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Can You Believe FDA’s Drug Safety Claims?

The Food and Drug Administraiton states unequivocally that it only approves drugs that are proved "safe." We think the FDA's drug safety claims are bogus.
Can You Believe FDA’s Drug Safety Claims?
FDA approved concept. Rubber stamp with FDA and medicine. 3d illustration

How do you define the word safe? We suspect that most people would start with a synonym such as harmless. Others might say free from risk or danger. The FDA’s drug safety claims, however, may include death as an acceptable side effect. Does death seem safe to you?

The FDA’s Drug Safety Claims:

The FDA has maintained for years that it never approves a drug that isn’t both “safe and effective.” In fact, the prior FDA Commissioner, Dr. Scott Gottlieb, sent a Tweet on Valentine’s Day, 2019:

“Some pills are red,

“Some pills are blue,

“All are safe and effective,

“If they undergo FDA review.”

Do You Believe Slogans?

We find the FDA’s drug safety claims disingenuous. The slogan that all FDA approved drugs are safe is preposterous.

We think slogans can be misleading.

Commercials once claimed that Coca Cola lifts your spirits and boosts your energy. The jingle closed with:

“Things go better with Coca Cola, things go better with Coke!”

We now know that sugary soft drinks can have negative health consequences.

Do you remember the slogan from the DuPont chemical company?

“Better Things for Better Living…Through Chemistry.”

Here’s a link to the 1964 New York World’s Fair “Wonderful World of Chemistry” Show with that jingle. 

These days most people recognize that chemicals such as pesticides, herbicides, nonstick chemicals like Teflon and some components of plastic have significant downsides as well as benefits.

Drug Companies Love Chemistry

The pharmaceutical industry adopted the concept of better living through chemistry during the 1950s and 1960s. It seemed as if there was a pill for every ill. Drugs like Valium (diazepam) were promoted to take the edge off anxiety. Thorazine (chlorpromazine), an antipsychotic medicine, was supposed to calm patients with schizophrenia as well as those with agitated senility. Dexedrine (dextroamphetamine) could “brighten the outlook in Menstrual Dysfunction.”

Those ads were mostly directed towards physicians. In the 1980s, though, the FDA started lifting restrictions on direct to consumer (DTC) advertising. By the mid 1990s the pharmaceutical industry was spending hundreds of millions on consumer advertising. Today the figure is around $5 billion annually.

FDA’s Drug Safety Claims Are Misleading:

“Safe and effective” may seem like a comforting slogan, but reality is much more complicated. All one has to do is watch a few drug commercials to realize that the FDA’s reassuring message is hard to defend.

Xeljanz XR:

The drug Xeljanz XR is widely advertised for rheumatoid and psoriatic arthritis. The announcer tells us that it can “reduce pain, swelling and significantly improve physical functioning.” But then there are the serious side effects:

“Xeljanz can lower your ability to fight infections like TB. Don’t start Xeljanz if you have an infection. Taking higher than recommended doses of Xeljanz for RA can increase risk of death. Serious, sometimes fatal, infections, cancers, including lymphoma, and blood clots have happened, as have tears in the stomach or intestines, serious allergic reactions and changes in lab results.”

While the announcer reads that long list, the mother and daughter characters on the screen arrive at the workplace and smile at everyone they meet as well as each other.

Clearly, cancer and death are pretty serious consequences of this medicine. Does the FDA really want us to believe that this drug is perfectly safe?

Jardiance:

Another heavily advertised medicine is Jardiance for type 2 diabetes. Restauranteur Dimitri “is on it.” After being told by the male announcer that “…Jardiance can help save your life from a heart attack or stroke,” the female announcer takes over:

“Jardiance can cause serious side effects, including dehydration, genital yeast or urinary tract infections and sudden kidney problems. Ketoacidosis is a serious side effect that may be fatal. A rare but life-threatening bacterial infection in the skin of the perineum could occur. Stop taking Jardiance and call your doctor right away if you have symptoms of this bacterial infection, ketoacidosis or an allergic reaction.”

Ketoacidosis:

While the announcer quickly warns about the potentially fatal complication of ketoacidosis, a small banner on the screen describes this condition:

“Symptoms of ketoacidosis include nausea, vomiting, stomach pain, tiredness, and trouble breathing.”

Whether most people are able to see those symptoms we leave to your imagination.

Perineum:

There is something else the female announcer mentions without describing it. Many viewers may not have any idea where to find the “skin of the perineum” where they might develop a “rare but life-threatening bacterial infection.” The banner on the screen explains:

“The perineum is the area between the anus and genitals. Symptoms include fever, weakness, and pain, tenderness, redness, or swelling of the genital area.”

Let’s Put an End to FDA’s Drug Safety Claims!

Maybe it’s time for the FDA to stop insisting that all the drugs it approves are “safe.” Every time we watch a drug commercial, we are reminded that is not strictly true.

Do you remember the phrase “doublethink” from George Orwell’s book, Nineteen Eighty-Four? Wikipedia describes it elegantly:

Doublethink is a process of indoctrination whereby the subject is expected to accept as true that which is clearly false, or to simultaneously accept two mutually contradictory beliefs as correct, often in contravention to one’s own memories or sense of reality.”

A spokesperson for the FDA described the Food and Drugs Act of 1906 as:

“…specifically unspecific describing ‘safe and effective’ as it applies to drugs.”

Apparently the FDA has not been very interested in clarifying the word “safe” for more than 100 years. If you would like to see how the FDA defines safe, here is a link to another article we have written on this topic:

Is the FDA’s Definition of Safe a Lie?
Words matter! That’s why we are outraged at the FDA’s definition of “safe.” The agency claims that all drugs it approves are safe, but some harm people.

Share Your Thoughts

Do you believe all FDA-approved drugs are safe? Please share your thoughts and experiences in the comment section below. What are your feelings about direct-to-consumer drug commercials on TV?

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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