Yes and No

Just one example on the matter of drug approvals.

A case in point is Replimune’s melanoma treatment, which the FDA rejected last month. About a third of patients who hadn’t responded to prior immunotherapy showed a strong response to Replimune’s in a clinical trial.
Tumors shrank in nearly all patients, and responses proved durable over three years. Serious side effects were rare. Oncologists who treated patients in the trial hailed the results.

These are responses in absolute terms. The drug was safe, and it worked.

The FDA blocked its release into the market though:

[T]he FDA said the trial was “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.”
Its quibble is that the trial lacked a control group.

This is a demand for a relative outcome—whether the drug worked better or worse, and whether it was safer or less so, than the status quo. The status quo is what a control group presents.

The answer, though, is not to stop “quibbling” about control groups when assessing drug trial efficacy. Instead, it’s necessary for the FDA to get out of the business of requiring, as a condition of approval, that a drug work. FDA’s role should hold out only for assessing a drug’s safety. The market, formed by patients and their doctors, will do a perfectly fine job of assessing the drug’s effectiveness, with no more exceptions than are extant in any other market. That Replimune’s drug was shown to work in absolute terms is a happy additional outcome and should not represent even this much of an acceptance criterion.

This is where FDA Commissioner and medical doctor Marty Makary can—and should—make the changes to the FDA’s approval processes. A doctor’s primary injunction is “first, do no harm.” So it should be with the FDA. A doctor continues, with his patient, actively to treat the medical problem. The FDA, on the other hand, should stop at the do no harm part. Let the practicing doctors and their patients do the rest.

Not Entirely Sufficient

Harvard University and the Federal government apparently are nearing a deal that would pressure Harvard to abide by federal regulations around merit-based hiring and admissions as well as protecting students’ civil rights in return for a $500 million payment to “workforce and vocational programs.”

Pressure only, though, no overt, absolute requirement.

The administration wouldn’t appoint a monitor to oversee Harvard’s compliance with the deal. The university would pledge to continue to abide….

That’s a serious weakness in the supposed deal. Harvard’s management team already isn’t abiding by those regulations, and it already isn’t protecting its students’ civil rights—much less better reducing the school’s antisemitic bigotry and its pro-terrorist stance. Since it’s not doing, it can’t be continuing.

An addition to this deal is needed: Harvard should be required to put up a cash bond, say $500 million, for 10 years against its performance of its pledge. At the end of those 10 years, should the university actually have abided, the principal would be returned, and the accrued earnings on the principal paid to those workforce and vocational programs.

Abandonment of Duty, Attempt at Tyranny

Texas Governor Greg Abbott (R) has asked the Texas Supreme Court to remove State Congressman Gene Wu from office and declare his seat vacant. Wu is the Texas House Democratic Caucus Chair and one of 57 Progressive-Democrats who ran out of Texas for the explicit purpose of denying the Texas legislature a quorum and thereby prevent it from operating at all.

Abbott’s argument centers on this [citations omitted]:

Every elected officer of this State, including Wu, swears an oath to “faithfully execute the duties of the office” to which they are elected. The principal duty of a legislator is to attend and participate in legislative sessions as required by Article III, Section 5 of the Texas Constitution. The quorum provisions further underscore that attendance is not optional; it is an affirmative constitutional obligation. The Texas Constitution authorizes the House to “compel attendance of absent members.” That power would be meaningless if members could freely make themselves absent for political advantage without consequence. Such actions also render meaningless the Governor’s authority to call a Special Session, for which the Legislature “shall meet.”
Representative Wu has openly renounced these constitutional mandates by fleeing the State of Texas to break quorum, obstruct legislative proceedings, and paralyze the Texas House of Representatives.

Wu answered via television interview (he doesn’t have to respond to the filing until late this afternoon).

Let me be unequivocal about my actions and my duty. When a governor conspires with a disgraced president to ram through a racist gerrymandered map, my constitutional duty is to not be a willing participant.
Denying the governor a quorum was not an abandonment of my office; it was a fulfillment of my oath. Unable to defend his corrupt agenda on its merits, Greg Abbott now desperately seeks to silence my dissent by removing a duly-elected official from office.

Aside from the fact that Wu’s irrelevant ad hominem inclusion illustrates the intellectual bankruptcy of his position, his oath of office requires him to obey his constitutional duty to appear in the State Congress when it is in session. There is no leeway for absenting himself solely because he disagrees with the outcome of a policy debate and ensuing vote—most especially is there no leeway for absenting himself as part of an effort to prevent that vote from occurring.

That he’s part of Party’s movement to block a single piece of legislation, a redistricting bill, from being acted on is merely the narrow, proximate implication of his action.

The question here, though, is much larger than a single disputed piece of legislation; it embraces the nature and basis of democratic governments. In a democracy, especially in a republican and representative democracy such as ours, there are those who win in a policy contest and those who lose. The foundation of (representative, republican, even popular democracy) requires that the defeat be accepted by those in the minority and that those who lost are free to try again in a succeeding, even later renewed, policy debate but are not free to shut off all legislative capacity unless and until they, this minority, get their losing position fully accepted.

Texas’ Progressive-Democratic Party politicians who are deliberately shutting down the Texas government, denying it its ability—its obligation—to legislate, are not filibustering a single piece of legislation in an effort to block its passage. Their behavior is categorically different from that. These persons are not just violating their oaths of office. They are attempting to impose, from their minority position, their demands on an entire government at the cost of no functioning government absent the majority acquiescing to them. This is the stuff of tyranny, and thus their preventing a quorum is antithetical to democratic principles. All of them should be removed from office.

Abbott’s filing can be read here.

I Have another Question

FBI Director Kash Patel has uncovered burn bags/room filled with hidden Russia Gate files, including the Durham annex.

Regardless of the current disposition of those bags’ contents (Patel is declassifying them and intends to release them), my question is this: what level of negligence has it been that those burn bags have not been burned and still exist after all these years?

While it’s presently convenient that those burn bags remain unburned so their contents can be released after suitable (limited) redacting, the negligence is a threat to our nation’s security. The individuals responsible for that security negligence need to be identified and fired for cause.

I Have a Question

In partial response to President Donald Trump’s (R) refusal to pay Progressive-Democrats $1 billion in released foreign aid and NIH funding—variously a bribe or an extortion payment, depending on who’s talking—in order to get Party Senators to agree to speed up the nomination confirmation process that Party has been busily stonewalling, Senate Minority Leader Chuck Schumer (D, NY) had this:

Sooner or later, Donald Trump—Mr “Art of the Deal,” or so he claims—is going to have to learn that he has to work with Democrats if he wants to get deals, good deals, that help the American people[.]

My question, and the answer illustrates the intrinsically partisan and obstructionist nature of Party, is this: when will “Democrats” work with Trump? When will “Democrats” work with Republicans generally? Party’s determined refusal to do so is harming us American people about whom Schumer and his Party so piously pretend to care.