The Opioid Abuse Mystery

How did the opioid abuse epidemic happen under the eyes of the FDA and DEA?

The opioid abuse epidemic, which has grown over the last decade or so, gives us an opportunity to ask whether, and how much, the FDA, with all its power and control, has been protecting us. How did the opioid abuse epidemic happen under the watchful eyes of the FDA?

What follows are two widely held views:

One: Drug companies, being motivated by profit, will sometimes sell unsafe or inefficacious drugs, or they will oversell their drugs via misleading advertising. As an example, here’s what a Harvard School of Public Health professor said to help explain the opioid abuse epidemic, “The profit motive of the pharmaceutical industry remains ever present.”

Two: Prescription opioids are inherently addictive. Every time someone uses a prescription opioid for pain relief, perhaps after surgery, she faces a substantial probability of becoming addicted.

Put these two beliefs together and they seem to perfectly explain widespread opioid abuse, properly termed opioid use disorder (OUD). In summary, drug companies were using misleading advertising to sell addictive medicines, leading to widespread addiction problems. It seems so simple and straightforward.

But there’s one thing missing from this picture: the U.S. Food and Drug Administration.

Those who hold the first view, that drug companies can’t be trusted, probably support the actions of the FDA, which oversees and controls drug companies. The FDA controls which drugs can be tested in humans and how. The FDA reviews all the safety and efficacy data from clinical trials and either approves or rejects each new drug based on its merits. The FDA, along with each drug company, carefully crafts the wording of the package insert, or “label,” explaining the prescribing information for doctors. The FDA monitors the promotion of all drugs to make sure that everything drug manufacturers say to potential customers about a drug is congruent with the label. The FDA also monitors the use of drugs by Americans to see if any unforeseen problems crop up. Drugs that have problems either have their label changed or are pulled from the market.

In short, the logic goes, the FDA protects us from unsafe or ineffective drugs and the drug companies that can’t be trusted.

Here's my honest question: For people who hold the two views described above, how can they explain the opioid abuse epidemic given the FDA’s muscular, eagle-eyed regulation of the pharmaceutical industry?

But wait, there’s more!

In addition to the FDA, we also have the U.S. Drug Enforcement Agency. The DEA’s mission is “to enforce the controlled substances laws and regulations of the United States.”

Manufacturers of controlled substances, of which opioids are one example (they are classified as Schedule II drugs and “have the tightest regulations when compared to other prescription drugs.”), must get permission from the DEA simply to purchase the ingredients needed to manufacture their medicines and their manufacturing and storage facilities are inspected regularly. Manufacturers must account for every order and every pill produced and shipped. Manufacturers of these sorts of drugs have been shut down for many months due to small issues, even insignificant paperwork errors.

The opioid abuse epidemic happened under the watchful eyes of two government agencies expressly designed to prevent such problems: the FDA and the DEA.

To rephrase my question: for people who hold the two views described above, how can they explain the opioid abuse epidemic given the FDA’s and DEA’s muscular, eagle-eyed regulation of the pharmaceutical industry?

Note: I’ll provide my answer in a future post.