Month: February 2018

One California town wants to try out a basic income for residents.

Steven Greenhut writes:

There’s a simple solution to the nation’s poverty and inequality problems, an acquaintance told me several years ago. He suggested that the federal government simply give $1 million to every citizen and, voila, we’d all be rich and happy. After some quick math (323 million x $1 million = more trillions than even the U.S. Treasury can print), he realized that he didn’t add enough zeroes to his cost calculation. Turning the United States into Zimbabwe, where a $1 trillion note won’t even buy a soda, isn’t much of an idea.

But while the above thought experiment is zany, a number of politicians and economists are proposing a similar idea—but on a much more modest scale. In fact, one of California’s most impoverished cities, Stockton, is working on a proposal that would provide a “Universal Basic Income” to a small number of residents. Instead of a million bucks, the city—thanks to a grant from some Bay Area tech entrepreneurs—wants to hand out $500 a month for two years without any limits on how it’s spent.

It’s not as controversial as Stockton Mayor Michael Tubbs’ proposal last summer “that pays people not to commit crimes,” as KCRA reported. But now Tubbs is back with this latest “let’s just pay people” plan. The income idea is backed by a group that believes “cash is an effective way” to rebuild the American middle class. It’s a pilot project that will help evaluate how this type of program works.

View this article.

Yesterday the Illinois Supreme Court unanimously ruled that a state ban on carrying guns within 1,000 feet of a public park violates the constitutional right to bear arms. The decision in People v. Chairez extends the logic of prior rulings by the same court and by the U.S. Court of Appeals for the 7th Circuit holding that Second Amendment rights exist outside the home and cannot be categorically restricted without a strong justification.

In 2013 Julio Chairez committed a Class 3 felony, punishable by two to five years in prison, when he carried a gun in the general vicinity of Virgil Gilman Trail, a park in Aurora, a Chicago suburb. Chairez pleaded guilty but subsequently challenged the constitutionality of the law he violated, which also prohibits guns within 1,000 feet of a school, a courthouse, a public transportation facility, or public housing. In practice, Chairez argued, those exclusion zones were tantamount to a blanket ban on carrying guns in public, which the 7th Circuit overturned in 2012. A Kane County circuit judge agreed, finding the law unconstitutional on its face.

The Illinois Supreme Court, in an opinion written by Chief Justice Lloyd Karmeier, says the circuit court decision improperly covered provisions that did not apply to Chairez and should have focused on the gun-free zone around parks. That rule is highly restrictive on its own, Karmeier notes. It covers “a vast majority of the acreage in the city of Chicago,” for example, “because there are more than 600 parks in the city.”

Even in areas with fewer parks, the rule makes it practically impossible to legally carry a gun for self-defense. “The most troubling aspect is the lack of any notification where the 1000-foot restriction zone starts and where it would end,” Karmeier writes. “Innocent behavior could swiftly be transformed into culpable conduct if an individual unknowingly crosses into a firearm restriction zone. The result could create a chilling effect on the second amendment when an otherwise law-abiding individual may inadvertently violate the 1000-foot firearm-restricted zones by just turning a street corner.”

The only way for a someone with a gun to avoid such inadvertent felonies would be to keep the weapon disabled, inaccessible, or unloaded and locked in a case, meaning it would be unavailable for self-defense. “The State conceded that an individual who lives within 1000 feet of a public park would violate [the law] every time that individual possessed a firearm for self-defense and walked to his or her vehicle parked on a public street,” Karmeier notes. “To remain in compliance with the law, the State said that the individual would need to disassemble his or her firearm and place it in a case before entering the restricted zone.”

The state argued that the 1,000-foot rule falls into the category of “laws forbidding the carrying of firearms in sensitive places such as schools and government buildings,” which the U.S. Supreme Court has indicated are consistent with the Second Amendment. But the Court did not mention parks, and it said nothing about the areas around “sensitive places.” The farther a gun ban extends, the bigger the impact on armed self-defense and the weaker the security rationale.

“The law at issue affects the gun rights of the entire law-abiding population of Illinois,” Karmeier notes. “It is therefore a severe burden on the recognized second amendment right of self-defense.” According to the 7th Circuit, such a burden is constitutional only if the state has “an extremely strong public-interest justification” and demonstrates “a close fit between the government’s means and its end.” In this case, the state did not even come close.

“The State provides no evidentiary support for its claims that prohibiting firearms within 1000 feet of a public park would reduce the risks it identifies,” Karmeier writes. “We see no direct correlation between the information the State provides and its assertion that a 1000-foot firearm ban around a public park protects children, as well as other vulnerable persons, from firearm violence. The State merely speculates that the proximity of firearms within 1000 feet threatens the health and safety of those in the public park.”

The principle that mere speculation does not suffice to justify abridgment of a constitutional right might seem self-evident. But other courts do not seem to agree, since they have upheld arbitrary restrictions on the right to carry arms in public and bans on wildly popular categories of firearms based on about as much evidence as Illinois offered in defense of the law that tripped up Julio Chairez.

A decade ago, the U.S. Supreme Court recognized that the Second Amendment protects an individual right to arms, which it said includes the right to keep usable guns in the home for self-defense. Since then the Court has said nothing to clarify whether that right extends beyond the home or how strong a reason the government needs to restrict it. If Illinois appeals this decision, the Court will have yet another opportunity to weigh in on those crucial questions.

In his State of the Union address this week, President Trump urged Congress to pass right-to-try legislation that would allow patients suffering from terminal illnesses to access new drugs and other treatments that have undergone preliminary Food and Drug Administration (FDA) safety trials, but have not yet been shown to be efficacious in clinical trials. It’s a good start. But it’s no substitute for a top-down overhaul of the agency’s entire process for testing and approving new drugs.

Traditionally, patients only get access to new drug treatments once they are approved by FDA after passing through three phases of clinical trials. The goal of phase 1 trials is to test new compounds for patient tolerabilty and safety. Typically 20 to 100 patients participate in Phase 1 trials. Phase 2 trials aim to determine proper dosage levels for new treatments while also checking for further evidence that the new compound is safe and possibly efficacious. Several hundred patients may be enrolled in Phase 2 trials. Phase 3 trials focus on efficacy and monitor for adverse reactions and may involve thousands of participants. In Phase 3 trials, the efficacy of new medications is often benchmarked against current treatments.

One recent report estimates that only 1 in 10 new drugs that enter clinical trials are eventually approved by the FDA. It is noteworthy that only 31 percent of drugs that currently enter Phase 2 studies go on to Phase 3 trials. In other words, more than two-thirds of biopharmaceuticals that pass through Phase 1 safety trials end up being deemed insufficiently efficacious as treatments for the diseases at which they are targeted.

So far, 38 states have passed right-to-try legislation. Since drugs and medical treatments are regulated at the federal level, state laws so far have had little apparent effect on enabling patients gain access to experimental treatments. Consequently, right-to-try proponents want Congress to pass legislation that would allow patients with terminal illnesses to seek access to experimental drugs that have passed through Phase 1 safety trials.

Many drugmakers have been reluctant to offer treatments not yet approved by the FDA on a right-to-try basis for fear being sued by patients or their heirs should bad outcomes occur. In addition, they worry that any adverse events among right-to-try patients would delay eventual FDA approval. Consequently, the proposed federal legislation provides that the makers of experimental drugs could not be held liable by patients for any untoward outcomes and that FDA regulators would be barred from taking into account the results of right-to-try treatments when reviewing such drugs for approval.

Opponents of right-to-try legislation fear that it would enable unscrupulous practitioners to sell the moral equivalent of snake oil to desperate people. In addition, opponents point out that the FDA already has a compassionate use program that allows patients and their physicians expanded access to investigational drugs.

New FDA administrator Scott Gottlieb recently announced changes that aim to speed up the process of providing access to drugs and devices for patients with serious conditions (generally prior to product approval), when there is no therapeutic alternative.

In addition, the agency provided guidance to drugmakers clarifying that suspected adverse reactions from experimental treatments administered on a right-to-try basis must be reported “only if there is evidence to suggest a causal relationship between the drug and the adverse event.” The FDA does also note that greenlighting access to experimental treatments does not require drugmakers to provide them to patients.

Right-to-try is at best a band-aid. Comprehensive reform of the clinical trial process is a better and cheaper way to speed new medications to the bedsides of patients. As I have earlier argued:

The FDA should be modernized so that new treatments become available to patients once they have made it through the Phase II safety testing. Patients who choose the new treatments would essentially be enrolled in Phase III efficacy trials. This would drastically cut the time and the expense it takes to get new medicines to people.

I am not alone in urging this reform of the drug approval process. In a February 14, 2012 Wall Street Journal op-ed, former FDA Commissioner Andrew von Eschenbach argued that “after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.” Elsewhere von Eschenbach pointed out this FDA reform would mean that new drugs could…

…come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required. Payers and patients would be the ultimate judge about the quality of the product, and companies could learn from the experience to develop superior products if needed.

Companies would still be liable for unforeseen side effects, but patients and doctors would be warned — through the drug’s labeling — that the product had been approved based on promising but provisional research.

Gradually replacing or reducing dependence on Phase 3 trials with smaller, faster adaptive trials and post-market surveillance would have a positive impact on medical innovation and the U.S. economy….

Ultimately, the molecular bases of health and illness will be unraveled later in this century, at which point the hit-or-miss process of using clinical trials to evaluate medicines will be superseded by precisely targeted individualized treatments.

This morning the White House cleared House Intelligence Committee Chair Devin Nunes (R-Calif.) to release “The Memo,” a document that contends that officials within the Department of Justice deliberately concealed the politically motivated origins of the information behind its surveillance of a Donald Trump advisor during the presidential election.

The highlights:

• The memo says that FBI officials knew that the infamous “Steele dossier” used to get permission by the Foreign Intelligence Surveillance Court to snoop on adviser Carter Page had been partly funded through a research firm (Fusion GPS) connected to the Democratic National Committee and Hillary Clinton’s campaign. They concealed this information from the court.
• The memo says that some additional information included in the warrant application used to corroborate the “Steele dossier” also actually came from Steele himself that Steele leaked to Michael Isikoff at Yahoo News.
• Steele was in regular contact with Bruce Ohr, a top DOJ official who really, really didn’t want Trump to be elected and said so. The memo claims Ohr’s wife assisted in the Trump opposition research used by Fusion GPS.
• Deputy Director Andrew McCabe (who announced his resignation earlier in the week) told the Intelligence Committee in December that a surveillance warrant would not have been sought without the Steele dossier.

(The full response from the White House and the memo will be embedded below the fold.)

Remember that this is one party’s description of what happened with the warrant. The underlying intelligence contained in the warrant application and the warrant itself has not been released.

It’s also worth the memo’s claims in context. Carter Page’s ties to Russia were well-known by intelligence officials before he was ever involved with Trump’s campaign. And one of the surveillance requests submitted to the court happened in October, after Page’s contacts with Russian officials had publicly reported and he stepped down from the campaign. And courts have typically ruled that it’s not necessarily disqualifying if the evidence used for a warrant comes from biased sources.

Arugably, what’s been exposed here is an investigation of Page, not surveillance of the Trump campaign itself or even allegations that Trump himself did anything wrong. This, interestingly enough, is exactly what FBI Director James Comey even told Trump before eventually getting fired.

More is going to play out from this, but from my perspective so far, I don’t see a smoking gun in any particular direction. This memo doesn’t seem to provide any coherent evidence that this investigation of Page was actually a plot to get at Trump. And neither does any of this suggest that Trump himself was engaged in any wrongdoing.

Read the memo for yourself below, and response from ranking Democratic member of the Intelligence Committee, Rep. Adam Schiff:

FISAWarrant by Scott Shackford on Scribd

Schiff responds:

Lengthy response from @RepAdamSchiff on The Memo: pic.twitter.com/SS1oJa1Guu

— Sahil Kapur (@sahilkapur) February 2, 2018

UPDATE: House Speaker Paul Ryan (R-Wis.) defended the release of the memo and said it detailed possible violations of the civil liberties of Americans. It’s worth noting that Ryan just last month voted to renew and expand the authority of the Foreign Intelligence Surveillance Act Amendments to secretly snoop on American citizens.

Speaker Paul Ryan, in a statement, defends the release of the Nunes memo but also calls for the release of the memo prepared by Democrats on the intel committee. pic.twitter.com/V81EYW5vys

— Tamara Keith (@tamarakeithNPR) February 2, 2018

But, hey, he’s also calling for the release of the Democrats’ own memo.