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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.