Why FDA Approval?

With the desperate search for a coronavirus vaccine and medicines to reduce the seriousness of the disease comes a lot of discussion about FDA approval. One side argues that speed is of the essence and we need to accelerate the process. The other side argues that we can never be sure of a drug’s effectiveness without proper testing. (This will reflect some of the information from last week’s entry, “Understanding Experiments.”) 

The FDA admits, “It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf.” The first step requires about three years of laboratory testing before testing on humans. “Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.” 

Next comes a three-phase process. First they must test for safety. Next they need 100 to 300 volunteers to test for basic effectiveness. Finally 1000 to 3000 patients in clinics and hospitals are monitored for effectiveness and to identify adverse reactions. Each phase can easily take years to complete. (And some people wonder why drugs cost so much and why the companies fight and scheme to protect their patents.)

In the interim some drugs that have been previously approved for other diseases are being tested on coronavirus patients. This practice of prescribing drugs off-label is really quite common in the US. WebMD writes, “Off-label prescribing isn't necessarily bad. It can be beneficial, especially when patients have exhausted all other approved options.”

This is why FDA approval is so valuable and why makers of so many pills, salves, ointments and medical devices are so eager to try to take credit for having cleared this hurdle. Otherwise the law requires them to post the familiar disclaimer: “The statements made regarding these products have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.” (But the disclaimer is familiar only to those who bother to read the fine print.)

If companies fail to do this, it’s not the FDA but the Federal Trade Commission (FTC) that comes after them for misrepresentation, as they did in this case – one of many that show up almost weekly.

“Under a settlement with the Federal Trade Commission, the marketers of an electrical nerve stimulation device called Quell have agreed to pay at least $4 million and stop making deceptive claims that the device treats pain throughout the body when placed below the knee and is clinically proven and cleared by the Food and Drug Administration (FDA) to do so.” (From an FTC press release.)

I checked their website and found that they no longer show the device as FDA approved (to treat or cure), but still do try to give that impression through endorsements and research posters. They continue to mention the FDA at least twice on the site, referring only to registration, not approval – big difference. In summary, the “FTC alleged that the defendants lack scientific evidence to support widespread chronic pain relief claims…” but the site lists no such disclaimer. It’s big business and a $4 million fine pales in comparison to a $350 million development cost.

That it is “100% drug free and non-surgical” while it “stimulates sensory nerves with safe and precise electrical pulses to trigger a natural pain relief response” appeals to people with chronic pain trying to avoid addictive drugs. It’s understandable how such a device would tempt people, and if placebo does the trick it might be worth $300 plus an on-going expense for fresh electrodes.

Like so many other health and medical decisions, avoiding such questionable products is all about a little research and critical thinking.