Some studies have estimated 5,000 to 10,000 lives saved each decade by preventing dangerous drugs from making it to market. This was done by looking at pre-FDA deaths in the US and deaths in foreign countries without an FDA.
In comparison, studies have shown that the added delays and cost of FDA regulatory hurdles range between 21,000 to 120,000 deaths per decade.
So the NET outcome of lives saved minus lives lost is likely between 11,000 and 115,000 additional deaths each decade due to added delays and costs of the regulatory process.
However, the FDA did not create its mandate which is:
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
The FDA mandate does not state that it should maximize the overall health of the population. It just states that it should ensure safety and efficacy without concern for cost.
From an ethical standpoint, the politicians who created this mandate and continue to fund it are ultimately responsible for these deaths.
How This Happened
For thousands of years, everything sucked and the average human life expectancy was 28. Then something happened around 1800 and life-expectancy exploded.
Structural Changes Leading to the Health Explosion
Let’s zoom in and see what happened in the last couple of centuries leading to this explosion.
We see on the timeline are two primary groups of factors:
- Research Improvements
- Incentive Improvements
Schools of Medicine
An influx of new state-affiliated pharmacy schools in the 1880s and 1890s helped to raise the level of the practice significantly. Many like the University of Wisconsin combined laboratory science with an experiential requirement for graduation. The growth in schools of medicine trained physicians and researchers in the systematic collection of clinical data on the safety and efficacy of treatments. They also served as hubs where new medical discoveries could be shared.
The advent of journals such as the Journal of the American Medical Association (JAMA) allowed new discoveries could also be widely disseminated.
AMA Drug Certifications
In 1905, the AMA formed its own Council on Pharmacy and Chemistry which levied a fee on manufacturers to evaluate their drugs for quality (ingredient testing) and safety. Drugs accepted by the Council could carry the AMA’s Seal of Acceptance. The AMA’s Chemical Laboratory tested commercial statements about the composition and purity of drugs in their labs. The Council on Pharmacy and Chemistry followed up with safety
evaluations and rudimentary efficacy evaluations designed to eliminate exaggerated or misleading therapeutic claims. The Seal was awarded to drugs that provided symptomatic relief.
During the 1920s, ’30s, and ’40s medical researchers began to conduct “cooperative investigations”. These were designed to overcome errors attributed to individual observers working in relative isolation. It instead replaced them with standardized evaluations of therapeutic research in hundreds of patients.
Freedom to Try
Therapeutic experimentation did not begin to gain a true foothold in modern medicine until the U.S. legal system stopped equating experimentation with medical malpractice. In 1935, the state of Michigan authorized controlled clinical investigations as a part of medical practice without subjecting the researcher to strict liability (without fault) for any injury so long as the patient consented to the experiment. In particular, the court accepted that experimentation was necessary not just to treat the individual, but also to help medicine progress. “We recognize,” noted the Court, “the fact that if the general practice of medicine and surgery is to progress, there must be a certain amount of experimentation carried on.”
Medical Patent Protections & Mass Production
In the late nineteenth and early twentieth century, interest in clinical objectivity grew, spurred on not only by astounding successes in laboratory science and clinical medicine abroad (e.g. discovery of microbes, pasteurization of milk, development of anthrax and rabies vaccines). International recognition of medical patents contributed to a boom in large-scale industrial pharmaceutical manufacturing led by Bayer and Pfizer. In 1880, patent medicines constituted 28% of marketed drugs. By 1900, however, they represented 72% of drug sales.
The industrial revolution gave way to technologies allowing for mass production and distribution on a global scale. This is vastly more efficient, and profitable than traditional means. These greater profits drove greater investment and thereby greater medical progress in the field.
The History of Drug Regulation
In the 1800s there was a big problem with snake oil salesmen making false claims about the concoctions they were selling. The original solution was the AMA Council on Pharmacy and Chemistry certification to ethical drug products that met their standards.
1906 – Ingredient Lists and No Lying on Labels
The 1906 Pure Food and Drugs Act empower the Bureau of Chemistry (forerunner of the FDA) to seize adulterated and misbranded products. The law also prohibited “false and misleading” statements on product labels. The law listed eleven so-called “dangerous ingredients” including opium (and its derivatives) and alcohol which, if they were present in the product, had to be listed on the drug label. This listing requirement alone inspired many manufacturers to abandon the use of many “dangerous ingredients” following the passage of the 1906 Act.
1938 – Safety Trial Requirements
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions:
- Extending control to cosmetics and therapeutic devices.
- Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.
Manufacturers were required to demonstrate to FDA that they had carried out all reasonably applicable studies to demonstrate safety and that the drug was “safe for use”.
1962 – Efficacy Requirements
The Drug Efficacy Amendment of 1962 additionally required manufacturers to provide proof of the effectiveness of their drugs before approval.
The primary reason the amendment was passed in the United States was due to the Thalidomide Tragedy that occurred in Europe. The drug thalidomide became available in 46 countries (but not the US) to treat nausea associated with morning sickness during pregnancy. Unfortunately, the potential side effects were not fully understood. As a result, thousands of children were born with birth defects, most notably phocomelia (limb malformations).
Fortunately, the existing 1938 FDA safety requirements completely protected Americans from the fate of Europe. However, amid the mass hysteria over the tragedy, the US government felt compelled to look like it was doing something in response. So it tightened our regulatory approval process of new drugs via the Drug Efficacy Amendment.
Results of Increased Restrictions
- Google Spreadsheet of FDA Spending vs Life-Expectancy
- Summary of NDA Approvals & Receipts, 1938 to the present
- Theory, Evidence, and Examples of FDA Harm
- Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50
- Consumer Price Index
- Estimates of World GDP, One Million B.C. – Present
- Newspaper Generator
- Report suggests drug-approval rate now just 1-in-10
- How many people die and how many are born each year?
- Gross World Product per capita
- History of Clinical Trials
- How many life-years have new drugs saved?
- Medical Innovation
- Timeline History of Clinical Research
- FDA and Clinical Drug Trials: A Short History