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Rosa Delauro, a Democrat congresswoman from Connecticut, introduced bill H.R 4565 on 2/12/16 that bans DTC ads in the first three years from approval. It also allows the Secretary of Health and Human Services to continue the ban if the drug has had significant adverse events during those three years.

The drug companies can apply to do DTC and the Secretary can approve if it is a positive for public health. Obviously this bill is meant to permanently kill DTC since the adverse event standard is so vague the Secretary can point to them as an excuse to continue bans after three years.

I doubt this bill has any chance to get voted on. First, it is unconstitutional to ban commercial speech without proving the ban is the only way to protect public health. Second, the bill is so vaguely written as to allow such broad and arbitrary authority to the Secretary as to make it clearly a ban of speech. Third, the idea that commercial speech must first apply for that right and prove public interest in advance is unconstitutional.

This bill is merely a political statement from a hard core Liberal democrat. It is the type of nonsensical response from a politician who has no interest in understanding the real cost of drug development. Ms. Delauro prefers to blame advertising for drug prices being high. Somehow, she believes, that if only drugs could be prohibited from advertising, prices would drop dramatically. This is absolutely false and has no basis in fact.

While this bill will go nowhere it does show there is an appetite among Democrats to make drug companies a campaign cause this year. We can expect more bills to end DTC tax deductions, allow foreign drug imports, force drug companies to disclose promotion spending, give Medicare price negotiation authority, and limit patent life.

Any bill introduced in Congress that limits DTC is serious and sets a dangerous tone. The drug companies, media suppliers, and advertising agencies need to call their representatives to voice their opposition. The drug industry employs over 800,000 people directly in the United States and over 3 million indirectly rely on it for jobs. Those jobs can only survive with a profitable drug industry not singled out for punitive treatment. China and India would love to have those jobs and politicians need to be careful vilifying our vitally important drug business.

Novartis has just started a non branded disease education campaign called “Keep it Pumping.” You can see the television ad on the Novartis web site: www.keepitpumping.com. This Novartis web site discusses the serious condition of heart failure which has only a 50% survival rate after five years from diagnosis.

The ad is very memorable, showing a man sitting in his living room as it fills with water, a metaphor for the rising danger of a heart not pumping well. I have read some physicians are concerned the ad is alarmist. They think the ad will stoke unnecessary fears among patients. Obviously Novartis thinks the serious tone is appropriate.

Like all drug companies that do disease education ads, Novartis is running the campaign because it has a new drug to treat heart failure. The drug was approved mid-last year. It is called Entresto, a combination of an old drug, valsartan and a new drug sacubitril. Novartis clinical studies show it is significantly better at reducing mortality versus ACE inhibitor enalapril.

While the ad apparently annoys some doctors, it is certainly memorable. The visual of a flood in a man’s living room while he seems oblivious to it is a good way to show the hidden symptoms and dangers of heart failure. The appropriateness of running an ad that may alarm patients is a legitimate issue. On the other hand, any disease that causes death in 50% of those who have it, is cause for alarm and therefore having an impactful campaign is warranted.

Like all these newer premium priced drugs, the advertisers will face sticker shock from those patients who have problems getting reimbursement or have high co-pays. The recent trend for drug makers has been to advertise drugs regardless of price. They want to create demand as this helps push reluctant payers to cover the drug. Most insurance companies would prefer patients use much cheaper, albeit, less effective old line treatments. DTC for newer drugs is trying to create patient awareness that there are very effective treatments now available. Cost/benefit will be debated by the payers and patient demand has been an important dynamic in pushing payers to cover the newer treatments.

I doubt many Americans who see this ad will suffer undue alarm. Basically, it is designed to get people to be aware that heart failure happens to many of us as we age. The incidence is about 20% over our lifetime. Novartis clearly benefits from encouraging discussions on heart failure because their new drug is premium priced.

I definitely disagree that the ad creates undue fear. Heart failure is not acne, or toe fungus and perhaps a sense of urgency is needed in the creative approach. People who see the ad who might be at risk for heart failure should discuss it with their doctor. Whether he will suggest Entresto or something else is between patient and doctor. Calls for pulling the ad are extreme as there is zero evidence consumers will panic or quake with fear. When I saw it, I paid attention and looked up the web site, not out of fear but out of interest in my health.

Novartis certainly will have to take seriously the opinions of its prescribers and I am sure is tracking physician attitudes. Drug companies should test disease awareness DTC in advance with both consumers and physicians. No ad should be pulled, however, based on a few negative comments. Impactful ads need to be attention getting. Keep It Pumping succeeds and I would keep pumping it out to consumers.

Yes I make my living on the back of DTC ads. That is one good reason I like them. But a more important reason is I learn what treatments might be available. I suffer from chronic sinusitis which makes me feel miserable much of the time. Having had two surgeries with no lasting effect, I learned through advertising about a new technique called balloon sinusplasty. It is the same thing they use to open up arteries, and it is done in a physician’s office under local anesthesia. Sinus openings get widened and better drainage prevents blockages.

I consider myself knowledgeable about new health treatments as I scan the Internet for medical news daily. I discuss my sinus condition regularly with my internist. Despite this I discovered this new treatment through a television ad. It may change my quality of life. Maybe it is not right for me but seeing the ad gives me the chance to investigate its usefulness fully.

While we like to think all relevant health treatments will be raised to us by our doctors, this is just not true. My internist never raised this despite prescribing antibiotics numerous times for sinus problems. When I mentioned it to him recently, he said he was thinking of having it done himself. So, only through seeing the TV ad did I get awareness of balloon sinusplasty.

Now consider the average American who is not employed in the medical field. They need the opportunity to learn of new treatment options in the media they use regularly. For many older Americans it is still through television and print. Seeing an ad for a new drug might be their first or only source of the information. Those who want to ban drug ads would be denying that information to the patient and relying on a doctor to raise it.

In a perfect world our doctor would be up on all new drugs, tests and procedures. We know that these over-stressed physicians are not always informed on new products. All the mass media ad is doing is promoting a discussion. Critics are concerned patients overstate advertised benefits, underplay risks, and ask for expensive drugs they really do not need. There is some of that happening. On the flip side, patients like to know what their options are for treatment. In my case that discussion with my doctor happened only because I saw an ad.

Information is not inherently good or bad. Consumers need to be skeptical about any advertising. Banning information which is reviewed for accuracy by FDA is bad public policy and a DTC ban would cause many patients to remain uninformed of treatment options. In my case I am very happy to have seen an ad for a potentially life altering alternative.

Yes, that is the name of a new documentary that hit theaters Friday, January 22. It is by a documentary film maker Chris Bell. While I doubt it has a wide release, the media will enjoy reviewing it and telling us it is a must see. The only preview I could get was a two minute trailer on You Tube. It may be an entertaining film and I did see Mr. Bell’s first film on steroids which was very good.

In that two minute trailer, the direction of Prescription Thugs was clear and unsurprising. The drug industry makes tons of money preying on naïve consumers. The pharmaceutical industry does not care about preventing or curing disease but likes to manage our diseases with expensive pills. We have become a society addicted to painkillers, anti-depressants, ADD drugs sold to us by big Pharma using advertising and high pressure sales tactics. Sounds like a familiar theme already done by Michael Moore and others.

Maybe all of us should find work in an industry that is more loved. It is getting tiring hearing how evil we are peddling expensive and unnecessary treatments. The media hates us but loves our ad dollars. The left wing politicians cannot wait to punish us for the crime of providing lower cholesterol, lower blood pressure, normalized blood sugar, cures for hepatitis, management of HIV, etc. Somehow drug makers deserve to get their due for years of screwing the public. Bernie or Hilary will make us pay for the years of thuggery. Iranian missiles, North Korean nukes, and ISIS seem to be less of a threat than drug ads and high prices.

Calling us thugs and enemies is sure to solve the cancer cure mission that President Obama just highlighted in the state of the union. I am sure in some Hollywood fantasy Matt Damon will play a government scientist who finds the cure for cancer. In the real world, Hilary and Bernie will have to count on their enemies in the profit making drug world to develop cures.

Documentaries like Prescription Thugs will be seen by few regular Americans, but cited by many industry critics for its revelations. Given the political focus on drug prices, DTC, and rising insurance premiums, we are sure to get a black eye from the negative publicity. I can see the film maker appearing before Congress, along with the usual drug industry haters to testify how the profit hungry corporations must be subjected to price controls and shorter patents.

If you are getting tired of getting hammered by the politicians, the AMA, the mainstream press, consumer activists, insurers, and your friends and relatives; then maybe we can all do something better for society. After all curing disease may be over rated. Maybe we should just let someone else do it, and hope it plays out like a Hollywood screenwriters’ fantasy.

Welcome back to Pradaxa, a drug to prevent stroke, with a new ad campaign. The new television ad is quite unique. It is entirely a simulation of what happens in a blood clot caused by atrial fibrillation. What is really interesting is the use of swimming fish to represent blood cells.

The competition Eliquis and Xarelto have been big DTC spenders since launch. Pradaxa appears to have stopped a heavy DTC television effort in 2014. It seems they decided to return with a heavy television media buy and completely new creative this month. The three heavy spending brands now have very different creative approaches. Eliquis has the very common theme of a patient telling a story of why they chose Eliquis. Xarelto has gone celebrity with golf legend Arnold Palmer actor Kevin Nealon, race car driver Brian Vickers, and basketball star Chris Bosh. All three ads can be seen on Ispot.tv.

Pradaxa decided to leave its past approaches of doctor testimonial and father and daughter conversation. Instead it changed to a very engaging, but simple visual of the red fish (blood cells) swimming through the circulatory vessels and showing how they can clump together to form a clot that can travel to the brain. I have to say I paid attention to this ad. Somehow the little fish were hypnotic and I could not stop watching.

I am sure the marketing team tested the ad and got very good recall of the visual and the message of how Pradaxa helps prevent the clot. What I like is that Pradaxa developed a unique look that gives it a competitive difference. All three commercials work and I cannot comment on which is actually best at generating sales increases. What I can say is Pradaxa needed something different and could not re-enter using standard vignettes or doctor testimonials. Using a memorable device allows potential customers to discuss the Pradaxa ad with doctors using either the brand name or saying the ad with the fish. I assume the Pradaxa detail force let doctors know about the new campaign in advance or as it aired.

The stroke category spends over $200 million a year and the re-entry of Pradaxa will add to that level. Whether this new ad is just a test by Pradaxa or a major full year campaign remains to be seen. If they are to get competitive share of voice they will need to spend at least $50 million as both Eliquis and Xarelto are saturating the airwaves with $75-100 million each. Usually an ad campaign needs at least three months to measure effectiveness and that means I expect to see Pradaxa ads at least through the spring.

Twenty years of DTC advertising has not seemed to be enough time to gain acceptance by physicians, consumer advocates, and politicians. In fact the anti-DTC sentiment seems to be reaching a frenzy this election cycle. I have discussed before why this is happening. In brief, it is because of the false assumptions that DTC raises drug prices, creates demand for over treatment, sets false expectations of efficacy, wastes physician time discussing drug requests, and discourages non drug alternatives.

The drug industry has largely failed to change attitudes among consumers about its image. Surveys show a lot of anti-drug company sentiment and a feeling that there is a problem in drug advertising. Despite the anti-drug company sentiment, consumers seem to rely on drug advertising for their awareness of new treatments. There is no doubt for most brands DTC is a successful investment.

The reason drug companies have PR problems is because of the fundamental issue that Americans do pay more for branded drugs than Canadians and Europeans. American prices fund drug company research budgets. It is hard to explain to Americans that they subsidize drug development for other developed countries. It is difficult to get politicians to stop bashing drug companies even though most are smart enough to recognize what would happen if the United States imposed price controls. Research would decline and government would not pick up the slack. Politicians on the left take the easy route and use prices as a campaign issue.

This PR nightmare is here to stay and drug companies are battling DTC critics as best they can. Mostly they are using tremendous lobbying clout to prevent price controls, tax penalties for DTC, and punitive patent policy.The media and advertising agency trade groups are also fighting any DTC restrictions through intense lobbying.

My recommendation for DTC marketers is to unapologetically market your products through advertising. I am convinced that DTC works because consumers learn important news through DTC and in many cases follow up with their doctors. Consumers may say they have issues with drug ads, but they act on them anyway. DTC is just the start of a consumer initiated process, and there are many opportunities to learn of alternatives to advertised drugs.

The best thing drug companies can do to blunt criticism is to make truly added value solutions that cure or control disease. Ask a Hep C sufferer if Harvoni is a miracle drug. Ask the people with HIV who now live a relatively normal life if drug companies changed their lives. Those drugs would not likely be here without the strong profit motive. DTC is not perfect and does lead to some issues for payers and doctors. On balance, DTC is a net positive and although Hilary and Bernie will disagree, DTC marketers should be proud of what they do.

I expect 2016 to be a strong year for DTC spending and could top $5 billion again. There are numerous media opportunities to improve DTC effectiveness and efficiency across mass and targeted media. These opportunities are in creating better ads and in optimizing media selection. Technology has created opportunities to do deep dives in how consumers digest DTC ads. All DTC advertisers have opportunities to get better ROI if they use the many tools suppliers have developed.

While we have gotten good at creating the basic DTC ad, can we say they are the best we can do? DTC is 20 years old but health care is changing so fast that the learning curve on what motivates consumers is still at its infancy. That makes being a consumer marketer of health products an exciting place to be despite the criticisms.

Judging by the first three quarters spending numbers from Nielsen, DTC should continue to grow in 2015 and 2016 versus the strong 2014 showing. Last year was the strongest spending in five years. DTC will probably grow more modestly in 2015 off a much higher base of $4.5 billion in 2014. DTC grew to $3.8 in 2013 from a disastrous $3.5 in 2012.

DTC spending could return to above the $5 billion level in 2016. The golden years were 2006 and 2007 with spending of $5.4 and $5.3 respectively. The financial crisis of 2008 and numerous patent expirations started a steep decline from 2009 through 2012. In fact, in 2012, some critics were predicting that DTC was in a long term decline as a promotional tactic.

What is interesting is to see television remain the dominant medium despite media gurus predicting its demise each year. I recognize the drug industry has an older demographic and that other industries are using television less than in the past. For drugs, however, television continues to take over 60% of the ad budget. There is no reason to think this proportion will change significantly in the next few years.

We know other targeted media are doing well based on other sources. Point of Care is exploding and estimated to be about $500 million, but is not measured by Nielsen. Internet is growing as well but is still a small slice of the pie at about 2% of spending. The world of DTC as media has not changed much over the last decade. Media gurus love to talk about the end of television, but drug marketers are still convinced it is where they should allocate 60-70% of their budget.

In fact we are now seeing television used for drugs that never would have considered it a few years ago. Highly targeted disease states are now using television. Cancer, Hepatitis, and Insomnia for the blind, are just a few now using television. High cost drugs like Opdivo for lung cancer recognize that the payback is there using a broad awareness medium.

With rising DTC spending comes renewed criticism that DTC is causing high consumer prices and over use. Critics were happiest when they though DTC would die a slow death. Now that it is growing again, the spending data will be used as political ammunition. The DTC Industry needs to keep close watch on the calls for a ban, or severe restrictions. The spending numbers show drug makers know using DTC has become critical to create a blockbuster drug. It is nice to see DTC recognized by drug marketers as a must do component of a large drug launch. While DTC may not be appropriate for all branded drugs, it certainly is right for most.

Those of us involved in DTC need a thick skin to deal with constant criticism from politicians, consumerists, physicians, news media, and insurance payers. At least the rising spending makes it easier to take and that uptrend should continue.

Who is Stuart Elliott and why should we care what he thinks? Let me back up a bit. Stuart Elliott was the advertising reporter for the New York Times for over 20 years. He left in 2014 to write for Media Village.com. In a column written on 12/9 Mr. Elliott said he no longer supports DTC. The piece is titled “ Madison Avenue Has Overdosed on Prescription Drug Ads.”

Mr. Elliott says he was a long time supporter of DTC ads. He now thinks they should be reconsidered. He cites the American Medical Association( AMA) call for a ban as a major reason. He also uses the criticism on high drug prices as a reason to end advertising. He thinks ending DTC may help the image of drug companies.

Whenever a long time DTC supporter changes positions it is significant and concerning. As a veteran advertising reporter Mr. Elliott certainly has the experience to weigh in credibly on DTC. I must, however, take issue with his column. Clearly I have my biases toward DTC, as the CEO of a company doing DTC conferences. That bias being revealed I think the facts support the drug industry in not reconsidering use of DTC.

All advertising for profit making companies is designed to increase sales. The fact that DTC does increase sales is apparently the reason critics want it banned. AMA does not like that patients ask for branded drugs potentially increasing use of higher cost drugs over cheaper alternatives. While DTC may lead to patient initiated discussion, I am not apologetic to doctors that patients want to be involved in drug selection. DTC advertising creates inquiries and discussion but doctors have the ultimate power what is prescribed.

Second, there is no basis to think ending DTC will improve the drug industry image. That position seems to based on the faulty assumption that advertising raises prices and takes money away from R&D. The reported $5 billion in DTC spending is really about 3.5 billion in actual spending because drug companies pay less than the reported estimates. That 3.5 billion is just a bit over 1% of drug revenue, not much of a price decrease if it was all used to provide price support . To think cutting all DTC would reduce consumer prices is just not true. If that DTC spending was banned sales would drop by about 10 billion, if we assume a 2 to 1 ROI on current DTC spending. Why would drug companies cut prices if they are losing revenue?

Consumer advocates and politicians complained about drug company pricing prior to DTC. They complained about patent life being too long before DTC. They complained about inadequate clinical studies before DTC. They complained about drug sales forces before DTC. Drug companies have been characterized negatively for decades, long before DTC. Unless drug companies charge generic prices for their branded drugs and never cause a drug related death, there will be critics.

Mr. Elliott says an outright ban might be phased in and maybe we should consider a two year moratorium on DTC ads for new products. Most companies already wait at least a year before they run ads. I am sure considering an extra year is a subject for reasonable discussion between industry and regulators.

What is interesting in this flip flop position is the failure to mention free speech. Mr. Elliott does not discuss why he feels a lawful product should be denied commercial free speech. His rationale that DTC creates image problems and that the AMA is against it, does not address free speech protection. I ask him where he draws the line? Does he think other industries with image problems should stop advertising? There are many advertised products such as cigarettes, alcohol, video games, birth control, and fast food that have numerous critics.

So, Mr. Elliott, while I understand the AMA reasons for being against DTC, I would hope you would investigate whether ending it would actually lower prices or raise the drug industry image. I think the facts are against either of Mr. Elliott’s anti-DTC argument.

The recent announcement by the American Medical Association(AMA) calling for a ban on DTC ads has created a media avalanche of coverage. Google “AMA DTC ban” and you get numerous articles covering the issue. Many are from newspapers with letters/op-eds supporting the ban of DTC. The prestigious New York Timesran an editorial on November 27 titled Turn the Volume Down on Drug Ads. The editorial does not call for an outright ban, recognizing free speech issues might be a barrier. It does say perhaps the public should fund alternate information on effectiveness to offer consumers alternatives to branded drugs. They also float the idea of banning DTC for the first two years of a drug. They end the editorial saying consumers need to be skeptical what they read and hear from drug companies.

The AMA call for a ban coincided with a recently released Kaiser Foundation study saying consumers wanted more DTC restrictions with 89% calling for prior FDA review. This study also received a lot of general media coverage.

Having reviewed the reaction to the AMA call for a ban, I am more nervous about new restrictions on DTC. A full ban is likely unconstitutional on first amendment grounds. The courts do not favor restrictions on commercial speech. That does not mean DTC cannot be further regulated. The FDA has broad authority to oversee promotion of drugs. Could they make advertising more burdensome for drug companies? If the FDA believes DTC is no longer in the public interest they could add more onerous fair balance or risk requirements. They could make it hard to run a DTC ad in 60 seconds forcing longer more expensive ad lengths.

The advertising lobby is of course responding to the threat. Numerous trade organizations take this latest anti-DTC wave seriously. No media company wants to have to replace drug ads which have become a major revenue source. The advertising lobby is telling Congress how many jobs would be lost if drug companies stopped consumer advertising. The New York Timeseditorial board may support restricting DTC but the publisher has to like the ad revenue.

We, as DTC professionals, need to take these threats very seriously. Remember, you as an individual have lots of influence with your member of Congress. I would be reminding them of the benefits of advertising to the consumer. Banning information is impractical in our world of easy access to the Internet. Consumers want to know what drugs are available and DTC helps educate them. Consumers do not need protection from FDA vetted information on DTC ads.

The New York Timesshould have more faith in consumers. Americans are skeptical of drug ads and use them as only one source of drug information. Product information from drug companies, their competitors, insurers, medical writers, consumer watchdogs, bloggers, patients and government researchers is available for both consumers and doctors to evaluate before a drug is prescribed.

As a society, the best protection for consumers is easy access to diverse sources of product information. Banning that information may make the AMA happy, but what else will they want banned next? Would they prefer no ads for alcohol, tobacco, fast food, sugared beverages, processed foods, chips, and other products potentially harmful to our health? Slippery slopes can be dangerous and the advertising industry is aware of the risks of a DTC ban.