We know that individuals and society as a whole save money when branded drugs go generic, but are we better off if our awareness of the diseases they treat and our knowledge of their symptoms and treatments diminishes?
In most cases, society preserves the knowledge of how to use a drug by incorporating it into written medical guidelines that all physicians are taught and expected to follow. For example, knowledge of the proper use of statins, which have now all gone generic, is codified in medical textbooks and treatment guidelines. Increasingly, instructions on when to prescribe statins are coded into electronic medical data systems so that doctors are reminded to prescribe them when a patient’s cholesterol is too high.
But there are some special cases in which patients don’t know they need treatment until it is too late, and those treatments require more than just the training of physicians—they require a general societal understanding of the drug and when and how it might be used. In those cases, we may find ourselves unprepared to take custody of a newly generic drug, and the patent-burning party may prove bittersweet.
After the Mortgage Is Paid Off
After a drug goes generic and DTC ads cease, if patient awareness wanes and diagnosis rates drop, then we fail to get the most out of an asset that society owns. Imagine that you buy a house with the help of a mortgage from a bank that provides free home maintenance for as long as you are paying the mortgage. If the plumbing breaks, you call the bank’s service department. They even do preventative work, like sending a service team each year to winterize your pipes and clean out your gutters before the first freeze. After 15 years, you pay off the mortgage on your home, throw a mortgage-burning party to celebrate the occasion, and then realize that the responsibility for maintenance has now fallen on you. That’s what happens whenever a branded drug goes generic: Society must preserve and disseminate its knowledge of how to use a drug, taking that duty over from a company that previously had the incentive and revenue stream to invest in public education and marketing. If we fail to engage, it’s like paying off the mortgage on a house and then letting it fall into disrepair to the point that you have to rent another apartment. For example, not using drugs to prevent a heart attacks can lead to surgery, a “rent” expense, since surgery never goes generic.
A Special Case: The EpiPen
A child with a severe allergy has accidentally eaten a peanut or been stung by a bee. Her throat is swelling shut, and every second counts. An epinephrine injection can hit pause on her body’s reaction, buying time to get her to an ER.
For 40 years, epinephrine has been used to treat anaphylaxis. The drug was originally available in small glass vials, and users had to carry around a separate syringe.255 If the need arose, a person had to insert the syringe into the vial, draw up the drug into the syringe, make sure to get the dose right, pause to push the air out of it, and then inject. Imagine a panicked parent doing this as his terrified child’s throat swells, or an adult struggling to do this to herself while experiencing anaphylaxis. So little time, so many steps.
The EpiPen, approved in 1987, was the first product to put epinephrine into a pre-filled auto-injector. This was a meaningful upgrade that deserved the patent it received. But there was a significant secondary benefit to the rebirth of epinephrine as the branded EpiPen: The company selling it had a financial motive to educate society about anaphylaxis and the benefits of the auto-injector. The strange thing is that, for a long time, they didn’t do so.
For its first 20 years on the market, the EpiPen was sold at a low price, less than $50 per device and was barely profitable. It was neither well known nor widely prescribed, and medical experts considered it underappreciated and under-prescribed.256 When the specialty pharmaceutical company Mylan acquired the (mostly generic) drug portfolio of the German company Merck KGaA in 2007,257 EpiPen was part of the deal. Mylan’s executives considered getting rid of the barely profitable product but decided to take another tack.258
Mylan recognized the potential in allergy preparedness and decided to raise awareness of anaphylaxis and, hence, increase the size of the market for the EpiPen. To fund all of this, they raised the net price of the EpiPen approximately 3-fold over the next decade (though public, media, and politicians focused on the more dramatic 6-fold list price increase, ignoring the growing rebates the company paid back to insurers).259 The resulting marketing and lobbying campaign raised the awareness of the public, healthcare professionals, teachers, restaurant staff, airline employees, police officers, and many others about food allergies and insect stings, how to recognize anaphylaxis, and how and when to administer the EpiPen. Mylan also funded non-profits such as Food Allergy Research & Education (FARE) and gave free EpiPens to schools to get them started on allergy-preparedness, provided that they reordered annually (since EpiPens expire after a year). Many schools and restaurants now stock EpiPens and know how to use them, thanks in large part to Mylan’s campaign.
The EpiPen grew to a nearly $1 billion/year blockbuster product by 2018. Critics derided Mylan’s outreach efforts as self-serving,260 but that is exactly the point: Higher prices provided the fuel and incentive for Mylan to do more good in terms of allergy awareness and preparedness in just one decade than other companies that owned the EpiPen had done over the prior two decades. In those companies’ hands, the EpiPen cost much less, but it remained relatively unknown and underutilized, doing good for too few patients.
As the EpiPen’s price climbed, an outcry arose from and on behalf of families who could not afford the EpiPen. Yet no one looked to America’s insurance system, which failed to do what it was designed to do for those patients (as discussed in Chapter 4). A number of articles criticized Mylan for charging so much for what was considered a very old drug, not taking into account the importance and complexity of upgrading epinephrine from a vial to an autoinjector, as well as other improvements to the device. The complexity and value of these upgrades should have become clearer as other companies struggled to make comparable products that could successfully compete. Some companies just couldn’t get their products past FDA review and in other cases had to recall them due to technical glitches uncovered after FDA approval.261 Even Mylan had to recall some of their batches of the EpiPen due to manufacturing problems.262 Drug-device combination products are technically challenging to manufacture to a high, consistent standard—errors can be fatal—but, as we’ll see, it’s not impossible.
From the standpoint of public awareness, Mylan was so successful that people thought it had a monopoly on epinephrine autoinjectors, although there was another cheaper autoinjector on the market called Adrenaclick, whose manufacturer Impax (now Amneal) did little to promote it to patients or physicians.263
The criticism of Mylan also left out a number of important facts that paint a much more complete picture of how much better prepared our society is for that moment when a child with an allergy gets stung by a bee or accidentally eats a peanut. For example, many schools have created allergen-free tables in their cafeterias, which helps prevent the need for EpiPens from arising—and that’s better than using them. Mylan’s EpiPen campaign is not solely responsible for these and other preventative measures, but its educational value deserves to be weighed against the criticisms.
Going forward, who will fund the campaign to continue raising awareness of the seriousness of food allergies and anaphylaxis now that the EpiPen is going generic?264 Anaphylaxis is a medical emergency that happens suddenly, often far from any physician. Parents, teachers, and many others outside of the healthcare system must be kept aware of the symptoms of anaphylaxis and be ready, willing, and able to administer a lifesaving dose of epinephrine. Attacks happen so rarely that it’s hard for any patient to become an expert at recognizing the symptoms and knowing how to treat an attack, yet hesitating to give epinephrine when it is needed can be deadly.
In fifty years’ time, physicians will still know when and how to prescribe epinephrine autoinje
ctors without any of the generic manufacturers having to invest in marketing, but who will pay for and do the outreach to the wider range of people that Mylan’s campaign reached? Could a portion of the money that society will save from having inexpensive generic epinephrine autoinjectors be used to fund ongoing public education? Would such advertisements be as effective if carried out by the government or non-profit sector as they would be by a profit-motivated company? Or is legislation the answer?
Currently, thanks in part to Mylan’s efforts, there is a law that encourages schools to consider adopting voluntary guidelines for food allergy preparedness. That’s pretty weak, but importantly, the law allows undesignated EpiPens to be stocked at schools (otherwise, every EpiPen would have to be assigned to a particular patient based on a physician’s prescription and could not be used to help other students). Laws nationwide could be strengthened to require schools and other institutions to stock epinephrine autoinjectors, routinely check them to make sure they aren’t expired, and require they always have someone on hand who is trained to use them, just as public pools must have lifeguards on duty. California passed such a law after media coverage of a student who died of anaphylaxis at a school.265
One solution might be for the government to require all generic epinephrine autoinjector companies to pay a fixed fee per device to a third-party marketing company that would be tasked with marketing these products to schools, airlines, restaurants, and other public places. The more autoinjectors sold, the more fees the marketing company would collect, reintroducing a profit motive. The generic companies would still compete on price to gain market share, with those that won the most market share providing the most funding towards marketing and education. The customers (or their pharmacies) would be the ones choosing which generic to buy based on price, but those prices would never be less than the cost of the product plus the fixed marketing fee. The marketing company would focus on volume, not price, since they would collect a fixed dollar amount per product sold.
Pitfalls of the X-Prize Model of Paying for Drug Development
Instead of allowing companies to charge high prices for a long time for their new drugs, society could decide to incentivize drug development with a large upfront X-prize model, whereby a company that gets a drug approved gets a huge reward, and then the drug is immediately allowed to go generic.266 It’s like paying less for a home with cash upfront instead of a mortgage, and saving money by not having to pay interest.267 A critical pitfall of the X-prize model is that it does away with the incentives to invest in the marketing and awareness campaigns needed to incorporate new medicines into the standard of care. That takes time and money. This might be fine for certain types of drugs, like antibiotics, in which case a small community of infectious disease specialists decide from the start how to use them judiciously to prevent the emergence of bacterial resistance. However, in the unlikely event that such an X-prize model were ever adopted more broadly for medicines that do require promotion,268 it would be prudent to pair it with the third-party marketing model I propose.
Sensible proposals like that take years to become policy, if they ever do. Meanwhile, the EpiPen is going generic, and I worry that the world is unprepared for what it will lose. When epinephrine autoinjectors are inexpensive once again and no one considers them worth marketing, I don’t think we will be better off.
Automated External Defibrillators (AEDs)
The points I’m making about preserving education apply equally well to automated external defibrillators (AEDs) developed to help people experiencing a heart attack. Just as the EpiPen can be life-saving for someone experiencing anaphylaxis, the odds of a patient recovering go up if someone properly applies an AED while waiting for first responders to arrive.269 There is a patchy array of laws in effect in many states requiring certain businesses, such as health clubs and public spaces, to have AEDs available and people trained in their use.270 Efforts to promulgate AED laws are funded by the handful of competing medical device companies that make these devices, but there is nothing to prevent free riders who just want to focus on selling at the lowest cost without investing in general awareness. Were the market to reward the lowest-cost companies, competitors might be forced to streamline their budgets, awareness of the importance and use of AEDs might fade, and we would all become a bit less safe.
A Personal Note
As an investor in the biopharmaceutical industry, it’s frustrating that after devoting years to helping bring about a new treatment for a disease—one that represents real progress—patients continue to go untreated because they don’t know about it, their doctors don’t know about it, or something else gets in the way. Sometimes a patient is embarrassed to discuss their condition or symptoms, as can be the case with depression, fibromyalgia (which many physicians dismissed as illegitimate for many years),271 intimacy issues, or irritable bowel syndrome. Some may not even know that what they are experiencing is caused by a treatable disorder that they should discuss with their physician. I want the entire world to know about each newly approved drug as soon as it’s available, and DTC advertising can help overcome many of the obstacles that prevent patients from getting the treatment they need.
As a father, this issue becomes even more personal, particularly the debate about the EpiPen and Mylan’s outreach campaign. My family grapples with food allergies and lives with constant anxiety that a mislabeled snack could trigger a crisis. We are grateful for the current awareness of anaphylaxis and wish there were more.272 Eating out with our children, whether at a restaurant or a friend’s home, requires hypervigilance. My wife and I do not take for granted that our daughter’s school takes allergies seriously and is staffed by people trained in how to use the EpiPen. It is no easy thing to put a price tag on that peace of mind.
But we also have insurance and are fortunate that we can afford our copayments. The fact that there are parents out there who don’t have insurance or can’t afford their out-of-pocket costs, who fear that they won’t be able to afford a treatment that could save their child’s life or even ease their child’s discomfort, is unthinkable. One of my primary motivations for writing this book is to advocate for reforms that will make sure no parent has to live with that fear.
* * *
219Lyrica, “Lyrica TV Commercial, ‘Beach Day,’” iSpot.tv, 2018, video, 1:00, accessed Oct. 15, 2019, https://www.ispot.tv/ad/dfvu/lyrica-beach-day.
220“Background on Drug Advertising,” US Food & Drug Administration, last modified June 19, 2015, https://www.fda.gov/drugs/prescription-drug-advertising/background-drug-advertising.
221Patients have never been consumers in the traditional sense. They aren’t engaging in discretionary spending on their medicines; rather, they are counting on physicians to prescribe what they need for problems they feel powerless to solve.
222“Basics of Drug Ads,” US Food & Drug Administration, last modified June 19, 2015, https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm072077.htm.
223Carolyn McClanahan, “Dinosaur Doctors and the Death of Paternalistic Medicine,” Forbes, Feb. 19, 2013, https://www.forbes.com/sites/carolynmcclanahan/2013/02/19/dinosaur-doctors-and-the-death-of-paternalistic-medicine/#3a1e1aeb6af3.
224Brian C. Drolet and Candace L. White, “Selective Paternalism,” Virtual Mentor 14, no. 7 (2012): 582-8, accessed Oct. 15, 2019. doi: 10.1001/virtualmentor.2012.14.7.oped2-1207, https://journalofethics.ama-assn.org/article/selective-paternalism/2012-07.
225Albert W. Morris et al., “’For the Good of the Patient,’ Survey of the Physicians of the National Medical Association Regarding Perceptions of DTC Advertising, Part II, 2006,” Journal of the National Medical Association 99, no. 3 (2007): 287-93, accessed Oct. 15, 2019. https://www.ncbi.nlm.nih.gov/pubmed/17393955.
226Milton Packer MD, “Does Anyone Read Medical Journal Anymore?” Medpage Today, March 28, 2018
, https://www.medpagetoday.com/blogs/revolutionandrevelation/72029.
227Thomas Sullivan, “Nearly Half of US Physicians Restrict Access by Manufacturer Sales reps—New Strategies to Reach Physicians,” Policy & Medicine, May 6, 2018, https://www.policymed.com/2013/10/nearly-half-of-us-physicians-restrict-access-by-manufacturer-sales-reps-new-strategies-to-reach-physicians.html.
228MedData Point, MedData Point Shares Physician Opinions on DTC & DTP Pharmaceutical Advertising (MedData Group), https://www.meddatagroup.com/wp-content/uploads/MedDataGroup_PhysOpinions_on_Pharma_Advertising.pdf.
229Jerome R. Hoffman and Michael Wilkes, “Direct to Consumer Advertising of Prescription Drugs,” BMJ 318 (1999): 1301-2, accessed Oct. 15, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1115695/pdf/1301.pdf.
230Farah Ahmad, “Are Physicians ready for Patients with Internet-Based Health Information?” Journal of Medical Internet Research 8 no. 3 (2006): e22, accessed Oct. 15, 2019. doi: 10.2196/jmir.8.3e22, https://www.jmir.org/2006/3/e22/pdf.
231Christine A. Sinsky, “Infographic: Date Night with the EHR,” NEJM Catalyst, Dec. 12, 2017, https://catalyst.nejm.org/date-night-ehr/.
232AMA, AMA Calls for Ban on DTC Ads of Prescription Drugs and Medical Devices, Nov. 17, 2015, accessed Oct. 15, 2019, https://www.ama-assn.org/content/ama-calls-ban-direct-consumer-advertising-prescription-drugs-and-medical-devices.
233“Direct-to-consumer Advertising Under Fire,” Bulletin of the World Health Organization 87, no. 8 (2009): 565-644, http://www.who.int/bulletin/volumes/87/8/09-040809/en/.
The Great American Drug Deal Page 21
