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Recently Opdivo from Bristol-Myers started television advertising for its advanced stage lung cancer indication. What Opdivo does is work with the immune system to help fight the lung cancer. Clinical studies show survival versus chemo of 9.2 months vs. 6 months among half the patients taking it.

The ad, which is on the Opdivo web site, says “it’s not every day something this big comes along.” This voiceover is followed by an image on a skyscraper saying “a chance to live longer.” The ad continues with supers imposed on other buildings on living longer.

The cost of Opdivo is quite high at over $100k a year. The survival benefit is clinically significant. Survival, however, is measured in months not years. The ad tells the survival benefit with a super. So we have a drug with a significant benefit and a very high cost to the insurer. While the patient and their families certainly want the extra months of survival, the insurance companies are going to be reluctant to pay that much for those few extra months.

The ad will be highly effective in getting patients to ask their doctor about Opdivo. Insurance companies and government critics will surely hate this ad because it increases demand and it costs the payers a lot. I can hear Bernie and Hilary shriek with indignation that patients are given hope by the ad, only to be turned down by insurers over the high cost.

The use of biologics is growing and many genomic cures are on the horizon. The recently launched Hep C drugs Solvadi and Harvoni cure this terrible life threatening disease. They cost about $80k for a course of therapy and have created the same angst among payers. Both drugs used DTC effectively in raising consumer awareness.

The use of DTC for drugs costing tens of thousands a year is rising. The backlash over price will make DTC for these drugs a target for legislative and payer critics. Drug companies need to be ready for the outrage. Consumers really do not know from drug ads what the cost will be for a new treatment. Advertised drugs have widely varied costs per pill or dose from a few dollars a pill for cholesterol drugs to a thousand a pill for Hep C. The commercials do not address price and consumers face potential sticker shock.

Most consumers have an idea what that new car, new TV, or new box of detergent will cost. Drugs are somewhat unique in that pricing is opaque. Watching the Opdivo ad gives no clue the drug is 100 times more costly than a cholesterol drug. Drug companies have price supports through compassionate use programs for the poor, but those are not used broadly. Insurers hate these DTC ads because it puts pressure on them from consumers to cover life extending drugs. Once consumers complain, legislators enter to cajole insurers to cover the drug.

Opdivo and other cancer drugs have every right to advertise. What they offer is life altering. They should, however, expect legislative and consumer pushback over advertising a benefit that is expensive. While many patients will get the drug covered, many will not. The lack of consumer price information is an important strategic issue in my opinion and unique within the drug industry. The industry needs to be better prepared to defend premium pricing and explain to consumers why some drugs cost thousands a month. DTC for those drugs will motivate price critics to scream for price controls and DTC bans.

With rising DTC expenditures it is clear all media segments have new opportunities for a piece of a larger pie. I have always been media agnostic in my job as advisor, publisher, conference organizer and writer of DTC columns. I know all media has its place in the marketing plan. Traditional media such as television, magazines, radio, and newspapers are still critical to drug advertising success.

One area, though, seems to be on the verge of exploding in use and should fuel growth in DTC spending. That area is reaching the consumer through their physician’s office, pharmacy, clinic, hospital, or remotely through smart phones or customized health tracking devices.

Most consumers think most about their drug when it is being prescribed, filled, or first used. Engaging patients through education at all of these points is critical for success. Engagement is changing beyond just awareness advertising at these points. While awareness advertising in physician offices or pharmacies is critical, new technologies are allowing more more robust interactions between physician, pharmacist and patient.

Drug companies are working to understand how technology can be used to help doctors and pharmacists educate patients. Of course drug companies are most interested in those professionals writing more of their drug. The two biggest technologies that will affect drug company marketing are electronic health records (EHR) and mobile device health apps.

While EHR is being rapidly expanded and not yet widely used as an advertising medium, over time drug companies will see major opportunities to partner with EHR companies. Doctors want to provide clear, concise benefit and risk information to their patients. Piggybacking on the EHR system with good drug information will be key in the future. Doctors will be using push newsletters, emails, texts, robo-calls more in the future. Drug companies will be involved in underwriting these efforts especially as it relates to persistency.

Mobile consultation and diagnosis through wearable trackers will be common place in the near future. People with diabetes, high blood pressure, heart conditions, and other illnesses can be monitored real time by their health providers. Imagine the possibilities for drug company partnerships in helping doctors monitor patients. Ensuring proper adherence to a prescribed medication is good for the provider, patient, and drug maker.

There is still enormous potential for growth in awareness advertising at traditional point of care locations. More offices are joining these networks and more exam and waiting rooms are being added. I expect more consolidation between media suppliers so they have a broader reach. Drug marketers and their agencies want the ability to reach desired specialties without dealing with fragmented buying. The growth of retail medicine through mini clinics is also offering new locations for patient education media.

From what I hear from the media companies in the point of care space sales are doing very well. What these media companies need to do is make it easier for drug marketers to buy in scale, track ROI, and learn how to work in concert with the providers to engage patients beyond awareness advertising.

I am concerned. DTC is under attack again by politicians and anti-drug company activists. While an outright ban is highly unlikely because of first amendment protections, it is possible to regulate DTC more and/or use tax policy to restrict its use.

The FDA, under a Clinton or Sanders presidency, would likely be told to do what it can to make advertising more difficult. That 1997 guidance allowing television to be done in 60 seconds was a liberalization of the interpretation of the rules. Does FDA have the authority to go back to the pre-1997 interpretation that required a full scroll of the package insert? Does free speech make that return to the restrictive old days unconstitutional?

While I would expect President Clinton or Sanders to try to ban DTC through FDA, I doubt the courts would allow it. Clinton and Sanders can alternatively ask FDA impose guidances to make advertising more difficult under the guise that consumers are overstating advertised drug effectiveness. They could then require more discussion of non-drug alternatives or increased discussion of comparative effectiveness to non-branded drugs.

Tax policy is a real threat by making drug ads a non-deductible expense. Of course, such a move would also restrict commercial speech as it would only apply to the drug industry. Courts have a dim view of government restriction of commercial speech. I doubt the advertising lobby would lose such a fight. You never know, however, until a law is enacted and tested in the courts.

Another threat to DTC may be the industry itself surrendering to pressure. Some drug executives may decide they do not want to deal with the critics any longer and just stop using DTC. They can decide to use other less public means of promotion. Of course it might be hard to stop DTC because it works so well for many brands. Drug executives have seen many brands succeed because of widespread awareness ads. Drug CEO’s may, however, surrender DTC in exchange for no Medicare price negotiation, no foreign drug imports, or patent life extensions. Most CEO’s are not consumer marketers and have no inherent love of consumer advertising.

My net is DTC should survive no matter who wins the election. It may, however, be faced with an FDA pressured to make DTC harder to execute. That could mean more onerous rules and more delays in approval. It could also mean more “voluntary” moratoria on advertising new drugs as a condition of approval. DTC spending continues to recover, and 2015 could be $5 billion again and higher spending is always erroneously blamed by critics for causing rising drug prices.

I urge my drug marketing colleagues and their agencies to take threats to DTC very seriously. Drug companies are easy targets and Congress is known for taking the easy path. Finding a way to punish branded drug companies by restricting advertising would be politically popular. Combine a pliant Congress with President Bernie or Hilary and watch DTC be placed on the endangered species list.

Anyone involved in DTC should make sure their representatives in Congress hear why restricting DTC advertising is a bad idea. The total spent on drug advertising is only about 1.5-2% of drug sales in the United States. That money, if no longer used for DTC, would not lower drug prices, despite the myth that drug companies price high to recover their DTC investment. Sales would in fact be lower if DTC were banned, and that would lead to cuts in research, not increases.

Jublia, from Valeant for toenail fungus, has made heavy use of the celebrity route in its advertising. First, they used tennis legend John McEnroe and now are adding talk show host Mario Lopez to the mix. Most of us remember Mario as Slater on Saved by the Bell.The Jublia ads are light in tone and I equate the ads to what an OTC drug might do. After all, toenail fungus is not cancer, so the ads can use a lighter approach.

I have mixed feelings about humor in health ads. While toenail fungus is not prostate cancer (Valeant also makes prostate cancer drug Provenge), it is not funny to those who have it. The thickening and yellowing of a toenail can be embarrassing and physically uncomfortable. When I was marketing antacids in the 1980’s, many ads tried humor. What patients said to us was there is nothing funny about acid reflux and burning the esophagus. So we proceeded with caution on our ads regarding making light of a painful condition.

My reservations about humor aside, the Jublia campaign is very good. The ads are memorable and get their message across clearly. They are in your face ads type ads, shouting their benefit out through the little animated toe icon and the celebrity presenter. Sometimes ads bordering on obnoxious are highly effective. Mr. Whipple from the please don’t squeeze the Charmins ads was a much hated character but the ad worked.

Jublia needs to compete against the many anti-fungal OTC’s. Therefore as an Rx they need to get consumers comfortable switching to an Rx alternative. That means dealing with consumer concerns about safety. While Jublia has few side effects as it is a topical versus a pill, consumers need to feel it is both effective and safe before they request it. The lighter tone does aid in making consumers feel the product is not something to fear.

I assume the celebrity campaign will continue and more will be added beyond McEnroe and Lopez. The drug has sales of about $450 million so there is plenty of profit to be invested in advertising. Jublia marketers have done an excellent job navigating that difficult area of being an Rx in an OTC dominated world of toenail fungus.

Outdoing Bernie is hard to do but Hillary seems to be more anti-drug company than the avowed socialist candidate. Hillary is tired of high drug prices. Here is someone that charges a public university $225,000 for a canned speech and is outraged at high prices from drug companies. Never let hypocrisy affect a good political talking point.

Hillary has a tax proposal that will kill DTC. She wants to make drug marketing a non-tax deductible business expense. That has been proposed before and successfully defeated. The advertising lobby knows that deciding to make drug advertising non-deductible is a slippery slope. Does the government then make advertising fast foods non-deductible because it harms public health? What about violent video game advertising? Beer? Having the government decide what can be advertised is dangerous. Proposing tax policy to discourage advertising certainly gets all the media company lobbyists nervous.

Hillary also wants to allow Medicare to negotiate drug prices, an oft-mentioned proposal by many on the left. She also wants to limit to $250 a month what consumers pay for drugs for chronic conditions. By doing this she thinks drug companies will be forced to lower prices.

Hillary knows when to time her outrage. The drug industry has increased prices more than inflation recently. Much of this is because they invented and marketed some high price cures for Hep C. There has also been a lot of negative publicity recently about a drug that went from $13.50 a pill to $750 a pill for reasons not well explained by the small drug company who recently bought the drug. Sometimes the critics have a fair point and the drug industry must be reasonable on pricing. This company responded to the harsh criticism and announced it would go back to the $13.50 soon.

Democrats like to use government power to limit prices. They usually have no business sense in proposing these price actions. They think if they mandate lower prices, that there will be no negative impact on innovation or supply. These proposals are quite naïve about how business works. That is likely because many key Democrats have no business background. Hillary thinks drug companies have these bags of ill gotten cash sitting in vaults. If she mandates they charge less, then these drug barons will just act as if nothing has changed. The drug companies, in her view, will still make enough to behave the same in terms of drug development. After all how many bags of cash do they need?

Drug companies are the greedy enemies of society, according to Hillary and Bernie because they charge more than decent people should pay. The left would like to decide what profits are acceptable for many industries they find are greedy. Oil companies and banks are also frequent targets. Free markets do a good job of deciding a fair price. Government is just not very good as a market referee.

Price controls just do not work. You reduce price and you get less re-invested on new products. In Bernieland the noble government scientist invents cures and gives them away for cost. In Hillaryland, the paternal government tells industry what a fair profit should be. I agree drugs should be affordable, but cost of research does matter. Drug companies are entitled to make good money. Hillary and Bill and are free to charge a market rate for a canned speech. If Hillary could only get $5000 a speech would she do as many?

Free markets can be messy but they ensure that those with needed products have incentives to keep making them. It is silly to think the laws of economics will be changed by government mandates. Cap drug prices and see how many breakthrough new products are developed. That expensive cure for Hep C would never have been invented. It will be politically popular to stick it to drug companies but incredibly stupid. That next pandemic that will inevitably occur will not be cured by Bernie or Hillary. It will be those “evil” drug barons who do it, but only if they have those bags of cash available to invest.

Bernie Sanders, the fast rising socialist/populist candidate for President, does not particularly like drug companies. He thinks they make outrageous profits and is for introducing legislation to cap prices. He will propose Medicare negotiate prices, something prohibited under the prescription drug act. He will also require disclosure of costs of developing drugs, and require transparency on what the drug costs in other countries. Finally his bill would permit importation of drugs from Canada.

These proposals have been made before, many times over. The same argument continues to be made that drug companies sell drugs for more in the U.S. than other developed countries. The typical Democrat response is to propose price controls and cite outrageous prices knowing the issue is political red meat to their constituents.

Do drug companies make outrageous profits? I compared the net profits at drug companies to other industries based on data summarized by the NYU Stern School of Business. Drug companies make about 16% net margin. That is a healthy profit but not that different from soft drinks at 13%, entertainment 13%, computers 14%, banks 19%, railroads 18%. Good profits yes, outrageous no. Career politicians who have no business knowledge consistently fail to understand that drug prices cannot be interpreted in a vacuum without looking at costs. Costs are more than the marginal production cost of stamping out a pill.

The argument that Medicare should negotiate better prices based on foreign price comparisons is in effect government price controls. Price controls in other countries do mean lower prices for the Europeans and Canadians. If price controls were instituted here profits would decline, and research would be geared to me-too drugs. Senator Sanders, a proud socialist, is not concerned with the cost of drug development and thinks he knows the acceptable level of profits for drug companies.

The importation of drugs from Canada will cause drug companies to quickly limit what is supplied to Canada. Drug companies will supply their higher priced markets first and will not allow re-importation to destroy their U.S. pricing. In the short run Canadian consumers will not be able to get their drugs because of increased demand here for cheaper Canadian drugs.

While it sounds easy to make prices lower here through government edict, one must be aware of unintended consequences. Bernie Sanders will get lots of applause talking about greedy corporations, but he is being naïve if he thinks he can have new drug innovation with price controls. We will end up with companies focused on high return R&D for minor me-too improvements only in large disease categories.

We need drug companies to take big risks to find cures for the next Ebola, bird flu, or resistant bacteria. While we like to think there is always a brilliant government scientist ready to find a cure but the reality is different. It is private sector drug research that finds our cures and that is expensive. High risk research deserves high rewards, even outrageous rewards Senator Sanders.