Concerns That Rosy Direct-To-Consumer Ads Hype Cancer Drugs To Vulnerable Patients

This story is part of our "This Moment In Cancer" series.

A few weeks ago, I was watching veg-out TV, quietly wondering to myself how a show called "Pure Genius" could be so darned dumb.

Then a commercial break added a new sort of mystification: A long, vivid ad touted the cancer drug Opdivo, a form of immunotherapy — an exciting new type of treatment that harnesses the body's own immune system — for lung cancer.

Lung cancer is the biggest cancer killer, so, in this anomalous country that allows direct-to-consumer drug ads, it was no surprise to see a lung cancer ad on network TV.

But the pitch was directed at a strikingly specific subset of patients, people "previously treated with platinum-based chemotherapy," including those with an abnormal "EGFR" or "ALK" gene, who've "tried an FDA-approved targeted therapy." For those patients, it said, "This is big. A chance to live longer."

Well, a little longer; the fine print cited a study in which patients lived about three months longer. But for desperately ill patients, even a day longer matters. So the appeal was clear. What I couldn't understand was the economics: How could it make sense to blast a whole network TV audience with an ad made for a sliver of people with cancer? And even if it makes business sense, does it make medical sense?

My bafflement only deepened when, a few days later, I opened the New Yorker and found a two-page spread advertising Opdivo's competitor, Keytruda. The specifics were slightly different but the upshot was the same: It was a direct-to-consumer ad for a new immunotherapy drug.

I turned to Dr. Lowell Schnipper, the newly emeritus clinical director of the Cancer Center at Beth Israel Deaconess Medical Center, who recently wrote a JAMA Oncology editorial arguing that direct-to-consumer cancer drug ads are, to quote the headline, "not beneficial to patients or public health."

(The counterpoint argued that direct-to-consumer ads can empower and inform patients: "Better-educated patients can make well-informed decisions regarding their own health care. Patients will never become knowledgeable, however, if they are not provided with disease and treatment information from a trusted, regulated source.")

I began by asking Dr. Schnipper about his editorial, which he co-authored with Dr. Gregory Abel of the Dana-Farber Cancer Institute. Our conversation, edited:

LS: The reason that we feel rather strongly about it is that cancer patients are incredibly vulnerable to what we might construe as misinformation.

So, some of the ads — admittedly for very exciting new drugs that enhance the immune system’s attack on the cancer — are being promulgated for treatment of certain types of non-small cell lung cancer, by showing very healthy-appearing, happy individuals, gazing skyward as though life has sort of an endless quality to it.

The ad does not convey the essence of the matter: that these folks are very sick, and have already been through quite a lot before they even come to the choice of whether or not it's an appropriate medication for them to take.

So we worry that the patients' expectations are raised somewhat inappropriately and unnecessarily in terms of what good the drug might do. They could be one of the lucky ones, but many people are not.

And some of the scientific literature suggested very modest enhancement in survival for patients treated with these drugs with certain types of lung cancer. For those with just a few months of added survival, if that, it really was not the kind of breakthrough that the impressive visuals convey.

Now, most doctors are not going to avoid mentioning to a desperately ill patient the possibility — even if it were a minor possibility — that treatment X or Y could help you; they will of course mention the particular side-effects, and some will alert the patient to the effect the therapy will have on the family's budget, because it's very expensive, and will have an enormous copay. Those kinds of conversations that include mention of physical and financial toxicities are now becoming not only appropriate but much more routine and expected.

So it felt, to us, completely unnecessary and excessive to present a new medication to vulnerable people and their families in a way that suggests more benefit than the facts bear out.

And how can it make financial sense to advertise to a general audience something that would apply to only a very specific subset of very sick cancer patients?

That's a very good question. I myself can't document with respect to any of the cancer drugs that are advertised to the public what the financial impact on the manufacturer is. What I do know is that when we were researching our piece, we looked over the past 10 or 15 years at what the increment in spending on direct-to-consumer advertising was by pharma or the biotechnology industry. And it's gone from a few millions to many billions of dollars, probably 6 to 8 billion dollars a year. So there clearly is a very substantial positive impact from the point of view of the manufacturer.

There must be, or they wouldn't pay for it.

Absolutely. The other thing is that the Food and Drug Administration, which must regulate this to some extent, looks at these advertisements to be sure the public is receiving fair and balanced information about a new drug.  The FDA then responds to companies that are felt to be rendering information that is not fair and balanced.

Based on data that our own research turned up, oncology drugs turns out to be one of the more frequent stimuli for manufacturers to be recipients of warning or alert letters — that something doesn't strike the FDA as being completely appropriate.

Do you think that the FDA should take a look at these recent ads for immunotherapy for lung cancer?

Well, this gets to be a very, very sensitive question relating to constitutional issues. We recognize that our commitment to free speech as a society would really protect the industry, unless they were projecting outright mistruths. And that doesn't appear to be the case.

It's really the nuanced perception and presentation on the part of the advertiser, and what the imagined interpretation might be by either vulnerable patients or their families.

So how would you want to counter-message what the public is seeing on TV?

Well, there are some Dartmouth scientists who have actually modeled and published what they call a 'drug facts box,' which is a readable — meaning it's understandable to the lay public — discussion or description of what certain drugs are doing, what their downside is, and what alternatives there might be for the same medical or clinical indication.

We think if we're going to have something akin to an advertisement as currently configured, that the whole idea of it ought to be broadened so other alternatives are mentioned. Conceivably, even the cost of these medications could somehow be incorporated into it, because some of the new ones are shockingly expensive.

The average new cancer drug costs about $100,000 dollars a year. So do you expect to see more direct-to-consumer oncology ads, given these rising price-tags?

I think so. You know, the US and New Zealand may be the only two places in which this kind of practice exists, and I doubt that it's going to stop.

One of the problems we have with these new drugs — and I want to emphasize that many of them, for specific disease circumstances, are highly effective for some patients — is that they have uncertain long term consequences, that only time will bear out. That happened with a treatment for anemia associated with chemotherapy for cancer. The early promising results were advertised widely; only years later did it become clear that some patients had shorter survival because of this drug

Also, I would imagine it's almost unthinkable that doctors would fail to mention Keytruda and Opdivo to a patient who might potentially benefit, right?

Absolutely. I'm sure they would. You know, I can imagine, in settings where the disease is not as ominous and fearsome as cancer, that perhaps a motivated patient might well introduce an idea to their physician who then might choose to act on it. But in the context of cancer, I know hundreds if not thousands of oncologists, and they jump at the opportunity to use a useful drug that might help their patients. So it's inconceivable that anything other than a full array of the possible treatments would be presented to any one patient, independent of the direct-to-consumer advertising.

So if ultimately the direct-to-consumer advertising could not be making care better, what do you think its effect actually is?

I think it has a potential positive effect insofar as it might encourage some degree of literacy regarding the patient's illness. Some people in the age of the internet might then be stimulated to look into the drug a little more, and that could lead them, if they read about it, to understanding a little more about their disease.

But more importantly, I think that it may contribute to their having overly enthusiastic expectations for what's possible, and that could get in the way of the doctor patient relationship — if the physician needs to spend lots of time explaining why Choice A seems preferred for this particular person than Drug B, the miraculous treatment that they saw on television. That has a way of eroding confidence.

The counter-argument to your JAMA Oncology editorial argued that these ads offer useful information that empowers patients...

Backers cite this type of ad as something akin to a public service announcement. That does feed into and support the idea that we, as oncologists and other physicians, do want our patients to be their own best advocates, and that means they need to be educated. But the counterpoint is: Of course they need to be educated, but the education needs to be rendered with tenderness, truthfulness and subtlety.

Listen below to Dr. Schnipper speaking with WBUR's Bob Oakes: