The Avandia Case, and What It Reveals About the FDA

FDA

Perhaps you’ve heard of the drug Avandia before. If you haven’t, it was at one point an extremely popular diabetes medication. However, in 2010, the FDA put strong warning labels on the drug because of health concerns.

European pharmacies took more decisive action, pulling the drug from store shelves. However, a few US citizens continued to take the medication, despite the FDA’s warnings.

Avandia is an interesting case because it calls into question the FDA’s role in allowing people to continue ingesting certain products. We’ll get into more detail below.

Why Did the FDA Consider Avandia So Dangerous?

The FDA approved Avandia in 1999. In 2006, it had global yearly sales that totaled $3.4 billion. Glaxo, the manufacturer, was an industry powerhouse.

The issue was that many of the patients taking Avandia suffered strokes and heart attacks. Others developed heart disease.

The question became whether Avandia was causing any of that or whether the drug’s use in that group was coincidental. It’s hard to say since those who have Type 2 diabetes are already at a higher risk for those outcomes.

The FDA’s Role in Drug Approval

The FDA, or the Food and Drug Administration, is one of America’s most powerful entities, though most citizens don’t think of it in that way. That’s because the FDA either approves foods, beverages, drugs, and so forth for consumption, or else they deem them not safe enough, and they ban them.

You might have a company, like Glaxo, Avandia’s manufacturer, that works for years on a single pill or medical product. They might have an R and D department that dumps millions of dollars into research.

At the end of that time, they submit their product to the FDA. The FDA ultimately green-lights that product or says that it’s not safe enough for mass consumption, perhaps due to side effect concerns.

If that product goes to market, it can make that same company billions. If they launch an IPO based on a single product’s success, we’re talking about a business entity becoming an industry titan overnight.

On the flip side of that, if the FDA turns them down, that company can go belly up. Hundreds or thousands of people might lose their jobs.

What Can We Take from All This?

It sometimes happens that the FDA might express doubts about a product, such as Avandia, but there is not enough evidence for them to say “yes, this product is safe,” or “no, it isn’t.” They will certainly look at any studies that reputable entities conduct, such as a Duke University’s Avandia study that factored into their final decision.

The FDA might decide to allow a product to get to market, but they’ll slap a big warning label on it. That way, those who made the decision have cleared their conscience, but they’re still letting the public decide.

As a member of the public who knows nothing about the product other than whether it’s available or not, it’s very difficult to decide whether to take a drug, consume a beverage, or eat some food product for lunch. You might see an FDA warning, but you’ll never know what to make of it since, presumably, you’re not spending hours poring over study results.

The reality is that while the FDA is a very powerful entity, it is not infallible. It sometimes allows a product to get to market while still having doubts about it. It also recalls products sometimes because it once thought they were safe, but now, the experts have changed their minds.

Also, as members of the general public, you have no way of knowing whether some lobbyist bought off a few FDA board members so they would approve a product, despite mounting evidence that it isn’t safe. If someone flashes enough money in front of a board member’s face to get them to vote “yes” on a product, how would you ever know about that?

You’d hope that FDA board members will act with integrity since lives are potentially on the line depending on their decisions. You can never completely know, though. We’re all human, and maybe some board member voted to allow a product’s availability, even in the face of damning evidence.

If you’re not sure about a commodity because it has a warning on it, speak to your doctor. Since you’re not an expert, that’s probably just about all you can do, other than use the product and hope for the best.

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