U.S. jury fails to reach verdict in latest J&J talc trial

A South Carolina jury on Friday could not agree on a verdict in a case of a woman whose family said her long-term use of Johnson & Johnson’s Baby Powder led to her death from asbestos-related cancer, resulting in a mistrial.

The case of Bertila Boyd-Bostic, who died of a rare form of cancer in 2017 at the age of 30, is the latest in a series of trials in the United States that center around allegations that the company’s talc-based powder contained asbestos.

“We’re disappointed the jury did not reach a unanimous verdict for Johnson & Johnson,” the company said in a statement emailed to Reuters.

“The talc in Johnson’s Baby Powder does not contain asbestos, which is supported by more than 50 years of independent, non-litigation driven scientific evaluations.”

Asbestos is a known carcinogen linked to mesothelioma, the type of cancer Boyd-Bostic had been diagnosed with at the age of 29.

After two weeks of trial, the jury in the Darlington County Court of Common Pleas said it could not decide whether J&J was responsible for the disease. Under South Carolina law, a jury has to make a unanimous decision.

Christopher Swett, a lawyer for the family of Boyd-Bostic, said in a statement that the plaintiffs would retry the case at the earliest opportunity.

“We continue to believe that the daily use of baby powder on Bertila from birth led to her death,” Swett said.

The case also named as a defendant the U.S. unit of talc supplier Imerys SA, as well as a local unit of Rite Aid, one of the largest U.S. drugstore chains, which allegedly sold the baby powder used by the woman.

Gwen Myers, a spokeswoman for Imerys Talc America, said: “We remain confident that talc does not cause cancer. Imerys follows all FDA and other regulatory guidelines and utilizes rigorous testing to ensure that our talc meets the highest quality standards. We continue to stand by the safety of our product.”

J&J is battling some 9,000 cases claiming its talc products cause ovarian cancer, but litigants have recently focused on claims based on alleged asbestos contamination.

A California jury on Thursday awarded $25.7 million in damages to a woman and her husband over allegations that the company’s baby powder had caused her mesothelioma.

A New Jersey court jury in April ordered J&J and Imerys Talc America to pay $117 million to a man who alleged he developed mesothelioma due to asbestos exposure from talc-based products.

The company won the only other asbestos-related trial in November, when a Los Angeles Superior Court jury ruled in its favor.

https://reut.rs/2IQJ5uW

Third Indian state checks suspect cases in outbreak of rare brain-damaging virus

Officials in a third Indian state were checking on Friday if two people had been infected with the brain-damaging Nipah virus that has killed 12 in southern Kerala, although the government described the outbreak as minor.

Such outbreaks are a concern in a country where hundreds die from infectious diseases each year for lack of vigorous disease tracking systems. There is no vaccine for the virus, carried by fruit bats, and the only treatment is supportive care.

The virus has not spread beyond Kerala, the government said after investigation by health officials linked the initial deaths to a well colonized by bats whose water the victims had been using.

“The Nipah virus disease is not a major outbreak and is only a local occurrence,” the government said in a statement, adding that a team of experts continued to monitor the situation.

Blood samples from two men who showed the flu-like symptoms of the virus were sent for testing, said a health official in Telangana, a state neighboring Kerala.

“We just sent them as a precaution,” said K Shankar, medical superintendent of the Sir Ronald Ross Institute of Tropical and Communicable Diseases in Hyderabad.

Two suspect cases in Karnataka, another state bordering Kerala, proved negative, said a medical official there.

All the confirmed infections have involved people who caught the virus from the first victim while he was being treated, said microbiologist G. Arun Kumar.

“Hospital-acquired infections are a major path of human to human transmission,” added Kumar, who heads the Manipal Centre for Virus Research that is testing virus samples.

The virus, spread through contact with bodily fluids, has a mortality rate of about 70 percent.

A global coalition to fight epidemics this week struck a $25-million deal with two U.S. biotech groups to speed work on a vaccine.

A clutch of dead bats discovered on the roof of a school in the northern state of Himachal Pradesh triggered a brief scare, but there are no suspected human infections, said health official Sanjay Sharma.

The finding of dead bats was not an unusual event, said one state forest official.

“This is not unusual, but the department has sent bat samples for tests as a precautionary measure,” said the official, Ramesh Kang.

https://reut.rs/2kq0vUF

Low-dose aspirin could help pregnant women with high BP avoid preeclampsia

A daily dose of aspirin could help pregnant women in the first stage of high blood pressure avoid a condition that puts both mother and baby in danger, according to a new study.

New guidelines lowering the threshold for what defines high blood pressure pose a quandary for doctors who treat pregnant women at risk for preeclampsia. High blood pressure is one risk factor for that condition, which can cause stroke and seizures; premature separation of the placenta; damage to the mother’s kidneys and liver; and premature birth and low birth weight.

And while women at high risk for preeclampsia already are given low-dose aspirin as a preventive measure, now doctors must decide whether to give it to women who were not considered candidates for the drug under previous blood pressure guidelines.

“We are going to have a lot more patients that come in with the new high blood pressure diagnosis, and we needed to figure out what to do. What is their risk for preeclampsia? Is it the same?” said Dr. Alisse Hauspurg, who is in her second year of a fellowship in maternal-fetal medicine at the Magee-Womens Hospital of the University of Pittsburg Medical Center.

She led the University of Pittsburg study, published Friday in the American Heart Association journal Hypertension, which shows low-dose aspirin could help prevent preeclampsia in women in the first stage of high blood pressure. The blood pressure guidelines issued in November now consider a reading of 130 on the top or 80 on the bottom to be stage 1 hypertension. In the past, that standard was 140/90.

Hauspurg’s research showed taking a low-dose aspirin reduced the risk of developing preeclampsia by 39 percent in women with stage 1 hypertension compared to those taking a placebo.

“I was really surprised that the difference is as big as it is,” Hauspurg said. The study was a second look at data collected in a trial investigating low-dose aspirin to prevent preeclampsia in high-risk women.

Credit: American Heart Association

However, aspirin didn’t significantly reduce the likelihood of preeclampsia in women who didn’t have high blood pressure but who were still at high risk for the condition. These included women with insulin-dependent diabetes and previous preeclampsia, among other risk factors, for whom preeclampsia risk dropped by just 3 percent.

The women were recruited between 1989 and 1992 and were given 60 milligrams of aspirin a day during pregnancy. Today, a dose of 81 to 160 milligrams is more common, Hauspurg said. The original study included 2,539 women but only 1,020 were used in this analysis, which did not include women carrying multiple fetuses and who had pre-existing hypertension that is now classified as stage 2.

The substantial difference in the outcome between women with high blood pressure and those without it highlights the need for more studies, doctors said. In fact, doctors said they don’t know what causes preeclampsia or how aspirin affects it.

Preeclampsia affects about 3.4 percent of pregnancies in the United States and causes 10 percent to 15 percent of maternal deaths worldwide, according to estimates from the National Institutes of Health.

“We are up against a problem we really don’t understand,” said Dr. Monique Chireau, an assistant professor of obstetrics and gynecology at Duke University School of Medicine, who was not involved in the study.

Chireau said the findings suggest there may be many pathways to preeclampsia and that aspirin may not work on all of them.

Hauspurg cautioned that one study isn’t enough to stop giving aspirin to all women at risk of preeclampsia. “I don’t want to jump to conclusions,” she said.

For now, Hauspurg said the study could help create more targeted trials. For example, statins and metformin are being tested as potential preeclampsia risk-reduction agents, although those drugs aren’t as safe as aspirin, she said. “Maybe we target new trials to populations that don’t benefit from aspirin.”

 Explore further: Give aspirin to all pregnant women at risk of preeclampsia, US experts say

More information: Alisse Hauspurg et al. Aspirin Effect on Adverse Pregnancy Outcomes Associated With Stage 1 Hypertension in a High-Risk Cohort, Hypertension (2018). DOI: 10.1161/HYPERTENSIONAHA.118.11196

https://bit.ly/2LtcIUS

Nylon halts fatal fungal infections

Antifungal resistance is a real and growing problem. According to an innovative new study, nylon polymers may help to tackle fungal species that currently defy treatment.

Could nylon (depicted here) be the answer to antifungal resistance?

Although it is less well known than antibioticresistance, antifungal resistance is also an expanding problem.

Particular fungi have always been hard to treat, but, increasingly, some that were once easy to manage are becoming ever more difficult to tackle.

For instance, the very common fungus Candida,which can cause invasive infections, is starting to become immune to conventional antifungals.

So, the race is on to design antifungal drugs that can circumnavigate this medical conundrum. One new and surprising contender is nylon.

A new antifungal?

Over recent years, researchers from the University of Wisconsin-Madison have been investigating nylon polymers’ ability to fight fungi.

The authors of the new study, which was led by Nancy Keller, wanted to locate a compound that would interact with the fungus in the same way that peptides in the immune system do.

Peptides are short chains of amino acids, so the team looked at other short chain molecules, and they settled on nylon.

Keller decided to join forces with microbiologist Christina Hull and chemist Samuel Gellman, who had previously developed polymers for use as antibiotics. Together, they sought to understand whether the polymers could be as successful against fungi as they had been against bacteria.

Three nylon polymers were pitted against 41 species of fungi. They compared their fungus-killing ability against azoles, a common class of antifungal drug.

The researchers were pleasantly surprised at the polymers’ success rates. The nylon polymers halted the growth of 24 species, some of which are already resistant to azoles.

“The fungi are very spread out, in a biochemical way. There was no way of predicting the polymers would be active against such a wide breadth of taxa.”

Nancy Keller

The scientists have now published their findings in the journal mSphere.

The species of fungi that were succesfully destroyed include Rhizopus arrhizus, which can cause life-threatening conditions in at-risk individuals, and Scedosporium prolificans, which can cause fatal infections and is impervious to existing antifungals.

However, not all fungi species succumbed. Notably, Aspergillus — a fungus that can cause serious lung conditions in susceptible people — did not respond.

A synergistic boost

Interestingly, the team found that when the polymers were used alongside azoles, fungi that were previously azole-resistant once again became susceptible to the drug. This offers a new potential treatment option; for fungi that respond to neither the polymers nor standard antifungals, it might be worth using them in unison.

Modern medicine rarely uses polymers in this way, and Gellman is excited by the possibilities they offer. He says, “Observations of this type should encourage the community to consider polymers as potentially useful biomedical agents.”

How the polymers fight fungi is unclear. As Gellman puts it, “We don’t really know how they work.” The next phase of research will make efforts to dig into the mechanisms behind it.

Additionally, because polymer use in medicine is a fledgling technology, no one knows how many powerful polymers there are out there, waiting to be designed and tested. As Gellman concludes, “There are more structures than we can imagine.”

https://bit.ly/2kpsfbW

Refusing Lung Cancer Treatment: Class Trumps Race

Which groups of people in the U.S. are more likely to put themselves at higher risk of death by refusing treatment for non-small cell lung cancer (NSCLC)? The answer varies by treatment modality, a new study finds, but one trend is consistent: Poorer people are more likely to just say no.

Still, the variable findings mean that “there’s no single magic bullet” that will lower treatment-refusal rates across the nation, said the lead author of the study presented here at the annual meeting of the American Thoracic Society, Alex Arto Balekian, MD, of the Keck School of Medicine at the University of Southern California in Los Angeles.

“There are going to be local factors about why patients have this hurdle,” he told MedPage Today. “We need to be diligent at looking at who in our local areas is not getting guideline-compliant care.”

For the study, Balekian and colleagues examined the American College of Surgeons’ National Cancer Database and focused on whether patients underwent recommended treatment for clinical stage 1A (surgical resection), pathologic stages II-IV (chemotherapy), and pathologic stages IIIA-B (radiation) disease.

According to the American Society of Clinical Oncology, the 5-year survival rate for stage 1A NSCLC is about 49%, but dips to about 14% and about 5% for stages IIIA and IIIB, respectively.

Many patients tracked by the database underwent treatment, while others were not offered treatment for reasons such as being too ill. Balekian noted that 3% of patients declined recommended surgery, 11% declined recommended chemotherapy, and 6-7% declined recommended radiation.

Among more than 166,000 patients diagnosed at clinical stage 1A, several groups were statistically significantly more likely to decline surgery compared with white patients: blacks (adjusted OR 1.94), East Asian (AOR 1.35), Pacific Islanders (AOR 1.72), and Native Americans (AOR 2.01). In addition, patients without insurance (AOR 2.60) and on Medicaid (AOR 2.24) were more likely to refuse surgery than those on Medicare.

Among nearly 159,000 patients with pathologic stages II-IV lung cancer who were eligible for chemotherapy, those without insurance (AOR 2.39) or on Medicaid (AOR 1.66) were more likely to refuse treatment compared with those on Medicare. Hispanics were also less likely to refuse treatment than were non-Hispanics (AOR 0.88).

And among nearly 58,000 patients with pathologic stages IIIA-B lung cancer and eligible for radiation, women were more likely than men to decline treatment (AOR 1.15), as were East Asians versus whites (AOR 1.73) and those without insurance (AOR 2.42) or on Medicaid (AOR 1.31) versus Medicare.

Overall, “the patterns in which this is occurring are highly variable and not consistent,” Balekian said.

The fate of the patients who refused treatment is not clear, but he said the treatment guidelines are well supported.

Why might patients in these different groups be especially resistant to various types of treatment? The findings don’t provide an answer, he said, noting, though, that he believes the findings reveal more of a class disparity than a race disparity.

It’s possible that poorer patients may face more obstacles in accessing treatment, he said, perhaps because they can’t take time off from work. Or they may not be able to use public transit to get to treatments, since radiation, for example, can require 3-4 days of treatment for 5 weeks.

Moving forward, he said, clinicians should be sure to ask patients individually — “for example, a black patient in Philadelphia may have different reasons for declining surgery than a black patient in South Central Los Angeles.”

• Primary Source

  American Thoracic Society

  Source Reference: Balekian A, et al “Refusal of recommended care for non-small cell lung cancer” ATS 2018; Abstract A6417.

https://bit.ly/2IMBphx

Mild Traumatic Brain Injury Patients Lack Follow-up Care After ER Discharge

Most patients treated for mild traumatic brain injury (TBI) at level-one emergency departments did not see a clinician for follow-up care or receive educational materials at discharge, researchers for the TRACK-TBI study reported.

The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) analysis showed that only 42% of patients with mild TBI received educational material when they were discharged from the emergency room and just 44% saw a physician or healthcare practitioner within 3 months after injury, according to Seth Seabury, PhD, of the University of Southern California in Los Angeles, and coauthors.

In addition, only 52% of patients who had three or more moderate to severe post-concussive symptoms saw a clinician by 3 months after discharge, they wrote in JAMA Network Open.

“This is a public health crisis that is being overlooked,” co-author Geoffrey Manley, MD, PhD, of the University of California San Francisco, said in a statement.

“If physicians did not follow up on patients in the emergency department with diabetes and heart disease, there would be accusations of malpractice. For too many patients, concussion is being treated as a minor injury.”

The low follow-up rates “most likely reflect poor coordination between acute and non-acute care settings,” first author Seabury told MedPage Today.

“As a healthcare system, we need to do a better job of tracking patients after a concussion and ensuring they get the care that they need,” he said. “While concussion has relatively low mortality risk, a number of patients will continue to experience post-concussive symptoms and disability for an extended period of time after their injury.”

Mild TBI has been tied to cognitive dysfunction, depression, anxiety, fatigue, and post-concussion syndrome, plus long-term risks of dementia and Parkinson’s disease. In an earlier report from TRACK-TBI researchers, 22% of patients with mild TBI still were functionally impaired 1 year after their injury. Few studies have investigated follow-up care after mild TBI, but prior research has shown that providing educational materials is associated with better outcomes.

TRACK-TBI is an ongoing prospective, longitudinal, observational study of TBI patients who present to the emergency department at one of 11 U.S. level-one trauma centers. For this analysis, researchers studied mild TBI patients from TRACK-TBI hospitals during 2015 to 2016 who had acute head trauma sufficient for an emergency department physician to order a clinical head computed tomography (CT) scan within 24 hours of injury.

Eligible patients had a Glasgow Coma Scale (GCS) score of 13 to 15 when they arrived at the emergency room, loss of consciousness for less than 30 minutes, and post-traumatic amnesia duration of less than 24 hours. At 2 weeks and 3 months, researchers surveyed patients about follow-up care and captured clinical outcome measures of physical and psychological symptoms.

Of 831 patients in the study, 58% were white, 65% were male and the average age was 40. More than half (59%) of the concussions resulted from traffic incidents; 24% were from falls and 6% from assaults.

The researchers found wide disparities across study sites; after adjusting for patient characteristics, providing TBI educational material varied from 19% to 72%, for example. Of 236 patients with a positive finding on their CT scan, 92 (39%) had not seen a medical practitioner 3 months after the injury. Among patients with 3 or more moderate to severe post-concussive symptoms, only 145 of 279 (52%) reported having seen a medical practitioner by 3 months.

Women (OR 1.44) and non-Hispanic white patients (OR 1.64) were more likely to have follow-up care by 3 months. Neither patient income nor insurance status was associated with receiving follow-up care. And patients admitted to the hospital ward or intensive care unit were no more likely to get follow-up care than those discharged directly from the emergency department.

“While recent media has focused on the important issue of repetitive brain injury among professional athletes, the cohort of individuals with mild traumatic brain injury who have been evaluated in the emergency department remains underappreciated,” observed Mary Iaccarino, MD, of Massachusetts General Hospital, in an invited commentary.

Post-concussive symptoms can produce a constellation of clinical challenges that may be difficult to treat, Iaccarino noted.

“In this population, early education and symptom-based treatment may be the best approach,” she wrote. “For example, a recent study has suggested that an aggressive program of rest may not be helpful, and there is some evidence that activity-based therapies addressing symptom complexes offer benefit. In addition, multidisciplinary care seems to shine as a theme toward success.”

Study limitations include small sample size, use of patient-reported data, heterogeneity of university-affiliated, level-one sites, and lack of multiyear follow-up. For these reasons, benefits of follow-up care and education only can be inferred, Iaccarino noted.

But despite these limitations,”this work is an important notation for next steps in understanding care needs and defining the phenotype of individuals who would most benefit from further education and integrated medical care.”

This study was supported by grant from the National Institute of Neurological Disorders and Stroke, National Institutes of Health and funding by Research to Prevent Blindness, New York, New York.

The researchers reported relationships with Precision Health Economics, Abbott, General Electric Healthcare, Novartis, Celgene, TauRx, and the National Football League.

The editorialist reported no conflicts of interest.

• Reviewed by F. Perry Wilson, MD, MSCEAssistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

• Primary Source

  JAMA Network Open

  Source Reference: Seabury S, et al “Assessment of follow-up care after emergency department presentation for mild traumatic brain injury and concussion: Results from the TRACK-TBI study” JAMA Network Open 2018; DOI: 10.1001/jamanetworkopen.2018.0210.

• Secondary Source

  JAMA Network Open

  Source Reference: Iaccarino, M “Mild traumatic brain injury: A clarion call for care of the postconcussive spectrum” JAMA Network Open 2018; DOI 10.1001/jamanetworkopen.2018.0211.

https://bit.ly/2J59QiK

Precision Medicines Approved More Quickly, With Less Data

Precision medicines are approved more quickly and on the basis of fewer patients and smaller pivotal trials than nonprecision medicines, according to a study in Health Affairsanalyzing nearly 5 years of recent FDA data.

Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found.

The less rigorous design makes it more challenging to determine the true magnitude of benefit for some of these drugs, said study co-author Jonathan Darrow, JD, MBA, of Harvard Medical School and Brigham & Women’s Hospital in Boston, in a phone interview.

When it comes to the speedier development and approval of precision medicines versus nonprecision medicines and the apparent reliance on smaller and fewer trials with less exacting parameters, Darrow had two concerns.

Either the evidence may be weak — due to trial designs that lack blinding, randomization or controls — or when there are high quality data, they show a precision drug that is not much better than placebo.

The FDA is free to approve drugs that are only slightly better than a placebo and companies can charge whatever they want for them, Darrow noted.

Consequently, he said, “We’ve created a system where drugs can be extremely expensive yet little better than placebos,” he said.

And following the drug’s release to the market, he noted, “the magnitude of benefit may be revised” — that is, it may turn out to be smaller or “disappear entirely.”

For their study, Darrow and colleagues at Harvard and the University of Queensland, in Brisbane, Australia, looked at the trial design and overall approval time for precision medicines from Jan 2013 through June 2017.

The study began one year after passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, which created the “breakthrough designation” pathway.

Darrow and his colleagues also examined the relationship between precision medicine status and breakthrough therapy designation and how such status is associated with the “speed of clinical development, review and approval.”

For the purpose of the study, they defined precision medicines as “medicines targeted at patients based on their genetic characteristics or the genetics of their disease-causing organisms.” This included drugs targeting specific tumor profiles, chromosomal abnormalities, or viral genotypes. They also categorized medicines as “precision” or “nonprecision” on the basis of “indications at the time of FDA approval.”

Ultimately, Darrow and his colleagues found that the total development and review process was 1.7 years faster for precision medicines than nonprecision medicines and nearly half of precision medicines — approximately 48% — qualified for a breakthrough therapy designation.

One reason for the abridged time frame was the products’ eligibility for this faster breakthrough pathway. Simpler trial designs were another, the authors noted — trials can be completed faster without blinding or control groups.

Precision medicines also gained approval using fewer pivotal efficacy trials, a median of one trial for precision versus two trials for nonprecision medicines.

Moreover, such trials included a median of 305 participants per trial for precision medicines compared with 584 for other drugs.

With more trials lacking control groups, “a greater proportion of participants in each of these [precision medicine] trials received the study intervention, compared to nonprecision medicine trials.”

“Shortened development and review times can translate into market advantages for drugs labeled as precision medicines and may be appropriate when those drugs are demonstrated to offer large clinical benefits,” the authors wrote.

The question, of course, is how often they actually do.

Can patients assume that any FDA approved drug is worth taking? Darrow called into question the binary nature of the question: a product being either effective or ineffective.

“It’s like saying we tested a parachute — it opened once out of the 100 times that we tried it, therefore it works,” he said.

In reality, “it’s all about magnitude,” he said. “You want to know how close [a drug] gets you to solving the problem … not just can you detect an impact of any magnitude on the problem.”

Clear understanding of a drug’s effect size is vital for informed decision-making, Darrow said. “Patients and physicians need to exercise their own judgment, look at the data and determine whether the benefits outweigh the risks in their own view.”

The study was supported by the Laura and John Arnold Foundation and the Engelberg Foundation.

https://bit.ly/2kpSD5z