Are pharmaceutical ads harming our health? Americans have become accustomed to seeing commercials for prescription medications on television. Last year the drug industry spent $5 billion on TV spots (Fierce Pharma, May 24, 2022). The FDA is supposed to prevent deceptive drug ads. But we believe many of the commercials you see are misleading because the visual images distract you from the required recitation of incredibly scary side effects including cancer and death.
Prescription Drugs Ads Proliferate:
If you watch any TV, chances are good that you have seem promotions for Dupixent to treat atopic dermatitis (eczema) and asthma, Rybelsus, Ozempic, Trulicity and Jardiance for type 2 diabetes, Humira for psoriasis and severe arthritis and Rinvoq for eczema, rheumatoid arthritis and ulcerative colitis.
That just scratches the surface. There are so many drug commercials that we have lost count. Let’s not forget Skyrizi, Rexulti and Tremfya. Why are there so many prescription drug ads on television anyway?
A Walk Down Memory Lane:
Prior to 1997, prescription drug advertising on television was virtually nonexistent. Climb into our People’s Pharmacy Time Machine to the early 1980s and you would rarely, if ever, have seen direct-to-consumer (DTC) prescription drug commercials.
When Representative John Dingell from Michigan asked some of the leading executives of pharmaceutical companies if they were planning to create DTC commercials, the answer was an unequivocal NO!
The Vice President for Corporate Affairs at Eli Lilly, Edgar Davis, told the U.S. House of Representatives:
“We do not believe that commercial advertising of prescription drugs is appropriate…prescription drugs embody a complex set of factors with potential human effects that can best be evaluated by the physician…Therefore, we believe that the need for the physician’s supervision of any prescription drug taken by the patient is paramount and that the potential pressures of public advertising of prescription drugs on the scientific decisions of the physician are both unwise and inappropriate.”
The PHARMA thought leaders all agreed that Rx advertising to consumers was a “terrible idea”! That was in 1984. You can read more about this slippery slope at this link.
Then the FDA Opened the Flood Gates:
In 1997 the FDA made it easier for Big Pharma to advertise prescription drugs to patients (American Journal of Public Health, Jan. 2010).
It did not take long for TV commercials for Rx drugs to start proliferating.
Today, they make up a sizable proportion of TV advertising dollars. The FDA is largely responsible for this avalanche. In our opinion, it has allowed deceptive drug ads to multiply like mosquitoes after a rainy spell.
What Leads to Deceptive Drug Ads on TV?
We think it is lax oversight by the FDA. That’s not just our opinion, though.
Here is what the Government Accountability Office (GAO) had to say about this in 2006:
“FDA reviews a small portion of the DTC materials it receives. To identify materials that have the greatest potential to impact public health, FDA has informal criteria to prioritize materials for review. However, FDA has not documented these criteria, does not apply them systematically to all of the materials it receives, and does not track information on its reviews. As a result, the agency cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority.”
“The effectiveness of FDA’s regulatory letters at halting the dissemination of violative DTC materials has been limited. The 19 regulatory letters FDA issued in 2004 and 2005 were issued an average of 8 months after the materials were first disseminated. By the time FDA issued these letters, companies had already discontinued use of more than half of the violative materials.”
The GAO called for more prompt FDA action:
“…in order to limit consumers’ exposure to false or misleading advertising.”
Remember Marlboro Country?
Once upon a time there were ads for cigarettes on television. For decades, the “Marlboro Man” was an icon of rugged masculinity and Marlboro cigarettes. For those of you who never saw or cannot remember “Marlboro Country” commercials, here is a link to a 1968 classic.
In 1970 Congress banned all cigarette advertisements from radio and television. The commercials disappeared early in 1971. These days, people would be shocked to see a cigarette ad on television.
Should Deceptive Drug Ads Be Banned?
Prescription drug ads, on the other hand, have proliferated. It’s hard to watch the evening news without seeing commercials for cancer treatments, medicines for psoriasis or rheumatoid arthritis or drugs for asthma and eczema.
Whenever someone suggests that such promotions should be scaled back, lawyers are quick to respond that companies have First Amendment rights of free speech. There is a perception that the Supreme Court would rule against any efforts to restrict prescription drug advertising directly to consumers.
What Are the FDA’s Rules for DTC Advertising?
Prescription drug advertising must meet certain criteria. For example, it should not be misleading (New England Journal of Medicine, May 31, 2007).
The FDA is supposed to protect us from deceptive drug ads. We don’t think the agency is doing a very good job, though.
We believe that many prescription drug ads on TV are misleading. That’s because they are designed to emphasize the potential benefits someone might experience from a drug without always providing actual data on effectiveness.
The Office of Prescription Drug Promotion (OPDP):
You are probably not aware that the FDA has people devoted to monitoring drug advertising.
“OPDP protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. This is accomplished through comprehensive surveillance, compliance, and education programs, and by fostering better communication of labeling and promotional information to both healthcare providers and consumers.”
FDA spells out what Pharma companies must do to avoid deceptive drug ads:
“The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that all drug advertisements contain (among other things) information in brief summary relating to side effects, contraindications, and effectiveness.
“In addition to the specific disclosure requirements, advertisements cannot be false or misleading or omit material facts. They also must present a fair balance between effectiveness and risk information. FDA has consistently required that appropriate communication of effectiveness information includes any significant limitations to product use.”
I do not know about you, but I find the effectiveness data on most prescription drug ads disappointing. What you often see is someone with a pretty serious health problem having a lot of fun thanks to the medication.
Take the Latuda commercial for bipolar depression. We see three people who look super sad. The announcer says:
“The lows of bipolar depression can take you to a dark place and be hard to manage.”
The visual images are dark and grim.
Then the visual image changes radically. We see a bright and airy space. A young man has a smile on his face and he embraces a smiling woman.
The announcer says:
“Latuda could make a real difference in your symptoms. Latuda was proven to significantly reduce bipolar depression symptoms.”
Under the happy video in smaller print we read that this benefit occurred:
“In 6-week clinical studies compared to placebo.
“Results may vary.”
That effectiveness data may satisfy the FDA, but I wish it were more detailed. I am not sure six weeks is adequate to assess long-term benefit.
Then come the side effects:
Drug companies are required to provide adverse reaction information. But commercial producers have become adept at serving up distracting visuals while a list of scary side effects is read. During the Latruda commercial we see two couples playing a board game.
They are smiling and having a great time as the announcer says:
“Latuda is not for everyone. Call your doctor about unusual mood changes, behaviors or suicidal thoughts. Antidepressants can increase these in children, teens and young adults. Elderly dementia patients on Latuda have an increased risk of death or stroke. Call your doctor about fever, stiff muscles and confusion as these may be life threatening or uncontrollable muscle movements as these may be permanent. These are not all serious side effects.”
That last sentence leaves a lot unmentioned. Other potential adverse reactions with lurasidone (Latuda) include jitteriness, agitation, anxiety, fidgeting, sleepiness, fatigue, nausea and digestive upset.
The Art of Distraction:
An ad for the breast cancer drug Verzenio (abemaciclib) shows women smiling while the announcer talks quickly about severe diarrhea, dehydration, serious infection that can lead to death and blood clots that can lead to death. That doesn’t even include common side effects such as nausea, headache, tiredness or hair loss.
Other commercials often include children or dogs during the side effect disclosures. There is also a lot of action. A Rinvoq ad features a young woman jumping out of a helicopter, a young man shadow boxing and a tattoo artist at work. Another Rinvoq commercial features exciting river rafting. With all that going on plus big smiles, it may be hard to focus on the chance that the drug could cause lymphoma and skin cancer.
Can We Overcome Deceptive Drug Ads?
Perhaps it is time for Congress to pass legislation that would regulate direct to consumer drug advertising. A bill called the Banning Misleading Drug Ads Act has been introduced by Representative Abigail Spanberger of Virginia.
Rep. Spanberger points out:
“Critical medical decisions should always be made between a patient and their doctor — not between a patient and their television screen.”
She and her colleagues believe that:
“for far too long, drug companies have used deceitful advertising tactics to distract consumers from the potentially harmful reactions to their products.”
We think this initiative is long overdue. The FDA was supposed to develop rules about avoiding distractions 15 years ago. If you think that it is time for the agency to crack down on misleading commercials, you may want to write to your Representative and urge support of this legislation. You can also contact the FDA Commissioner, Dr. Robert Califf, to tell him what you think about prescription drug ads on television.
One More Thing: Report Bad Ads!
The FDA actually has a “Bad Ad Program.” It is:
“…an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to raise awareness among healthcare providers including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees about potentially false or misleading prescription drug promotion while also providing them with an easy way to report it to the Agency.”
“To report potentially false or misleading prescription drug promotion:
• Email: BadAd@fda.gov
• Call toll-free 855-RX-BADAD or 855-792-2323
Bad Ad Program
5901-B Ammendale Rd
Beltsville, MD 20705-1266
We would like to see fewer prescription drug commercials on television. What about you? Share your thoughts in the comment section below. Would you like to see fewer smiling faces and distracting images during the mandatory listing of serious drug side effects? Please share your comments. We will pass them along to executives at the FDA. Maybe someone there will listen.
If you think this is an important message, please share it with friends and family. You know the drill. Scroll to the top of the page and click on email, Twitter or Facebook. Please spread the word that the FDA needs to crack down on deceptive drug ads. And Congress needs to pass legislation like the bill that Abigail Spanberger has submitted: Banning Misleading Drug Ads Act.