law, so the mandate can no longer be upheld under Congress’s power to tax.
The next step in the argument is where legal experts especially become skeptical, though. The GOP challengers argue that because the mandate is unconstitutional, the entire rest of the health law should also be struck down because it is inseparable. Even conservative legal experts who supported previous ObamaCare challenges, though, have argued that it is clear Congress intended for the rest of the ACA to remain standing, because lawmakers only repealed the mandate penalty and left the rest untouched.
While much of the Democratic primary has focused on a debate over Medicare for All, the lawsuit could return attention to the ACA, to the relief of some mainstream Democrats who think that is more favorable ground to fight on.
If Sen. Bernie Sanders (I-Vt.) in particular is the nominee, Republicans are sure to counter by pointing to Medicare for All and its elimination of private health insurance coverage.
“A vote for a Republican is a vote to take protections away from people with pre-existing conditions,” tweeted Dan Pfeiffer, a former top aide to President Obama, after the announcement on Monday, summarizing the Democratic message.
A conservative district court judge in Texas struck down the entire ObamaCare law in December 2018, and the Fifth Circuit Court of Appeals partially agreed in December 2019.
That has led the Supreme Court to now step in, granting the calls of Democratic-led states to end the uncertainty hanging over the system, and rebuffing the Trump administration, which had called for letting the lower court process play out further.
Chief Justice John Roberts has already ruled to keep ObamaCare intact twice and is largely expected to do so again, combining with the four liberal justices to provide at least a five-vote majority to uphold the law.
But as time goes on and there are possible changes to the Court’s makeup, that calculus could change, which is part of the reason some Democrats wanted the Court to take up the case as soon as possible.
https://thehill.com/policy/healthcare/485429-supreme-court-to-hear-obamacare-appeal

U.S. Senate leader wants to pass coronavirus bill within two weeks

U.S. Senate Majority Leader Mitch McConnell said on Monday he wanted the Senate to pass a spending bill for the coronavirus “within the next two weeks.”
The bill is expected to provide billions of dollars for the virus response. The House of Representatives is expected to vote on its version of the legislation as soon as Wednesday.
https://www.reuters.com/article/us-health-coronavirus-senate/u-s-senate-leader-wants-to-pass-coronavirus-bill-within-two-weeks-idUSKBN20P34K

HPV tied to miscarriages and preterm births

Pregnant women infected with human papillomavirus (HPV) may be at increased risk for miscarriages and preterm deliveries, a review of past research suggests.
Mothers who have HPV are almost twice as likely as those who are not infected to have their water break before babies are full-term and 50% more likely to deliver babies too early, the analysis of data from 38 previous studies found. Women with HPV are also more than twice as likely to experience a miscarriage or stillbirth.
“There are no treatments to eliminate HPV,” said senior study author Helen Trottier of the University of Montreal.
“The solution lies largely in HPV vaccination before initiation of sexual relationships,” Trottier said by email.
A vaccine to prevent HPV, a common sexually-transmitted infection that can cause cancer, has been available in the U.S. since the late 2000s.
It’s currently recommended for boys and girls at age 11 or 12, with the goal of protecting them against the virus before they become sexually active. It’s also recommended for teens and young adults who may not have been previously vaccinated, and for some adults up to age 45 who determine they can benefit after discussions with their doctor.
Many women who become pregnant today may not have received the vaccine as children or teens, either because it wasn’t available when they were younger or because their parents chose not to vaccinate them.
Most infections don’t cause symptoms and go away on their own, but the virus is still a leading cause of cancer deaths among women worldwide. It can also cause genital warts, as well as cancer of the anus, penis and throat.
While previous research has also linked HPV to preterm births, miscarriages, and other pregnancy problems, results have been of varying quality and often inconsistent, the study team notes in The Journal of Infectious Diseases.
One limitation of the current analysis is that it pooled data from many smaller studies that used a wide variety of methods to define and measure pregnancy complications.
The included studies also were not designed to prove that HPV directly causes pregnancy complications.
Still, the evidence of a link between HPV and preterm birth and premature rupture of membranes, or water breaking early, was strong and consistent, the study team concludes. The connection between HPV and other outcomes like low birth weight, miscarriages and stillbirths wasn’t as strong and the evidence was of lower quality.
There are things women can do to minimize their risk of getting HPV or experiencing pregnancy complications when they do have this infection, said Dr. Christina Chu of the Fox Chase Cancer Center in Philadelphia.

“All children and young women and men should receive HPV vaccination,” Chu, who wasn’t involved in the study, said by email.
Condoms can lower the risk, as can being in a mutually monogamous relationship, Chu said. Women of childbearing age should also get routine cervical cancer screenings and HPV tests, and seek prompt prenatal care as soon as they suspect they might be pregnant.
SOURCE: bit.ly/2VE2UPi The Journal of Infectious Diseases, online February 5, 2020.
https://www.reuters.com/article/us-health-pregnancy-hpv/hpv-tied-to-miscarriages-and-preterm-births-idUSKBN20P3AJ

Trillium Asset calls for separation of J&J’s CEO and chairman roles

Trillium Asset Management LLC has called for the separation of Johnson & Johnson’s (JNJ.N) chairman and chief executive officer roles, currently held by Alex Gorsky, according to a regulatory filing here by the healthcare conglomerate on Monday.
The asset management firm is seeking a vote on the shareholder proposal at J&J’s annual meeting on April 23.
https://www.reuters.com/article/us-johnson-johnson-trillium-asset/trillium-asset-calls-for-separation-of-jjs-ceo-and-chairman-roles-idUSKBN20P39O