The FDA’s MedWatch Reporting System Fails Consumers and Physicians

Natalie Moore, February 1, 2016

As PBS attempts to slam the supplement industry, it ends up revealing the shortcomings of the FDA
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Recently, PBS released an hour-long expose episode of Frontline that attempted to bash the dietary supplement industry.

As usual, the main points of criticism hinge on the worn-out claims of the supplement industry’s loose regulations, selling of worthless and/or harmful products, and hoodwinking of unassuming customers for billions of dollars every year.

$30 billion annually, to be exact, as correspondent Gillian Findlay gladly points out.¹

While $30 billion may seem like a sizable amount, it’s small potatoes compared with Big Pharma’s $711 billion annual profits.²

But beyond the profits and exhausted pitfalls, the most damning and clear theme of the documentary is the incompetence and carelessness of the FDA’s adverse-reaction reporting line, MedWatch.

The documentary profiles two cases of adverse reactions. Frontline reveals how MedWatch’s many blunders in reporting resulted in lengthy waits by consumers and physicians for answers. The documentary goes on to show how this faulty reporting system kept dangerous products on the shelves up to six months after receiving an initial report.

In fact, the reactions of the some of these FDA employees will shock you.

Today, we will explore these cases a bit further to see where the FDA failed to protect the public.

More importantly, I want to assure you that there are safe, reliable, and pure dietary supplements on the market. The key is knowing how to find them.

I will guide you through the best buying practices for supplements in a bit.

First, let’s explore MedWatch’s responsibilities and how they failed consumers in two cases.

Oh, You Think Your Medication Is Killing You? Hold, Please… I’ll Transfer You.

According to the MedWatch website, it’s an avenue “to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement, or cosmetic.”³

MedWatch is the first stop for adverse-reaction reporting for so many different types of consumers and manufacturers. It’s troublesome to think about how many different types of dangers are slipping through the cracks.

In the highlighted cases, it wasn’t MedWatch’s balancing act of all of these industries that led to the injury of supplement consumers but rather MedWatch’s failure to act on reported adverse reactions that cost some folks their health.

Kenneth Spaeth, a doctor involved in the first of the cases, told Frontline in an email he tried to reach the FDA via email regarding the suspected contamination of a supplement. This supplement, made by a company called Purity First, was affecting 20 of his patients.

After the FDA ignored his first email, Spaeth emailed them again. Finally, the FDA responded by referring him to the MedWatch hotline.

Spaeth called MedWatch numerous times. He was placed on hold and transferred several times before being disconnected not once, but twice.

Once he did get through, Spaeth reported the operator he spoke with “was acting as if I was telling her that aliens put messages in my Cheerios” when he was giving her the report.

Sounds like a real top-notch team working at MedWatch.

Five weeks later, he still didn’t have any answers for his patients.

According to the manufacturers of the reported contaminated supplement, when FDA representatives came to investigate the claim, it was never specified which product was under scrutiny. Furthermore, when they asked the FDA if they should stop making the supplements, FDA representatives replied, “Nobody died, you don’t have to pull the product.”

When the manufacturers offered to pull the products, the FDA replied, “People call the FDA all the time to report minor things, so don’t worry about it.”

Of course, the FDA denies these claims.

It took the FDA six months to get the Purity First supplements off the market.

In the next case, a dietary supplements caused liver damage to consumers living mostly in Hawaii.

Physicians made several attempts to reach MedWatch via their website and by telephone. It was only after they reached out to the state health authority that they got a response from the FDA.

Per Dr. Wong, a transplant specialist, the FDA told one of the liver doctors attempting to reach them that they thought she was a “prankster” because she had used her private email address.

Dr. Wong went on to say, “They [FDA] thought we were joking.”

It took a month for the FDA to remove the product, and this was after 20 reported cases of liver damage.

These types of cases raise important questions:

How many times a day does a concerned consumer or physician call MedWatch just to have these negligible results?
How many consumers have died or been harmed due to inaction of the FDA?

While we may never have firm answers, these situations do point us to one clear fact — you can’t trust your health to someone else, especially a government entity.

And I am not denying there is room for improvement with the regulation of dietary supplements, just as there is for prescription drugs.

However, it is worth mentioning, your chances of dying from a dietary supplement reaction are significantly lower than the odds of your dying from a prescription drug overdose.

For example, in 2013 (most current data I could find), over 22,000 Americans died from prescription overdoses, while there were only two deaths from dietary supplement usage .^4,5

The bottom line is you need to get your supplements from reliable sources.

I recently sat down with Jasmine LeMaster, head of quality assurance here at Living Well Daily, and she shared some important pointers on how to find a quality supplement:

Research the company: A simple Google search of a supplement company can provide you with important information about their manufacturing process. You want to be sure they are (or use) a manufacturer certified in Good Manufacturing Practices (GMPs). If you can’t find that information on their website, call the company and ask them about their manufacturing processes.
Independent testing: Make sure the company is having quality testing done by an independent laboratory. You can request to see these results. For example, here at Living Well, Jasmine sends our products to an independent laboratory for testing to ensure the results match what our manufacturers’ test results say. This is a quality measure we take in order to assure our customers are getting the products they are paying for.
Look for contact information: Be sure the packaging of a supplement has a direct contact number, not an email. You should scan the bottle or box to verify there is a contact number before making a purchase. When you have contact information, you can go straight to the source if you have questions about dosages or need more product information.
Ask your doctor: Anytime you start a new supplement, you need to talk to your physician. Your doctor can give you instructions on dosages and advice on how a new supplement may interact with your current medications.
Stop at the first sign of an adverse reaction: You know your body better than anyone else, so be sure to listen to it. If a supplement is making you feel bad or you experience signs of an adverse reaction — stop taking it immediately. You need to call your doctor, the supplement company, and even MedWatch. While your call to MedWatch may fall on deaf ears, at least you have taken the extra step that may (or may not) protect someone else.

Have you had any MedWatch or FDA experiences you would like to share? Let me know! nmoore@lfb.org

Live well,