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Day: November 14, 2023

Health equity and trial diversity questions still not answered by pharma

While global players are more aware of health equity problems across the world, there are still lingering problems, according to Access to Medicine Foundation CEO Jayasree Iyer.

Speaking at the panel discussion ‘Health Equity – How Can Pharma Make a Difference?’ on the last day of the FT Global Pharma and Biotech Summit in London, UK, Iyer highlighted that commercial and access incentives need to be put together to improve health equity.

Seyda Atadan Memis, general manager of the UK and Ireland at Takeda, noted that while focusing on patients and building trust is crucial, it is also important to address affordability questions in each country.

Memis also said that health equity goes along with ethical considerations inside clinical trials. Takeda has translated its clinical trial guidelines into multiple languages for potential participants and caregivers to improve diversity and representation.

Clinical Trials Arena has previously reported on the importance of including patients from racially diverse backgrounds, improving female representation in early-stage studies, and the inclusion of the pregnant population and patients with cognitive disabilities.

Even though data plays a crucial role in the drug development process, it may also affect diversity. Liz Hampson, executive director of Europe at Deloitte Health Equity Institute, explained that biased data used to pick which products should enter clinical trials will influence what cohorts are enrolled into trials.

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Apresiasi UU Kesehatan untuk Kegiatan Usaha dan Investasi

Rokok elektrik, yang dikenal juga dengan nama vape, saat ini merupakan bagian yang tidak terpisahkan dari keseharian jutaan orang di seluruh dunia, termasuk juga di Indonesia. Saat ini, dengan mudah kita bisa menemukan berbagai pengguna vape di banyak tempat, dan juga toko-toko yang menjual produk-produk rokok elektrik dari berbagai merek.

Semakin meningkatnya pengguna vape di Indonesia ini tentu merupakan hal yang sudah menjadi rahasia umum. Pada tahun 2021 lalu misalnya, jumlah pengguna vape di Indonesia hanya sebesar 0,3% dari seluruh penduduk di tanah air. Angka ini meningkat drastis menjadi 10 kali lipat pada tahun 2021menjadi 3% (republika.co.id, 31/5/2022).

Dengan semakin meningkatnya jumlah pengguna vape, tentu membuat industri produk ini menjadi semakin berkembang dengan pesat, dan menyerap semakin banyak tenaga kerja. Saat ini, diperkirakan ada sekitar 150.000 – 200.000 pekerja yang diserap oleh industri vape (jawapos.com, 1/6/2023).

Angka ini tentu bukan jumlah yang sedikit, dan sangat penting untuk diperhatikan oleh pemerintah. Selain itu, semakin meningkatnya jumlah pengguna vape, dan juga tenaga kerja yang bekerja di sektor industri tersebut, tentunya juga membuat sumbangan kepada negara menjadi meningkat. Pada tahun 2022, diperkirakan sumbangan cukai industri vape kepada negara mencapai angka 1,02 triliun rupiah (vapeboss.co.id, 7/7/2023).

Di sisi lain, semakin besarnya industri vape di Indonesia, dan juga fenomena peningkatan pangguna vape di tanah air, juga menimbulkan pro dan kontra. Tidak sedikit pihak-pihak yang mengutarakan pandangan yang negatif terhadap fenomena tersebut, dan menganggap vape merupakan produk yang sangat berbahaya bagi kesehatan sama seperti rokok konvensional yang dibakar.

Padahal, beberapa lembaga kesehatan publik dari luar negeri sudah mengeluarkan laporan yang menyatakan vape merupakan produk yang lebih tidak berbahaya bila dibandingkan dengan rokok konvensional yang dibakar. Penting dicatat bahwa, 95% lebih tidak berbahaya ini bukan berarti tidak ada dampak negatif sama sekali dari produk tersebut. Melainkan bahwa, tingkat bahaya produk tersebut jauh lebih rendah bila dibandingkan dengan rokok konvensional.

Lembaga kesehatan asal Inggris, Public Health England (PHE) misalnya, pada tahun 2015 lalu menyatakan bahwa, vape 95% lebih tidak berbahaya bila dibandingkan dengan rokok konvensional yang dibakar. Dengan demikian, rokok elektrik atau vape merupakan produk yang bisa digunakan sebagai alat untuk membantu para perokok untuk berhenti merokok (theguardian.com, 28/12/2018).

Untuk itu, dibutuhkan serangkaian kebijakan regulasi yang tepat agar upaya untuk mengurangi konsumsi rokok di Indonesia dapat tercapai, dan tidak kontraproduktif. Hal yang patut diperhatikan tidak hanya dalam aspek kesehatan publik saja, tetapi juga aspek ketenagakerjaan, mengingat bahwa industri vape meruapakn salah satu sektor industri yang telah menyerap ratusan ribu lapangan kerja.

Beberapa waktu yang lalu, Dewan Perwakilan Rakyat (DPR) mensahkan Undang-undang No. 17 tahun 2023 tentang Kesehatan. Dalam undang-undang tersebut, terdapat poin yang mengakomodir dan memberikan kepastian hukum terhadap industri dan juga produk-produk rokok elektrik.

Undang-undang tersebut menggolongkan vape sebagai salah satu produk tembakau padat dan cair. Dengan adanya kepastian hukum tersebut, tentu hal ini merupaakn berita yang baik bagi industri vape di Indonesia, dan juga sangat membantu para perokok yang ingin berhenti merokok melalui produk rokok elektrik.

Selain memberikan kepastian hukum, UU tesebut juga membuat serangkaian regulasi yang ditujukan untuk mengatur peredaran produk-produk vape yang dijual dan dikonsumsi di Indonesia. Beberapa diantaranya adalah hanya orang dewasa yang secara legal bisa membeli dan menggunakan rokok elektrik. Hal ini tentu merupakan sesuatu yang penting, mengingat vape merupakan produk yang dibuat untuk digunakan orang dewasa, dan bukan anak-anak.

Adanya kepastian hukum dan juga regulasi produk-produk rokok elektrik di Indonesia dalam UU tersebut juga disambut baik oleh pelaku usaha industri vape, diantaranya adalah Aliansi Pengusaha Penghantar Nikotin Elektronik Indonesia (APPNINDO) dan Asosiasi Ritel Vape Indonesia (ARVINDO). 

APPNINDO menyatakan bahwa dimasukkanya produk vape ke dalam UU tersebut akan mempermudah pelaku industri untuk berinvestasi dan melakukan kegiatan usaha. 

Selain itu, ARVINDO mengapresiasi adanya regulasi vape dalam UU tersebut, dan berkomitmen untuk menindak tegas para pelaku usaha vape yang menjual produk tersebut kepada anak di bawa umur (vuva.co.id, 31/8/2023).

Adanya kepastian hukum dan juga regulasi vape di Indonesia tentu merupakan sesuatu yang sangat penting, mengingat tingginya jumlah perokok aktif di Indonesia, dan juga banyaknya pekerja yang mencari nafkah melalui industri tersebut. 

Dengan adanya kepastian hukum, para perokok di Indonesia bisa memiliki opsi lebih banyak yang dapat membantu mereka untuk berhenti merokok, dan para pelaku usaha juga bisa menjalankan usaha mereka dengan aman.

Diharapkan, dengan adanya kepastian hukum tersebut, akan semakin banyak para perokok aktif yang terbantu di Indonesia untuk menghentikan kebiasaan merokoknya dan beralih ke produk lain yang lebih tidak berbahaya. Dengan demikian, kesehatan publik di Indonesia akan semakin baik.

Originally published here

Remédier au manque de nourriture grâce au marché libre

Légaliser le génie génétique est une bonne nouvelle pour tout le monde.

L’Union européenne prépare la légalisation du génie génétique pour l’utilisation dans l’agriculture. Dans un rapport datant de 2021, la Commission européenne a conclu que la législation actuelle sur les OGM n’était pas adaptée à l’édition de gènes et qu’elle freinait le développement de cultures innovantes. Analysons comment cette décision a été prise et ce qu’elle signifie pour les agriculteurs et les consommateurs.

Les règles existantes en matière de génie génétique dans l’agriculture remontent à 2001, avec la « directive OGM » de l’Union européenne. Bien qu’elle ne soit pas totalement interdite, cette législation a eu pour effet que, dans la pratique, presque aucun OGM (OGM n’est pas un terme scientifique mais, pour les besoins du débat public, c’est celui que nous utiliserons ici) n’est cultivé en Europe. En fait, seuls deux pays, l’Espagne et le Portugal, cultivent du maïs BT, un vieil OGM répulsif pour les insectes.

Lorsque le génie génétique est devenu disponible, la question s’est posée de savoir si cette nouvelle technologie était la même que celle utilisée pour créer les OGM. La réponse est non : le génie génétique est utilisé pour apporter des modifications au matériel génétique natif. Contrairement aux OGM, qui introduisent de nouvelles configurations de matériel génétique généralement dérivé d’autres organismes, le génie génétique modifie le matériel génétique existant de manière à obtenir des résultats bénéfiques.

Toutefois, ce n’est pas l’interprétation que la Cour européenne de justice a autorisée. Dans un arrêt rendu en 2018, la CJUE a estimé que les OGM et les cultures génétiquement modifiées constituaient une seule et même chose et devaient donc être réglementés de la même manière. Cela signifie que les cultures génétiquement modifiées au moyen des technologies CRISPR-Cas9 – une technologie co-développée par la scientifique française Emmanuelle Charpentier, lauréate du prix Nobel – ne sont toujours pas disponibles en Europe, même si elles ont été utilisées en toute sécurité aux Etats-Unis, au Canada et au Brésil.

Pourquoi cela est-il important ? Tout d’abord, il convient de s’interroger sur le principe de ce règlement. Les scientifiques ont mis au point une technologie dont l’utilisation est sans danger et qui est souhaitée par les producteurs ; il est donc difficile de comprendre en vertu de quel droit les régulateurs empêchent son autorisation.

Mais surtout, le génie génétique est une technologie passionnante et nécessaire. Il permet de réduire l’utilisation de ressources telles que les engrais ou l’eau, il peut résister aux parasites, ce qui réduit les besoins en pesticides, et il peut tenir compte des allergies des consommateurs. Des chercheurs européens ont déjà mis au point du blé et des noix sans gluten qui ne provoquent pas de réactions allergiques chez les personnes allergiques aux noix.

L’un des effets très positifs de cette technologie, également lié à la réduction de l’utilisation des ressources, est la nécessité d’utiliser moins de terres pour atteindre la même quantité de production. Très souvent, les défenseurs de l’environnement affirment que ce n’est pas la quantité de nourriture que nous produisons qui pose problème, mais sa distribution. Ils ont partiellement raison, l’Europe n’a pas de problème de manque de nourriture, alors que l’Afrique a un problème de disponibilité et d’accessibilité de la nourriture. Cela dit, étant donné que la population mondiale ne cesse d’augmenter, nous devons également réfléchir à la manière d’accroître notre production alimentaire globale.

La réduction de la superficie des terres nécessaires à la production alimentaire a un autre effet positif : elle stimule la biodiversité. L’abattage des forêts pour produire de la nourriture a des effets négatifs évidents sur notre écosystème. C’est ainsi que l’humanité a malheureusement menacé certaines espèces et que des pays comme le Brésil réduisent la taille de la forêt amazonienne pour accroître ses capacités agricoles. Avec le développement du génie génétique, nous verrons également une réduction des terres nécessaires, ce qui signifie que nous n’aurons pas besoin d’utiliser plus de terres pour nourrir plus de gens. Telle est, en substance, la caractéristique fascinante du marché libre : faire plus avec moins et, ce faisant, améliorer le niveau de vie de chacun.

A titre de référence, des chercheurs de l’université de Stanford ont découvert que si nous pratiquions la même agriculture qu’il y a 60 ans, il faudrait défricher une superficie égale à la totalité de la Russie, soit trois fois la taille de l’Amazonie et quatre fois celle de l’Union européenne, pour y installer des forêts et des habitats naturels et les transformer en production agricole. En outre, l’agriculture à haut rendement a permis d’éviter 161 gigatonnes de dioxyde de carbone depuis 1961, tandis que des recherches menées au Royaume-Uni ont montré que le passage de l’ensemble de l’agriculture actuelle à l’agriculture biologique entraînerait une augmentation des émissions de gaz à effet de serre pouvant aller jusqu’à 70%.

Cela montre que les militants qui s’opposent au génie génétique au motif que notre système agricole était meilleur dans le passé se trompent tout simplement.

La proposition présentée par la Commission européenne n’est pas parfaite. Davantage de variétés devraient être mises à disposition et les agriculteurs du secteur bio devraient également avoir accès aux nouvelles techniques de sélection. Cela dit, il s’agit d’un pas important vers la prise en compte par Bruxelles des réalités scientifiques de ce siècle.

Biden’s Plan for ‘Digital Equity’ Will Soon Lead to Government  Micromanaging ‘Nearly Every Aspect’ of the Internet, FCC Commissioner Warns

‘In the guise of “digital equity,” President Biden has called for the FCC to exercise a degree of control over Internet services and infrastructure that we have never seen before,’ an FCC commissioner tells the Sun.

The Biden administration may soon implement sweeping regulations that would give it control of the internet, analysts are warning ahead of the Federal Communications Commission’s November 15 vote on the proposed rules. 

“In the guise of ‘digital equity,’ President Biden has called for the FCC to exercise a degree of control over Internet services and infrastructure that we have never seen before,” an FCC commissioner, Brendan Carr, tells the Sun in an email. 

“It will give the Administrative State the power to micromanage nearly every aspect of how the Internet works,” he adds. “These types of command and control regulations will only make it harder for Internet infrastructure and services to be built out and could make our networks look more like the sluggish networks that consumers in Europe have to deal with.”

The Democratic-controlled FCC says the new rules would “prevent discrimination in access to broadband services based on income level, race, ethnicity, color, religion, and national origin.”

“We recognize that the ultimate goal of this proceeding is to facilitate equal access to broadband just as the law says,” the FCC chairwoman, Jessica Rosenworcel, says. 

Read the full text here

A Nuclear Renaissance Is the Best Path Forward

For decades, the fruits of the fracking revolution, plus our newly minted status as the world’s top net exporter of natural gas, demonstrated that American consumers were swimming in bountiful energy.

But as the pandemic effects of supply chain shortages, the war in Ukraine, and higher government spending gave way to inflation hikes, suddenly all eyes were on utility bills. In 2021, Americans spent as much as 25% more on energy than in the previous year.

Compounding that problem for energy consumers are political pledges aimed at the “electrification of everything,” including massive subsidies for electric vehicles, home heat pumps, and solar panels in pursuit of a carbon neutral future.

Now state policies are accelerating that, as at least 22 states — plus Puerto Rico and Washington, D.C. — have committed to either 100% carbon-free electricity generation or “net zero” carbon emissions by 2050.

But rather than subsidize our way toward political climate goals with foreign-made solar panels, batteries, and wind turbines, what if we looked to the new generation of a safe technology that is already the densest and carbon-free source of electricity in the world? What if it’s time to once again champion nuclear energy?

Energy investors, customers, and even green politicians should have every reason to love the atom. Nuclear energy is safe, clean, and reliable for decades. It produces no emissions and produces tens of thousands of good jobs for generations. There’s a reason nuclear plants have larger parking lots than wind turbines or solar farms.

At least three states — Illinois, New Hampshire, and South Carolina — currently generate over 50% of their electricity needs from nuclear power, making them effectively carbon neutral and an ideal hub for energy-intensive industry. 

Even green warrior California Gov. Gavin Newson was forced to rethink the closing of Diablo Canyon in the face of aggressive climate goals, giving the state’s only nuclear plant a lifeline. Other states are reconsidering nuclear energy as their licenses head toward their expiration date.

That said, traditional nuclear energy faces several obstacles. Environmental and radiation concerns are invoked, though new innovations like accident-tolerant fuels have lessened the risk. Regulatory restrictions and permitting can delay approvals and renewals for up to a decade. Most importantly, nuclear projects are significantly labor and capital intensive, testing the financial limits of private investors and utilities who dip into subsidies to stay afloat.

But the age of the brutalist concrete cooling towers and highly centralized state control as the only features of nuclear power may already be over.

Next-generation nuclear energy technology — such as small modular reactors — may share the splitting of the atom with its predecessor, but its modern form is anything but.

SMRs can be as small as an SUV but still produce plenty of megawatts of energy. They can more quickly and reliably deliver power to the electric grid or industry, and in some cases, the spent fuel can be reused. SMRs could become the main carbon-free power source for a large manufacturing facility that would employ thousands of people and keep the load off residential grids. 

For example, SMR developer X-energy is collaborating with chemical giant Dow to install  an advanced SMR nuclear plant at Dow’s manufacturing site in Seadrift, Texas. The Dow project is focused on providing its Seadrift site with safe, reliable, zero carbon emissions power and industrial steam as existing energy and steam assets near their end-of-life.

The project is contingent upon delivering on various reviews and approvals, as companies like Dow must follow strict timeframes to ensure continued operation of its site. X-energy first initiated NRC pre-application activities for their Xe-100 reactor in 2018.

Only one small modular reactor design, made by Oregon-based NuScale, has been certified by the National Regulatory Commission, which released its final rulemaking after a decade-long application process.

If we want to deliver energy at scale and at a low cost for millions of energy consumers, that pace will have to move to a warp speed timeline.

There are simple solutions that could save us time. Every state with an expiring nuclear license should consider supporting plant life extensions. States with anti-nuclear statutes should rethink their implications. Where possible, states should include nuclear and fusion technology within “clean energy” definitions, as North Carolina seems poised to do. The NRC should continue its steadfast efforts in reducing regulatory burdens to fast-track reviews and permits for new nuclear while still keeping a laser focus on safety.

Rather than closing coal plants without alternatives, states should quickly allow experienced project proponents to convert those facilities into nuclear stations. The US Department of Energy estimates that over 80% of the country’s existing coal plants could be cheaply converted into SMRs or advanced nuclear reactors, saving up to 35% in infrastructure costs while reducing emissions for decades. Roadmaps already exist to convert coal plant jobs to next-generation nuclear jobs.

This would represent billions in savings to energy customers, hundreds of thousands more good-paying jobs, and unlimited opportunities for innovators to unleash the next generation of nuclear power technology both domestically and as a global export.

Politicians and regulators have created the paradigm of a net zero world. Nuclear energy will enable that and provide prosperity, resilience, and sustainability that will keep us energy independent. 

It’s time we recognize nuclear energy’s vital role and champion it as a force for good in our world.

Originally published here

Biden’s AI “Collaboration” With Europe Will Hurt Innovation

Last week, President Joe Biden unveiled an executive order that marks the beginning of a U.S. regulatory path for artificial intelligence. The order is a prelude to forming a U.S. AI Safety Institute, housed within the Department of Commerce—announced by Vice President Kamala Harris in the UK last week. This period of “close collaboration” with the UK and EU is a considerable threat to decades of American leadership in tech.

Rather than embracing traditional hallmarks of American innovation, the Biden administration seems intent on importing some of the worst aspects of Europe’s fear-driven and burdensome regulatory regime. If the current approach continues, AI innovation will be smothered, overly surveilled, and treated as guilty until proven innocent. 

Two distinct worlds are taking shape on each side of the Atlantic regarding the future of artificial intelligence and its benefits.

The first is one with cutting-edge competition between large language model developers, open-source software coders, and investors tooling the best practical applications for AI. This comprises ambitious startups, legacy Big Tech companies, and every major global corporation looking for an edge. As anyone can guess, a high percentage of early movers in this category are based in the United States, with close to 5,000 AI startups and $249 billion in private investment. This space is hopeful, energetic, and forward-looking.

The second world, languishing behind the first, is characterized by bureaucracy, intense approval processes, and permitting. The predominant mindset around AI is threat mitigation and a fixation on worst-case scenarios from which consumers must be saved. 

Europe is that second world, guided by the nervous hand of its Commissioner for Internal Market, Thierry Breton, a key foe of American tech firms. Breton is the face of two sweeping digital EU lawsthat place additional burdens on tech firms hoping to reach European consumers. 

On AI, Breton’s distinctly European approach is entirely risk and compliance-based. It requires that generative AI products, such as images or videos, are slapped with labels, and specific applications must undergo a rigorous registration process to determine whether the risk is unacceptable, high, limited, or minimal.

This process will prove restrictive to an AI industry that is constantly changing and ensure that tech incumbents will have a compliance advantage. EU regulators are accustomed to dealing with the likes of Meta and Google and have established some precedent for subordinating these high-flying American companies. 

It’s a convoluted system that EU bureaucrats are happy to champion. They adopt burdensome rules before the industries even exist, with the hope of maintaining a certain status quo. As a result, Europe lags far behind the investment and innovation taking place in the United States and even China. 

At present, the United States hosts a significant portion of the AI industry—whether it be Meta and Microsoft’s open-source large language model known as LLAMA, OpenAI’s Chat-GPT and DALL-E products, as well as Midjourney and Stable Diffusion. This is not a fluke or bug in the international order of tech innovation. America has a specific ethos around entrepreneurial risk-taking, and its regulatory approach has historically been reactive.

While President Biden could have taken that as a signal that a light touch is needed, he has instead taken the European route of “command and control,” a way that may prove even more expansive.

For instance, Biden’s executive order invokes the Defense Production Act, a wartime law designed to help bolster the American homefront in the face of grave outside threats. Is AI already classified as a threat?

Using the DPA, Biden requires that all companies creating AI models must “notify the federal government when training the model, and must share the results of all red-team safety tests.” Like the European risk system, this means firms will have to constantly update and comply with regulators’ demands to ensure safety.

More than increasing compliance costs, this would effectively lock out many startups who wouldn’t have the resources to report how they’re using models. Larger, more cooperative firms would swoop in to buy them out, which may be the point.

Andrew Ng, a co-founder of Google’s early AI project, recently told the Australian Financial Review that many incumbent AI companies are “creating fear of AI leading to human extinction” to dominate the market by directing regulation to keep out competitors. Biden appears to have bought that line.

Another aspect that threatens existing development is that all firms creating models must report their “ownership and possession.” Considering Meta’s LLAMA, the largest model produced thus far is written as open-source software, it is difficult to see how this could be enacted. This puts the open-source nature of much of the early AI ecosystem in jeopardy.

Is any of this truly necessary? Singapore, which has a nascent but rising AI industry, has opted for a hands-off approach to ensure innovators create value first. In the early days of Silicon Valley, this was the mantra that turned the Bay Area into a global beacon for tech innovation. 

This impetus to regulate is understandable and follows Biden’s ideology. But if Washington takes the Brussels approach, as it seems to be doing now, it will risk innovation, competition, and the hundreds of billions in existing AI investments. And it could be precisely what the incumbent big players want.

Congress should step up and rebuff Biden’s “phone and pen” approach to regulating a growing industry. 

To ensure American leadership on AI, we must embrace what makes America unique to the innovators, explorers, and dreamers of the world: a risk-taking environment grounded in free speech and creativity that has delivered untold wealth and surplus value for consumers. Taking our cues from European superregulators and tech-pessimists is a risk we can’t afford.

Originally published here

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