The U.S. and New Zealand are the only two countries that allow pharmaceutical companies to advertise on TV or radio.1 Although the FDA had always allowed advertising, they also required that a long list of side effects be published at the same time. This was possible in newspaper advertising with small print, but in a 30-second TV ad it couldn’t be done.
It was during a speech at the American Advertising Federation conference when then FDA commissioner Arthur Hayes talked about drug advertising and said it2 “may be on the brink of exponential growth phase of direct-to-consumer promotion of prescription products.” This simple sentence was taken to mean the FDA may support direct-to-consumer (DTC) ads for pharmaceutical products.
In 1996, a TV spot from Schering-Plough for Claritin allergy medication promised “clear days and nights” and recommended the viewer “see your doctor” without mentioning what the product treated.3 The ad forced the FDA’s hand and they relaxed earlier guidelines, changing the requirements from an exhaustive list of side effects to a brief summary of the most important risks.
According to the FDA,4 advertising must also list at least one approved use and the generic name. Once this happened, it appeared there was no turning back. In 1998, one year after the decision, David Kessler, a past FDA commissioner, was speaking to a group of executives from Big Pharma, and warned:5
“Your companies likely will face lawsuits eventually about the claims they make for their products in television commercials. One day in a courtroom, I assure you, one of you is going to have your DTC ads played.”
There is no doubt these advertising campaigns are controversial and there are groups on both sides who adamantly defend their position. One underlying debate is the role consumers play in medical decisions6 and the time it may take from already limited time with a doctor.7 But, despite the arguments, it’s difficult to ignore the manipulation and financial gain associated with these campaigns.
US Is One of Two Countries Allowing Direct Ads
DTC advertising is big bucks — for Big Pharma and the media. While New Zealand currently allows the ads, large medical groups have come out with statements against them, calling for a total ban in much the same way the American Medical Association has.8
As consumers and advocates in the U.S. are battling Big Pharma and the media, New Zealand has taken aim at changing legislation.9 One agency claims 57% of consumers in New Zealand want the ads to stop10 but the country continues to allow the DTC selling of pharmaceuticals.
Dr. Michael Carome is director at Public Citizen,11 a nonprofit consumer advocacy organization boasting 500,000 members and supporters throughout the U.S.12 In an interview with Sharyl Attkisson on Full Measure,13 Carome discussed the billions of dollars pharmaceutical companies are spending each year on TV and radio ads, and the attendant repercussions on public health.
He claims most people who watch television every day will see up to nine pharmaceutical ads per day and up to 30 hours of pharmaceutical ads every year.14 Carome spoke about the role this plays in the fourth leading cause of death and injury in the U.S. — people taking prescription drugs as prescribed.
Thomas J. Moore, scientist at the Institute for Safe Medication Practices, notes there is no system for adding up the number of prescription drug deaths unrelated to a prescription error or overdose.15 Although it’s recommended that health care providers report complications to the FDA, the system is not mandatory.
According to Donald Light, a medical sociologist and author, about 2,460 people die each week as a result of taking prescription medications. To clarify, this is separate from those who died from errors in prescription, self-medication or overdose.16 These numbers are significant, as DTC advertising increases the probability that people will request medications that advertising convinces them they need.17
Prime Time Pushers Effectively Boosting Profit
Big Pharma operates on profit. In 2018, Open Secrets reported the pharmaceutical industry spent $283.44 million lobbying for their industry.18 In 2016, the health industry spent $29.9 billion on medical marketing, including $20.3 billion on physicians to persuade them of the benefits of their prescription drugs.19
Additionally, in a study published in the Journal of the American Medical Association,20 it was shown that the pharmaceutical industry increased their total spending on DTC from $2.1 billion in 1997 to $9.6 billion in 2016. Of that, $3.45 billion was spent in 2017 on TV ads which increased to $3.7 billion in 2018.21
Money spent on lobbyists and advertising pays off in higher revenues and profit for the pharmaceuticals. Carome believes there are serious downsides to this process. Drug companies advertise the newest medications for which there is the least amount of information about safety,22 and often they hold an exclusive patent.
Although there are older drugs available for the same conditions with a more favorable history of side effects, they are often generic, and the generic industry does not engage in this type of advertising. Safety is the reason the FDA requires a disclosure of risks associated with a drug.
According to Alan Adamson, brand strategy consultant, most of the marketing is aimed at individuals over 65, and an unexpected side effect of compliance with the FDA’s regulation is that it enhances credibility of the advertising.23
Jeff Rothstein24 serves as chief executive officer at CultHealth,25 an ad agency specializing in health care. Rothstein says although it is counterintuitive, they find that when individuals hear about risks it increases their belief in the truthfulness of the whole ad.26
Side Effects Spoken Against Backdrop of Happy Faces
Advertising campaigns used by the pharmaceutical industry may comply to the letter of the law but not the intent. Some have been caught using clever tactics to minimize the risks and overstate the benefits. Risks are mentioned in the ads in a way people do not remember, often listed in small print on the screen or told to the consumer while distracting images play across the television.
One such ad was for Sanofi’s long-acting insulin drug, Toujeo.27,28 Carome ssiad the FDA had warned the company29 about showing distracting images while they discussed alarming side effects.
Once the FDA finds that an ad violates their regulations, they send a warning letter. The ad might be pulled, or it might be reconfigured, but by that time it likely has been on the air for weeks or months and individuals may have been misled.
Bayer was warned about marketing tactics used for their birth control pill Yaz, because their campaign minimized risks and overstated benefits. During the ad,30 side effects were printed on the side of colorful balloons rising into the sky.31 After the warning, Full Measure32 reported Bayer ran a $20 million corrective campaign but was again warned for failing to disclose risks such as heart attack, stroke and death.
In another ad run by Pfizer for the drug Lipitor, Dr. Robert Jarvik, inventor of the artificial heart, talked about his support for it. Jarvik was paid $1.3 million for the ad, which the FDA called misleading. Pfizer pulled the ad.33 Pfizer was also warned about ads for Estring,34 a drug for postmenopausal women, as those ads failed to provide any risk information, including the risk of uterine cancer associated with use of the drug.35
The FDA initially did not agree to an interview, but once Full Measure began investigating, they told the group they were launching a new study about TV commercials, in particular those falling under the disease awareness category.36 The aim was to determine if these ads “may result in consumers misinterpreting and being confused” by the information presented.37
Disease Awareness Ads May Slip Through a Legal Loophole
One example of a disease awareness ad that does not disclose side effects under the current regulations is a vaccine by GlaxoSmithKline for adult whooping cough.38 The ad plays on the Red Riding Hood fairy tale, portraying grandmother as a big bad wolf unintentionally passing along a big bad cough to her darling grandbaby.39
At the conclusion of the ad, they offer a URL to a website where they describe more about the “big bad cough” and how to get vaccinated. If the ad doesn’t mention a brand, it’s considered educational and doesn’t have to mention risks. This is a legal loophole that pharmaceutical companies have used to promote their products.
Merck is yet another pharmaceutical company using the same loophole with its ads for its HPV vaccine.40 Without mentioning its name, Gardasil, the advertisement preys on the guilt a parent may feel in not protecting their teen from cancer spread through sexual contact.
Aside from the fact that Gardasil is not actually a cancer vaccine, but rather a vaccine for a viral infection41 that clears itself in the majority of cases (but can lead to cancer in some cases when a persistent infection is left untreated), the ad does not disclose that the vaccine is associated with blood clots, seizures, motor neuron disease, pancreatitis and paralysis.42
These are the types of ads the FDA is spending tax dollars to “study” in order to determine if the information — or lack of information — is misleading the public.
Michael Sinkinson, assistant professor of economics at Yale School of Management,43 offers a financial perspective on the situation. In his interview with Full Measure, Sinkinson expressed concern that without advertising, drug companies may lose enough revenue and fail to develop new medications:44
“Maybe the math no longer makes sense and you don’t develop the drugs. I think it’s more likely that advertising is the net positive for society for novel drugs, for new treatments and for drugs that are just very cost effective, very effective at keeping you out of the hospital.”
What Has to Happen for Change?
While it may be simple to identify the challenges and obstacles you face from pharmaceutical advertising on television and other media, strategically identifying and executing a plan is more complex. Carome believes45 it’s unlikely we’ll see the demise of these ad campaigns in our lifetime as they are highly profitable for Big Pharma and the media.
Although some believe pharmaceutical companies may lose enough revenue to stop research and development on new drugs, that is how they make money. Once a medication has lost its patent, the company loses exclusive rights to sell the brand name drug and generic copies at a lower cost begin to flood the market.
You may not see a change in advertising on television and other digital media in your lifetime, but you are able to take control by making small changes to improve your health and reduce your dependence on medication. I encourage you to share this newsletter with friends and family so they may discover how to take control of their health, which ultimately impacts daily life and finances.
Simple choices reduce your risk for cardiovascular disease, diabetes, cancer and Alzheimer’s disease, all of which are in the top 10 leading causes of death.46 Here are some of my past articles to help you get started:
- The Metabolic Approach to Cancer Treatment
- Fasting Prevents and Halts Diabetes
- Cholesterol Does Not Cause Heart Disease
- Lifestyle Factors Linked to Alzheimer’s