A and advertising campaign is terrifying millions of people and provoking sharp criticism from doctors. The critics include Milton Packer, MD, a top expert who ran the main trial testing the company's big new heart failure drug, Entresto (sacubitril/valsartan).
The ad depicts a middle-aged man in an easy chair reading the newspaper, oblivious to a rising flood that threatens to drown him, though his dog, climbing onto a couch for safety, expresses considerable anxiety.
With a background of ominous sounds, including a beating heart and the dog's whines, a narrator darkly intones:
"With heart failure, danger is always on the rise. Symptoms worsen because your heart isn't pumping well. About 50% of people die within 5 years of getting diagnosed. But there's something you can do. Talk to your doctor about heart failure treatment options. Because the more you know, the more likely you are to keep it pumping."
The website and the ad don't mention Entresto, but there can be little doubt that this new campaign is designed to get patients to talk to their doctor "about heart failure treatment options." Entresto is the only major heart failure drug still under patent protection; the rest of the major heart failure drugs are off patent and available as inexpensive generics. The ad and the campaign are part of a "disease awareness" campaign, often used by pharmaceutical companies to drive patients to new products without actually mentioning the name of a product.
I first saw the ad on the NBC "Nightly News" on Monday evening. The ad, and a lot of supporting material, can be found on a .
, a leading heart failure expert at Baylor University Medical Center at Dallas, has been the most prominent advocate of Entresto. But he said he is deeply disturbed by the ad:
"This ad really disturbs me. It is alarmist, and I am not certain that is a good thing for patients.
"There is a good reason to tell patients that there may be new options for them for the treatment of heart failure.
"But the role of a new treatment for heart failure is part of a discussion that first needs to take place among physicians before the message is delivered to patients.
"I have been a strong advocate for angiotensin-neprilysin inhibition (one of the new approaches to heart failure). And I have written a number of position pieces that express my views. My friends may or may not agree with me, but that is how the process should work. The cardiology community needs to digest the data and have a debate. That is what is going on now, and it is very useful.
"After that debate has taken place and we collectively find a good path forward, we can deliver that message to patients. Delivering such a message to patients BEFORE the debate has occurred is just going to cause confusion.
"And that makes me really uncomfortable."
, of Oregon Health and Sciences University in Portland, was an , but he criticized the ad on another basis entirely:
"I find the ad to be horrifying. Obviously, it has been crafted to evoke fear and uncertainty. In all honesty, even I felt rising terror as the water level rose, and the inevitable loomed near. I think if there is any proof that our nation was misguided to pursue direct-to-consumer advertising this is it. We are only one of two nations that allow this sort of manipulation of the practice of medicine. The ad should earn every advertising award; it should also earn public outrage."
, of the University of California at San Francisco, became concerned when he saw the ad on Monday night:
"I think it's irresponsible to play on the fears of patients in such a brazen and manipulative way. It is potentially terrifying to them, their families and friends and could have a tremendous negative impact. They should be ashamed."
Heart failure patient advocate agreed:
"Terrible ad. There are very effective treatments for heart failure already on the market. Many people diagnosed with heart failure get their heart failure under control, as I did, and live long lives. Just because you are diagnosed with heart failure does not mean you will ever die from a heart condition. Shameful for a drug manufacturer to try to scare people with active heart failure who are at risk of sudden death just to try to sell a new product."
Novartis has placed a lot of expectations on the success of Entresto. Many experts believe the drug will become a multi-billion dollar blockbuster, but, as I reported last week, it is . It is unclear whether the company will benefit from this campaign or whether it will suffer from a backlash.
Novartis sent me this response to the criticism:
"Our goal is to create awareness of heart failure so people with the condition can take action to live longer and healthier lives. We developed the Keep It Pumping ad with those intentions -- to educate people and facilitate patient-physician dialogue.
"According to stats published in NEJM and JAMA, about 50% of people diagnosed with heart failure die within five years. This is widely cited -- by organizations like CDC and AHA."
But it is worth noting that the terrifying statistic used in the ad -- that half of all heart failure patients die within 5 years -- is no longer accepted by heart failure experts. It is based on Framingham data that is more than 30 years old and reflects neither the changing heart failure patient population not any of the effects of new treatment advances.
But there is another common heart failure statistic -- and this one has the virtue of being largely true -- that might be relevant here. This statistic is that about half of all heart failure deaths occur when the heart abruptly ceases beating (sudden cardiac death). It is not hard to imagine that this ad will increase the incidence of sudden cardiac death.