Healthcare

Gene Editing, Pandemi Corona, dan Perlindungan Hak Paten

Ketika Anda mendengar istilah gene editing, apa yang terlintas di benak Anda?

Ada kemungkinan, hal pertama yang terlintas di pikiran Anda adalah berbagai pahlawan super yang hadir di berbagai film Hollywood. Spiderman, Hulk, X-Men, dan Fantastic Four merupakan beberapa tokoh superhero yang mendapat kemampuan super karena susunan genetik di dalam tubuh mereka berubah dan bermutasi.

Gene editing memang merupakan salah satu hal paling populer yang dieksplorasi oleh para pembuat film Hollywood, khususnya film-film fiksi ilmiah. Gene editing telah membuka pintu kreativitas yang sangat lebar bagi para pembuat film, yang telah memukau miliaran penonton di seluruh dunia.

Namun, teknologi gene editing sendiri bukanlah sesuatu yang hanya hadir di film-film fiksi ilmiah, namun juga di dunia nyata tempat kita tinggal, yang memiliki potensi untuk menyelamatkan nyawa jutaan manusia. Gene editing sendiri merupakan salah satu bentuk rekayasa genetika, di mana susunan DNA di dalam genom organisme diubah dan dimodifikasi.

Gene editing memiliki potensi yang sangat besar untuk mengatasi dan mencegah terjadinya berbagai penyakit kronis yang dialami oleh jutaan orang di seluruh dunia. Dan di tengah pandemi Corona saat ini, gene editing merupakan salah satu teknik yang digunakan oleh ilmuwan dalam membuat vaksin virus tersebut.

Sebagaimana kita ketahui, pandemik Corona saat ini sudah berada di hampir seluruh negara dan teritori di dunia. Setidaknya, virus yang berasal dari kota Wuhan, China, ini telah menginfeksi lebih dari 3 juta jiwa, dan menyebabkan 200.000 lebih orang kehilangan nyawa. Sebagian besar dari mereka yang meninggal adalah orang-orang lanjut usia dan yang memiliki riwayat penyakit.

Pandemi ini sudah merubah total kehidupan sehari-hari milyaran orang di seluruh dunia. Sebagian besar negara memberlakukan kebijakan lockdown total dan memaksa penduduk mereka untuk berdiam di rumah. Jutaan orang kehilangan pekerjaan atas pandemi tersebut, dan ribuan usaha terpaksa ditutup dan gulung tikar.

Vaksin untuk virus Corona tentu merupakan hal yang saat ini sangat mendesak. Tidak mungkin dunia dipaksa berhenti total untuk waktu yang sangat lama. Oleh karena itu, berbagai pemerintahan dan lembaga yayasan di seluruh dunia berlomba-lomba mendanai para ilmuwan untuk menemukan vaksin bagi Covid-19.

Rekayasa genetika sendiri bukanlah sesuatu yang baru. Rekayasa genetika melalui teknik bioteknologi, yang secara langsung mengubah genom organisme, sudah dilakukan sejak dekade 1970-an. Pakar biokimia asal Amerika Serikat, Paul Berg, adalah ilmuwan pertama yang membuat DNA rekomninan (DNA hasil buatan di laboratorium) dengan mengkombinasikan DNA virus SV40 dan virus Lambda (Jackson, Symons, dan Berg, 1972).

Seiring berjalannya waktu, rekayasa genetika juga terus berkembang. Tidak seperti metode rekayasa genetika pada masa lalu, di mana ilmuwan hanya bisa memasukkan atau menambahkan material genetik tertentu secara acak, gene editing sendiri merupakan salah satu teknik rekayasa genetika yang paling mutakhir. Teknik tersebut memungkinkan ilmuwan untuk mengubah bagian tertentu dari susunan genom organisme secara akurat (Smithsonian Magazine, 2019).

Ilmuwan dari North Carolina State University, Rodolphe Barrangou, menulis dalam jurnalnya bahwa, salah satu teknik gene editing yang saat ini paling berkembang adalah CRISPR gene editing. CRISPR (clustered regularly interspaced short palindromic repeats) merupakan rangkaian DNA yang terdapat di dalam bakteri prokariotik (Barrangou, 2015).

Barrangou menambahkan, rangkaian DNA ini terbentuk dari pecahan DNA bakteri virus yang sebelumnya menginfeksi bakteri prokariotik tersebut. Rangkaian ini berfungsi untuk mendeteksi bila ada virus yang sama yang kembali menginfeksi bakteri tersebut, dan menghancurkan DNA dari virus tersebut, Dengan kata lain, CRISPR merupakan sistem pertahanan yang dimiliki oleh bakteri prokariotik (Barrangou, 2015).

Enzim yang digunakan oleh CRISPR untuk mendeteksi dan menghancurkan DNA virus yang menginfeksi bakteri tersebut adalah Cas9. Pakar genetik menemukan bahwa Cas9 dapat digunakan sebagai alat pendeteksi bila seseorang ingin memodifikasi lokasi tertentu yang spesifik di dalam genom organisme (Esvelt, Smidler, Catteruccia, dan Church, 2014).

Melalui CRISPR gene editing ini berpotensi besar untuk memusnahkan segala bentuk penyakit kronis yang dialami manusia saat ini, seperti kanker dan penyakit genetik lainnya. Teknik ini juga berpotensi besar dapat memperkuat sistem imun yang ada di dalam tubuh manusia (Science Daily, 2019).

Terkait dengan upaya untuk menyelesaikan pendemik Corona, pakar biologi sintesis saat ini sudah dapat membuat beberapa bagian dari virus Corona secara sintesis dengan menggunakan CRISPR. Upaya ini dilakukan untuk menemukan vaksin bagi virus tersebut. Salah satu lembaga yang berperan besar dalam mendanai penelitian tersebut adalah Bill & Melinda Gates Foundation (Statnews, 2020).

CRISPR juga dapat digunakan sebagai “mesin pencari” untuk genom spesifik tertentu yang dimiliki oleh virus Corona. Hal ini membantu para peneliti untuk dapat mendeteksi pasien yang terkena virus Corona dengan prosedur yang lebih cepat dan sederhana (Synthego, 2020).

Pandemi Corona saat ini tentu bukanlah pandemi terakhir yang akan dialami oleh manusia. Besar kemungkinan di masa depan, virus ini akan kembali bermutasi dan menjadi virus yang lebih sulit untuk diatasi. Selain itu, di masa depan, tidak mustahil pandemi lain akan muncul dan disebabkan oleh virus atau bakteri dengan jenis yang lain.

Rekayasa genetika merupakan salah satu bidang ilmu pengetahuan yang paling terdepan, yang berpotensi akan membawa banyak manfaat bagi umat manusia. Oleh karena itu, sangat penting bagi kita untuk mendorong penemuan terbaru di bidang bioteknologi dan tidak membatasi melalui serangkaian regulasi sangat ketat yang berpotensi menghambat kemajuan dan merugikan masyarakat yang tidak bisa mengambil manfaat dari hasil temuan tersebut.

Selain itu, perlindungan hak kekayaan intelektual (HAKI) di bidang rekayasa genetika juga sangat penting untuk mendorong kemajuan. Profesor ekonomi dari Universitas California, Berkeley, Brian D. Wright misalnya, menyatakan bahwa perlindungan hak paten terhadap produk rekayasa genetika dapat mendorong inovasi dan kemajuan.

Wright memberi contoh sejak dekade 1980-an, perlindungan hak paten terhadap produk hasil rekayasa genetika di Amerika Serikat semakin menguat. Hal ini membuat bidang rekayasa genetika di negeri Paman Sam tersebut semakin maju dan berkembang, karena berbagai lembaga swasta berlomba-lomba untuk melakukan riset dan menemukan teknik rekayasa genetika yang terbaru (Wright, 2006).

Sebagai penutup, rekayasa genetika, khususnya gene editing, merupakan salah satu bidang ilmu bioteknologi yang paling terdepan untuk saat ini, yang berpotensi besar membawa banyak manfaat kesehatan bagi umat manusia, khususnya di masa pandemi seperti sekarang.

Untuk itu, sangat penting bagi pemerintah agar tidak memberlakukan regulasi yang sangat ketat yang dapat menghambat perkembangan tersebut. Pemerintah juga harus bisa memastikan penegakan atas perlindungan paten terhadap para inovator dan investor yang melakukan riset dan menginvestasikan dana mereka, untuk memastikan insentif dan kompetisi di bidang rekayasa genetika dapat semakin maju dan berkembang.

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Perché il Sistema Tedesco Funziona

l servizio sanitario in Germania ha retto molto meglio la pressione della crisi Covid-19 rispetto al quello italiano. Stiamo pagando scelte di spesa e investimenti sbagliati, e una burocratizzazione estrema del sistema ospedaliero. Cosa potrebbe succedere qualora in autunno il virus tornasse con forza?

PERCHÉ È IMPORTANTE   Sia in Italia che in Germania circa lo 0.4% della popolazione è risultato positivo al Coronavirus. Mentre la curva dei contagi sembra seguire la stessa traiettoria, la percentuale di morti su 1000 casi è di 3,5 volte superiore in Italia che in Germania.

Perché? Gli ospedali tedeschi hanno una maggior resistenza in tempo di crisi, grazie ad una forte competizione tra di essi, siano essi pubblici o privati.

TESTARE LA DIFFERENZA   Al contrario di quanto avviene in Italia il governo centrale tedesco, insieme ai lander, ha dato via libera ai laboratori privati ai test e nel momento in cui scriviamo più del 3% della popolazione è stata testata. In Italia invece i test si limitano allo 0.5% della popolazione fermandosi a quota 3 milioni circa di cui la metà nelle regioni di Lombardia, Veneto e Piemonte.

Ricordando che in Germania l’epidemia è iniziata circa 10 giorni dopo rispetto l’Italia possiamo ampiamente notare come il governo a guida Merkel abbia reagito diversamente da quello Italiano.

CENTRALISMO VS. FEDERALISMO   Infatti non solo in Germania sono i cittadini a decidere se fare il test e dove, ma il governo federale ha anche istituito grazie al supporto di aziende private, i cosiddetti laboratori drive in dove i tamponi vengono fatti direttamente dal finestrino dell’auto.

In Italia al contrario si è deciso per centralizzare tutto in alcuni laboratori statali, e seguendo le direttive OMS, si è deciso di fare i tamponi solo ai soggetti fortemente sintomatici (fatta eccezione per il Veneto dove invece il governo locale ha deciso di testare tutta la popolazione sia essa sintomatica o meno), portando questi laboratori al quasi totale collasso.

SPESA PUBBLICA E POSTI LETTO   Ma veniamo ad un’altra domanda che in tanti si chiedono. Come mai abbiamo così pochi posti di terapia intensiva quando la spesa sanitaria è la seconda voce per volume della spesa pubblica dopo le pensioni? ln Germania i posti letto a inizio pandemia erano circa il triplo di quelli Italiani (8,6 ogni 100 mila abitanti in Italia contro i 33,9, tedeschi) arrivando a circa 50.2 letti ogni 100 mila abitanti a inizio Maggio. 

Se si considera che la maggior parte dei posti in terapia intensiva sono nelle regioni del Veneto, Lombardia, Piemonte ed Emilia Romagna (circa 3600 su un totale di 9200) si può ampiamente dire che una buona parte dell’Italia è quasi completamente scoperta.

Il motivo di questa scelta è da vedersi nelle scelte dei governi degli ultimi 10 anni in cui si è deciso di investire sul welfare più che sulla cura della persona, e dove si è deciso di non copiare i modelli del nord d’Italia ma di proseguire una politica dedicata a sussidi pubblici ad enti burocratici non funzionanti.

UN PAESE A RISCHIO   L’emergenza è passata e ora c’è da chiedersi siamo pronti per una nuova ondata, che molti esperti dicono arriverà in autunno. Siamo attrezzati per una nuova pandemia?

La risposta è no. Dobbiamo lasciare i privati investire, seguire il modello lombardo di organizzazione sanitaria, che in tanti criticano ma che ha resistito ad uno tsunami, e aggiungere il campionamento a tappeto fatto in Veneto. Bisogna insomma riformare la nostra sanità in stile tedesco, lasciando spazio ai privati di fare competizione al pubblico, senza mai dimenticarsi il principio di universalità del sistema sanitario nazionale.

È necessario riformare il nostro sistema e farlo alla svelta, i modelli vincenti ci sono. Sarà la nostra classe politica pronta a fare questa riforma oppure sarà ancora schiava di logiche clientelari?


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Après cette crise, ne cédons pas au protectionnisme

Face à la crise du COVID-19, nous entendons de plus en plus d’appels en faveur d’une politique économique protectionniste. Cependant, cette politique est intellectuellement en faillite depuis des siècles et nuit au bien-être des consommateurs.

Au niveau politique, le COVID-19 nous a montré une chose : les positions politiques sont bien enlisées. Tous les bords politiques se sentent confirmés dans leurs visions du monde précédant cette crise. Les socialistes affirment que cette crise confirme que la sécurité sociale n’est pas assez développée. Pour les nationalistes, c’est la globalisation et l’ouverture des frontières qui a causé cette pandémie. Les fédéralistes européens pensent que la crise COVID-19 démontre l’importance de la  centralisation des décisions dans l’Union européenne. Enfin, les écologistes trouvent que la baisse drastique de la production permet une société plus propre et qu’il est possible de vivre avec beaucoup moins..

Comme tous ces groupes, les protectionnistes jouent leur propre jeu politique et affirment que non seulement il nous faut plus de droits de douane mais aussi qu’il faut “faire revenir” la production en Europe. 

Ils se plaignent de la dépendance européenne face à des pays comme la Chine ou l’Inde et que cette crise a montré l’intérêt de rapatrier des industries qu’ils jugent plus essentiels que d’autres. Les idées protectionnistes ont la particularité d’être représentées autant à l’extrême-gauche qu’à l’extrême-droite voir même au centre du spectre politique. Il s’avère que le protectionnisme est ancré dans notre esprit politique depuis des siècles.

Le colbertisme semble éternel

Jean-Baptiste Colbert, ministre des finances sous Louis XIV, s’était engagé dans une avalanche d’octroi de monopoles, de subventions de luxe et de privilèges de cartels, et avait mis en place un puissant système de bureaucratie centrale régenté par des fonctionnaires appelés intendants. Le rôle de ces derniers était de faire respecter le réseau de contrôles et de réglementations qu’il avait créé. 

Son système fonctionnait également à grand coups d’inspections, de recensements et de formulaires pour pouvoir identifier les citoyens qui auraient pu s’écarter des réglementations de l’État. Les Intendants ont utilisé un réseau d’espions et d’informateurs pour découvrir toutes les violations des restrictions et des réglementations du cartel. De plus, les espions se surveillaient les uns les autres. Les sanctions pour les violations allaient de la confiscation et la destruction de la production jugée “inférieure”, à de lourdes amendes, des moqueries publiques voir même l’interdiction d’exercer sa profession.

Colbert était aussi convaincu que le commerce international était un jeu à somme nulle. S’inspirant des idées du mercantilisme, il estimait que l’intervention de l’État était nécessaire pour assurer qu’il garde une plus grande partie des ressources à l’intérieur du pays. Le raisonnement est assez simple : pour accumuler de l’or, un pays doit toujours vendre plus de biens à l’étranger qu’il n’en achète. Colbert cherchait à construire une économie française qui vendait à l’étranger mais qui achetait sur le marché intérieur. L’ensemble des mesures économiques de Jean-Baptiste Colbert était connu sous le nom de “colbertisme”.

De nos jours, ce système est connu sous le nom de “protectionnisme”, et reste tout à fait courant dans la pensée politique. En Europe, nous avons abandonné cette philosophie économique (même si la Commission européenne accepte que certains Etats membres subventionnent leurs industries locales en cas de crise), mais vers l’extérieur, l’UE a maintenu trois catégories de mesures protectionnistes :

  1. Les taxes douanières par le tarif extérieur commun,
  2. Les normes de production qui imposent des coûts de convergences,
  3. Les subventions aux producteurs locaux, à travers la Politique Agricole Commune (PAC).

La question est de savoir si ces mesure protègent réellement l’économie européenne. S’il convient de retourner dans le temps pour expliquer les origines du protectionnisme, il faudrait également tirer quelques leçons du passé. Dans son Traité d’économie politique publié en 1841, l’économiste français Jean-Baptiste Say expliquait :

“L’importation des produits étrangers est favorable à la vente des produits indigènes ; car nous ne pouvons acheter les marchandises étrangères qu’avec des produits de notre industrie, de nos terres et de nos capitaux, auxquels ce commerce par conséquent procure un débouché. — C’est en argent, dira-t-on, que nous payons les marchandises étrangères. — Quand cela serait, notre sol ne produisant point d’argent, il faut acheter cet argent avec des produits de notre industrie ; ainsi donc, soit que les achats qu’on fait à l’étranger soient acquittés en marchandises ou en argent, ils procurent à l’industrie nationale des débouchés pareils.”

Considérer l’échange international, surtout dans une perspective de “déficit commercial”, comme un jeu à somme nulle, est erroné. L’idée qu’il faille faire revenir l’industrie en Europe, probablement à travers des mesures commerciales, est également fallacieuse. Il s’avère que la libéralisation des liens commerciaux est avantageux à la fois pour les pays exportateurs et ceux qui importent : les ressources entrant nous procurent la possibilité d’améliorer notre situation économique. 

L’acte commercial bénéficie aux deux acteurs et non à un seul. Croire que seul le vendeur est gagnant (car il gagne de l’argent) est une incompréhension économique grave.

Certes la crise du COVID-19 est très problématique, et nous voyons en effet une pénurie de certains matériaux médicaux. Ceci dit, produire des gants et masques en Europe ne sera pas viable économiquement et qui nous dit que les mêmes outils seront nécessaires pour la prochaine crise sanitaire ? Ceci nous montre encore une fois l’erreur fatale de penser qu’il serait possible d’organiser la société et son économie par une planification centrale gérée par l’Etat.

Tout comme le disait Jean-Baptiste Say dans ses oeuvres, pour (re)lancer l’activité économique, il faut enlever les mesures qui nous ralentissent, dont la bureaucratie excessive et l’excès de taxes. En d’autres termes, il s’agit de ne pas entraver les échanges mais plutôt permettre la multiplication des échanges.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Federal attack on patents will hurt innovation

Hundreds of global pharmaceutical manufacturers have narrowed their sights on a vaccine or cure, which is a considerable undertaking in terms of cost.

By speeding up the approval process for any vaccine or drug intended to treat Covid-19, Health Canada has shown that it can be responsive in this pandemic. But, not every decision the federal government has made has been for the better. Especially when it comes to amending the Patent Act and completely sidestepping the patent process in our country, which will have some serious negative externalities. 

In amending this law, the government has given itself the power to override patents for drugs, vaccines and medical equipment allowing for manufacturers to create generic copies of patented drugs, without having to negotiate or settle with the patent owners. Only after the fact will patent holders be compensated, at a rate unilaterally determined by the government.

While “sticking it” to Big Pharma may sound fashionable, it will actually end up hurting more people in the end. Suspending patents via compulsory licensing runs the risk of seriously hindering the innovation process that creates new drugs in the first place. Medical innovation is needed now, more than ever, under the threat of Covid-19, and we must pursue it at any cost. What regulators fail to see in their move is that innovation and intellectual property are intrinsically linked and people would suffer without them both. 

Hundreds of global pharmaceutical manufacturers have narrowed their sights on a vaccine or cure, which is a considerable undertaking in terms of cost. IP rights are what provide incentives for these manufacturers to create innovative treatments and get a return on their investment to create new drugs. Even modest IP protections ensure that manufacturers recover costs, which allows them to continue the process of heavily investing in research and development. That’s something we should encourage, not erase.

An example of a patented medicine saving the lives of hundreds of thousands, without compulsory licensing, can be seen in the vast expansion and availability of Gilead’s Hepatitis C drug. Under a very extensive partnership campaign, Gilead licenses out their drugs to local partner firms in middle and low-income countries, offering the drugs at-cost. What easily clocks in at $100,000 USD is sold for hundreds to ensure that patients have access – all without upending patents.

Outside of innovation, the federal government’s patent retreat may not even work in the first place. Upending intellectual property rights doesn’t all of a sudden mean that newly permitted manufacturers have the knowledge and resources needed to scale up production. A generic manufacturer, as a result of changes to the Patent Act, may have the formula for a drug, but that doesn’t mean they can simply flip a switch and produce that drug at scale. 

Many of these generic manufacturers will not have the proper supply chain infrastructure needed to produce these drugs, and won’t be able to access the active ingredients needed in the face of growing medical export bans. India, one of the world’s largest producers of ingredients for medicines, has already implemented an export ban for 26 pharmaceutical ingredients and products, further compounding supply chain problems for producers of generics. 

In that sense, suspending patents is a lot like giving producers of generics the blueprints without access to the tools, labour, or raw materials needed to turn a building plan into a finished product.

While it may sound good to suspend patents in a pandemic, it should be recognized that doing so runs the risk of severely hindering both present and future innovation, which are so desperately needed. Added to that, examples like Gilead’s partnerships in middle and low-income countries prove that upending patents isn’t required to ensure drug availability. Rather than shredding intellectual property rights and patents to respond to Covid-19, the Canadian government should focus elsewhere.  Easing the regulatory approval process, fast tracking drugs approved by health regulators in other OECD countries, and eliminating tariffs on medical equipment would have more of an impact. 

We all want medical innovation and for Canadians to have access to the care and drugs they need. Let’s not make it more difficult to achieve that with bad public policy. 

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Public Health Agencies Care More About Controlling You Than Prepping For Pandemics

Public Health Agencies Care More About Controlling You Than Prepping For Pandemics

What were public health officials at every level of government doing last year? Were they preparing for a pandemic? Or were they using their office to meddle with your lifestyle choices?

The partisan political sniping over Covid-19 is completely predictable and counter-productive. There’s plenty of fault to go around, but the blame-gaming should be ignored or discounted for what it is: self-aggrandizing grandstanding.

It is, however, worthwhile to examine a tension that has been brewing in the public health world for decades. That dichotomy is: should we focus on communicable diseases, as has long been the mission of public health institutions, or do we have enough bandwidth and resources to venture out into the much more controversial area of non-communicable diseases (NCDs)?

To get to the answer, think about this. What were public health officials at every level of government doing last year? Five years ago? Were they first ensuring that their track and trace systems were in place for a pandemic? Or were they using their office to meddle with your lifestyle choices?

The discipline of public health has long been rooted in fighting contagious diseases. For the most part, it has done very well. Notwithstanding the current Covid-19 pandemic, sanitation, vaccines and therapies—mainly drugs—have dramatically reduced the toll of communicable diseases.

That success has led many in public health agencies, especially in the United States, to argue that we must now use our limited resources to combat NCDs, and that we can address both effectively. It isn’t exactly working out that way.

Efforts to fight non-contagious diseases such as heart disease and diabetes frequently raise questions about individual liberty, including the freedom to make poor choices. All too often, the politicized debate causes both sides to overstate or manipulate the science supporting their viewpoints.

When former New York City Mayor Michael Bloomberg, the biggest booster of today’s public health movement, campaigned against sugary drinks like soda, it landed the city’s health department in hot water. For instance, a taxpayer-funded ad campaign created by the Department of Health showed a photo of a man purportedly with amputated legs. The city’s ad agency had Photoshopped his legs out of the photo to support the valid claim that Type 2 diabetes can lead to amputations.

The Bloomberg administration’s antics, which even elicited criticism from within the health department, indicates the degree to which his wing of the public health movement has lost sight of its most primary and unifying functions: preparedness.

This lack of preparedness is not partisan. It exists in the current Republican administration, as it did in the prior Democrat administration. Cities, counties, and states long governed by each party were equally ill-prepared for a pandemic.

Commentators on the left and the right have referred to Coronavirus and Covid-19 as a “black swan event.” But it doesn’t meet the definition. A pandemic of this type was not only predictable, it was something communicable disease experts have warned about rather specifically for many years. The warning signs were ignored, and we were ill-prepared.

A 2007 review article in the American Society for Microbiology’s publication, Clinical Microbiology Reviews, entitled, “Severe Acute Respiratory Syndrome Coronavirus as an Agent of Emerging and Reemerging Infection,” concluded: “Coronaviruses are well known to undergo genetic recombination, which may lead to new genotypes and outbreaks. The presence of a large reservoir of SARS-CoV-like viruses in horseshoe bats, together with the culture of eating exotic mammals in southern China, is a time bomb. The possibility of the reemergence of SARS and other novel viruses from animals or laboratories and therefore the need for preparedness should not be ignored.”

Rather than marshal finite resources towards preparedness for a coming communicable disease, lots of public health resources, including taxpayer dollars, media attention, and legislative priorities, were deployed to address non-communicable diseases, from domestic violence to gun regulation.

Think back to a different time not so long ago. During the second half of 2019, federal, state and city health officials throughout the country were busy confronting a new and scary lung disease. The health reporters covering them churned out news articles, regularly garnering front-page placement. Major charities such as Bloomberg Philanthropies were making large public health grants. So it should come as no surprise that the American public and political leaders were keenly focused on this emerging health threat.

The disease wasn’t Covid-19, of course. It was a something the Centers for Disease Control called e-cigarette or vaping product use-associated lung injury, or EVALI.

At the time, public health activists were, for years, calling for bans on the types of e-cigarettes used to quit smoking. Despite strong evidence that nicotine e-cigarettes are 95 percent less harmful than smoking and can help smokers quit, public health agencies treated e-cigarettes as the most important threat to public health. Yet they still failed to convince policymakers to institute widespread bans on the most popular e-cigarettes.

But as consciousness of EVALI reached a crescendo, states began to ban most flavored e-cigarettes, and the FDA further tightened the regulatory screws on nicotine-containing e-cigarettes.

It turned out that none of these nicotine e-cigarettes were ever responsible for the lung disease that bears their name. It took until late December for the Centers for Disease Control to (partly) acknowledge that the lung injuries were caused not by vaping liquid nicotine e-cigarettes such as Juul, but by the use of THC oil contaminated with vitamin E acetate.

Public health agencies were so ideologically opposed to e-cigarettes as a tool for tobacco harm reduction that they sowed panic, promulgated misinformation, and actually caused a failure to identify the true culprit in a life-saving and timely way. Still, nobody has been held accountable.

So, back to the question about communicable and non-communicable disease: Has public health been able to “do both” well? It turns out, that when purportedly trying to do both, public health hasn’t been able to do either effectively.

I’m not suggesting that public health’s EVALI scandal was the only or even primary culprit for the failure of public health departments around the country to ensure that their communities had an adequate supply of personal protective equipment in the event of a predictable communicable disease outbreak, or that the CDC was otherwise preoccupied. Instead, the EVALI episode was more of a symptom of something wrong in public health.

The institution of public health has largely been co-opted by those with a desire to control individual choices to such a degree that it has largely lost sight of its fundamental role of pandemic preparedness. At this point, taxpayers should realize that we are giving the keys to the public health car to people who have long been driving in the wrong direction.

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

How liability lawsuits drive up drug prices, stifle innovation, and harm patients

A single drug can cost up to 2 million dollars per treatment. In the light of COVID-19, patient groups and activists have been using the crisis of the moment to call for capping drug and vaccine prices and cracking down on barriers to access for patients. In developing countries, large parts of drug prices are caused by tariffs, taxes, and other regulatory barriers. The United States, on the other hand, has the highest per-capita drug expenditure and drug prices in the world.

Bringing a drug to the US market is usually critical for a company to recoup the roughly 2 billion dollars of development costs per successfully launched medicine. At the same time, the country’s unique legal liability and injury system (called tort law) leads to higher drug prices without necessarily creating benefits for patients. Once a drug has passed the rigorous approval process demonstrating safety and efficacy to the US Food and Drug Administration (FDA), it is still subject to various liability laws at the state level.

In the last two decades, Pfizer set aside a whopping 21 billion dollars for settlements following tort lawsuits against the diet drug Fen-Phen. Those who were harmed by the drug were able to seek legal recourse. That said, thousands and thousands of people who were not harmed by the drug were also able to seek compensation. So much so that it is assumed that at least 70% of the payouts went to claimants who weren’t harmed at all by the drug.

Johnson & Johnson was ordered to pay 8 billion dollars to one patient for side effects caused by the antipsychotic drug Risperdal. These are just a few examples of a plethora of multi-billion-dollar payments drug companies have been compelled to make after being dragged to court, despite them being deemed safe by the FDA.

Patient advocates who are passionate about lowering drug prices in the USA should take a serious look at liability laws and how their misuse inflates prices. Abolishing liability beyond FDA requirements could reduce drug prices in the United States by 12 to 120 billion dollars a year and therefore give many more patients access to medicines. 

In 2019, US patients spent a total of $360 billion on prescription drugs. Between 3 and 30% of this amount could be freed up for other treatments or price cuts if liability rules for FDA-approved drugs would be reformed. This change might seem radical, but it is what Congress has approved for FDA-approved medical devices. A similar preemption was extended to vaccines in the late 1980s via the Vaccine Injury Compensation Program.

Another impact of lawsuits following product withdrawals of FDA-approved drugs is that they negatively affect new investments in development. Pfizer’s settlement for Fen-Phen alone could have been used to bring 10-15 new innovative and life-saving drugs to patients.

Rather than using these financial resources for more research and development, or to lower drug prices, pharmaceutical manufacturers have to fight law firms who enrich themselves by abusing the US tort system. Tort law on top of FDA regulation is not just stifling innovation, but also an expensive way to compensate for the harm caused to patients. Paul H. Rubin suggests that the costs of settlement for the legal process account for half of the total settlement fees. Reducing this burden could increase the speed of new drugs being developed and reduce their price. Critics of tort reform will say that changing liability rules will endanger patients, but that’s far from the truth. A 2007 study shows that tort law reform in some states led to a total of 24,000 fewer deaths due to price reductions and the arrival of new innovative drugs. That’s something to keep in mind.

As long as we keep existing tort law on top of the FDA approval framework, consumers are being de facto forced to pay a massive markup on drugs in order to get insured against potential side effects. This is a very expensive and inefficient way of insuring patients against harm. 

A smarter way of designing such a compensation scheme is to either expand the vaccine compensation scheme to pharmaceuticals or to allow consumers to personally purchase insurance against such damages. This could, for instance, be supplementary insurance on top of the patient’s existing health insurance plans. Such a system would allow patients who opt-in much lower fees than the existing mandatory tort law system.

Exempting drugs from state tort law would be an easy step to reduce drug prices without putting patients under more risk. American patients would save billions a year and be able to access more treatments than they can currently. This will lead to a net benefit for patients and the health of the nation. Why not give it a try?

The folly of opposing patents on a Covid vaccine

The folly of opposing patents on a Covid vaccine

Doctors Without Borders does incredible work in the interest of patients around the globe. It has an exemplary track record of bringing doctors to the front lines of combat zones, famines, and pandemics — helping those patients that are left alone and victims of large crises.

During the 2014-2015 Ebola epidemic in West Africa, MSF (to use its French acronym) was the leading organisation fighting for patients — far more so than the World Health Organization, which is bureaucratic and has slow response times. For that and its previous 48 years of service, it needs to be applauded.

However, its current opposition to patents on drugs treating Covid-19 misunderstands the importance of intellectual property rights for medical innovation.

MSF is also running a campaign on access to medicines which distorts the realities of the drug market, while calling for solutions that would harm scientific innovation. The “Campaign for Access to Essential Medicines” wants to increase the availability of medicines in developing nations by addressing drug pricing and intellectual property rights. In the eyes of MSF, producers and researchers are enriching themselves off the backs of those who can least afford it.

What MSF gets wrong is that intellectual property rights and patents do not hinder innovation but actually enable medical progress.

Dozens of pharmaceutical companies have not only started searching for a vaccine against Covid-19 but have also thrown a lot of resources into getting millions of tests produced, looking at what existing drugs might be able to treat the disease, and donating money and materials to health systems across the world.

In fact, the philanthropic efforts of pharmaceutical companies are impressively underreported. By any standard, these companies are offering charitable support, including to organisations working with patients on the ground. However, Doctors Without Borders has said that it will not accept in-kind donations of drugs from pharmaceutical companies, but instead purchase them at market prices. Donors to MSF would probably be stunned by the idea that their donations are spent on drugs that MSF could have got for free.

While the industry also cares about access a lot, dysfunctional health systems and infrastructure are often the barrier between a patient and a treatment or vaccine. We need to realise that charitable acts are only possible if profits are also encouraged. Pharmaceutical companies develop drugs, protect their inventions and make profits. If you cut out patent rights from the equation, the incentive to innovate disappears, and life-saving medicines that cost billions to develop will stay off the market.

Doctors without Borders calls for preventing drug profiteering on the novel coronavirus, while ignoring the significant donations being made to help stop this virus. In fact, most efforts to combat the disease are public-private partnerships, much like the fight against Ebola was.

Remember too that stopping companies making a profit from drugs both eliminates incentives and ignores both the risks and the costs of working on a new drug. Who are we to tell lab workers to come into work every day for free, when there are risks associated with going to work and interacting with fellow employees?

The idea of so-called compulsory licenses, which de facto takes a patent away from a manufacturer in one country and gives it to another, might even delay the introduction of a Covid-19 vaccine even more. It takes know how and supply chains to manufacture and deliver a working vaccine. It is questionable whether a vaccine produced under compulsory licensing would actually be less expensive than the original one.

Much can be said about drug manufacturing and access to essential medicines. But a proper debate needs to be held on the basis of certain basic facts. Among these is that pharmaceutical companies invest vast sums of money to provide life-saving medicines, and those same companies have also taken action to help those in the most need. With Covid-19, we are facing one of the biggest public health crises ever – Innovation and medical breakthroughs are needed now more than ever. Undermining the ownership of innovations will definitely not lead to the breakthroughs that will ultimately get us out of this nightmare.

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

A roadmap for the NHS: lessons from Germany

In both Germany and the United Kingdom, around 0.18 per cent of the total population has recently tested positive for coronavirus. While the spread of the pandemic is roughly equal in these countries, the fatality rate is 420 per cent higher for patients treated by the NHS compared with those treated in Germany. This is because Germany’s hospitals are better placed to be resilient in times of crisis, thanks to the private and competitive aspects of the country’s healthcare system.

Germany’s decentralised and private laboratory network had already tested over two per cent of its population when the UK’s figure still stood at a meagre 0.7%. Britain’s centralised testing system, and its failure to scale up Covid-19 tests, might explain part of this mortality gap. One could assume that only very severe cases are being tested by the NHS and, as such, the fatality rate of this more concentrated group is higher.

Even if you make very generous adjustments to the figures and assume that Britain’s fatality rate would remain unchanged even if the NHS tested as many people as the German system, the UK would still have a 49 per cent higher death rate.

Not only are the NHS’s testing facilities incapable of dealing with black swan events, the entire healthcare system simply doesn’t have sufficient resilience to minimise the harm caused to patients by a virus such as Covid-19.

Conversely, Germany’s mainly private and non-profit hospital system leads the way in Europe when it comes to successfully facing this wave of patients. In early March, hospitals had already freed up beds in intensive care by pushing back elective surgeries, and the total capacity of ICU beds was ramped up 40 per cent within a month. Germany’s hospitals now have a total of 40,000 ICU beds and 30,000 beds with respiration units.

And all of this was achieved while still ensuring the provision of critical services such as cancer care and screening, which is something that the NHS is struggling to do – a problem that may cause more harm than Covid-19.

Thanks to the recent increase, Germany has now 48 ICU beds per 100,000 inhabitants, which is more than seven times the capacity the UK currently has. This month, the NHS published the occupancy rate of critical care beds in February, which showed over 80 per cent of those were in use. And while Germany was deploying a new public database showing critical care capacity per hospital, which is updated at least once a day, the NHS paused the publication of many of its own statistics, and those that are released are at least a month old.

What’s more, Germany’s new online ICU capacity register was built overnight, a tool that provides patients and doctors with invaluable guidance. One map, for example, shows that in Bavaria, which is the state worst-hit by Covid-19, just 16.1 per cent of ICU beds are occupied by patients with coronavirus. It also shows the available number of empty ICU beds. Bavaria still has 37 per cent of all its ICU beds empty and can, therefore, comfortably treat three times more Covid-19 patients than now.

This successful approach has taken place within a system where the government owns less than 30 per cent of all hospitals. Germany’s universal healthcare system embraces competition and private ownership of hospitals and outpatient services. So while the social insurance system covers 90 per cent of the population, the provision of care is mainly carried out by private for-profit hospitals or charities. 

Simply put, private hospitals and competition lead to much more efficient structures, and Germany’s decentralised healthcare system, which allowed for a speedy mitigation strategy, is now showing its value by saving thousands of lives. Indeed, Germany is not only weathering this storm better than the NHS but it is even able to fly in and treat hundreds of patients from Italy, France and Spain.

British policymakers will need to show courage in the coming months and be honest about the failings of the UK’s healthcare system during this crisis. There are two crucial lessons that will need to be learned in order to prevent, or at least mitigate, another lacklustre response in the future.

The first is that introducing more market mechanisms in the NHS would not mean that patients were denied care – you can have universal healthcare in a social insurance model too. And the second is that having more private hospitals does not necessarily lead to fewer hospital beds, but a better allocation of skills and resources. Indeed, it allowed Germany to scale up its ICU capacity, as well as keeping services such as cancer treatments and screenings open in different locations.

The centralised nature of NHS does not allow for any part of the chain to fail. Unfortunately, failure is in our nature and less centralised systems are therefore necessary in order to achieve resilience and adaptability in times of urgent need.

We should make the UK fit for the next nasty virus by decentralising testing and allowing for more private sector involvement in our healthcare system. It’s high time we faced the facts about the NHS and stopped ignoring success stories from around the world.

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

6 Amazing Medical Breakthroughs we should be thankful for

Thanks to continuous innovation in medical sciences and biotechnology we have seen amazing breakthroughs in medical technology and pharmaceuticals in the past two decades. These breakthroughs would not have been possible without incentives for inventors and investors. We can still only cure or treat 5% of all known diseases. Reducing incentives for innovation and intellectual property rights would risk finding cures for the remaining 95%.

This is a list of just six innovations of the last two decades that dramatically improve the lives of millions of people.

La nueva herramienta contra la lucha de los virus, la edición genética: en qué consiste y por qué deberíamos estar entusiasmados con esta nueva tecnología?

Imagen de Arek Socha en Pixabay

Actualmente, la humanidad está atravesando un gran desafío impuesto por el Coronavirus. Las fronteras están siendo cerradas, las aerolíneas suspendiendo sus operaciones y algunos negocios cerrando sus puertas.

Simultáneamente, científicos, investigadores y profesionales de la salud se encuentran arduamente trabajando en nuevos tratamientos que permitan encontrar pronto una solución a la pandemia producida por el COVID-19.

Probablemente, lidiar con el coronavirus y sus consecuencias debe ser uno de los retos más grandes que el mundo contemporáneo ha enfrentado en las ultimas décadas. Sin embargo, no será el ultimo virus que debamos enfrentar.

Por tal motivo, se vuelve importante abrazar a las biociencias y permitir una mayor apertura a la aplicación de métodos de alteración de genes.

Para comprender mejor las ventajas que brinda la biociencia y cómo esta puede mejorar considerablemente nuestra calidad de vida, revisaremos las cuatro alternativas más comunes para alterar los genes de una planta o animal:

X- Men (Dr Charles Xavier) – Mutaciones naturales/espontáneas

20th Century Fox
20th Century Fox

Las mutaciones per se suceden de manera regular en la naturaleza. Fue justamente de esta manera que unos aminoácidos terminaron siendo seres humanos luego de unos miles millones de años. La evolución biológica puede suceder justamente gracias a este tipo de mutaciones. Las mutaciones naturales suceden de manera aleatoria o son causadas por factores exógenos como la radiación (p. ej. el sol). Para los amantes de los cómics entre nosotros, las mutaciones que tienen lugar en “X-men” son un ejemplo de mutaciones naturales, debido a que (en muchos casos) ocurren de manera espontánea.

Hulk – Mutaciones por exposición (mutágenos)

Imagen de Alexander Gounder en Pixabay
Imagen de Alexander Gounder en Pixabay

Una de las formas más comunes de manipular semillas es a través de la exposición a la radiación y esperar a mutaciones positivas (p. ej. una resistencia mayor a plagas). Este método es muy común desde 1950 y es un método bastante preciso en la búsqueda de obtener plantaciones más resistentes o agradables para el consumo. Sin embargo, requiere de miles de intentos para obtener un resultado deseable. Este método es ampliamente utilizado y legal en gran parte de los países. En nuestro universo de cómics, Hulk seria un buen ejemplo de este tipo de mutaciones causadas por la radiación.

Spiderman- Organismos genéticamente modificados (transgénicos OGM)

Imagen de djedj en Pixabay
Imagen de djedj en Pixabay

El método utilizado para la creación de organismos genéticamente modificados (OGM) suele ser temido por muchos. El procedimiento se basa en insertar los genes de una especie en otra especie. En la mayor parte de los casos, las plantaciones de transgénicos OGM han sido inyectadas con la proteína de otra planta o bacteria que permite a la plantación o cosecha desarrollarse de manera más acelerada o resistente hacia ciertas plagas.

Otros ejemplos pueden palparse en el cruce del salmón con la tilapia que permite al salmón crecer de manera mucho más acelerada. Un ejemplo a nivel de los cómics para este caso es Spider-man, mejor conocido como el “hombre araña”. Luego de ser mordido por una araña, puede escalar rascacielos y desarrollar una agilidad sobrehumana gracias a su potenciado ADN aracno-humano (transgénico).

GATTACA / La Ira de Khan- Edición genética (las tijeras de la biociencia)

Screenshot de Star Trek: La ira de Kahn | https://www.espinof.com/criticas/especial-star-trek-star-trek-2-la-ira-de-khan-de-nicholas-meyer
Screenshot de Star Trek: La ira de Kahn | https://www.espinof.com/criticas/especial-star-trek-star-trek-2-la-ira-de-khan-de-nicholas-meyer

Super villanos libre de gluten: La edición genética no se trata de super humanos, sino de mantenernos y darnos una vida saludable

Este método puede llevarse a cabo en personas adultas que se encuentra vivas, lo cual significa una gran oportunidad sobre todo para aquellos que sufren trastornos genéticos. La edición genética permite “reparar” los genes en organismos vivos. Este método también es miles de veces más preciso que el método de bombardear con radiación. Algunos ejemplos son la desactivación del gen responsable de generar el gluten en el trigo: el resultado es trigo sin gluten para celiacos.

Existen varios métodos utilizados en la edición genética. Uno de los más populares estos días es aquel llamado CRISPR Cas-9. Estas “tijeras” son usualmente bacterias reprogramadas para transmitir un nuevo gen o desactivar genes no deseados.

Muchas novelas de ciencia ficción y películas nos muestran un futuro en el cual podemos desactivar defectos genéticos y curar a las personas de enfermedades catastróficas. Algunos ejemplos de historias de este tipo donde métodos similares al CRISPR han sido utilizados son GATTACA-La Ira de Khan, Start Trek o la serie Expanse donde la edición genética juega un rol crucial en desarrollar plantaciones para ser cultivados en el espacio.

Qué relación tiene todo esto con el Coronavirus?

Biólogos sintéticos han comenzado a utilizar CRISPR para recrear de manera artificial partes del coronavirus en un intento de producir una vacuna en contra de esta afección del sistema respiratorio para desarrollarla de manera masiva y rápida.

Gracias a la combinación de simulaciones computarizadas con inteligencia artificial, este proceso acelera la producción de una vacuna de años a cuestión de meses. De igual forma, en tiempos de crisis las instituciones encargadas de aprobar nuevas pruebas y procedimientos para este tipo de tecnología como la DEA en los EEUU han demostrado estar a la altura de las circunstancias.

El CRISPR permite también identificar genes específicos en un virus. Esto ha permitido a los investigadores construir de manera rápida y sencilla tests para ser utilizados en los pacientes con coronavirus.

En el largo plazo, la edición de genes nos permitiría ampliar la inmunidad que poseemos los seres humanos para alterar nuestros genes y convertirnos más resistentes a los virus y las bacterias.

Esta no será la última crisis

Mientras el coronavirus pone a prueba nuestra sociedad contemporánea, también necesitamos ser conscientes de que este no será el último patógeno que tendrá el potencial de matar millones de personas. Si no contamos con mucha suerte, el COVID-19 podría tener alguna mutación que lo haga mucho más difícil de combatir.

El próximo virus, hongo o bacteria letal podría estar a la vuelta de la esquina. Por este motivo, debemos adaptarnos y aceptar las nuevas innovaciones en biotecnología y evitar bloquear las investigaciones genéticas que están teniendo lugar y la aplicación de sus resultados.

En estos momentos, varias prohibiciones se encuentran en vigencia bloqueando la posibilidad de utilizar innovaciones como la del CRISPR en pacientes alrededor del mundo. Debemos repensar aquella hostilidad que existe hacia la ingeniería genética y aceptarla por lo que es, una alternativa prometedora para nuestra supervivencia. Para ser franco, siempre nos encontramos en aquella disyuntiva entre nuevas enfermedades que aparecen y la necesidad de implementar herramientas innovadoras como el CRISPR que podrían salvar millones de vidas.

by Julio Clavijo

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

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