Full Measure has learned the FDA is planning a new study on TV advertising of prescription drugs. It’s a multi-billion dollar industry benefiting both pharmaceutical companies and the television networks paid to run the ads. Supporters say patients benefit too. But almost nowhere in the world is it allowed except here. And with prescription drugs a leading cause of death and injury, we investigate the Pill Pitch.
Dr. Michael Carome leads the Health Research Group at the watchdog Public Citizen.
He’s against prescription drug advertising on TV. It was forbidden until a fierce lobbying campaign by the pharmaceutical industry in the 1990s.
Dr. Michael Carome: In 1997, the FDA opened the floodgates to broadcast media: television, and radio ads, for prescription drugs, and we now have companies spending billions of dollars every year on this advertising.
Dr. Michael Carome: The average person in the US sees 9 drug ads a day, or 30 hours of drug ads per year. It’s just an extraordinary amount of exposure to prescription drug advertising.
The ads upset the longstanding rule that doctors alone should decide the best pills for patients.
To get an idea of how much the ads boost profits, you need only look at how much is spent on them. In 2018, the pharmaceutical industry shelled out $6.4 billion dollars on so-called “direct-to-consumer ads.” No-one from the drug industry would agree to an interview. Representatives have said in the past that advertising saves lives and improves public health.
Dr. Carome say there are serious downsides.
Dr. Michael Carome: they’re newest drugs, so we often know the least about their safety because they haven't been on the market for a while. And often there are older alternatives that may be equally effective, and safer, and because those drugs aren't advertised, because the generic drug industry doesn't do this type of advertising, it can worsen the public health overall.
Experts say taking prescription drugs as prescribed is a leading cause of death in the US – a factor in as many as 200,000 deaths a year.
Safety is a big reason why the FDA requires the ads to clearly disclose risks.
Dr. Michael Carome: they're going to make sure that the viewers leave the commercial with an understanding of the benefits of perhaps some miracle cure, and not hopefully remember too much about the potential harms and risks.
One infamous case involves clever marketing of Bayer’s birth control pill Yaz.
The FDA has hit Yaz ads with multiple complaints for minimizing risks and overstating benefits. Bayer ran a $20 million corrective ad campaign.
Even after that, the FDA flagged Yaz ads again for failing to disclose any risks— including heart attack, stroke, gall bladder disease, blood clots and death.
Then there’s the cholesterol drug Lipitor.
At one time Lipitor was the best-selling drug in the world generating $12 billion a year for Pfizer. Dr. Robert Jarvik, who invented an artificial heart, got a $1.3 million dollar contract to pitch Lipitor.
But the FDA called his ad misleading because Jarvik isn’t a cardiologist, and he never treated patients or prescribed drugs. By the way, that’s not him rowing the boat, it’s a stunt double. Pfizer eventually pulled the ads.
Another problem, says Dr. Carome, is when risks are told in a way people won't likely remember.
Dr. Michael Carome: There are certainly advertisements where they're reading the risk information but what's being portrayed is smiling people, interesting cartoon characters. And those are classic examples of distracting information.
A case in point: ads for the diabetes medicine: Toujeo
The FDA warned Toujeo’s maker Sanofi about showing distracting, upbeat images while Toujeo’s risks are presented.
The FDA also dinged ads for Pfizer’s menopause drug Estring for failing to present “any” risk information— including uterine cancer.
Dr. Michael Carome: Sometimes they may find an ad that violates the regulations, and they'll write a letter, a warning letter to the company, and the company will pull the ad. But at that point the ad may have been out for many weeks or months, and patients may have already been misled by it.
The FDA wouldn’t agree to an interview. But after we began investigating this story, the agency told us it’s launching a new study into prescription drug TV commercials and particularly a category called “disease awareness” ads.
We don’t know which disease awareness ads are part of the FDA study but this is an example from GlaxoSmithKline for adult whooping cough vaccine.
As long as they don’t mention a brand, these ads are considered educational and don’t have to mention any risks. Critics say it’s a legal loophole that drug companies use to promote their products in a one-sided fashion. In this ad, viewers won’t hear that whooping cough vaccine is linked to paralysis and possible heart problems, and 4% of patients report serious adverse events within 6 months.
Merck’s disease awareness ads for HPV cervical cancer vaccine prey on parental guilt.
No mention of the vaccine’s risk of blood clots, seizure, appendicitis and paralysis.
The FDA told Full Measure that it’s focusing on “disease awareness” communications to find out if they “may result in consumers misinterpreting and being confused” by the information and claims.
Michael Sinkinson has researched drug advertising and is an assistant economics professor at Yale.
Michael Sinkinson: Just to be clear, the US and New Zealand are the only two developed countries that allow this, right? So, most countries have weighed the costs and benefits and said, "No. We don't want to allow pharma companies to advertise on TV to patients."
Sinkinson doesn’t speak for the drug industry and is skeptical of some of their claims. But he says pharmaceutical ads can benefit Americans’ health by selling more product.
Michael Sinkinson: If the government comes along and says, "Actually, you can't advertise on TV,” well, you need to revise those forecasts. You're not going to sell as many year after year after approval, and maybe the math no longer makes sense, and you don't develop the drug. I think it's more likely that advertising is a 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 and out of kind of other parts of the healthcare system that are very costly.
With the FDA taking a new look at all of this, Dr. Carome says drug risks should be clearer in audio and matching bold words on the screen— with no distractions.
Sharyl: if you could wave a magic wand, what would the FDA do about the challenges that you've described?
Dr. Michael Carome: So if I could wave a magic wand we would no longer allow this type of direct consumer advertising at all.
Sharyl: Are TV drug ads in the US ever going to go away, do you think?
Dr. Michael Carome: Unfortunately, probably not in our lifetime.
The FDA has proposed allowing drug companies to reduce the amount of risk information in ads. And the pharmaceutical industry is seeking approval to advertise so-called off-label drug uses not approved by the FDA. The industry’s lobbying group spent more than $128 million lobbying politicians and federal agencies in 2017.