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You may have noticed we have increased the pace of content on PolicySphere. Here are some of our latest articles you may have missed:
Interesting New Paper On How The Fed Produces Disinflation
Analysis: Excellent New Paper Makes National Security Case for Free Trade
Immunotherapy Could Cure Cancer, But The FDA May Be In The Way
We first heard of immunotherapy as a potential quasi-miracle cure for cancer in the 2010s, around the time Sean Parker launched a foundation to fund cancer immunotherapy.
Immunotherapy works by harnessing the power of the body’s own immune system. Instead of directly attacking cancer cells like traditional treatments, immunotherapy works by enhancing or stimulating the immune system’s natural ability to fight cancer. In our era of fake science and replication crisis, we made a silent bet with ourselves that, like so many previous cancer silver bullets, this would prove to be a dud. And for a time, it looked like the hype on cancer immunotherapy was dying down. But perhaps this was just because the technology was harder than originally envisaged.
Now, it seems, cancer immunotherapy is seeing extraordinary results. According to an article by Christopher Cox at New York magazine, there have been breakthroughs in cancer immunotherapy.
His article focuses on a promising new CAR-T cell treatment for glioblastoma, an aggressive form of brain cancer. Researchers at Mass General Hospital in Boston, led by Dr. Marcela Maus, have shown remarkable results in a small clinical trial, with patients experiencing significant tumor regression. The treatment involves genetically modifying a patient’s T cells to target specific cancer proteins and infusing them directly into the brain.
While the results are promising, challenges remain, including high production costs and the need for larger trials.
The broader implications of this potential breakthrough are significant: if glioblastoma, one of the most difficult cancers to treat, can be effectively targeted, it opens up possibilities for treating other stubborn cancers. This development represents a potential turning point in cancer treatment, showcasing the evolution of immunotherapy from a fringe idea to a revolutionary approach in oncology.
However, the article also emphasizes that while the treatment shows great promise, it is still in early stages and faces hurdles in terms of cost, scalability, and long-term effectiveness. Researchers are cautiously optimistic, with some predicting FDA approval for this therapy by 2029, potentially reshaping the landscape of cancer treatment in the coming years.
Treatments for such serious ailments should not even need FDA approval. Even though the Federal Right to Try Act was passed into law in 2018, uptake hasn’t been what proponents would have liked, in large part because doctors and pharmaceutical companies are afraid of potential liability issues.
However, the FDA has streamlined its expanded access, or “compassionate use” program, since Covid. This is a pathway that allows patients with serious or life-threatening conditions to access investigational medical products (drugs, biologics, or medical devices) outside of clinical trials. a physician must request access on behalf of a patient directly to the FDA, but the FDA has streamlined that process, and it can respond within days for emergency situations.
Of course, there is an entire menu of reforms we can wish for to make treatments like cancer immunotherapy more available: The FDA’s lengthy and costly approval process should be streamlined, with a greater emphasis on adaptive trials and real-world evidence. Expanded access programs should be broadened, and Right to Try laws strengthened to give patients more autonomy in accessing experimental treatments. Regulatory barriers to data sharing and international cooperation should be dismantled to foster global innovation. Intellectual property laws should be reformed to encourage open collaboration while still protecting investment. Government should step back from price controls and instead focus on creating a competitive marketplace that drives innovation.
However, we feel that the low-hanging fruit that offers the most bang for the buck concerns liability protections (including in the context of Right to Try). Post-Covid, many segments of the electorate are angry that pharmaceutical companies got liability protections to bring vaccines and other treatments to market quickly under Operation Warp Speed, but this was crucial and completely warranted not only by the emergency but by the insanity of America’s medical liability jurisprudence.
To address this, policymakers should implement robust “safe harbor” provisions for companies and healthcare providers involved in developing and administering experimental therapies. These protections should shield them from lawsuits when they can demonstrate they have acted in good faith. In addition, a specialized, streamlined arbitration system could be established to handle disputes, reducing legal costs and uncertainty. Informed consent processes should be streamlined, clearly communicating risks to patients while protecting providers who disclose known information. Another potential reform would be to create a no-fault compensation fund, similar to the National Vaccine Injury Compensation Program, for cutting-edge treatments like immunotherapy, ensuring patients have recourse without stifling innovation. By recalibrating the balance between patient protection and scientific progress, these liability reforms would encourage bolder research, faster clinical trials, and increased willingness to offer promising but experimental treatments, ultimately speeding up the availability of potentially life-saving cancer immunotherapies.
Policy Links
#ChildlessCatLadies – Governor and Vice Presidential nominee Tim Walz’s children were conceived through IVF after years of struggling to conceive with his wife. Perhaps this has nothing to do with why he was selected. Or perhaps the Democrats want to try to make the election about JD Vance’s now-infamous “childless cat ladies” comments. So it may be worthwhile to point out that, while of course infertility is a horrible personal tragedy for countless people and everyone should be sensitive about the topic, Vance was simply correct as a factual matter in his off-hand comments regarding childless women’s political leanings.
#FamilyPolicy – Speaking of, the great Brian Wilcox of the Institute for Family Studies is at American Compass arguing for a “pivot” to family policy. He is certainly right that we are in a bad way: “The American heart is in danger of closing to that which matters most: love, marriage, and family. Dating is down, the marriage rate has fallen more than 60% since 1970, and our fertility rate hit a record-low 1.6 babies per woman just last year.”
#Antitrust #FreeSpeech – Yesterday, X and Rumble (a free-speech video hosting platform) filed antitrust lawsuits against the Global Alliance for Responsible Media (GARM) and others. This follows a House Judiciary Committee Report suggesting GARM violated federal antitrust laws by organizing an advertiser boycott of X in November 2022. The report also suggests GARM leadership went after companies it deemed ideologically problematic. The Silicon Valley tech & politics magazine Pirate Wires has a good primer on this “shadowy global cabal” and the issues surrounding it.
#LGBTQ – You may have seen the controversy around an Olympic women’s boxing match, where Italian boxer Angela Carini had to forfeit after 46 seconds after being pummelled by Algerian boxer Imane Khelif. There has been a lot of controversy but also confusion around this, as Khelif is not, strictly speaking, transgender. The great Colin Wright has a very good explanation at WSJ. The bottomline is that Khelif is indeed male, with XY chromosomes, male sexual organs, male puberty, male testosterone levels and male muscle mass, albeit has a very rare disorder that gives him some female traits. This qualifies him as arguably intersex, but not transgender. More importantly, the reason this story is a global headline rather than an afterghought is that, as Wright correctly points out, it is transgender ideology that led a biological male to be allowed to punch women in public, and “the language of transgender ideology has led to widespread confusion.”
#Infrastructure – It’s one thing to pass a law. It’s another to have the state capacity to turn its lofty goals into reality. Cato points out that “the 2021 Infrastructure Investment and Jobs Act […] which dedicated $1.2 trillion to a variety of infrastructure initiatives, has yet to yield many of its expected deliverables.” Rural broadband, EV charging stations, and more… We spent the money and got very little, sometimes nothing. Here’s their primer.
#AI #PublicHealth – We have been greatly enjoying R Street’s “AI and Public Health” series. The latest article, by Adam Thierer, is “How AI Can Help Tackle Major Causes of Suffering and Death.” The article helpfully includes real-world examples and data of the many ways medical professionals are already tapping the power of AI to significantly improve lives.
#Immigration – New WSJ op-ed: “Foreign Physicians Can Help Solve America’s Doctor Shortage” Talk about going for a complicated solution when there is a very simple one. The doctor shortage is artificially created by licensing requirements of the AMA put upon medical schools. It should also be noted that quantity is one thing, but quality is another, and DEI policies are making the American medical profession worse. Plenty of qualified Americans want to become doctors and can’t because of DEI and licensing requirements. There’s plenty to fix at home before having to look abroad.
#Immigration – New study: in Denmark, as in the US, the descendants of migrants are more criminally inclined than migrants themselves.
#Immigration – More immigration! It turns out that, in a revelation that should shock no one, the Biden-Harris Administration’s CHNV program, which allows tens of thousands of illegals to fly or travel directly into the US, is full of fraud.
#AI – Quote of the day: “When a supercomputer defeats a man in a game of chess or Go, the man is using twelve to fourteen watts of power, while the computer and its networks are tapping into the gigawatt clouds of Google data centers around the globe.” – Discovery Institute co-founder George Gilder
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