The faulty products--hip replacements and vaginal implants--were made by Johnson & Johnson. Problems with the devices "sparked thousands of patient lawsuits," so the FDA wants to "prevent repeats" by acquiring more power to block what it judges to be "unsafe products" like these.
But a handful of government bureaucrats have no right to block any products from entering the market, which already provides a remedy for customers who believe they have been harmed by faulty products--the civil court system. One of the government's proper roles is to mediate contractual disputes, which is exactly what is happening in the J&J cases.
Courts are an objective venue for settling such disputes, and for establishing legal guidelines to govern future contractual arrangements, including product sales. In the meanwhile, the company should be free to decide whether to continue to market the product, and doctors and patients have a right to examine all of the available information and then decide whether they want to use the product.
The government has no right to interfere in whatever mutual contractual choices manufacturers, doctors, and patients make in the marketplace, based on its own concept of what constitute a "safe" product.
Indeed, the FDA’s zeal for “safety” stymies medical entrepreneurship, with devastating results. Julie Crawshaw, citing Scott Gottlieb, a former Food and Drug Administration deputy commissioner, reports that government overregulation causes many unnecessary deaths in America.
“As evidence,” Crawshaw writes, “Gottlieb points to a tiny catheter approved and used in Europe [since 2007] to replace a deteriorated aortic in lieu of ... open-heart surgery...” An FDA advisory panel didn’t recommended approval until July 2011, Crawshaw reports, and as of October the device was still not available in the U.S. "Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery, have died during the intervening four years." In the name of “safety,” the FDA blocks products that might be a risk, even if the patient’s alternative is death.
This case is the tip of the iceberg. About 15 years ago, as CATO noted in a report:
By a conservative estimate, FDA delays in allowing U.S. marketing of drugs used safely and effectively elsewhere around the world have cost the lives of at least 200,000 Americans over the past 30 years. That figure does not include deaths that might have been prevented by the use of drugs such as Prozac, which is associated with the decline in suicides of individuals suffering from depression. FDA regulations denying Americans timely access to new drugs have extracted a high cost in health and lives.
That's just drugs, and only up until the mid 1990s. The toll is much higher today--and potentially vastly higher in the future. Steve Forbes notes that crushing FDA regulations are crippling the development of new antibiotics at a time when drug-resistant bacterial infection is on the rise, potentially resulting a "bacterial apocalypse" the could "kill millions of us." Forbes notes:
But this play-it-safe attitude--even at the expense of human lives--is creating a devastating and potentially far more deadly impact: The pipeline for new antibiotics is drying up. Since the 1940s the miracle of penicillin and its relatives has saved tens of millions of lives. Antibiotics easily conquered such illnesses as pneumonia and tuberculosis, which routinely killed countless numbers of people each year. Bacteria, of course, can become drug-resistant, but for decades pharmaceutical companies, especially in the U.S., routinely came up with new antibiotics to fell new killer germs. Now, however, the flow of new stuff has dried to a trickle.
Yet, politicians and government bureaucrats ignore the evidence, demanding wider powers over private industry.
But, rather than award the FDA more power to delay or block the sale of medical devices, which violates the rights of manufacturers to freely market their products, it should be stripped of that power. In its place, as Stella Daily Zawistowski explains, “the drug-monitoring equivalent of Underwriters Laboratories (UL) in electronics or A.M. Best in insurance” would arise in the private sector, and “do the job [of evaluating product safety and efficacy] far better than the FDA.” The same would be true of medical devices.
Armed with research from such private watchdog agencies, past court findings, and in consultation with their doctors and families, patients are perfectly capable of balancing risks and rewards of medical devices, and judging accordingly. More importantly, the decision is morally and rightfully theirs. A properly restructured FDA, or one folded into another government entity, can and should provide protection against, and prosecution of, any unscrupulous manufacturer who fraudulently misrepresents its product.
The house bill should be defeated. Instead, we should demand the elimination of the loopholes of statism that empowers the FDA to violate the rights of American citizens to pursue or market medical devices or other healthcare products based upon their own rational judgements.
[Related NOTE: In "Loophole": Anti-euphemism of Statism, The Objective Standard's Craig Biddle--citing an article by Jack Shafer and the observations of philosopher Ayn Rand--explained the insidious nature of today's use of the term:
"To what facts of reality does the word “loophole” refer as used by the media in this context? It denotes various means by which people are still free to act on their own judgment; it specifies aspects of life in which individual rights are not yet being thoroughly violated by the government. In other words, it names a wonderful yet rapidly diminishing thing called freedom—which users of the term “loophole” seek to smear as corrupt."]
For more, see:
Life and Liberty vs. the FDA

Posted by Michael A. LaFerrara on
In Bain And Our Screwed-Up Culture, liberal columnist Froma Harrop recently took a pot shot at Bain Capital, Governor Romney's former private equity firm. I culled this bit for commentary:
Let's talk about capitalism. Granted, self-interest fuels the "animal spirits" that create our great business enterprises. Because the benefits of capitalism flow down to society at large, we are often at pains to divide ethical behavior from the other kind. Sometimes labor costs must be cut to stay competitive. Not every factory can be saved. And Bain apologists argue with some merit that the companies acquired were in trouble to begin with.My commentary:
Yes, indeed, "let's talk about capitalism."
Since self-interest fuels the creation of "our great business enterprises," what does that tell you about which side of the ethical "divide" self-interest inhabits? Business--large and small, great and modest--is the core of capitalism that creates all of the goods and services our lives depend upon. What does that tell you about capitalism, the only social system that liberates all individuals--"society at large"--to pursue their own self-interest, by inalienable right?
It tells you that capitalism--properly understood as the separation of economics and state rather than the mixed economy we have now--is the moral social system, because self-interest--properly understood--is the life-giving moral ideal. "The benefits of capitalism flow down to society at large" because successful business enterprises are saturated with self-interest, from the owners who pursue profits, to the investors and lenders who supply capital, to the employees who choose to fill the jobs they create, to the suppliers they buy from, to the customers who buy its products.
Doing what is truly self-interested requires virtues such as sound judgment, honesty, integrity, long-range planning, self-discipline, the ability to engage constructively with others, and so on--in other words, a commitment to rationality. After all, chasing after instant gratification without regard for long-term consequences is hardly in one's self-interest. It is self-destructive, and self-destruction has never built anything, let alone a successful business enterprise.
What's screwed-up is our culture's understanding of self-interest as morally corrupt, and of capitalism as a necessary evil.
One more juicy bit from Harrop, which I can't resist:
OK, but if a company is in trouble, do you multiply its debt by a factor of 22 and immediately take out millions for yourselves? That's what Bain did at Ampad, and, sorry, "looting" is the word.This sounds like a miniaturized version of the welfare state, with its massive transfer of wealth from those who earned to those who didn't that is measured not in a few paltry millions but in the multi-$trillions of debt? If what Bain did is "looting," then the welfare state is the elephant and Bain the flea.
If Leftists are going to bring up looting, the first place they should be pointing the finger is at the person staring back from the mirror.
For more, see:
Hypocracy Left and Right
Labels: Capitalism and Free Markets, Politics 2012, Socialism

Posted by Michael A. LaFerrara on
Much has been made of the many acts defining marriage as the bonds between a man and a woman, which, as instituted by God, was described as the binding of two into one, and remaining one for life. For thousands of years, this [marriage] institution has remained that of religion, in particular our common form of marriage being of Christian descent, and in keeping with the principles first set forth by God in the Garden of Eden, between Adam and Eve. Either all who support this demanded change are fools, or they have intent to destroy what true marriage has provided us, as societies, for all the time it has been established. If they are fools, we are fools to even countenance their cries. If they do have the intent to undo what marriage un-arguably has done throughout history, we must consider them enemies of society, and deliberately destructive. Is it possible to consider this issue in any other way and be true to logic, reason, and the nature of Man?
For more, see:
Gay Marriage and Individual Rights
Message to Gov. Christie and His Critics: Gay Marriage is a Moral Right
Should a "Homosexual Contract" be called something other than marriage?
Labels: Culture, Individual Rights, Religion

Posted by Michael A. LaFerrara on
Here is the opening semtence from my latest post at The Objective Standard Blog, Soviet-Style Test Question Highlights Dangers of Government-Run Schools:
Many New Jersey parents were recently shocked to learn that their state’s standardized student test contained a asking students “to reveal a secret about their lives [and] explain why it was hard to keep.”
For more, see:
Toward a Free Market in Education: School Vouchers or Tax Credits?
What is the Purpose of Education?
By All Means, Let Parents Lead
Does Freedom Equal the Wild West?
Labels: Education, History, TOS Blog

Posted by Michael A. LaFerrara on
America’s military is unique. It fights for a set of ideas…the most radical set of ideas in man’s history. America is the first and only country founded explicitly and philosophically on the principle that an individual’s life is his to live, by unalienable right. America is the first and only country founded on the explicit principle that the government exists as servant for and by permission of the people, with the solemn duty to protect those rights; or, as Ronald Reagan put it in his first inaugural address:
We are a nation that has a government—not the other way around!
Sadly, the knowledge of what this country stands for is steadily slipping away…and along with it, our rights. Fortunately, we’re still free to speak out. So the best way to honor our military personnel, for those of us who still retain that knowledge, is to remind our fellow Americans in any small way that we can about America’s unique, noble, and radical Founding ideals.
We can still prevent “the other way around”. But we must rediscover the knowledge of, and think about, what it means to be an American. So, let us reflect on what really made this country possible.
This Memorial Day weekend, we will hear a lot about the “sacrifices” made by those who died defending America.
It is said that this nation, our freedom and our way of life, are a gift bestowed upon us by the grace of the “sacrifices” of the Founding Fathers and the fighters of the Revolutionary War. But, was it? Is it even possible that so magnificent an achievement – the United States of America – could be the product of sacrifice? As the closing words of this country’s Founding philosophical document – the Declaration of Independence – attest, the Founding Fathers risked everything to make their ideals a reality:
“And for the support of this declaration, with a firm reliance on the protection of Divine Providence, we mutually pledge to each other our lives, our fortunes and our sacred honor.”
Some point to those words, and bestow on the signatories of that document the “honor” of having sacrificed for us, the "future generations." Nothing can be further from the truth. Sacrifice--properly understood--is the giving up, rather than the achievement, of values. America was achieved.
What is any human being’s highest attribute and value? It is his mind and his independent judgement. To use one’s mind – to think – is an exclusively personal, individualistic, self-motivated, self-chosen effort. All else in a person's life is a consequence of the use, or lack of use, of his mind – for better or for worse. One’s convictions about what one believes is right, one’s passionate concern for ideas, is the product of the independent use of one’s mind. The man who places nothing above the judgement of his own mind, even at the risk of his own physical well-being, is not engaging in self-sacrifice. To fight for one’s own fundamental beliefs is the noblest, most egoistic endeavor one can strive for.
The Founders were thinkers and fighters. They were egoists, in the noblest sense, which is the only valid sense. They believed in a world, not as it was, but as it could be and should be. They took action – pledging their “sacred honor” at great risk to their personal wealth and physical well-being – to that end. They would accept no substitute. They would take no middle road. They would not compromise. They would succeed or perish.
Such was the extraordinary character of the Founders of this nation.
To call the achievement of the Founders a sacrifice is to say that they did not deem the ideals set forth in the Declaration as worthy of their fighting for; that the idea that the individual’s life belongs to him and not to any collective and not to any ruler was less of a value to them than what they pledged in defense of it; that they did what they did anyway without personal conviction or passion; that the Declaration of Independence is a fraud. To say that America was born out of sacrifice is a grave injustice and, in fact, a logical impossibility.
World history produced a steady parade of human sacrifices, and the overwhelming result was a steady stream of bloody tyrannies. The Founders stood up not merely to the British Crown, but to the whole brutal sacrificial history of mankind to turn the most radical set of ideas ever conceived into history’s greatest nation. It is no accident that the United States of America was born at the apex of the philosophical movement that introduced the concept of the Rights of Man to his own life, liberty, and pursuit of happiness, the Enlightenment.
Only the most extraordinary men of the most ferocious personal strength and courage could have so uncompromisingly upheld, against overwhelming odds and hostility and personal risk, so passionate a belief in their own independently held convictions so as to have established the American Founding. The American Revolution was history’s brightest demonstration of the rationally selfish pursuit of a noble goal by any group of people, ever. It was a monumental human testament to the dedication these men had to their cause – the refusal to live any longer under any social condition except freedom.
The highest tribute I can pay to those Americans who died in the line of military duty is not that they "sacrificed" to fight for their country. Self-sacrifice is not a virtue in my value system. It is an insult, because that would mean that their country and what it stands for was irrelevant to them; that they had no personal interest in it; that they were not passionate about their service; that they saw no difference between America and its enemies; that it made no difference to them whether they returned to live in freedom or to live in slavery.
The highest tribute I can pay to our fallen is to say that they were cut from the mold of the Founding Fathers; that they did not set out to die for their country but rather that they set out to fight for that radical set of ideals that is the United States of America.
In honor of those who perished fighting for the American cause, and to all of America’s service men and women past and present:
Thank you for your service in defense of American ideals, for your desire to live in freedom, and for your fierce determination to accept no substitute.
Happy Memorial Day!

Posted by Michael A. LaFerrara on
My current post, titled The Sentencing of Dharun Ravi: Judge's Reasoning Highlights the Dangers of "Hate Crime" Laws, vindicates exactly the point I made in the original post on the subject.
Labels: Constitution and Law, First Amendment

Posted by Michael A. LaFerrara on
Roman Catholic leaders opened a new front against the Obama administration mandate that employers provide workers birth control coverage, filing federal lawsuits Monday on behalf of dioceses, schools and health care agencies that argued the requirement violates religious freedom.So reported the Associated Press' Rachel Zoll on Tuesday, May 22.
It is always welcome when someone takes a firm stand in defense of their inalienable rights. Whenever someone--or in this instance, an institution--does so, he/she is implicitly defending all rights of all people.
But as I said earlier, the Catholic Church has been quick to subordinate fundamental rights to its collectivist visions of "social justice," so its action rings hollow from the perspective of principle.
Nevertheless, I welcome the Church's fight for religious freedom. Perhaps, as noted at FIRM, the Church will come to realize that all rights are interlinked. To protect religious freedom, one must protect all freedoms, including rights to free trade and property.
On the healthcare front:
Men should no longer receive a routine blood test to check for prostate cancer because the test does more harm than good, a top-level government task force has concluded in a final recommendation that immediately became controversial. The recommendation from the U.S. Preventive Services Task Force runs counter to two decades of medical practice in which many primary-care physicians give the prostate-specific antigen (PSA) test to healthy middle-aged men.
As I said earlier, "It’s notable that the study was done under the purview of the same bureaucrats charged with administering federal health care programs." If this were an independent research group operating in a free market, a man could simply agree to disagree.
But being a government entity operating in the context of expanding government control of healthcare, with its associated rationing powers, this decision implicitly carries the coercive force of law. It is just on the basis of such "advisory board" recommendations that government bureaucrats will determine who gets what healthcare and when.
For more, see:
What About the Freedom of Non-Catholics, Mike Spina?
The Double Standard of the Catholic Church
PSA Testing: Are Death Panels Arriving Under Cover of "Scientific Evidence?"
Forbes: "Death Panels... We Already Have One"
Labels: Death Panels, Healthcare, Individual Rights, ObamaCare, Religion


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