Drug companies used to focus their marketing strategies exclusively on doctors. They spent millions on sales representatives who traveled the country chatting up physicians and handing out free samples. There was no such thing as direct-to-consumer (DTC) drug advertising. Now it seems as if every third commercial on television is for a powerful medication. A physician from the 1980s would be astounded to see prescription drug ads to treat asthma, cancer, ulcerative colitis, rheumatoid arthritis or psoriasis.
Doctors Are Also Fed Up With Prescription Drug Ads!
You and I are not the only ones who are fed up with prescription drug ads on television. A research letter in JAMA Network Open (Jan. 13, 2023) reveals that some very thoughtful health professionals are also concerned about prescription drug advertising. One of the authors is Aaron S. Kesselheim, MPH, MD, JD. He is also a Professor of Medicine at Harvard Medical School. Dr. Kesselheim is an expert on pharmaceutical policy, generic drugs, FDA regulations and bioethics.
In this new article Dr. Kesselheim and his colleagues point out that direct-to-consumer (DTC) drug advertising quintupled over the last two decades. You have seen the commercials where almost everyone seems to be in good health and having a great time.
Not infrequently there’s a dog or a child in the scene. Almost always there are visually compelling images, especially when it comes to the long list of scary side effects. Even as the announcer lists serious adverse reactions such as heart attacks, strokes or cancer, the actors are smiling, dancing or jumping for joy. Drug companies and their advertising agencies have perfected the art of distraction.
New Research Punctures the Balloon:
The latest research in JAMA Network Open describes how the drug companies justify these commercials and why the authors undertook this research project:
“Proponents have argued that such advertising improves public health by promoting clinically beneficial prescribing. We assessed the therapeutic value (ie, whether they represent advances over existing treatments) of drugs subject to most direct-to-consumer television advertising from 2015 to 2021.”
These investigators wanted to know whether the drugs being advertised the most were really valuable therapeutic agents. Here are their conclusions:
“Fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared with existing therapies. Manufacturers’ television advertising spending on included products rated as low therapeutic value was $15.9 billion from 2015 to 2021.”
Why would drug companies spend so much money on prescription drug ads there were not of extraordinary value? The authors answer:
“One explanation might be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have greater incentive to promote drugs of lesser value.”
The Spread of Prescription Drug Ads:
Prescription drug ads pay for a lot of your television viewing. If you have the impression that there are more such commercials on TV than there used to be, you are correct.
A study published in JAMA (Jan. 8, 2019) found that direct-to-consumer advertising went from $2.1 billion in 1997 to $9.6 billion in 2016. The proportion of marketing dollars spent on reaching consumers also increased during the last two decades. It went from 11.9% of total marketing dollars in 1997 to 32% of the total in 2016.
The U.S. Government Accountability Office (GAO) reported in May, 2021 that:
“Drug manufacturers spent $17.8 billion on direct-to-consumer advertising (DTCA) for 553 drugs from 2016 through 2018, and spending was relatively stable at about $6 billion each year. Almost half of this spending was for three therapeutic categories of drugs that treat chronic medical conditions, such as arthritis, diabetes, and depression. GAO also found that nearly all DTCA spending was on brand-name drugs, with about two-thirds concentrated on 39 drugs, about half of which entered the market from 2014 through 2017.”
A Brief History of Prescription Drug Ads:
In 1983, then-FDA commissioner Arthur Hayes asked drug companies if they were planning to push for prescription drug ads directed at patients.
According to an article by Dylan Scott (Stat, Dec. 11, 2016):
“Almost all of them said, ‘No, that would be a terrible idea.’”
In 1984 drug companies responded to Representative John Dingell from Michigan about DTC drug advertising:
R.T. Parfet, Chairman of the Board, Upjohn Company, (U.S. House of Representatives, 1984):
“The view of the Upjohn Company is that the direct advertising of prescription pharmaceuticals to consumers…would be detrimental to the pharmaceutical industry and, more importantly, a potentially disruptive element in our medical delivery system as a whole…Our view is that there is a vast difference between education and promotion…Product specific consumer ads could increase costs.”
Allan S. Kushen, Senior Vice President, Public Affairs, Schering-Plough (U.S. House of Representatives, 1984):
“We have serious concerns about proposals to allow advertising directly to patients. We do not believe it is in the public health interest; indeed we believe that, in most cases, it cannot safely be accomplished.”
Edgar G. Davis, Vice President, Corporate Affairs, Eli Lilly and Company (U.S. House of Representatives, 1984):
“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.”
An About-Face About Prescription Drug Ads:
In 1997, for reasons that remain mysterious to us, the FDA decided to make it easier for drug companies to advertise prescription drugs directly to consumers. The companies conveniently forgot their concerns about such practices. The floodgates opened.
The special communication in JAMA (Jan. 8, 2019) by Drs. Schwartz and Woloshin noted the change from 1997 to 2016:
“DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies.”
Can you believe it? In 2016 there were 663,000 TV commercials for prescription drug ads! We bet there were a lot more than that last year.
Our Readers Despise Prescription Drug Ads!
Most of our readers really dislike prescription drug advertising on television. As far as we can tell, only two countries in the world permit this kind of direct to consumer drug promotion. Here are just a few comments.
Heide wrote:
“Frankly, I HATE TV ads for drugs. I don’t believe they should be advertised. Isn’t my doctor smart enough to know what to prescribe?”
Nancy added:
“I have watched the drug commercials during the evening news breaks. Everyone is smiling and doing some kind of (usually pleasurable) activity. No one in the ads looks the least bit sick; all are full of happiness and health! It is criminal that these kinds of misleading and dangerous ads are allowed to proliferate. Their only purpose is to pile up profits.”
Cindy offered her opinion:
“I honestly do not believe that drug companies should be allowed to advertise. Some shows only seem to have commercials from drug companies.
“I had a serious allergic reaction to an arthritis drug. I reached out to the company and received no response.”
Carol’s experience and thus her perspective are distinct:
“I worked for a major pharmaceutical company for 27 years in the research and development area. I believe they do many good things for the world. They are the only companies with the facilities, money, and research brain power that can provide the medicines we all need at some time in our lives.
“This said, I do not believe big pharma should be allowed to advertise their products on television or in print. Advertising these products does more harm than good. Allow doctors to decide what is good for their patients.”
Why Doesn’t the FDA Crack Down on Prescription Drug Ads?
Where is the FDA when it comes to monitoring prescription drug commercials? Why does the agency warn physicians about really serious adverse drug reactions with one hand and allow these DTC commercials to proliferate with the other? Here is an example that has blown our minds.
The Rinvoq Challenge!
On January 14, 2022 the FDA issued an update on some very serious warnings for a category of drugs called Janus Kinase (JAK) inhibitors. The drugs in question include baricitinib (Olumiant), upadacitinib (Rinvoq) and tofacitinib (Xeljanz):
“We are requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.”
The “Boxed Warning” is the FDA’s way of saying watch out (National Library of Medicine, Sept. 19, 2021):
“Boxed warnings (formerly known as Black Box Warnings) are the highest safety-related warning that medications can have assigned by the Food and Drug Administration. These warnings are intended to bring the consumer’s attention to the major risks of the drug.”
Here is a link to the BOXED WARNING for Rinvoq: The headline:
“WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS”
I won’t bore you with the long and complex boxed warning for Rinvoq. It discusses serious infections like tuberculosis and “invasive fungal infections” along with “bacterial, viral, herpes zoster, and other infections due to opportunistic pathogens.”
Then there are the “major adverse cardiovascular events” aka MACE. They are “defined as cardiovascular death, myocardial infarction [heart attack], and stroke.”
One of the Prescription Drug Ads for Rinvoq:
A commercial for Rinvoq promotes this drug for treating eczema (atopic dermatitis). This condition often causes redness, itching or rash. While it is certainly unpleasant, eczema is not a life-threatening condition.
The Rinvoq commercial features very active young adults. One is climbing into a helicopter, while another works out in a gym. In addition, we see a DJ spinning records and a tattoo artist at work.
Then we hear about the side effects:
“Rinvoq can lower your ability to fight infections including TB. Serious infections or blood clots, some fatal, cancers, including lymphoma and skin cancer, death, heart attack, stroke and tears in the stomach or intestines occurred. People 50 and older with at least one risk factor for heart disease have higher risks. Don’t take if allergic to Rinvoq, as serious reactions can occur.”
We have always wondered how someone would know that they were allergic to a drug like Rinvoq before they started taking it.
The visual images during the announcements about adverse effects are arresting. A man hits a punching bag and shadow boxes. A woman jumps out of a helicopter and starts running. The DJ adjusts her volume while moving to the music and the tattoo artist shows off the finished design. Check out the commercial for yourself at this link.
Big Bucks Being Spent on Rinvoq Commercials!
Rinvoq is not just for eczema. The FDA has given this JAK inhibitor a green light for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis (eczema), and ankylosing spondylitis. Fierce Pharma monitors the pharmaceutical industry. It provides news and analysis about drug companies. An article on July 8, 2022 about drug marketing was titled:
“Dupixent dethroned as AbbVie rival Rinvoq shoots to the top of pharma’s TV ad spenders.”
The bottom line seems to be that Rinvoq is now #1 when it comes to prescription drug ads:
“AbbVie spent $26.3 million on TV ads for the arthritis and psoriasis med last month, more than double the $12.9 million it spent the month prior.
“Most of that spend ($15.1 million) went to its new TV ad “Helicopter”, which went live on May 31 and is the first commercial for its new eczema approval, which should be a big money spinner for the drug.”
So, even with a boxed warning, Rinvoq is expected to be a “big money spinner.” Check out the “Helicopter” ad to promote the treatment of eczema at this link.
We were already concerned about older Rinvoq commercials. You can read my take on the way the drug is being promoted for rheumatoid arthritis at this link.
Where Is the FDA?
We asked the FDA if it approves such commercials before they air.
The answer:
“No, FDA does not approve the wording and/or visual presentation of every DTC [direct to consumer] prescription drug advertisement.”
The FDA added this:
“Please also note that the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that all prescription 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.”
We applaud the idea of communicating effectiveness information. Sadly, though, relatively few prescription drug ads actually tell viewers how likely they are to get meaningful benefit. We call this “absolute risk reduction.” Our favorite example involves the cholesterol-lowering drug Lipitor (atorvastatin). Here is a link to one commercial for this popular drug.
There is nothing in the commercial about actual effectiveness. The print ads are a bit more revealing, however. The company boasted that Lipitor lowered the risk of heart attacks by 36 percent. On the surface, that seems quite impressive. Many people might think that if they took Lipitor they could reduce their chances of developing a heart attack by more than one third over five years. But there was an asterisk next to the 36 percent.
If someone took the time to look for the asterisk and the smaller print they would discover:
“That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”
The absolute risk reduction after several years on Lipitor was 1%. You did not see that effectiveness data in the TV commercial!
Do DTC Prescription Drug Ads Work?
There is little question that these commercials are effective. Drug companies would not spend billions of dollars if they weren’t getting a substantial return on their investment.
What they may not realize, however, is how much the American public dislikes these ads. Here is just a smattering of comments we have received.
Chris in Florida wrote:
“The drug ads should actually show the TV actors experiencing the side effects of the advertised drug with an annoying soundtrack in the background. If one of the side effects is potential death, then show a funeral scene. I think that would make a funny SNL skit.
“They should also show a range in price per dose. That will not distract the audience. It would cause big pharma stocks to plummet, and only then will they pull their distracting ads.”
Jerry in North Carolina stated:
“Pharma ads should be banned for the simple reason that we are not qualified to make those decisions ourselves based on showing us happy people. Only our doctors are.
“A health care system such as ours makes as much profit from their product as they can. Showing happy faces is how they get us to ask our doctor for it. European countries do not allow prescription drug commercials to be aired.”
Patricia in California said:
“Everyone complains about ads, but no one does anything about them. I turn the channel off and don’t go back but invariably when I go to CNN, there they are again.
“Could someone explain to me why telling everyone they may commit suicide or have a heart attack or stroke is a good selling point? I wouldn’t take any of them. Also, this is the reason drugs are off-the-chart expensive.”
Keith in Massachusetts summed it up:
“All I have to say is AHHHH! I am going crazy listening to them. Instead of breaking the TV, I run to mute it.”
One of the co-authors of the JAMA study, Dr. Steve Woloshin, told Kaiser Health News:
“Marketing drives more testing. It drives more treatments. It’s a big part of why health care is so expensive, because it’s the fancy, high-tech things that get marketed.”
We Have Complained to the FDA!
We are starting to sound like a cracked record when it comes to complaints about prescription drug ads. The “formula” that drug companies have come up with to distract people from the part of the commercial that talks about nasty side effects. In virtually every ad you will see people smiling and having a good time when the announcer starts listing horrific drug side effects. Here is an article we wrote about this:
Do NOT Trust People Smiling During Drug Commercials
We complained about this practice to the FDA’s Office of Prescription Drug Promotion.
Here’s what came back in response:
“Thank you for taking the time to alert us to potentially misleading promotion. You and other healthcare providers are some of the most important resources we have in monitoring promotional activities in the prescription drug market. Below is a detailed explanation of how we will use the information you have provided to help stop misleading promotion.
“If you provided contact information in your complaint, an Office of Prescription Drug Promotion (OPDP) representative may contact you to see if you would like to discuss your complaint.”
As far as we can tell there has been no follow-up. People are still smiling during the scary parts of the commercials. There is one other tactic. The Chantix “Cold Turkey” commercial has come up with other visual strategies to distract you. Here is a link so you can see for yourself.
What that means is that consumers should view such commercials cautiously. Close your eyes when the side effects are listed so you won’t be distracted by the action.
Are You Fed Up Yet?
If you have become fed up with prescription drug ads, why not let the Commissioner of the Food and Drug Administration know? You can contact:
- Dr. Rob Califf, Commissioner of the FDA
- 10903 New Hampshire Ave
- Silver Spring, MD, 20993-0002.
Tell Dr. Califf that Joe sent you. Encourage him to adopt the advice of Dr. Kesselheim and his colleagues in JAMA Network Open (Jan. 13, 2023):
“The American Medical Association and public health advocates have called for restrictions on direct-to-consumer drug advertising, warning that it inflates demand for newer, more expensive drugs at the expense of less costly alternatives. Policy makers and regulators could consider limiting direct-to-consumer advertising to drugs with high therapeutic or public health value or requiring standardized disclosure of comparative effectiveness and safety data, but policy changes would likely require industry cooperation or face constitutional challenge.”
Any changes in prescription drug ads will likely require an act of Congress. You may want to express your thoughts to your Senators and Representative. Sadly, though, they likely take a lot of money from the pharmaceutical industry. The chances that they will shoot the golden goose or the “turkey” that is contributing to their campaign funding committee is pretty slim.
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