Category Archives: Op-Eds

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

The Amazon is Not Enough to Hold James Bond

A James Bond filming location in Phang Nga Bay, Thailand. Photo by CEphoto, Uwe Aranas.

“Even James Bond Needs Protection” warned John Logan, whose pen helped create the fictional spy’s most recent cinematic adventures, in a New York Times guest essay on June 2. Is Bond menaced by Vladimir Putin’s Russia reviving the KGB, or perhaps a betrayal by his American sidekick Felix Leiter under orders from the CIA? Or is he finally taking precautions against contracting an STD?

The three-letter words in the new threat are instead “WWW,” “dot” and “com.” To be sure, Amazon.com, Inc. may not have the lairs in the Amazon river basin and outer space of Bond movie villain Hugo Drax. But its mastery of international distribution chains and communications satellite networks has given it the power to reduce Bond’s formerly regal home studio, MGM, to just another sideshow under its big tent of products.

Drax eventually conceded to his nemesis: “Mr. Bond, you defy all my attempts to plan an amusing death for you.” Logan instead fears that Amazon’s “lawyers and accountants and e-commerce mass marketing pollsters” will be the end of Bond creatively.

MGM was always more commercial than the “art for art’s sake” of its motto, but it granted Eon Productions the breathing room to lavish time and money on efforts that could eventually recoup their budgets and plenty more — and to find their own ways of incorporating trends that seemed to be supplanting Bond in popular culture. The filmmakers could take an extra year or three to fine-tune Bond’s next big-budget blockbuster, and neither MGM nor Nintendo rushed video game developer Rare out of taking two years past GoldenEye‘s premiere to get its version right.

Eon has also avoided the temptation to dilute Bond with the “endless anemic variations” Logan worries that “corporate and commercial pressures” will make inevitable.  Bond creator Ian Fleming was so incensed by The Harvard Lampoon‘s “J*mes B*nd” parody Alligator that he demanded his estate never give its authors permission to officially use the character. MGM faced a raft of copycats and a couple of non-Eon Bond movies exploiting legal loopholes, but limited authorized variants to James Bond Jr., who Times reporter Caryn James found “amusing for five minutes” on Cartoon Network in 1995.

Yet it is worth noting that the same market forces which built Amazon can hold it to account far more firmly than any antitrust lawsuit. Science fiction writer Thomas M. Disch saw the “forty feet of shelf space devoted to Star Trek books” at his local Barnes & Noble as proof that “an age of franchises” was crowding out an audience for original genre novels in 1998, the year Harry Potter would cross the Atlantic to become the most popular British hero in the USA since Bond.

The World Wide Web may not be enough for Amazon, but without a charter to squelch or subsidies to outcompete alternatives, there will always be room outside the company’s tributaries for those who have had enough of it.

New Yorker Joel Schlosberg is a contributing editor at The William Lloyd Garrison Center for Libertarian Advocacy Journalism.

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