Mary Ruwart, Ph.D. Author of Death by Regulation

As a research scientist, ethicist, and libertarian author and activist, Dr. Mary J. Ruwart has had a long and accomplished career in various fields. But it was perhaps her position in the Upjohn Company, as a senior research scientist working on developing new therapies for diseases such as AIDS and liver cirrhosis, that gave her the greatest insight into serious problems stemming from the 1962 amendments to the Food and Drug Act.

Dr. Ruwart believes that these amendments, which are in effect to this day, have had the unintended, devastating consequence of causing millions of Americans to die prematurely.

“Regulations can have side effects that are just as deadly as drugs,” she observes.

Alarmed by this state of affairs, Dr. Ruwart was moved to write her new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

In the book, Dr. Ruwart details how the amendments have not significantly improved drug safety or effectiveness, have been extremely detrimental to innovation, have greatly slowed the process of getting important drugs from the lab to patients, and have shifted American healthcare from inexpensive preventions to expensive treatments.

LE: You trace the current problems of what you call “the deadly side effects of pharmaceutical regulations” back to the 1962 Kefauver-Harris amendments to the 1938 Food and Drug Act.

MR: Yes. The intent of the amendments was to protect the American public. Unfortunately, new laws, like new drugs, often have deadly side effects. Behind the scenes, the 1962 amendments reshaped the pharmaceutical, nutritional, and medical industries in ways that are detrimental to our health and longevity. Because of the way they were written, the amendments continue to metastasize into these three areas today. Almost all drug-related legislation passed since then has attempted, with limited success, to correct the ever-growing problems created by the amendments. The deadly side effects of the amendments have likely cost each and every one of us many years of life.

LE: What exactly did the Kefauver amendments do?

MR: They gave the FDA the power to decide which animal-safety studies that drug companies had to do before they could test their drugs on people. The FDA could determine what human studies were necessary for it to approve a drug as “safe and effective.” Before the amendments, a drug had only needed to be shown “safe for intended use.” Once a drug company asked the FDA to approve a drug, someone at the agency had to sign off rather than simply letting six months elapse without objection.

The FDA could determine manufacturing standards for the new drug and do inspections to insure that its dictates were met. The FDA was given jurisdiction over all pharmaceutical advertising as well. In other words, the FDA was given unprecedented control over the entire drug development process in the hopes that drugs would not only be safe, but effective. Advertised accurately and manufactured carefully.

What the amendments actually did was to increase the time it takes for a new drug to move from the lab bench to the marketplace from about four years to 14 years over the next several decades. Terminally ill patients who couldn’t live with that delay had to turn to the black market in order to get access to potential cures. Every year, the costs of satisfying the FDA soared, resulting in ever-increasing prices at the pharmacy.

More than half of our potential innovations never made it to patients, as companies realized that they couldn’t recoup their investments under the new regulations. Investors began demanding a greater return as the amendments made it riskier to try to bring a drug to market.

LE: You argue that this has had catastrophic consequences.

MR: Loss of innovations and delays in the ones we do get have caused the premature death of almost half of the Americans who have died from disease since 1962. By discouraging the use of inexpensive supplements in favor of FDA-approved pharmaceuticals, the amendments shifted the healthcare paradigm in the United States from inexpensive prevention to costly treatment. The loss in lives and money from this shift is probably higher than the devastating cost of the amendment-driven reshaping of medical practice and the pharmaceutical industry, as every one of us has been adversely affected.

LE: This seems like it should be a major news story. Why isn’t it?

MR: Without insider information about how the amendments act behind the scenes, even a dedicated journalist would have a difficult time putting the story together.

In addition, most insiders have good reason to be silent. Blowing the whistle on the Kefauver amendments would make their job difficult and might even endanger the financial solvency of their company. Still, many might speak out if they thought their comments would be taken seriously instead of simply ridiculed. However, if drug companies or their employees tell the American public that the regulations meant to police the pharmaceutical industry and protect consumers often do just the opposite, their concerns are likely to be discounted. Such comments would, at best, be labeled politically incorrect, and, at worst, self-serving. Why risk your job, your company, and your good name when no one is likely to believe you anyway?

LE: Why does the FDA drug-approval process take so long?

MR: When I joined the Upjohn Company in the mid-1970s, I had no idea what was involved. Shortly after I arrived, however, I could hardly believe that any drug actually was able to jump through the maze of ever-changing regulatory hoops and make it to the marketplace.

Company chemists would make 5,000 to 10,000 potential new drugs, which were then studied in the test tube or in vitro (not in whole animals) to see if they slowed cholesterol synthesis, inhibited a particular enzyme that helped create the disease, or killed the target microbes. Drugs that looked promising might then be tested on animals to see if they worked in vivo (in whole animals) with few problematic side effects at the effective doses.

From the original batch of 5,000 to 10,000 compounds, about 250 began FDA-mandated animal-safety testing and other preclinical work. Prior to the passage of the Kefauver amendments in 1962, pharmaceutical firms, not the FDA, decided which studies were most appropriate.

Somewhere between three to six years are now consumed by the in vitro, in vivo, and preclinical regulatory and animal safety (toxicology) studies. Since there were only a few instances of too little preclinical testing prior to passage of the amendments, it’s not clear how much benefit the extended testing provides.

LE: What will be the benefits if and when the FDA undergoes major reform?

MR: Without the Kefauver amendments to the Food, Drug and Cosmetic Act, many of the legislative band-aids that were put in place to alleviate problems caused by the amendments would no longer be necessary. User fees driven by the Prescription Drug User Fee Act would be lower or nonexistent, since FDA certification wouldn’t be necessary for marketing. The seven-year monopoly that drug companies receive for orphan drug status would no longer be available, since there would be no more approvals. Because development costs would be lower without the amendments, fewer drugs would be orphans—many more would be able to recover the less intensive development costs. The Waxman Restoration Act wouldn’t add to the patent life of drugs since clinical development times would plummet.

Instead of doing large human trials to get statistically significant results, drug companies would focus on smaller trials designed to determine which patients respond best to their potential new product. This will allow companies to target their product to those who will actually benefit. Because patients will be taking fewer drugs that might help them, the incidence of drug-drug interactions will go down. Deaths from “properly prescribed medications,” which now rank close to the fifth largest cause of death, should go down too. Although the technology to determine who will benefit most from a particular drug is often available, pharmaceutical firms must focus instead on the outdated studies demanded by the FDA.

People who fear that earlier access might mean less safety could elect to only take drugs that have FDA certification, even though drugs could be marketed without it. Patients who want earlier access could also have it. Everyone could choose for themselves. That is the freedom upon which our country was founded.

LE: What other benefits might result without the amendments?

MR: As the marketplace adjusts to the less intensive regulatory climate, we’d see more innovation, both in pharmaceuticals and nutraceuticals. Without the amendments, the FDA could not pose restrictions on what manufacturers’ representatives could say to doctors. Supplement suppliers could educate physicians on the benefits of using natural products (e.g., vitamins) instead of drugs. Pharmaceutical firms would be able to combine their drugs with CoQ10 and other nutrients to lessen side effects. Instead of being at odds, drug companies and nutraceutical firms might find it profitable to collaborate on research, marketing, or product design.

Without the FDA’s ability to dampen prevention through the use of natural products or combine them with pharmaceuticals to lessen side effects, physicians would likely become more knowledgeable about prevention. This will help the American public become healthier as well.

Since about two-thirds of the American populace is currently overweight, drug companies needn’t worry that they will run out of people who will need treatment. Unfortunately, many people won’t take the initiative to eat less, exercise more, or do other things to promote their well-being, even after being diagnosed with diabetes, cardiovascular disease, and other lifestyle-dependent maladies. Many will continue to prefer drugs to lifestyle changes or will find that we don’t know enough about prevention to control their disease without drugs.

LE: What would be the implications for stem-cell therapies?

MR: Without the FDA able to treat stem-cell products as drugs that need to go through an intensive development program before those in need can benefit, stem-cell research will return to the United States, making it much more affordable. Individual physicians will no longer have to worry about being continuously hauled into court simply because they have not checked all the regulatory boxes required by a bureaucratic development plan. Parents will not have to beg the agency to allow their children to try new treatments that might save their lives or keep them out of wheelchairs.

In short, we will once again be poised at a golden gateway of medical innovation as we were in the early 1960s. However, this time we will have better science, more know-how, and a better understanding of what spurs innovation and what squelches it.

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