The FDA and the Erosion of “First Do No Harm”

20 for 2020 is a newsletter sent to 20 people in preparation for the U.S. Presidential election of 2020. The recipients include Business, Government and Society members including three Presidential candidates. The newsletter goes beyond the headlines and provides factual information on key issues including healthcare, the economy, society and how we can come together as a nation and as a people. Sept 2019

This is the third issue of 20 for 2020 and the subject is poorly defined decision criteria for government agencies and how it can result in calamity and harm: The FDA 

When the government starts altering its decisions criteria in a way that strays from its mission to protect, we all suffer and it dilutes the benefit of government, that of a protector.

The FDA’s mission seems clear enough:

FDA Mission: 

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. Source FDA Website

The statement then goes on to list responsibilities:

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

These statements dilute and can add confusion to the mission statement, especially helping speed innovations. Really, how can a regulatory agency speed innovations when it does not innovate? Its job is to assure that innovations are safe, according to its mission.

In practice, the decision criteria used to approve new drugs strays and truly precludes the FDA from adhering to its mission to protect. According to the FDA website, the FDA approval of a drug means that data on the drug’s effects have been reviewed by the Center for Drug Evaluation and Research (CDER) of the FDA and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

“ The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.

This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.

New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.” According to A Health Affairs Blog titled Serious Risks and Few Benefits from FDA Approved Drugs.

The Blog goes on to state that most new drugs are not blockbusters but rather just minor iterations of existing formulas and they are not necessarily safer than existing drugs. A French study showed of drugs similar to those in nature approved by the FDA 918 showed little or no improvement, 61 showed some advantage, 13 had a real advantage and 2 were breakthrough. Expediting me to drugs at the expense of protecting people doesn’t make sense and does not protect.

When responsibilities and decision making criteria are not subordinate to the mission or even present conflict, the mission is doomed for failure.

The blog goes on to state that “Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.

This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place.”

The recent court decision in Oklahoma is holding Johnson and Johnson responsible in part for the Opioid epidemic and states the company caused a public nuisance. The decision to as to how to allow Opioids to be prescribed was an ill fated FDA decision and I wonder when it will come under fire? Only then will be on the path to true change and not just a band aid.

Approximately 100 million Americans suffer from chronic pain allowing Purdue Pharma to capitalize on this extensive market. The FDA approved Purdue Pharma’s time released oxycodone as safe for long term use in 1995. The addictiveness of this drug has led to an opioid epidemic causing thousands of overdoses every year in America. Safer alternatives to treat chronic pain exist. One of the head FDA employees responsible for Purdue Pharma’s drug’s approval went on to work for Purdue two years later.

Many mental health drugs cause organ damage and other issues for the body and even cause destructive behavior and are known to be addictive, yet they too are readily approved and prescribed. This is a hidden epidemic that needs to be addressed.

The Canadian FDA is somewhat clearer in its mandate toward public safety. “Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety.” Source: Health Canada website. The Canadian decision process is more restrictive than that of the U.S. FDA.

I recommend keeping it simple and returning to the Hippocratic Oath. People deserve safe drugs.

Our bodies are fearfully and wonderfully made by God and good science and good medicine respects this.