What’s wrong with the FDA? On the one hand, the agency just issued scary new warnings for two popular rheumatoid arthritis (RA) drugs. On the other hand, it allows commercials for these drugs that make it seem as if they are fabulous. They are portrayed as just the thing to get you performing amazing feats of physical activity. If you haven’t watched the Rinvoq (upadacitinib) ad, here is a link.
The Rinvoq Commercials:
Commercials for Rinvoq have been in heavy rotation recently.
In one ad you see a woman kickstarting a motorcycle as the announcer says:
“Your mission: stand up to moderate to severe rheumatoid arthritis and take it on with Rinvoq!”
She roars off and the scene shifts to women welding and drilling a heavy metal sculpture. Then we see our motorcyclist coming upon a woman with a flat tire. Next she is seen changing the tire and tightening the lug nuts with a heavy-duty lug wrench. Our RA heroine then kickstarts her motorcycle and roars off once again.
“Your Mission: Zip Line”
In another commercial, a woman clips her harness onto a zipline and swings high above a green valley. Then we see her speeding along in an all-terrain vehicle as she drives through a stream with reckless abandon.
The message is clear. Rinvoq will allow you to participate in vigorous and highly demanding leisure-time activities.
Rinvoq Side Effects:
Of course, there is the standard list of scary side effects during the TV commercial.
While people are distracting us with their strenuous activities, the announcer warns:
“Rinvoq can lower your ability to fight infections, including tuberculosis. Serious infections and blood clots, sometimes fatal, have occurred, as have certain cancers, including lymphoma, and tears in the stomach or intestines and changes in lab results.”
The New Scary FDA Warnings:
If you think that sounds dangerous, the FDA has just issued new worrisome warnings for Rinvoq and other drugs in the same class. These medications are called JAK (Janus kinase) inhibitors.
Another highly advertised medicine in this category is Xeljanz (tofacitinib). Doctors prescribe it for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. Olumiant (baricitinib) for RA is also subject to the FDA’s heightened cautions.
“Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz.”
Why New Warnings Now?
What prompted this new safety concern? When the Food and Drug Administration first approved Xeljanz it required the manufacturer (Pfizer) to conduct further safety research on the medication.
This is what the agency refers to as a Phase 4 study. In the case of Xeljanz, the FDA wanted to compare this JAK inhibitor to an older class of anti-inflammatory drugs called TNF blockers such as Humira (Adalimumab) or Enbrel (Etanercept).
The results are now in and they aren’t pretty. The FDA saw more blood clots and deaths with Xeljanz compared to the older TNF blocker drugs for rheumatoid arthritis. The idea that Xeljanz could increase the risk for “heart attack, stroke, cancer, blood clots, and death” is disconcerting, to say the least.
Revised Black Box Warnings:
Because of this study the FDA is strengthening the black box warnings:
“We are requiring revisions to the BOXED WARNING, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death… In addition, to ensure the benefits of these three medicines outweigh the risks in patients who receive them, we are limiting all approved uses to certain patients who have not responded or cannot tolerate one or more TNF blockers.”
In other words, doctors are not supposed to prescribe drugs like Rinvoq unless they have first prescribed a medicine such as Humira and it has not worked.
The industry insider publication FiercePharma (Sept. 2, 2021) suggests that the new precautions could throw a monkey wrench into Rinvoq’s “megablockbuster” ambitions:
“If Rinvoq is only used in second or later lines, it could mean a $1 billion to $3 billion reduction from AbbVie’s $8 billion 2025 sales estimate for the drug, SVB Leerink Geoffrey Porges wrote in a Wednesday note to investors. For his part, Bernstein analyst Ronny Gal reined in his 2030 sales projection for Rinvoq to $11.2 billion from the previous $17.2 billion.”
As you can see, this drug is expensive. The insiders anticipated big bucks to flow into the Rinvoq basket.
The Take Home Message:
The moral to this tale: serious side effects are often revealed long after a medication is introduced into the marketplace. Xeljanz was first given FDA approval for the treatment of rheumatoid arthritis in November, 2012.
The phase 4 Xeljanz trial that the FDA required after the drug went on the market began in 2014. It took seven years to collect and finalize the data and for the FDA to evaluate the results.
On September 1, 2021, the FDA revealed the results of its review. According to our calculations, it took almost 9 years for the FDA to make the public aware of serious complications associated with Xeljanz.
Roses and Red…
The Food and Drug Administration has long contended that it never approves a medicine unless it is absolutely “safe and effective.” On Valentine’s Day 2019, the then-FDA Commissioner, Scott Gottlieb, MD, sent out this Tweet:
“Some pills are red,
“Some pills are blue,
“All are safe and effective,
“If they undergo FDA review.”
If by “safe” the FDA means:
“…heart attack or stroke, cancer, blood clots, and death…”
then perhaps we are now living in a 1984 world. If you recall, in George Orwell’s book the concept of “doublethink” was introduced.
The protagonist, Winston Smith offers this:
“…To know and not to know, to be conscious of complete truthfulness while telling carefully constructed lies, to hold simultaneously two opinions which cancelled out, knowing them to be contradictory and believing in both of them…”
The Rinvoq Commercial and the FDA:
The FDA presumably reviews all prescription drug commercials for accuracy. The agency requires pharmaceutical manufacturers to list some of the most serious adverse drug reactions.
The FDA does not seem to care, however, about how the information is presented. That’s why the visual images on the screen can be distracting while the announcer runs through a long list of scary drug side effects.
In the Rinvoq “zipline”commercial, the voice-over message about side effects is paired with people hiking up rough terrain, lifting heavy plants, and swinging off a zipline. The action is fast and furious…and distracting.
Other commercials feature people smiling during a long litany of serious side effects. In this article we have actually documented this process:
Do NOT Trust People Smiling During Drug Commercials
We counted at least two dozen smiles during a commercial for a medicine to treat metastatic breast cancer.
That’s while the announcer says things like:
“Serious liver problems can occur. Symptoms may include tiredness, loss of appetite, stomach pain and bleeding or bruising more easily than normal.
“Blood clots that can lead to death have also occurred. Talk to your doctor right away if you notice pain or swelling in your arms or legs, shortness of breath, chest pain or rapid breathing or heart rate.
“Common side effects include nausea, infections, low red and white blood cells and platelets, decreased appetite, headache, abdominal pain, tiredness, vomiting and hair thinning or loss.”
What Do You Think?
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