Informa Connect's Copay, Reimbursement and Access Congress
November 18-20, 2024 | Hilton Penn’s Landing in Philadelphia, PA
Drug Channels readers save 10% with code USAVE24*

The access and affordability landscape is undergoing a seismic shift. Evolving legislation, disruptive market forces and the ever-growing complexities of cost sharing programs threaten patient adherence and commercialization strategies. Are you ready?

A program driven by marketplace insights and led by industry trailblazers, Copay, Reimbursement and Access Congress is back November 18-20 and will deliver up-to-date insights necessary to enhance patient affordability, ensure program sustainability and navigate the regulatory landscape. In a time where remaining compliant has never been more complex and program innovation has never been more important, be sure to join your industry counterparts to drive adherence, access and commercialization forward.

Why attend the Copay, Reimbursement and Access Congress?

Keeping up with shifting market dynamics in the midst of maximizing access, while also meeting business objectives is a challenging task and brings about many questions for access professionals.

• Is your program sustainable and innovative to better support patients?
• Accumulators, maximizers, AFPs – What are your next steps to ensure effective reimbursement strategies?
• In an election year, what is the future of health policy?

Experts will tackle these questions and more as the industry comes together to benchmark best practices to accelerate access and commercialization. Do not miss your chance to join seasoned leaders, your peers and leading solution providers as they navigate marketplace trends and dive into the impact coupons, benefit design, accumulators, maximizers, alternative funding programs and drug pricing legislation have on patient affordability and out-of-pocket costs. This is your chance to gain critical insights on industry standards, forward-thinking strategies to optimize your copay and cost sharing programs and so much more.

Content highlights:

• Over 20 hours of content, including 7+ dedicated sessions to help decipher copay legislation
• Crucial perspectives from Pfizer, Sanofi, Janssen, Teva, Ascendis Pharma, Melinta Therapeutics, GSK, HIV + Hepatitis Policy Institute and more
• Insights direct from enforcement agents on the top trends and actions within the copay and patient services space
• Illuminating case study, Navigating the Patient Journey in a Shifting Copay Landscape from Spark Therapeutics
• 465 minutes of valuable in-person networking with colleagues and counterparts to expand your network and establish powerful partnerships
• Additional content access through Streamly, a platform that gives you 12-month access to all of the available conference content** to review at your leisure
• And more!

Download the agenda and register today—Be sure to use your exclusive promo USAVE24 to save 10% off* of your registration

See you there!

*Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply.
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This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Click here to see the original post from June 2024.

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The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:Read more »

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

We still don’t know what COVID-19 is doing to the heart or how we should be investigating it and treating it. Last month JAMA Cardiology published a German cohort study of 100 patients recently recovered from COVID-19… A number of striking problems with the study were noted on Twitter…...

Click here to continue reading...

The Royal Pharmaceutical Society and the British Pharmaceutical Students’ Association have called for all overseas candidates to sit the March 2021 registration assessment in their home countries.

The government implied wholesalers had more personal protective equipment in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association has said.

The Pharmaceutical Services Negotiating Committee is in talks with the government over potential plans to distribute COVID-19 treatments in primary care.

Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal.

The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence.

Starting COVID-19 patients on prophylactic anticoagulation within 24 hours of being admitted to hospital has been linked to a reduced risk of mortality.

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.

Around half of Wales’ community pharmacies have expressed interest to health boards in providing COVID-19 vaccinations as part of the national programme.

Community pharmacies able to administer up to 400 COVID-19 vaccines per week can now apply to become designated vaccination sites, NHS England has said.

PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.

I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.

Two words that make us mistrust Duke:  Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:

I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. 

(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

• Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
• Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:

When they're frothing at the mouth, even Atticus doesn't let them publish a review

A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.

(Emphasis mine.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:

In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.

I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.

There has been considerable noise coming out of the UK lately about successes in clinical trial enrollment.

First, a couple months ago came the rather dramatic announcement that clinical trial participation in the UK had "tripled over the last 6 years". That announcement, by the chief executive of the

Sweet creature of bombast: is Sir John writing press releases for the NIHR?

National Institute of Health Research's Clinical Research Network, was quickly and uncritically picked up by the media.

That immediately caught my attention. In large, global trials, most pharmaceutical companies I've worked with can do a reasonable job of predicting accrual levels in a given country. I like to think that if participation rates in any given country had jumped that heavily, I’d have heard something.

(To give an example: looking at a quite-typical study I worked on a few years ago: UK sites were overall slightly below the global average. The highest-enrolling countries were about 2.5 times as fast. So, a 3-fold increase in accruals would have catapulted the UK from below average to the fastest-enrolling country in the world.)

Further inquiry, however, failed to turn up any evidence that the reported tripling actually corresponded to more human beings enrolled in clinical trials. Instead, there is some reason to believe that all we witnessed was increased reporting of trial participation numbers.

Now we have a new source of wonder, and a new giant multiplier coming out of the UK. As the Director of the NIHR's Mental Health Research Network, Til Wykes, put it in her blog coverage of her own paper:

Our research on the largest database of UK mental health studies shows that involving just one or two patients in the study team means studies are 4 times more likely to recruit successfully.

Again, amazing! And not just a tripling – a quadrupling!

Understand: I spend a lot of my time trying to convince study teams to take a more patient-focused approach to clinical trial design and execution. I desperately want to believe this study, and I would love having hard evidence to bring to my clients.

At first glance, the data set seems robust. From the King's College press release:

Published in the British Journal of Psychiatry, the researchers analysed 374 studies registered with the Mental Health Research Network (MHRN).

Studies which included collaboration with service users in designing or running the trial were 1.63 times more likely to recruit to target than studies which only consulted service users.  Studies which involved more partnerships - a higher level of Patient and Public Involvement (PPI) - were 4.12 times more likely to recruit to target.

But here the first crack appears. It's clear from the paper that the analysis of recruitment success was not based on 374 studies, but rather a much smaller subset of 124 studies. That's not mentioned in either of the above-linked articles.

And at this point, we have to stop, set aside our enthusiasm, and read the full paper. And at this point, critical doubts begin to spring up, pretty much everywhere.

First and foremost: I don’t know any nice way to say this, but the "4 times more likely" line is, quite clearly, a fiction. What is reported in the paper is a 4.12 odds ratio between "low involvement" studies and "high involvement" studies (more on those terms in just a bit).  Odds ratios are often used in reporting differences between groups, but they are unequivocally not the same as "times more likely than".

This is not a technical statistical quibble. The authors unfortunately don’t provide the actual success rates for different kinds of studies, but here is a quick example that, given other data they present, is probably reasonably close:

• A Studies: 16 successful out of 20 
• Probability of success: 80% 
• Odds of success: 4 to 1
• B Studies: 40 successful out of 80
• Probability of success: 50%
• Odds of success: 1 to 1

From the above, it’s reasonable to conclude that A studies are 60% more likely to be successful than B studies (the A studies are 1.6 times as likely to succeed). However, the odds ratio is 4.0, similar to the difference in the paper. It makes no sense to say that A studies are 4 times more likely to succeed than B studies.

This is elementary stuff. I’m confident that everyone involved in the conduct and analysis of the MHRN paper knows this already. So why would Dr Wykes write this? I don’t know; it's baffling. Maybe someone with more knowledge of the politics of British medicine can enlighten me.

If a pharmaceutical company had promoted a drug with this math, the warning letters and fines would be flying in the door fast. And rightly so. But if a government leader says it, it just gets recycled verbatim.

The other part of Dr Wykes's statement is almost equally confusing. She claims that the enrollment benefit occurs when "involving just one or two patients in the study team". However, involving one or two patients would seem to correspond to either the lowest ("patient consultation") or the middle level of reported patient involvement (“researcher initiated collaboration”). In fact, the "high involvement" categories that are supposed to be associated with enrollment success are studies that were either fully designed by patients, or were initiated by patients and researchers equally. So, if there is truly a causal relationship at work here, improving enrollment would not be merely a function of adding a patient or two to the conversation.

There are a number of other frustrating aspects of this study as well. It doesn't actually measure patient involvement in any specific research program, but uses just 3 broad categories (that the researchers specified at the beginning of each study). It uses an arbitrary and undocumented 17-point scale to measure "study complexity", which collapses and quite likely underweights many critical factors into a single number. The enrollment analysis excluded 11 studies because they weren't adequate for a factor that was later deemed non-significant. And probably the most frustrating facet of the paper is that the authors share absolutely no descriptive data about the studies involved in the enrollment analysis. It would be completely impossible to attempt to replicate its methods or verify its analysis. Do the authors believe that "Public Involvement" is only good when it’s not focused on their own work?

However, my feelings about the study and paper are an insignificant fraction of the frustration I feel about the public portrayal of the data by people who should clearly know better. After all, limited evidence is still evidence, and every study can add something to our knowledge. But the public misrepresentation of the evidence by leaders in the area can only do us harm: it has the potential to actively distort research priorities and funding.

Why This Matters

We all seem to agree that research is too slow. Low clinical trial enrollment wastes time, money, and the health of patients who need better treatment options.

However, what's also clear is that we lack reliable evidence on what activities enable us to accelerate the pace of enrollment without sacrificing quality. If we are serious about improving clinical trial accrual, we owe it to our patients to demand robust evidence for what works and what doesn’t. Relying on weak evidence that we've already solved the problem ("we've tripled enrollment!") or have a method to magically solve it ("PPI quadrupled enrollment!") will cause us to divert significant time, energy, and human health into areas that are politically favored but less than certain to produce benefit. And the overhyping those results by research leadership compounds that problem substantially. NIHR leadership should reconsider its approach to public discussion of its research, and practice what it preaches: critical assessment of the data.
Ennis L, & Wykes T (2013). Impact of patient involvement in mental health research: longitudinal study. The British journal of psychiatry : the journal of mental science PMID: 24029538

Did that rock move, or is it a squirrel crossing the road? Tracking objects that look a lot like their surroundings is a big problem for many autonomous vision systems. AI algorithms can solve this camouflage problem, but they take time and computing power. A new camera designed by researchers in South Korea provides a faster solution. The camera takes inspiration from the eyes of a cat, using two modifications that let it distinguish objects from their background, even at night.

“In the future … a variety of intelligent robots will require the development of vision systems that are best suited for their specific visual tasks,” says Young Min Song, a professor of electrical engineering and computer science at Gwangju Institute of Science and Technology and one of the camera’s designers. Song’s recent research has been focused on using the “perfectly adapted” eyes of animals to enhance camera hardware, allowing for specialized cameras for different jobs. For example, fish eyes have wider fields of view as a consequence of their curved retinas. Cats may be common and easy to overlook, he says, but their eyes actually offer a lot of inspiration.

This particular camera copied two adaptations from cats’ eyes: their vertical pupils and a reflective structure behind their retinas. Combined, these allowed the camera to be 10 percent more accurate at distinguishing camouflaged objects from their backgrounds and 52 percent more efficient at absorbing incoming light.

Using a vertical pupil to narrow focus

While conventional cameras can clearly see the foreground and background of an image, the slitted pupils of a cat focus directly on a target, preventing it from blending in with its surroundings. Kim et al./Science Advances

In conventional camera systems, when there is adequate light, the aperture—the camera’s version of a pupil—is small and circular. This structure allows for a large depth of field (the distance between the closest and farthest objects in focus), clearly seeing both the foreground and the background. By contrast, cat eyes narrow to a vertical pupil during the day. This shifts the focus to a target, distinguishing it more clearly from the background.

The researchers 3D printed a vertical slit to use as an aperture for their camera. They tested the vertical slit using seven computer vision algorithms designed to track moving objects. The vertical slit increased contrast between a target object and its background, even if they were visually similar. It beat the conventional camera on five of the seven tests. For the two tests it performed worse than the conventional camera, the accuracies of the two cameras were within 10 percent of each other.

Using a reflector to gather additional light

Cats can see more clearly at night than conventional cameras due to reflectors in their eyes that bring extra light to their retinas.Kim et al./Science Advances

Cat eyes have an in-built reflector, called a tapetum lucidum, which sits behind the retina. It reflects light that passes through the retina back at it, so it can process both the incoming light and reflected light, giving felines superior night vision. You can see this biological adaptation yourself by looking at a cat’s eyes at night: they will glow.

The researchers created an artificial version of this biological structure by placing a silver reflector under each photodiode in the camera. Photodiodes without a reflector generated current when more than 1.39 watts per square meter of light fell on them, while photodiodes with a reflector activated with 0.007 W/m² of light. That means the photodiode could generate an image with about 1/200th the light.

Each photodiode was placed above a reflector and joined by metal electrodes to create a curved image sensor.Kim et al./Science Advances

To decrease visual aberrations (imperfections in the way the lens of the camera focuses light), Song and his team opted to create a curved image sensor, like the back of the human eye. In such a setup, a standard image sensor chip won’t work, because it’s rigid and flat. Instead it often relies on many individual photodiodes arranged on a curved substrate. A common problem with such curved sensors is that they require ultrathin silicon photodiodes, which inherently absorb less light than a standard imager’s pixels. But reflectors behind each photodiode in the artificial cat’s eye compensated for this, enabling the researchers to create a curved imager without sacrificing light absorption.

Together, vertical slits and reflectors led to a camera that could see more clearly in the dark and isn’t fooled by camouflage. “Applying these two characteristics to autonomous vehicles or intelligent robots could naturally improve their ability to see objects more clearly at night and to identify specific targets more accurately,” says Song. He foresees this camera being used for self-driving cars or drones in complex urban environments.

Song’s lab is continuing to work on using biological solutions to solve artificial vision problems. Currently, they are developing devices that mimic how brains process images, hoping to one day combine them with their biologically-inspired cameras. The goal, says Song, is to “mimic the neural systems of nature.”

Song and his colleague’s work was published this week in the journal Science Advances.

This article appears in the November 2024 print issue.

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

Breaking COVID-19’s chain of transmission requires effective physical distancing, contact tracing and rapid analyses of demographic data to reveal illness clusters and populations at high risk, such as people older than 65, Latinos and Blacks.

Sales of medically important antibiotics for use in food-producing animals increased 3% in 2019, according to recent data from the U.S. Food and Drug Administration. This is the second year in a row that the quantities of antibiotics sold for animal use have risen, underscoring the need for further FDA action to ensure judicious use of these lifesaving drugs.

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.

 We introduced a Topics tab in the online documentation a few releases ago, and there are corresponding pages in our focus area that briefly describe the topic areas and the procedures that perform analyses for those areas.

 This paper presents the essential information that you need to get started with ODS Graphics in SAS 9.4.

Johnson & Johnson must pay US$15 million (S$19.6 million) to a Connecticut man who alleges that he developed mesothelioma, a rare form of cancer, as a result of using the company's talc powder for decades, a jury found on Tuesday (Oct 15). Plaintiff Evan Plotkin sued the company in 2021 soon after his diagnosis, saying he was sickened by inhaling J&J's baby powder. The jury in Fairfield County, Connecticut Superior Court also found that the company should pay additional punitive damages, which will be determined later by the judge overseeing the case. "Evan Plotkin and his trial team are thrilled that a jury once again decided to hold Johnson & Johnson accountable for their marketing and sale of a baby powder product that they knew contained asbestos," Ben Braly, a lawyer for Plotkin, said in an email. Erik Haas, J&J's worldwide vice president of litigation, said in a statement that the company would appeal "erroneous" rulings by the trial judge that kept the jury from hearing critical facts about the case.

To mark Breast Cancer Awareness Month, we speak to inspiring Singaporeans about their journey in battling and overcoming cancer.  Warda Ismail gets anxious about things easily, especially when it comes to her health.  So much so that her doctor once told her that she is a "borderline hypochondriac", she shared with AsiaOne in an interview.  For the uninitiated, hypochondria is a condition where a person is excessively and unduly worried about having a serious illness. To keep her mind at ease, the 44-year-old preschool educator has the habit of going for regular medical checkups.  Though she was vigilant, her worst nightmare came true — she was diagnosed with breast cancer on May 8 this year.  And in the midst of her recovery journey, she got more terrible news — her mother, who had been caring for her, was diagnosed with stage-three gall bladder cancer.  Despite the string of unfortunate events, Warda persevered and tried to have a more positive outlook on life and her health. 

NEW YORK – Moves by major US fast-food chains to temporarily scrub fresh onions off their menus on Oct 24, after the vegetable was named as the likely source of an E. coli outbreak at McDonald’s, laid bare the recurring nightmare for restaurants: Produce is a bigger problem for restaurants to keep free of contamination than beef. Onions are likely the culprit in the McDonald’s E. coli outbreak across the Midwest and some Western states that has sickened 49 people and killed one, the US Department of Agriculture said late on Oct 23. The company pulled the Quarter Pounder off its menu at one-fifth of its 14,000 US restaurants. In past years, beef patties dominated the dockets of food-borne-illness lawyers, before US federal health regulators cracked down on beef contamination after an E. coli outbreak linked to Jack in the Box burgers hospitalised more than 170 people across states and killed four. As a result, beef-related outbreaks became much rarer, experts say.

NEW YORK — McDonald's on Sunday (Oct 27) ruled out beef patties as a source of the E. coli outbreak linked to Quarter Pounder hamburgers, which has killed at least one person and sickened nearly 75 others. "We remain very confident that any contaminated product related to this outbreak has been removed from our supply chain and is out of all McDonald's restaurants," the fast-food chain's chief supply chain officer Cesar Pina said in a statement. The Colorado Department of Agriculture said that all subsamples from multiple lots of McDonald's brand fresh and frozen beef patties had tested negative for E. coli, adding that it had completed beef testing and does not anticipate receiving further samples. McDonald's said it would resume distribution of fresh supplies of the Quarter Pounder and that it is expected to be available in all restaurants in the coming week, according to the statement.

The US Centers for Disease Control and Prevention said on Wednesday that slivered onions served on McDonald's, opens new tab Quarter Pounder hamburgers and other menu items were the likely source of an E. coli outbreak that sickened 90 people. The outbreak linked to Quarter Pounder was first reported on Oct 22, and slivered onions were suspected to be the source of the infections. The US Food and Drug Administration and the company have confirmed that Taylor Farms was the supplier for the affected locations, and it has since recalled several batches of yellow onions produced in a Colorado facility. The FDA on Wednesday said it had initiated inspections at a Taylor Farms processing center in Colorado, a state where 29 people have fallen ill due to the outbreak. An onion grower of interest in Washington state is also being investigated, the FDA added. The CDC said the number of infected people has risen by 15 people from 75 and 27 persons have been hospitalised due to the illness, which has already killed one person.

David Duchovny and Gillian Anderson didn't speak to each other for "weeks at a time" when they worked on The X Files. The 64-year-old actor and Gillian, 56, enjoyed huge success with the iconic sci-fi series — but the duo actually had a turbulent relationship for many years. David said on the Fail Better podcast: "There was a long time, working on the show, where we were just not even dealing with one another off-camera. And there was a lot of tension. Which didn't matter, apparently, for the work cause we're both f****** crazy, I guess. We could just go out there and do what we needed to do." Gillian was amazed that they achieved so much success while their off-screen relationship was so tense.

Michelle Yeoh had never heard of Wicked before she was asked to join the cast of the movie-musical. The Oscar-winning actress plays Madame Morrible in the new film version of the hit stage show, which is based around characters first seen on screen in 1939 movie The Wizard of Oz. She's confessed she knew nothing about the popular musical before she was approached by director Jon M. Chu about joining the cast. According to The Hollywood Reporter, she said: "At that point, I had no clue what he was talking about because I had not seen Wicked the musical before. I knew Wizard of Oz, who doesn't, but not Wicked because I hadn't been going to the theatres and was not doing what I love which is watching musicals for quite a while, I hate to say." The new movie stars Cynthia Erivo as Elphaba and Ariana Grande as Glinda during their time at Shiz University in the Land of Oz with Michelle's character Madame Morrible serving as the school's headmistress. Michelle went on to say: "So I read it [the script] and called Jon back and said, 'This is a musical and she sings'. And he said, 'Oh easy, you'll have fun, you're up for the challenge.'

Monday blues were non-existent at the Singapore Indoor Stadium yesterday (Nov 11) as fans of Blackpink's Lisa strolled into the venue in their Y2K-style outfits inspired by the Thai singer's Rockstar music video. Singapore was the first stop for the 27-year-old's first solo fan-meet tour and needless to say, the excitement could be felt, and heard. Once the lights turned off and Lisa appeared, the screams were deafening. The show started with a bang, fittingly with her self-titled hit song Lalisa. Usually at fan-meets of K-pop idols, the special effects are kept to a minimum unlike concerts. PHOTO: UnUsUaL Entertainment But at Lisa's, the performances were elevated with bursts of pyrotechnics and visual effects. After the first song, she sat down for a few interactive segments. During Welcome Lisa, she tried local delicacies like kaya toast and chicken rice.

Armie Hammer's mom got him a vasectomy for his birthday. The Call Me by Your Name actor — who has two children, Harper, nine, and Ford, seven, with his ex-wife Elizabeth Chambers — has revealed the bizarre gift Dru Hammer got him for his 38th birthday in August. Speaking to his mom on the second episode of a two-part chat on his new podcast Armie HammerTime Podcast, she said: "Let's talk about what I gave you for your birthday this year." She continued: "I call Armie, and I go, 'What would you like for your birthday this year?' He was like, 'I don't know. Maybe money. Whatever.' And I was like, 'I believe I'm going to give you a vasectomy.'"

South Korean actor Song Jae-rim died yesterday (Nov 12) at the age of 39. The Seongdong Police Station in Seoul confirmed that he was found deceased in his apartment at around 12.30pm. According to media reports, a friend whom he was supposed to meet for lunch had visited his home and reported the death. A two-page letter was reportedly found at the scene but the cause of death has not been confirmed. A police official, however, stated that there are "no signs of foul play". His wake was held at Yeouido St. Mary’s Hospital Funeral Hall at 5.30pm yesterday. His funeral will be held tomorrow at Seoul City Crematorium. Jae-rim gained popularity after starring in the 2012 drama The Moon Embracing the Sun and the 2014 reality series We Got Married. This year, he starred in two dramas — My Military Valentine and Queen Woo. Following news of his death, comedian Hong Seok-cheon and other celebrities posted tributes to Jae-rim on social media.

TORONTO — A teenager is in critical condition in a British Columbia children's hospital, sick with Canada's first presumptive human case of avian influenza. "This was a healthy teenager prior to this, so no underlying conditions," said provincial health officer Bonnie Henry in a news conference on Tuesday (Nov 12). "It just reminds us that in young people this is a virus that can progress and cause quite severe illness and the deterioration that I mentioned was quite rapid." British Columbia health officials said on Saturday the province had detected Canada's first human case of H5 bird flu in a teenager.

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.

Donald Trump has begun the process of choosing a cabinet and selecting other high-ranking administration officials following his presidential election victory. Here are the early picks and top contenders for some of the key posts overseeing defence, intelligence, diplomacy, trade, immigration and economic policymaking. Some are in contention for a range of posts. Susie Wiles, chief of staff Susie Wiles reacts as Republican presidential nominee and former US President Donald Trump speaks, following early results from the 2024 US presidential election in Palm Beach County Convention Center, in West Palm Beach, Florida, US on Nov 6, 2024. PHOTO: Reuters Trump announced last week that Wiles, one of his two campaign managers, will be his White House chief of staff.

The Public Service has expressed its commitment to implementing flexible work arrangements (FWAs) for its employees, taking into account the workforce's changing needs. In a written answer to a Parliamentary question posed by Choa Chu Kang GRC MP Zhulkarnain Abdul Rahim on Monday (Nov 11), Minister-in-charge of the Public Service Chan Chun Sing said the Government recognises the growing need for FWAs, given Singapore's demographic changes and its ever-changing demands on Singaporeans. Zhulkarnain had asked whether the Civil Service will continue to support flexible working arrangements despite some companies in the private sector requiring employees to work from the office five days a week. Grab Singapore, for example, said it will enforce its five-day return-to-office mandate starting Dec 2, reported CNA. Referencing the Tripartite Guidelines on FWA Requests (TG-FWAR), which will be enforced starting Dec 1, Chan stressed the importance of such arrangements in supporting working caregivers, encouraging workforce re-entry, sustaining labour force participation, and attracting and retaining talent.

As a group of friends circled a hearse, chants were heard. Then, they stopped and bowed to the portrait displayed at the front of the vehicle. This was not a typical Buddhist funeral, but rather the unconventional birthday celebration of a funeral director, reported Shin Min Daily News. According to the Chinese evening daily, a video circulating online showed the friends chanting a birthday song. The hearse's interior had been decorated with balloons and a birthday banner, with the man even laying inside for photos. The clip garnered criticism from netizens, with some deeming it overboard and disrespectful to the funeral industry. In an interview with Shin Min, director of Xin An Funeral Services Chen Weisong (transliteration) explained that he had celebrated his birthday at the company's premises with his friends and family last week. Halfway through the performances by singers, his employees and business partners had surprised him with the birthday-themed hearse bearing his portrait. Chen told 8world he was not angry and did not think it was taboo. "I was too embarrassed to turn down their gesture," he said. 

SINGAPORE - When an online retailer began selling his products on e-commerce platform Qoo10 in August 2023, he did not bat an eyelid when it took 30 to 45 days for the platform to disburse his first payout, compared with about three to seven days for other e-commerce sites he was using. But nearly a year later in July, payments owed to his business by Qoo10 had ballooned to about $1.6 million, as the platform’s payment delays exceeded two months and disbursements began trickling in, in smaller amounts. The Singaporean, who wanted to be known only as Mr T and did not wish to divulge what he sold, pulled the plug on his Qoo10 shop this year in the middle of July, and filed a civil claim with the courts. He obtained a default judgment in October for Qoo10 to pay him what he is owed, after the e-commerce site failed to serve a notice of intention to contest or not contest the claim. Mr T, who added that he had borrowed nearly $1 million from banks, friends and relatives to pay his suppliers, said: “I am not holding out hope that I will get much, or any, of my money back from Qoo10... By this point, I just want closure because it’s been so stressful.”

Singapore Telecommunications (SingTel) reported a 42 per cent fall in its half-year profit on Wednesday (Nov 13), as the firm was hurt by the absense of S$1.2 billion it had logged through the divestiture of Telkomsel shares in its prior corresponding period. Last year, Telkomsel, the Indonesian associate of Southeast Asia's largest telecom firm, agreed to merge with its parent's IndiHome broadband arm in an effort to expand into Indonesia's fixed broadband market. SingTel's Australian unit Optus, currently embroiled in a legal battle with the country's competition watchdog, reported operating revenue of A$4.02 billion (S$3.51 billion) during the six months, in line with A$4.02 billion reported a year ago. "Optus and NCS drove the positive momentum, underscoring our focus on execution and operating rigour," the group's Chief Executive Officer Yuen Kuan Moon said. Southeast Asia's largest telecom firm said net profit for the six months ended Sept. 30 was S$1.23 billion, as compared to S$2.14 billion last year and missing a Visible Alpha estimate of S$1.37 billion.

In July 2024, internet personality Bobby Saputra posted a video of himself living it up at what appeared to be the star-studded, ultra-lavish wedding of Radhika Merchant and Anant Ambani, the youngest child of Indian billionaire and Asia's richest man, Mukesh Ambani. The video featured clips of Saputra dancing, feasting and soaking up the "completely crazy" celebrations. He gushes in the voiceover: "It was like watching a Bollywood production." The video quickly went viral, racking up 6.6 million views on Instagram, 5.1 million on TikTok, and another 2.2 million on YouTube. Thousands left comments, including some celebrities who claimed they spotted him there. Except… he never set foot in the party. As it turns out, he had pieced together clips from a wedding he attended a few months prior — complete with him in full Indian attire, dancing with friends — and spliced in shots from the Ambani wedding that he found online. The result? Social media magic.

KOLKATA — A court in the eastern state of West Bengal began the trial on Monday (Nov 11) of a police volunteer accused of raping and murdering a doctor at a government hospital in August, a case that sparked outrage over the lack of safety for women in India. The woman's body was found in a classroom at the R.G. Kar Medical College and Hospital in the state capital Kolkata on Aug 9, the federal police said. They also said they had arrested a police volunteer, Sanjay Roy, for the crime.

SEOUL — South Korean President Yoon Suk-yeol recently began practising golf, for the first time in eight years, in preparation for future meetings with US President-elect Donald Trump, Yoon's office confirmed on Tuesday (Nov 12). South Korean media said Yoon visited a golf course on Saturday for a sport his office said he had last played in 2016. "A lot of people close to President Trump... (told me) President Yoon and Trump will have good chemistry," Yoon told a press conference on Thursday, after congratulating Trump by telephone on his win. Former Trump administration officials and influential Republicans had offered to help build ties with the incoming president, he added. Analysts said Yoon may seek to find a way to capitalise on a personal friendship with Trump to advance Seoul's interests as Trump's "America First" foreign policy plans and his unpredictable style play out in his second term. South Korean companies rely heavily on trade with the United States, and during Trump's first term, the countries clashed over cost-sharing for the roughly 28,500 US troops stationed in South Korea as a legacy of the 1950-1953 Korean War.

CANBERRA — China is putting ever-greater pressure on the Philippines to cede its sovereign rights in the South China Sea, Secretary of National Defence Gilberto Teodoro said on Nov 12 after a meeting with his Australian counterpart in Canberra. "What we see is an increasing demand by Beijing for us to concede our sovereign rights in the area," he said, adding that the Philippines was a "victim of Chinese aggression". China and the Philippines have sparred repeatedly this year over disputed areas of the South China Sea, including the Scarborough Shoal, one of Asia's most contested features. Teodoro's meeting with his Australian counterpart Richard Marles, their fifth since August 2023, reflects growing security ties between the countries, both of whom have expressed concern about Chinese activity in areas of the South China Sea claimed by the Philippines and other Southeast Asian nations. The two nations signed a strategic partnership in September 2023 and held their first joint sea and air patrols in the South China Sea several months later. The Philippines also joined war games in Australia this year for the first time.

ISLAMABAD — The International Monetary Fund's Pakistan mission chief Nathan Porter on Tuesday (Nov 12) opened unusual talks with Pakistan over a US$7 billion (S$9.4 billion) bailout approved by its board in September, the finance ministry and sources said. The unscheduled visit of the IMF mission and talks beginning with meeting the country's finance team are too early for first review of the IMF's Extended Fund Facility (EFF), which is due in the first quarter of 2025. The chiefs of Pakistan's central bank and federal board of revenue also attended the meeting besides other officials from both the sides, the statement said. The ministry and the IMF have not officially released details of the visit. Sources in the finance ministry said the Nov 11-15 visit will discuss recent developments and programme performance to date, adding the mission was not part of the first review. The sources declined to be identified as they were not authorised to speak with the media. Pakistan has been struggling with boom-and-bust economic cycles for decades, leading to 23 IMF bailouts since 1958.

Feb 10, 2024

Assaf Zoran argues that it is crucial to hold Iran accountable and convey the cost associated with arming, training, financing, and promoting violence through proxies.