“Regulations are just as powerful as drugs are and can have side effects that are just as deadly.” – Death by Regulation
In May 2018, President Trump signed the federal Right-to-Try Act allowing terminally ill patients access to potentially lifesaving treatments that remained unapproved by the Food and Drug Administration (FDA). Forty-one states have also passed their own right-to-try for patients seeking the use of experimental drugs unavailable due to the FDA’s increasing delays in getting drugs to market. Allowing patients who are the only ones who will suffer the potential consequences of unapproved drugs to make their own decisions, gives them some measure of hope when all other options have been exhausted. As you will see, earlier legislation is having a profound effect on healthcare services, particularly with prescription drugs, keeping critical treatments, and vital information, from even more Americans.
In Dr. Mary J. Ruwart’s 2018 book, “Death by Regulation”, Ruwart details the devastating changes to our healthcare system caused by the 1962 Kefauver/Harris Amendments to the Food and Drug Act of 1938. Sold as an attempt to make drugs safer and more effective following a Thalidomide catastrophe in the United Kingdom, the new legislation actually did more harm than good. By putting more power into the hands of the FDA, the results have made it harder to innovate and develop drugs for treatment. Now, Americans are paying with premature deaths and poorer health outcomes, as not only has the approval process been extended, but therapy options have also been reduced. Research and development are now so expensive that many promising drugs are abandoned, and new drugs significantly curtailed as the development process has expanded from 4 to 14 years.
By requiring not only more studies, but more complex analyses, the cost of drug production has skyrocketed. The ensuing increase in development time has led to the consolidation of drug companies from more than 40 to less than 10, forcing out smaller, and thus more entrepreneurial markets that were no longer able to compete. Now, with more money needed for development, less is available for new drug creation, leaving drug companies to focus only on drugs popular enough to recover the increased cost of manufacturing. This has had the unfortunate effect of producing drugs that must be taken long-term. With fewer drugs available for treatments, desperate patients have been forced to travel to other countries for medication, or worse, rely on black markets for alternative options.
Before the 1962 Amendments, the bar for new drug approval was proof of safety for its intended use. After the Amendments, the requirement now called for drug companies to prove effectiveness. Since all drugs have side effects, and no two people are alike, effective for one, may be unsafe for another. This has created an impossible threshold for drug companies to meet. Drugs are both a replacement for more expensive hospitalizations and other health care costs, and increasingly a substitute for improving one’s health through lifestyle changes (i.e., healthy eating and exercise). Even generic costs have soared as these alternatives must also pass enhanced scrutiny. Making it more profitable for a drug company to produce a new drug that can receive patent protection, and thus, help to recoup rising costs.
The worst outcome may have been a shift from low-cost disease prevention to costly medical intervention. In Robert F. Kennedy’s 2021 book, “The Real Anthony Fauci”, Kennedy summarizes the differences between the miasma theory of medicine, which emphasizes disease prevention through good nutrition and proper sanitation, and germ theory, therapy focused on treating diseases of the body. While the prior looks to improve immunity through public health improvements, the latter focuses entirely on health intervention and treatments, with a large emphasis on vaccinations. Diseases create significant costs that could have been avoided with good health and supplements including vitamins and minerals.
Today, there is little focus on the importance of how a healthy lifestyle can lessen future health problems, making healthcare interventions less likely. Nothing proves this more than an American population rife with morbid obesity, and reliant on pharmaceutical medications to control the resulting illnesses. Yet, drug companies can no longer sell nutritional supplements and vitamins profitably because of the Amendments. Now, nutritional supplements, vitamins, and even foods run the risk of being treated like a drug and then subject to a lengthy FDA approval process. Drug companies are also not allowed to advise doctors or the public about studies and benefits without risking prosecution. In fact, even as Vitamin D deficiency continues to be a cause of concern for Americans, we now know that Vitamin D is a recommended treatment against COVID. Once upon a time, prevention and the use of nutritional supplements were considered best practices, providing the recommended daily allowance of nutrients that would otherwise be lacking.
Too many Americans are relying on pharmaceutical medications to control diseases rather than doing the harder work of maintaining a healthy weight and eating well. Now, fewer available drugs and less competition have resulted in higher costs for patients needing prescription drugs. With expensive drug production lagging, Ruwart suggests that the best solution to lower costs and increase prescription drug options is to remove FDA regulations and replace them with a certification process. Once done, liability would determine appropriate testing protocols and govern safety practices, making drug companies, like all other businesses, responsible for their own products.
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