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In what may be a major step towards reducing the litany of risks presented in DTC television ads, the FDA released their new study that shows that less risks presented is better for consumer comprehension and retention. While saying further study is needed, FDA cleared the way for perhaps eventually changing its guidance on the number of required risks presented. This study, originally posted for public comment in January 2015, saw the results published August 2017 in an online research journal.

FDA studied alternate risk disclosure in three categories for this study. Insomnia, depression, and high cholesterol were tested with reduced risk disclosure. While full details were not yet published the conclusion is that consumers remembered more when less was presented. We all know the current approach is not optimal because consumers get bombarded with so many risks and side effects, both in voice overs and on screen supers.

So here we are 20 years into DTC on television and we get the widely expected answer from the FDA study. While this study is better late than never the FDA says further research is needed. FDA would be wise to issue a new guidance soon giving drug makers the chance to reduce the number of risks and side effects. Consumers could immediately benefit by retaining more of the important information. I am even supportive of keeping the ads just as long with fewer risks discussed. Supers could kept on the screen longer and a slower voice speed could be used for discussing risks.

FDA has lots on its DTC research agenda, but this area of risk presentation is of major importance. Action should be a priority because consumers are overwhelmed with risk information under current requirements. The goal of all involved in DTC should be helping consumers get comprehensible risk information. The shortened risk requirement would help in achieving that goal.

The Vaccine makers have been very active using DTC to build awareness for some very serious diseases. Prevnar 13 from Pfizer has had a high spend campaign for its pneumonia vaccine. HPV has also been prominently promoted by Merck for Gardasil. Recently two new vaccines for meningitis B have hit the market and are going head to head. Pfizer’s Trumenba and GSK’s Bexsero both are going after the 10-25 year old market.

Meningitis B is a very serious bacterial disease involving inflammation of the spinal cord or brain. While rare it is deadly for about 10% of those afflicted and causes lifelong damage in many more who survive. About 10% of us have the bacteria in our saliva but overwhelmingly it does not cause meningitis. For about 600-1000 people annually the disease is devastating because it rapidly can cause death.

Trumenba became available in late 2015 and Bexsero a few months later. Trumenba began heavy DTC 3Q 2016 with Bexsero starting this June. Analysts estimate the meningitis market at about $2 billion. These are interesting case studies on DTC for a rare disease. The odds of getting meningitis are very low but the impact is so devastating that physicians, young adults and their parents are being advised by the CDC to consider these vaccines.

Drug makers have been criticized by some physicians and consumer groups for using fear based campaigns for vaccines. Why scare teens and parents? Is it right to use fear as a motivator in these DTC ads? Is it ethical to show the devastation of a disease that is rare to incentivize people to get vaccinated?

Yes, it is because untreated meningitis consequences are so bad. The vaccine is safe. It is moderate in price. The cost is usually covered by college health clinics but even self pay is reasonable at $350-600 for the series of injections. The ads for both vaccine brands are hard hitting and are directed at parents to show what could happen if the child got meningitis B. Of course, the drug makers want to increase the use of their vaccines and they know the market is wide open and incidence of use is currently low. They are trying to warn parents and yes to scare them. Sometimes we need to be scared into action. I see nothing wrong in these ads because the disease is a real, albeit low risk, and can be controlled with vaccines.

Would we have massive outbreaks of meningitis B without these vaccines? No, but saving lives and long term disability of teens and college aged kids is the issue. Society needs to balance the cost to payers for the vaccine versus the risks to the young adult population. Because the disease can spread so quickly any campus that gets a case will cause widespread fear across the community.

We want drug makers to invest in disease prevention for what we see now and may face in the future. If drug makers can develop markets through DTC they will be willing to devote more R&D investment to the vaccine segment. Vaccines and antibiotics are generally lower profit categories because use is short term. Let’s hope for success for current vaccines being advertised because one day we will need to be protected from a pandemic and must have a well developed vaccine infrastructure at big pharma.

Many recent FDA warning letters involve what they say are distracting visuals during risk discussion. Last year Otezla and Toujeo were cited for that. A recent study using eye tracking reinforced their view that visual backgrounds on TV ads are potentially hurting comprehension of risks. Drug makers frequently mention some of the risks using supers on screen.

This FDA research completed in 2016 said that consumers do not absorb information well from those supers when there are distracting visuals. Of course, what is distracting is a subjective judgement from the FDA reviewer. My concern on citing drug makers for distracting visuals is the lack of evidence for that specific ad other than reviewer opinion. I understand FDA cannot quantitatively prove distraction for every TV ad they cite and must use informed judgement. I would hope, however, that FDA is consistent between reviewers and does not change over time. In a past column I said I did not think the Otezla or Toujeo ads were any different than many others not cited by reviewers.

The problem with the fair balance requirement is that consumers are bombarded with information that may meet an FDA requirement but not be meaningful in terms of consumer understanding. FDA is studying the potential use of less warning information under the theory that less information may be better absorbed. My concern with this risk presentation is DTC is held to a different standard than every other advertising category for lawful products. Yes, drugs are different than most categories because they can cause harm. I recognize the need for telling consumers that drugs are potentially dangerous. The current litany of risk approach is, in my view, ineffective since a long list is not likely to be absorbed.

The issue is the role of warnings and risks in a television or print ad where time and space is limited. Drug ads are meant to inform consumers of an option for treatment and that is just the beginning of the pathway to prescription. The decision to prescribe any drug is an important one and side effects and risks are important for both physician and patient to understand. My view has been that only the most serious risks with the most harmful consequences should be disclosed in an ad and some quantitative odds should be mentioned. Any more than that is not particularly useful in the ad awareness stage. I clearly would want to know if anyone has died taking the advertised drug and the odds of it happening. I do not really need to hear a litany of possible non-fatal risks at the ad stage.

I hope the drug makers and FDA can work out a DTC risk and warning strategy that meets consumer needs. Consumers should be educated on benefits and risks but fair balance must be re-evaluated in the context of what consumers can meaningfully remember in 60 seconds or one page.

The Novartis psoriasis drug Cosentyx has taken an interesting approach on use of a celebrity. Rather than have a celebrity alone plug a drug this new ad mixes Cyndi with regular folks. It makes her seem like just another psoriasis sufferer who happens to be a famous pop star rather than the celebrity spokesperson for a drug. The difference is subtle but important. You can see the add on ispot.tv.

Celebrities are a mixed bag when promoting a drug. They can be effective or polarizing depending on how they are used. Some recent celebrity campaigns illustrate that a celebrity can be the star as well as one of the cast. Jennifer Anniston is great in Shire’s disease ed ad Eyelove. She is clearly the star and although we know that she is acting she is warm, and believable.

Here, Cyndi Lauper is being used as a member of a community that suffers from an embarrassing condition. She is not even identified with her last name but most of us would remember her, at least those over 40 years old. I like the approach which puts a celebrity with us regular folks rather than lecturing us as the obvious paid spokesperson.

Most of us know that a celebrity is not usually a knowledgeable medical expert. Having a celebrity tell us about a drug therefore has risks that we see them as paid endorsers who may not really use or like the product. In this Cosentyx ad, however, Cyndi Lauper comes across as sincere and believable. She is one of three psoriasis sufferers in the vignette ad and her presence gets attention without being dominant.

This is not the only ad to blend real people with celebrities. Enbrel does a nice job using golfer Phil Michelson with a regular person to discuss psoriatic arthritis. Both Enbrel and Cosentyx appear to recognize that celebrity use may be enhanced by toning down their star power by mixing them in with regular folks. That works in these two cases and I am not saying a celebrity cannot work being the sole presenter. My view is celebrities work well for disease education as the sole presenter because they are believable in highlighting a disease or condition. When you plug a brand, however, they may become less credible carrying the message. That does not mean it will not be effective just that it takes the right celebrity to be a sole branded spokesperson.

We all remember Sally Field was great plugging osteoporosis drug Bonita and Blythe Danner pulls it off for Prolia. There is no hard rule when you should use the celebrity as the star or mix them in with real folks. Consumers can tell, however when a celebrity is just hawking a product for money versus actually a user or concerned about a disease. There are many who make living hawking dubious products and it is obvious they have little concern about the product efficacy.

The Cosentyx campaign “See Me” has been working well for the last two years and has done good work adding celebrity Cyndi Lauper while maintaining its core strategy and executional style.

With the failure of the Republicans to pass repeal and replace we are left wondering what next. We are now at increased risk of drug pricing and DTC regulation. As now it appears that Republicans and Democrats will come up jointly with a salvage plan for Obamacare, drug makers will be in the crosshairs to make concessions to reduce costs.

The lessons learned from this debacle are several. First, the public is supportive of increased government guarantees of coverage. The PR battle showing all the cases of newly insured people being saved from death and bankruptcy have been compelling. Taking away a benefit, albeit costly and unsustainable, is impossible to sell.

Second, Republicans have shown they cannot explain their plan to sway public opinion. There is a lot of good in the plan but that nasty Congressional Budget Office keeps saying the plan will cause millions to lose coverage and seniors will pay much more for coverage, as will people with pre-existing conditions. Not great selling points for passage.

We can now expect Chuck Schumer to claim he is willing to make Obamacare even better and cut a deal with Republicans. Of course, we know that means throwing more money to subsidize premiums and deductibles for more people. Being an election year in 2018 most in Congress will be happy to spend more borrowed money to look like they care about American’s healthcare.

So where can Congress look for a bi-partisan villain in 2018? Give me a second to think. Oh, I know, how about everyone’s favorite scapegoat, the drug makers. We all know that healthcare costs would be dramatically lower (not) if only those drug profiteers sold their lifesaving medicines just a bit above cost. Most in Congress know that is not true but so what. It sounds good and will get lots of support for Medicare price negotiation, reimportation, shorter patent life, and restricting those pesky DTC ads which are believed to be a main driver of health costs. We all know DTC has the hypnotic power to convince gullible doctors to prescribe whatever patients request.

It is clear that Democrats are moving towards enacting single payer. As costs mount for the new Obamacare, it is only a matter of time before the great savior will be our government running all insurance. Then we can look forward to the end of private insurers and free market pricing for health services and drugs. Bernie will be happy because America will look more like Canada and Europe or perhaps Venezuela. We can all take our generics and hope the government will come up with all the new drugs. It is not that single payer cannot work, it is just that our government has not been very good at running mass programs efficiently and with great customer satisfaction.

I know Bernie Sanders thinks people all love Medicare. That may be because Medicare is really just a processor of payments to the private sector. Yes, seniors can currently pick their doctor and hospital. Wait until everyone is covered and see how fast that changes. To be affordable Medicare for all would need to greatly restrict choice. Look for new government boards to decide what options we have for covered services.

The DTC industry is low hanging fruit to be offered up at the altar for sacrifice. After all the AMA, insurers, many in state and federal government would love to see it banned. Taxing it, or adding regulations to make it hard to do in 60 seconds on television could kill it. There may still be DTC but it could be very limited to non-branded or long form print, Internet, and in-office literature. Maybe our strong lobby will head off the anti-drug forces but it is getting harder to be optimistic.