All posts by Thomas L. Knapp

After COVID-19 Fiasco, a Sign of Internal Reform at FDA?

Photo by US National Institute of Allergy and Infectious Diseases
Photo by US National Institute of Allergy and Infectious Diseases

On June 7, the US Food and Drug Administration granted “accelerated approval” to Biogen’s new Alzheimer’s medication, aducanumab, two years after the company halted its first set of Phase 3 clinical trials over “disappointing” results. Accelerated approval is based not on the usual required finding that a drug is proven “effective,” but instead on a finding that it is “reasonably likely to predict a clinical benefit.”

The decision comes with some  controversy. FDA advisor Dr. Caleb Alexander is “surprised and disappointed” by the decision, saying he thinks the FDA “gave the product a pass” despite lacking good evidence for its efficacy.  Dr. Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research acknowledges “residual uncertainties,”  but holds that “the data supports patients and caregivers having the choice” to try aducanumab.

In a free society, FDA would have no authority to come between doctors, patients, and medical treatment choices in the first place.

Private certification mechanisms,  like those provided by Underwriters Laboratories for electrical equipment, would almost certainly do a better and cheaper job of ensuring the safety and efficacy of medications and treatments. Doctors, insurers, and most patients would likely heed the findings of such mechanisms.

As for those who choose “alternative medicine,” home remedies, and even potentially dangerous black market drugs, they already make those choices now, regardless of what FDA says, and they would likely continue to do so.

Nonetheless, “accelerated approval” of  aducanumab is a good sign and hopefully the beginning of a trend.

FDA foot-dragging has likely killed tens of thousands of patients every year for decades. It takes far too long and costs far too much to get government approval of life-saving medications. From beta blockers to human body glue, Americans have paid for FDA’s skewed incentives and bureaucratic delays with their lives.

That continuous but largely unnoticed cost became, tragically, much higher and much more obvious last year. More than 300,000 Americans — including my mother — died in the six-month interregnum between Moderna’s COVID-19 vaccine  establishing its basic safety and FDA finally granting an emergency use authorization.

We’ll never know how many departed friends and loved ones might still be with us if FDA had applied a “reasonably likely to predict a clinical benefit” standard to medications we count on today but had to wait years for.

Can FDA make itself more useful and less deadly? Only time will tell. Here’s hoping the answer is yes.

Thomas L. Knapp (Twitter: @thomaslknapp) is director and senior news analyst at the William Lloyd Garrison Center for Libertarian Advocacy Journalism (thegarrisoncenter.org). He lives and works in north central Florida.

PUBLICATION/CITATION HISTORY

A Convention of States Wouldn’t Fix the US Constitution

Washington at Constitutional Convention of 1787, signing of U.S. Constitution. Painting by Junius Brutus Stearns. Public Domain.
Washington at Constitutional Convention of 1787, signing of U.S. Constitution. Painting by Junius Brutus Stearns. Public Domain.

The Convention of States Project seeks, as its name reflects, a convention of states as provided for in Article V of the US Constitution. Such a convention, CPS claims, would “only allow” discussion of amendments that “limit the power and jurisdiction of the federal government, impose fiscal restraints, and place term limits on federal officials.”

The magic number of states for calling a convention  is 34. According to a map on the CPS site, 15 states have passed the required resolution, while one legislative chamber has passed it in nine, and another 16 have “active legislation” on the matter. So, while it may or may not happen, it’s certainly a live proposal.

The idea comes with quite a few problems.

One is that such a convention would decide for itself what it was “allowed” to do, just as the first such convention exceeded its own mandate (it was only “allowed” to propose amendments to the Articles of Confederation, but instead proposed replacing those Articles with the Constitution).

A second problem is that (fortunately, vis a vis the first) it’s unlikely that the states would be able to agree on much at all.

A third problem is that even if they did agree in convention, it’s unlikely that 3/4 of the states would ratify term limits or fiscal restraints. Every state legislator sees a future US Representative, Senator, or president in the mirror each morning, and they all tend to a (secret, contradicting their campaign rhetoric) variant on St. Augustine’s prayer:  “Give me chastity and continence, but not right now.”

The biggest problem, though is that a constitution is, even at its very perfected best, only as good as adherence to that constitution.

Why do supporters of an Article V convention expect the US government would obey the proposed amendments any more than it obeys the existing document?

“In questions of power,” Thomas Jefferson wrote in 1798, “let no more be said of confidence in man, but bind him down from mischief by the chains of the Constitution.” Three years later, Jefferson was President of the United States.  Five years later, he proved himself (and Congress) unbound by those chains with the Louisiana Purchase, an act provided for nowhere in that Constitution.

In 1870, American anarchist Lysander Spooner observed that “whether the Constitution really be one thing, or another, this much is certain — that it has either authorized such a government as we have had, or has been powerless to prevent it.”

“In either case,” Spooner concluded, “it is unfit to exist.”

I’m skeptical of the notion that political government can ever be forced to limit its own power and prerogatives. The history of the United States tends to justify that skepticism.

Absent evidence that America’s rulers can be bound down from supposedly forbidden mischief by the chains of the existing Constitution, attempting to amend that Constitution seems more like an eccentric hobby — on the order of building model UFOs or collecting rare tuna cans — than a serious attempt to secure our rights and defend our liberty.

Thomas L. Knapp (Twitter: @thomaslknapp) is director and senior news analyst at the William Lloyd Garrison Center for Libertarian Advocacy Journalism (thegarrisoncenter.org). He lives and works in north central Florida.

PUBLICATION/CITATION HISTORY

Joe Biden’s a Big Spender, But Not Quite Big Enough for Republican “Defense” Scammers

F-35 Lightning II variants in flight near Eglin AFB in 2014. Photo by U.S. Air Force photo by Staff Sgt. Katerina Slivinske. Public Domain.
F-35 Lightning II variants in flight near Eglin AFB in 2014. Photo by U.S. Air Force photo by Staff Sgt. Katerina Slivinske. Public Domain.

US President Joe Biden rolled out his 2022 federal budget request on May 28, surprising no one with his proposals for lavish expenditures on education, healthcare, and infrastructure, or with his promise that only the rich will be soaked to pay for it all (the $1.8 trillion projected deficit will be borrowed in your name, but you’re not supposed to notice).

Given that the US is drawing down its 20-year war in Afghanistan, one might expect some kind of peace dividend on the mis-named “defense” line of the proposal, but no such luck.

Biden proposes an increase of “only” 1.7%, to $715 billion, with “only” eight new warships instead of the 12 called for in the Navy’s shipbuilding plan. Biden also wants to “invest” in 85 more F-35 Lightning combat aircraft, one of the US “defense” industry’s favorite white elephants.

“Wholly inadequate!” complain US Senator James Inhofe (R-OK) and US Representative Mike Rogers  (R-AL), ranking members on their respective houses’ Armed Services Committees.

US Senator Lindsey Graham (R-SC) calls the general budget proposal “insanely expensive,” but also gripes that “over time it will result in a weakened Department of Defense.”

In mid-May, anticipating the possibility that Biden might not offer to forklift much larger pallets of new cash into “defense” contractors’ getaway trucks, US Representative Liz Cheney (R-WY) declared that failing to increase US military spending by 3-5%, above and beyond inflation, would be a “red line” for Republicans.

Let’s be clear on one thing: The US “defense” budget has little to do with defense. If it was really about defense, it could be cut by 90% and still be bloated.

The US “defense” budget is about two things: Redistributing wealth from your wallet to the bank accounts of “defense” contractors, and trying unsuccessfully to rule the world.

On the former front, if it was really  about defense, US Coast Guard ships would be patrolling the US coast, not the Iranian coast, and a much smaller force of US military personnel would have spent the last 20 years in places like Texas and Vermont rather than in Iraq, Afghanistan, Somalia, Syria, etc.

On the latter front, it’s no coincidence that, as Reuters reports, “Senators and governors have come out to support the[F-35] which has a huge industrial base.” That is, a base of generous campaign contributors who also create artificial “jobs” in the Senators’ and governors’ states, building something for which there’s no real market demand but which you can be forced to buy whether you want it or not.

“All the armies of Europe and Asia,” Abraham Lincoln said in 1838, “could not by force take a drink from the Ohio River or make a track on the Blue Ridge in the trial of a thousand years.” He was right then, and even with an actual defense budget one tenth the current size of the military budget, he’d be right today.

The US “defense” budget is a transparent scam.  It’s disappointing, but not especially surprising, that Joe Biden is an only slightly less aggressive con artist than his Republican counterparts.

Thomas L. Knapp (Twitter: @thomaslknapp) is director and senior news analyst at the William Lloyd Garrison Center for Libertarian Advocacy Journalism (thegarrisoncenter.org). He lives and works in north central Florida.

PUBLICATION/CITATION HISTORY