With distressing frequency, the Food and Drug Administration rejects safe drugs it says haven’t demonstrated enough efficacy. These pages documented the FDA’s recent rejection of Replimune’s melanoma drug RP1, a case in which the agency seemed confused about key facts and failed to apply good judgment.
Here’s a solution: Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives.
Medicine is a matchmaking exercise in which potentially beneficial drugs are tested patient by patient, using trial and error. Clinical trials, while useful, don’t tell us which patient will respond to which medication. Consider anticoagulants, which reduce blood clots. Some patients respond to Pradaxa but not Xarelto, and vice versa.
No drug works for everyone. Only antibiotics, vaccines, insulin, anesthetics and direct-acting antivirals for hepatitis C come close. The top-selling drug in the world, Merck’s Keytruda, helps little more than a third of melanoma patients.
That’s where trial and error comes in—but only if the FDA approves the drug. If a new drug helps 10% of patients, that drops to zero if the FDA rejects it. If the FDA were to focus on safety, the question of efficacy would be left entirely to the medical community to answer.
Safety and efficacy are fundamentally different. Lack of safety kills. Lack of efficacy requires trying a different drug.
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Drug approvals became much slower and more expensive. Why? Roughly one-fourth of drug development costs are to demonstrate safety while three-quarters are for efficacy. The cost of the FDA’s efficacy requirement is tremendous, and the value is close to zero. If the FDA went back to its pre-1962 rules, Americans would live longer and healthier lives.
Jason Riley, writing at City Journal, busts currently popular, sophomoric myths about America and slavery. Two slices:
Slavery was neither central to America’s founding nor the primary source of the country’s subsequent prosperity. Yet both ideas have gained currency in recent years, making it likely that the nation’s slaveholding past will figure prominently in commemorations of the 250th anniversary of American independence.
Scholarly studies offering a more accurate and balanced history of slavery in the United States are not impossible to find, but they are far outnumbered by ideologically driven treatments that downplay the institution’s ubiquity across the world and throughout history. Often the aim is less to illuminate a complex subject than to emphasize the sins of the West. As a result, what should be understood as a global evil is reduced to a single narrative: Europeans and their descendants enslaving Africans—in the Western Hemisphere generally, and in the southern United States especially. End of story.
The reality is that slavery has existed since time immemorial. It has taken many forms—field hand, domestic servant, soldier, artisan, concubine—and has been practiced on every continent. “There is no region on earth that has not at some time harbored the institution,” Harvard sociologist Orlando Patterson writes in the preface to Slavery and Social Death, his landmark study. “Probably, there is no group of people whose ancestors were not at one time slaves or slaveholders.” Ancient Greece and Rome were slaveholding societies, as were medieval Europe, Africa, China, Southeast Asia, the Islamic kingdoms, the Caribbean islands, and pre-Columbian America.
Nor were the magnitude and savagery of slavery in the New World unprecedented, despite recent efforts to slant the historical narrative in that direction.
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The economist Deirdre McCloskey also challenged the authors’ claim that capitalism in the West is an outgrowth of slavery. Yes, raw cotton produced by slave labor was an important commodity in the South, but the “enrichment of the modern world did not depend on cotton textiles,” McCloskey wrote. “Cotton mills, true, were pioneers in some industrial techniques, techniques applied to wool and linen as well. And many other techniques, in iron making and engineering and mining and farming had nothing to do with cotton. Britain in 1790 and the U.S. in 1860 were not nation-sized cotton mills.” Plantation slavery “made a few Southerners rich; a few Northerners, too. But it was ingenuity and innovation that enriched Americans generally.” And, contra Marx, slave labor wasn’t essential to cotton production, noted McCloskey. “By 1870, freedmen and whites produced as much cotton as the South produced in the slave time of 1860.”
A review of the Baptist, Beckert, and Johnson books by two economic historians, Alan Olmstead and Paul Rhode, took no issue with the authors’ broad claims about slavery’s legacy of social inequality and frayed race relations. “However, to agree that slavery was important and evil does not mean that it was economically essential for the Industrial Revolution, for American prosperity, or even to produce cotton in the United States.” They add that the three authors’ “new history of capitalism” makes “spectacular but unsupported claims, relies on faulty reasoning, and introduces many factual inaccuracies.”
Logan Tantibanchachai wisely refuses to swallow the tales told by Hasan Piker and his ilk.
Wall Street Journal columnist Gerard Baker urges his fellow Americans to take pride in the U.S. – a country which, despite its many warts, is indeed one worth celebrating. Here’s his conclusion:
I can’t do much about this cold civil war. But as an immigrant, perhaps I’m better placed than others to make the case that America’s greatness far outweighs its faults. The U.S. economy remains the envy of the world; its capitalist system is pushing out the frontiers of technology in ways that will transform lives and enhance our already world-beating prosperity. It remains a beacon of opportunity for almost the entire world. Most remarkable isn’t that our liberal values are again under attack, but how long and how firmly they have endured. Americans embarked on a wild experiment to preserve and advance liberty 250 years ago. How many other countries’ institutions that were around in 1776 are recognizably the same today?
This isn’t a call to complacency: We are all familiar enough with the mistakes America has made and continues to make to know that supremacy isn’t guaranteed. But you would have to be incredibly ignorant to believe that the accumulated genius of America won’t survive a flawed president or three, or a bout of cultural self-loathing,
If none of this persuades you of the intrinsic greatness of this country, my fellow Americans, then at least use this historic moment to take a holiday from the bad stuff. If the British in the 1970s, a byword for national decline and institutional collapse, could find a way to celebrate what their country stood for, perhaps by focusing briefly on America’s virtues more than its vices, you’ll get a better appreciation for what it is.
Take pride in your country, America. Despite 250 years of trying, no one has been able to come up with a better one.
Is it an advantage, however, for a nation to set up manufactures on its own territory which, in order to furnish it with a certain money income and quantity of production, absorb more funds than the purchase of these products would have required? We can reply in the affirmative only in supposing that if these funds were not thus employed, they would not be employed at all. Now, this supposition is clearly absurd. If these funds were not employed in this way, they would be employed in some other way and more advantageously. This is to say that with a portion of these resources one would buy products which the whole lot of them is now used in producing, while the remainder would be redirected to some other branch of production which it would vitalize. Governments, in forcing their subjects to manufacture themselves things they would not voluntarily have manufactured, force them to employ their resources inefficiently. They diminish the output of their capital and their labor. They therefore diminish their wealth and thereby the national wealth.
Tollison saw few differences between antitrust law enforcement and the perhaps more familiar industry-specific regulation of prices and entry conditions (e.g., public utilities). Both are vulnerable to influence by well-organized, politically powerful special interests having stakes in policy processes and, in catering to such lobbying pressure, undermine rather than promote competition.
Paul Krugman enthusiastically tweeted about Thaler’s prize: “Yes! Behavioral econ is the best thing to happen to the field in generations.” Thaler gives Paul and the other plausible illiberals another reason to recommend bossing people around. For their own good, you understand.
In civilized society it is indeed not so much the greater knowledge that the individual can acquire, as the greater benefit he receives from the knowledge possessed by others, which is the cause of his ability to pursue an infinitely wider range of ends than merely the satisfaction of his most pressing physical needs. Indeed, a ‘civilized’ individual may be very ignorant, more ignorant than many a savage, and yet greatly benefit from the civilization in which he lives.
