Tag Archives: FDA

FDA Policies Kill, by Walter E. Williams

Posted on December 20, 2018 | Leave a comment

People die when the drug gatekeepers refuse to allow in safe, beneficial new drugs. From Walter Williams at lewrockwell.com:

Among the U.S. Food and Drug Administration’s responsibilities are approval and regulation of pharmaceutical drugs. In short, its responsibility is to ensure the safety and effectiveness of drugs. In the performance of this task, FDA officials can make two types of errors — statistically known as the type I error and type II error. With respect to the FDA, a type I error is the rejection or delayed approval of a drug that is safe and effective — erring on the side of over-caution — and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.

Let’s examine the incentives of FDA officials. If FDA officials err on the side of under-caution and approve a drug that has unanticipated dangerous side effects, the victims of their mistake will be highly visible. There may be congressional hearings, embarrassment to the agency and officials fired.

It’s an entirely different story if FDA officials err on the side of over-caution and either disapprove or delay the approval of a drug that is both safe and effective. In that case, the victims will be invisible. They will have no idea that their suffering could have been eliminated, or in the case of death, their loved ones will have no idea why they died. Their suffering and/or death will be chalked up to the state of medicine rather than the status of an FDA drug application. Their doctor will simply tell them there’s nothing more that can be done to help them. The FDA officials go scot-free.

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Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It, by Davis Taylor

Posted on June 23, 2018 | Leave a comment

When the FDA makes a mistake and approves a drug that turns out to be dangerous, we hear about it. When the FDA makes a drug and doesn’t approve a drug that could save lives, we don’t hear about it. From Davis Taylor at tenthamendmentcenter.com:

Most people believe government agencies like the Food and Drug Administration keep them safe. But a book by Dr. Mary J. Ruwart explodes this myth.

People often argue that without the protection of government agencies, we would face constant peril. Allegedly, without the FDA, our pharmacy shelves would be lined with unregulated products containing deadly substances, marketed by the unscrupulous.

Of course, this argument rests upon the unspoken assumption that the laws and regulations enforced by the FDA are benign, causing little or no harm, and few, if any, deaths. It also rests upon the assumption that, without government regulation, there are no market-based mechanisms for certifying the safety of drugs and products.

In her important new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It, Dr. Ruwart provides information which thoroughly refutes these assumptions.

Dr. Ruwart holds a B.S. in biochemistry, a Ph.D. in biophysics and spent 19 years as a pharmaceutical research scientist for the Upjohn Company. She has also chaired an IRB (Institutional Review Board), consulted with nutraceutical companies and been an expert witness against the FDA. Therefore, she is intimately familiar with the impact of the FDA and the laws and regulations it enforces. Her easily digestible book focuses specifically upon the detrimental impact of the 1962 Amendments to the 1938 Food and Drug Act (“the Amendments”).

Dr. Ruwart reviews the burdensome effects of the Amendments, including a lengthening of the average period for new drug development from approximately four years to 14 years. She explains the numerous additional requirements set forth in the Amendments, and the additional development time caused by them and provides heartbreaking examples of the effect of this wait time on those with life-threatening illnesses.

For example, she discusses how, in the early years of the AIDS epidemic, United States AIDS patients often had to travel to other countries with fewer regulatory requirements to obtain new therapies still unapproved by the FDA, sometimes having the drugs confiscated upon reentry to the United States. She further discusses black market AIDS Buyers’ Clubs which quickly formed in response to the need for therapies and hired chemists to make drugs undergoing development, in violation of pharmaceutical companies’ patents. She also points out that, although making, selling and distributing these drugs without FDC approval violated the law, the FDA often took no action against most violators, “especially those in California who were well organized and vocal,” and that instead “the FDA selectively prosecuted those who were least likely to fight back.” This illustrates that organizing and fighting back against unfair laws can be effective in preventing or reducing their enforcement.

To continue reading: Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It

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Posted in Civil Liberties, Government, Labor, Politics

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Drug Companies Want to Use the State to Shut Down the Competition, by Hunter Lewis

Posted on May 25, 2018 | Leave a comment

This shouldn’t come as a shock to SLL readers, but sometimes business uses government to stifle the competition. Got a supplement that cures cancer? Don’t tell anyone about it or you’ll probably get thrown in jail. From Hunter Lewis at mises.org:

Blue jeans have more in common with drugs than you might think.

One of the more consequential episodes in the history of crony capitalism occurred in 17th and 18th century France. Cheap clothing made from cotton was threatening the rich woolen, linen, and silk manufacturers, so they persuaded the government to ban it. In short order, government agents began spying into homes and coaches and reporting on anyone who dared to wear the new fabric. Thousands of violators of the ban were rounded up and either sent to prison or to ships as galley slaves, which was a death sentence.

In Britain, the same manufacturers demanded a similar ban from the King, but were turned down. As a direct result, Britain launched its industrial revolution by making cheap cotton clothing for the world, and began to get rich, while France stagnated economically. If France had not banned cotton, and had not fallen so far behind Britain economically, Napoleon might have had the money to build a huge fleet and successfully invade Britain. European and world history might have turned out quite differently.

It is easy to recognize and mock the absurdities of crony capitalism in the past, but not always easy to spot it today. For example, we have a replay of the cotton story in contemporary American medicine. It is increasingly recognized that food, supplements, and lifestyle changes are the most potent medicines. But this represents a threat to drug companies, oncologists, and surgeons, and they have enlisted the power of the government to protect their interests.

It is illegal to claim that any substance, even a food, not approved by the Food and Drug Administration (FDA) can cure, control, or even prevent an illness. But approval costs many billions of dollars, so with few exceptions only new to nature molecules, that is, patentable drugs, can be approved. A producer of food or supplements who violates this law will be threatened with massive fines and long jail terms.

To continue reading: Drug Companies Want to Use the State to Shut Down the Competition

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