As recently as 2015, the American Medical Association (AMA) called for a ban on DTC ads, claiming that they drive up demand for expensive drugs when lower-cost alternatives are available and that the cost of ads contributes to rising drug prices.232 Others have argued that DTC ads can boost off-label use of some treatments.233
Some of these arguments have more merit than others. Critics are right to complain when companies misrepresent their products by claiming more efficacy than has been proven or omitting important side effects. That’s what the FDA and Department of Justice (DOJ) are there to police—and they do so regularly.234
When it comes to conditions like irritable bowel syndrome, food allergies, and depression, diagnosis can be inexact, so DTC advertising may well contribute to over-diagnosis and over-treatment.235
As with anything else, potential risks must be weighed against potential benefits in order to arrive at a reasonable conclusion. When it comes to DTC advertising, the FDA, the very agency that shut it down the first time around, has conducted many such benefit-risk analyses over the years. They have repeatedly found that, when done in accordance with regulations, DTC drug advertising confers a net benefit by making patients better equipped to advocate for their care.236 Let’s look at the major benefits and some counter-arguments to the risks to see what might have led the FDA to arrive at that conclusion.
The Benefit-Risk of Informing Patients
As you may have noticed, a number of arguments against DTC drug advertising assumes that the biopharmaceutical industry is singularly focused on increasing profits, which they achieve by influencing vulnerable and unwitting patients to take advantage of well-meaning but powerless physicians. Those are pretty shaky assumptions.
First of all, as anyone who has ever seen a drug commercial knows, DTC advertising urges patients to “Ask your doctor if [drug name] is right for you.” These ads are meant to spark conversation and inform patients, not to encourage patients to bully their doctors and demand specific prescriptions. Physicians and nurses are trained to say “no” to inappropriate requests, even when patients are adamant.
The US legal system considers a doctor to be a “learned intermediary,” and that part of her role is to protect even the most insistent patient from harm.237 An informed physician should always have the fortitude to say no and will have a range of strategies for doing so. No, you don’t need that drug. No, there’s an alternative that’s cheaper and probably safer, because we understand it better. No, let’s try to treat this without drugs first. No, I’d rather order a test that confirms you have that condition before prescribing this. No amount of pestering or biased information can force a physician to write a prescription against her own better training and judgment.
At no point in the educational process are doctors and nurses trained to violate the Hippocratic Oath and cave to a patient’s demands for inappropriate treatment.238 The vast majority of healthcare professionals understand this and practice with judgment and care. Are there exceptions? Based on what physicians themselves have said, it seems there are, but that is hardly grounds for reducing patients’ access to information that meets FDA standards. Granted, saying no isn’t always easy, especially when physicians are increasingly being held accountable with patient satisfaction surveys and online reviews. But it is part of the job—and the oath—they took.
A study published in 2005 elegantly demonstrates the benefit-risk tradeoff of patients asking for treatment based on DTC advertising.239 In the experiment, actors were trained to pose as patients with different types of mood disorders. Some reported symptoms consistent with major depression that, based on medical guidelines, merited treatment with an anti-depressant. Others reported symptoms consistent with an “adjustment disorder” that didn’t merit a drug prescription. The actors were instructed to either request that the doctor prescribe a specific branded drug, Paxil; ask for medication in general without mentioning a specific drug by name; or not request treatment, leaving it up to the physician to initiate a treatment discussion.
Those who were in the major depression group but didn’t request medication were treated in accordance with standard of care only 56% of the time (which doesn’t necessarily mean that they got anti-depressants; some were appropriately referred for counseling). Those who did ask for treatment, either generally or for Paxil specifically, were treated in accordance with standard of care 90% of the time. In other words, patients who asked for proper care were more likely to get proper care. Only a minority (27%) of the major depression group who requested Paxil by name were actually prescribed Paxil. Another 26% got a different drug, including generic drugs, and others were referred for counseling. The results suggest that even when patients ask for drugs they saw in an advertisement, doctors can make their own decisions about proper treatment.
Equally important, actors in the adjustment disorder group that did not ask for treatment were offered a drug only 10% of the time. So, 90% of physicians acted appropriately and only 10% misdiagnosed the condition. However, 39% of actors in the adjustment disorder group who made a general request for medication received a script for an anti-depressant, and 55% of those who asked for Paxil specifically got a prescription for Paxil. Yes, those doctors were over-treating. While some may have misdiagnosed the condition, many more simply failed to say “no.”
In this study, many doctors practiced medicine properly regardless of what the patients asked for. Many did not. Pressed for time as many doctors are, maybe it can be expedient to give patients what they want even when it isn’t what they need. But that’s not proper medicine and it shouldn’t be blamed on DTC advertising. Trying to make patients less informed and less inquisitive smacks of old-fashioned paternalism and negatively impacts those actually suffering from treatable conditions who wouldn’t get treatment if they didn’t know to seek or ask for it. The data show that patients who don’t speak up risk not getting the treatment they need.
What people on both sides of the DTC advertising debate can agree on is that physicians need more productive time with patients. There are lots of ways to help achieve those ends. For example, people need more training on how to be effective patients (e.g., how to effectively share their own stories with doctors,240 how to find credible medical websites, and how to read drug labels).241 Doctors need better electronic health records that reduce the need for redundant data entry. We should train and hire more primary care physicians and allow nurses to handle more routine care so that doctors have the time to put their advanced training to good use.
Physicians report that one of their greatest challenges is getting patients to stick with a prescribed treatment. An estimated 50% of patients regularly undermine their own care by forgetting to take doses of their medication.242 It’s worth noting that DTC advertisements help in that regard, reminding patients who have been prescribed a medication to take it as directed.243
DTC Advertising: Driving Costs Up…or Down?
Let’s consider AMA’s claim that the drug industry charges higher prices for drugs in order to pay for DTC advertising. In 2017, DTC spending amounted to $6.1 billion, less than 3% of total branded US drug revenues.244 So, even if AMA’s claim were true and DTC spending were completely eliminated, the overall savings for patients would be minimal—and that’s assuming that DTC costs are passed directly to patients in the form of higher drug prices, which is not necessarily true.
In fact, DTC advertising most likely lowers the cost of a drug on a per-patient basis. Here’s why.
A biopharmaceutical company invests in a drug’s development believing that it will generate a future return that is based on the price of the drug, the number of patients with the relevant disease, and the fraction of those patients who will be diagnosed and actually prescribed that drug (i.e., the penetration of the drug into its target market). DTC advertisements increase the number of patients diagnosed with a given disorder as well as the number of diagnosed patients who are
then treated with the advertised drug, boosting overall revenues and profits.245 However, that doesn’t mean costs go up on a per patient basis.246
As with any product, the costs of developing and bringing a drug to market are spread across the entire customer base. Without DTC advertising, drug companies would have to presume lower penetration, which would mean fewer patients treated, and, hence, a higher cost per patient. In today’s environment, where patients’ out-of-pocket costs are influenced by drug prices, that means DTC advertising lowers out-of-pocket costs for patients who need treatment.
DTC advertising can also indirectly lower costs for patients and all of society. Advertisements for branded statin drugs (back when statins were still branded) drove more patients to seek treatment for high cholesterol, and yet physicians were able to treat many of them with non-advertised generic statins, inexpensively preventing heart attacks and strokes associated with high cholesterol and driving further savings in medical expenses.247
Critics who think that DTC advertising is purely profit-motivated and only pretends to have educational aims are missing the point. DTC advertising is indeed profit-driven. If it weren’t, companies wouldn’t be able to justify the expense. But that doesn’t mean that it doesn’t have informational value that can lead to better patient outcomes. That’s not just the biopharmaceutical industry’s opinion; it’s the FDA’s, too. What’s the point of a new invention if people don’t know it exists and don’t benefit from it?
Why Not Promote Disease Awareness Instead of Drugs?
Many countries around the world take a very different approach to DTC drug advertising. Some even go so far as to outlaw all advertisements, even those that only describe the symptoms of a treatable disorder and urge sufferers to talk to their doctors. Other countries, such as Canada, compromise by permitting limited ads that mention either a drug or a disease, but not both. Only the US and New Zealand explicitly permit companies to mention both a drug and the disease it treats in the same ad.
Promoting disease awareness, even without mentioning a particular treatment, is itself beneficial. Raising awareness can help destigmatize a disease and encourage sufferers to seek medical care. For instance, throughout the 1980s, an HIV/AIDS diagnosis was met with fear and prejudice, prompting many to avoid being tested or seeking treatment. When the basketball legend Magic Johnson announced in 1991 that he was HIV positive, his courage made it okay for millions of people to talk about their experience with the disease.248 Later, in public service announcements, he urged people to get tested and many did.
Advertisements meant to increase disease awareness can achieve many of the same benefits as the traditional “ask your doctor about this brand” DTC approach. Both types of ads inform potential patients about conditions they might not have known about, both point out symptoms, and both can result in patients initiating useful conversations with their physicians. Awareness-oriented DTC advertisements are less controversial with physicians, since they are less likely to send patients into their offices with specific drugs in mind. So, is this the ideal way to go? As usual, we should engage in some benefit-risk analyses first. Let’s look at an example.
The disease-awareness approach makes the most sense for the biopharmaceutical company producing the drug that is the logical best choice for any patient with a particular diagnosis. Gilead funded a hepatitis C awareness campaign encouraging people to get tested for the virus but often didn’t mention the name of any drug (they didn’t need to since most physicians already considered Gilead’s drugs to be the best).249
Sometimes patients don’t even realize that what they suffer from is actually a treatable disorder. Consider the rare neurological disorder known as pseudobulbar affect (PBA), which is characterized by uncontrollable, spontaneous episodes of crying or laughing that have nothing to do with how a patient is actually feeling.250 Until they get a diagnosis of PBA, patients can’t understand what is happening to them and struggle to get others to take them seriously. After Otsuka launched a treatment for PBA, the company funded a documentary that profiled several patients and ran ads to help others recognize their own plight and seek a proper diagnosis and treatment.251 Because Otsuka’s drug is the only FDA-approved option, simply raising awareness of the disease also drove awareness and utilization of their drug.
So if DTC advertising were exclusively restricted to campaigns that increased disease awareness and we outlawed the mention of specific drugs, only the companies that either sold the physician-preferred or only available treatment for a given condition would be motivated to run such ads. But what happens when a better drug comes on the market?
For example, patients with rheumatoid arthritis today are treated with antibodies that require injections or infusions. These drugs have a risk of causing infections because they strongly suppress the immune system. There are drugs in development that have a lower risk of infection, so let’s assume that those drugs get approved. If DTC advertising were restricted to disease awareness with no mention of new drugs, word would spread slowly to patients about these new and better options. Even physicians who heard about the new drugs would not call all of their patients to get them to come in to change their prescription; it’s more likely that they would wait until their patients’ next appointments and possibly switch prescriptions at that time. It stands to reason that a patient who sees a traditional DTC ad for a new drug and proactively calls their doctor would be more likely to get the newer, safer therapy—and wouldn’t that be a better result?
These are among the reasons why the FDA continues to allow DTC advertising in its current form.
DTC Advertising and Generics
When Lyrica’s patent expired in mid-2019, the FDA quickly approved nine low-cost generics of this neuropathic pain treatment, sparking the usual price competition.252 The original drugmaker, Pfizer, is losing Lyrica’s billions in annual sales, though no one should feel badly about that. Pfizer has made tens of billions of dollars on Lyrica since the drug first hit the US market in 2004 and will continue to market a longer-acting version of the drug for a few more years before it, too, goes generic. As discussed in Chapter 2, this is cause for celebration—another example of the biopharmaceutical industry fulfilling its end of the Biotech Social Contract.
This also means that Pfizer has no further incentive to market Lyrica, or to raise awareness of those shooting, burning, “pins-and-needles”-like sensations that should prompt a patient to talk to their doctor about neuropathy. No more budget for 60-second TV spots or glossy, four-page ads in Time magazine. The DTC advertising campaign is over.
This is standard practice in the industry and understandable from a financial standpoint. When a drug goes generic, the message that patients and physicians hear from the industry switches from a loud, “Let me teach you why you may need my expensive product,” to an unspoken, “We’ll sell you an inexpensive product if it occurs to you that you need it.” Generic companies compete with one another purely on cost to serve whatever demand exists. Why would Teva, one of the companies that makes generic pregabalin (Lyrica’s generic name), spend money on DTC ads touting pregabalin when pharmacies will just fill a patient’s prescription with pills sourced from the lowest-priced manufacturer? Because of how generic drug companies compete, a smarter strategy is for Teva to keep its own costs as low as possible (i.e., not spend money on advertisements) and compete on price.
But considering the benefits of DTC advertising campaigns and the tremendous societal boon that generic drugs represent, it’s a shame that there are almost no DTC advertisements for generic drugs and diseases that can be managed with them.
Insurance companies have some motivation to inform patients of diseases that can be managed inexpensively with generic drugs. Just as companies that offer flood insurance are motivated to help their customers prevent water damage by installing sensors and automatic shut-off valves, some health insurance companies try to educate patients on the
dangers of high cholesterol and other conditions commonly managed with generics. A flyer in the mail or email may encourage patients to inform their doctors of symptoms that aid in a proper diagnosis and to take their medications as prescribed. If effective, these efforts save the insurance company money by preventing heart attacks, strokes, and other downstream consequences of these conditions that are much more expensive to treat. This practice might be much more common if our insurance system were truly motivated to reduce healthcare costs in the long run, but it’s not. As discussed earlier, insurance companies are allowed by law to keep a fixed percentage of healthcare spending and therefore profit from the whole pie expanding. Their incentives are not yet aligned with making the healthcare system efficient. Hopefully with reforms, they could be. In any case, educational campaigns run by insurance companies do nothing for patients without insurance.
The closest we get to DTC ads for generic drugs are public service announcements (PSAs). For instance, the American Heart Association, American Stroke Association, and the AMA jointly funded a PSA to drive awareness of high blood pressure.253 Because promoting generic drugs doesn’t fit with anyone’s business model (even non-profits have to have a business model to survive) there are unfortunately few examples.254
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