We discuss the historical transition from before DTCA to its emergence in the 1980s, and subsequent legislation that allowed it to flourish in the mid-to-late 1990s.
[00:00:00] If you think history is boring, go to the next episode. Bear with us. Edits have been made on this episode. Cut us some slack.
Ethan: Back in the late 1800s, early 1900s, drugs were split into two categories. One were patent medicines, or proprietary medicines. These are medicines with unknown ingredients, trademarked brands, and heavy advertising. Most of the ingredients were like tonics, bitters, water, but some of 'em also contained addictive substances like opium, alcohol, and cocaine. Lydia E Pink's Vegetable Compound, purported to cure entirely [00:01:00] the worst form of female complaints, all ovarian troubles, inflammation and ulceration, falling and displacement. Some other interesting names, Hamlin's Wizard Oil, Kickapoo Indian Sagwa, Warner's Safe Cure for Diabetes, so we're in kind of a wild west back when the west was still wild.
That was the one category of medicines. The other were “ethical,” or American Medical Association-approved drugs, considered effective by 11 independent MDs. These are things like Morphine, Aspirin, Ether, Diphtheria, Digitalis, some of the drugs that are still in use today. Drugs were categorized solely to physicians as ethical, which created this big incentive for pharmaceutical companies to initially focus their promotional efforts on doctors. Starting in [00:02:00] 1905, the Council on Pharmacy and Chemistry set standards for drugs to steer patients away from patent medicines and towards these “ethical” medicines. 1906, the Pure Food and Drug Act, wanting to make sure that the drug maker could prove the medicine was effective.
In 1937, there was an antibiotic called Sulfanilamide. They made a kid-flavored version, raspberry-flavored antibiotic preparation. The pharmaceutical company, however, at the time, was not required by law to test for safety prior to mass production and distribution. So you had people who died all around the country because they were taking this poorly-prepared antibiotic. It was (essentially) Antifreeze. Unfortunately the drug company, the S.E. Massengill Company, initial response was not aggressive enough. They failed to indicate the severe [00:03:00] urgency with which they needed to act.
There's a couple of excerpts, one from a physician, A.S. Calhoun said, ‘But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently. And to realize that medicine, which I had used for years in such cases, suddenly had become a deadly poison in its newest and most modern form as recommended by a great and reputable pharmaceutical firm in Tennessee. I have known hours when death for me would be a welcome relief from this agony.’
A woman who lost her child wrote a letter to FDR at the time, ‘the first time I ever had occasion to call in a doctor and she was given elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain. It is my plea that you will take [00:04:00] steps to prevent such sales of drugs that will take little lives and leave such suffering behind in such a bleak outlook on the future as I have tonight.’
Michael: Maybe there’s implicit trust that if it's being prescribed, therefore it must be safe or else why would I be given it? Probably the provider too, that, if it's being compounded in a certain way, it's gonna be safe. And that's where the law comes in and says, ‘Okay, now we need to show not just effectiveness, but it has to show safety as well.’
Ethan: The next year, in 1938, the Food Drug and Cosmetic Act is passed. The FDA says that you also have to prove that drugs are safe and receive FDA approval prior to marketing them.
Michael: The flip side of it is to contrast is with something like supplements. With a supplement and over the counter products, you have to show that it's dangerous to move it off the shelf. Something can be on the shelf as long as it doesn't seem like it's gonna be harmful. But then once they prove there's a problem, you pull it off.
Ethan: Remember there's a very limited number [00:05:00] of prescription drugs at this point, and then you've got supplements. So the American consumer of healthcare really needs to feel like the prescription drugs are safe because we know the supplements have all kinds of crazy shit in 'em. They're not regulated, they're not tested for any sort of purity. You could have a bunch of cocaine or opium in your cold medicine.
Michael: To be fair, some of them were literally, that was the goal. Yeah. That was literally all that was in there.
Ethan: 1951 Amendments to the Food, Drug and Cosmetic Act required more of these drugs or supplements to be sold by prescription and to be studied better and therefore be able to deem some of these potentially too harmful. Between 1929 and 1969, prescription drugs made up 83% of consumer spending and prescription drug sales rose from 300 million to all almost 2.5 [00:06:00] billion, with all but 4 million of the increase related to prescription drugs. This led to all of pharmaceutical promotions now going to physicians. In 1958, you had almost 4 billion pages of paid advertising in medical journals. You had 750 million pieces of direct mail sent and 20 million phone calls to doctors and pharmacists.
In 1959, pharmaceutical marketing practices became the focus of several congressional hearings in response to drug ads aimed at physicians that made efficacy claims when they didn't exist. So this company put out this drug called Chlorpropamide, and they quote ‘an almost complete absence of unfavorable side effects.’ When they actually studied it, more than a quarter of people had serious side effects, including jaundice, you know, when your skin goes yellow because your liver's failing. Then in [00:07:00] 1960, just right on the tail end of this, this Thalidomide crisis hit Europe.
Michael: You had this noble idea is childbearing, this beautiful thing, you have this intractable nausea and vomiting. Let's give a medication that can help with that.
Ethan: Thalidomide, now we know, causes all kinds of birth defects. Most notably, phocomelia, where people are born without a limb.
Michael: Literally kids born with more like flippers, these very short limbs… With hands.
Ethan: The Food and Drug Administration was born right around this time. They added an amendment that you had to go through a specific process to prove your efficacy as opposed to just saying, ‘oh yeah, it works,’ before you could market anything.
Michael: Thalidomide led the FDA to feel like, ‘okay, we've been justified that some of these drugs, by slowing approval processes we avoided some of the problems other countries had by playing it safe.’ (i.e. Thalidomide). However, slow and more methodical processing of [00:08:00] approvals, that's a tough thing from a consumer standpoint, or from wanting a drug treatment as well. Have other countries move it through faster? Yes. Is it better that way? Again, it really depends.
Ethan: Getting to the emergence of direct to consumer advertising. 1970, the FDA starts forcing drug makers to add patient packet inserts inserts. If you've ever gotten a medicine, they've got so much freaking information in 'em that I would say most consumers wouldn't be able to make sense of a whole lot of it.
Michael: Yeah. I feel bad. We're required to put a lot of it into the labeling or into the bags of medications. First of all, the writing is tiny. No book writer's gonna write in those kind of fonts and it might make your eyes bleed a little bit if you don't have a magnifying glass.
Ethan: Yeah. Especially if you're, I don't know, over 55, you're not gonna be able to read it. The 1980s (brings) the mini-emergence of Direct To Consumer Advertising, not like we see it today, but Pfizer basically used what they called public education health programs [00:09:00] to educate the public on ‘under-diagnosed’ conditions like high blood pressure, diabetes, chest pain, but they didn't mention any drugs specifically by name. So they're able to get around the restrictions and regulations by promoting awareness of the conditions that their medicine will be used for.
Michael: A couple years ago I was hearing this ad for a condition called non-24, that a lot of people who are blind have difficulty with sleep wake cycles. The ad is just educating the public about what non-24 is and there's a website, non24.com. The website, it's actually run by a pharmaceutical company, which lo and behold, has a patent on a melatonin receptor agonist used to treat, what do you know, something involving sleep wake cycles? These are educational sessions, but it's not like they just wanna make you aware of it for no reason. By golly, we have a product that fixes that thing you didn't know existed till we just told [00:10:00] you about it. And now maybe you have that condition and if so, oh, there's a drug for this and I can get information about it right now
Ethan: The ultimate goal is to sell your product. And it's a very covert way of doing it. Anyway, you had Boots Pharmaceutical promoting Rufen in TV ads. You had Merck advertising the Pneumococcal vaccine in 1982. Then in 1983 you have Eli Lilly that claims Oraflex might prevent the progression of arthritis. The problem is that it had a bunch of adverse drug reactions in its patients, and it was pulled voluntarily only five months later.
That kind of pushed the federal government and Congress to intervene again. They called for a voluntary moratorium on Direct To Consumer Advertising until they can figure out what they want to do. And I got a little excerpt from the commissioner of the FDA, Arthur Hall Hayes. He really hit the nail on the head. He says, ‘DTCA would lead patients to [00:11:00] pressure physicians to prescribe unnecessary or unindicated drugs, increase the price of drugs, confuse patients by leading them to believe that some minor difference represents a major therapeutic advance, potentiate the use of brand name products rather than cheaper, but equivalent generic drugs, and foster increased drug taking in an already overmedicated society.’ It's really interesting how, 40 years later, that exact quote checks all the boxes of what we're going through as a healthcare system now.
Michael: There's a lot to unpack there. The idea that the physician is this gatekeeper. Actually, John Oliver did a segment 6, 7 years ago, talked about this and said that everything ends with, ‘Talk to your doctor.’ And sometimes then they add, ‘or pharmacist’, and I'm like, ‘Woohoo! Yes, we too can be a gatekeeper,’ but it's mostly with vaccines, but the doctor is now the one that can give you it. This is a product. Nobody says, kids talk to your parents before getting jump rope or hula hoop or whatever the kids are doing these days, but the physician is the [00:12:00] barrier, is the gatekeeper. And so the only thing you can do then is, you gotta get through the gatekeeper to get this product and I can't get it unless they give it to me.
Ethan: In 1985, (Hayes) lifts the moratorium because of what we're talking about. He's like, ‘There's no way they can fit all this stuff into an ad so it won't take off.’ At the time, 84% of physicians were against Direct To Consumer Advertising. You had the American Society of Internal Medicine, the Ophthalmology Society, Family Medicine, American Medical Association the OBGYN Association, all took positions against DTCA, as well as the Health Research Group. The AARP recognized consumers wanted more information, but also didn't feel like they had enough knowledge to make those calls by themselves. And the crazy thing that, this blew my mind, is I got all these excerpts from 1984 big pharmaceutical reps that were against Direct To Consumer Advertising.
Edgar G Davis, who's the [00:13:00] Vice President of Corporate Affairs at Eli Lilly spoke these words on the House floor in 1984, ‘We do not believe that commercial product advertising of prescription drugs is appropriate. Prescription drugs embody a complex set of factors with potential human effects that can best be evaluated by the physician. Therefore, we believe that the need for the physician's supervision of any prescription drug taken by the patient is paramount in that the potential pressures of public advertising, of prescription drugs on the scientific decisions of the physician are both unwise and appropriate.’
The Senior Vice President of Schering-Plough, ‘We have serious concerns about proposals to allow advertising directly to patients. We do not believe it's in the public's health interest. Indeed, we believe that in most cases it cannot safely be accomplished.’
Michael: I'm guessing it's one of those where, if everyone's gonna do it, then we've gotta beat everyone to it. Both of them are [00:14:00] huge business, especially if you get both ends. I can get the patient, but maybe those physicians that are hesitant, what if I can allay the physician fears too? We can hit the patients and get them going to the doc. What if the physician is not the gatekeeper? What if they just open that door up and then boom, I can hit a bunch of patients, but if I can just hit one or two of the doctors and they talk about things like key opinion leaders or thought leaders. And if you can get somebody big, like some of these names that show up on a whole lot of papers, this doctor gives credence to what this company is saying. I feel a little bit better. They're one of my own, they're not a drug rep now. Sure, they're paid by the drug company for it, but they're a physician, or a pharmacist. They're like me. And so if they're good with it, maybe I'm good with it too.
Ethan: As we get into the 90s, some changes in healthcare spur these companies to reconsider DTCA: employers turn to managed care plans that require utilization reviews, puts a cap on provider payments, and forces people to have selected providers that are within their jurisdiction or within [00:15:00] their plan. The public loses trust in their physicians. In 1966, 75% of people said that they had a great deal of confidence in their leaders in medicine. By 1990, that number had dropped to less than 25%. Also, from ‘97 to 2002, the use of alternative things like supplements went up from 33% to 42%. Public perception of who should make healthcare decisions is shifting back to the consumer and Big Pharma’s like, ‘All right, let's roll out DTCA.’ The Internet, all of a sudden you've got widely available information, you've got more access to medical and health information, the patient-doctor relationship starts to shift from this more paternalistic or maternalistic model to this shared decision making model. You also have the emergence of Consumer Advocacy Groups, groups that [00:16:00] get together nationally rallying around one diagnosis and they start to ally themselves with pharmaceutical companies. It's a noble pursuit because their end goal is to get a medicine approved for, say, a rare condition that otherwise would not be funded. What they don't realize is that the pharmaceutical company is like a fifth grade bully, just pretending to be your friend because they want something in return at the end of it. Next thing you know, somebody's paying out the wazoo for that drug that doesn't work and potentially has serious side effects.
Pharmaceutical companies spending on DTCA explodes, 55 million in 1991 to 363 million in 1995. 1994 comes around and the House Speaker is Newt Gingrich. He calls the FDA the #1 Job Killer. Public perception is everything. [00:17:00] The HIV and AIDS crisis, the drugs were not being manufactured quickly enough or approved quickly enough, because now, the drug companies have to include in their marketing side effects, contraindications and efficacy.
Michael: I remember watching it, people trying to climb over the walls of the White House, trying to import AZT, like the movie Dallas Buyers Club. The US and FDA dragged their feet. I really think the Thalidomide and Clozapine and some of the hesitations as far as prescribing was validated because they avoided some major fatalities. But now we're being too conservative as a problem.
Ethan: David Kessler, the head of the FDA appointed by George W. Bush fails to enact regulations, including viewing tobacco as a drug, also did not put forth a lot of regulations on health claims for dietary supplements, and allowed Oxycontin to be approved in 1996 for chronic pain, certainly one of the worst medical mistakes[00:18:00] of his career. 1997, Kessler left and Congress decided on these brief summary requirements, this exhaustive list of things that you could not cram into a 60 second TV ad: side effects, contraindications, efficacy, all the information… they then allowed them to refer customers or consumers to toll free phone number or a printed ad, to a website, or to their pharmacist or physician for a complete list of risks, benefits, side effects and alternatives.
Michael: That was one of the laws coming out of 97, if there are significant warnings, you have to say those warnings, but as far as all the other pieces of it, as long as you provide them a way to get that package insert, that giant flipping leaflet that we talked about before, that becomes the route. Or they'll send you to the website or a toll free phone number. I don't even know if they do that anymore. But as long as you do that and say, talk to your doctor and give a little bit of information about the [00:19:00] condition and what it is, then that gives you the okay pass.
Ethan: Big pharma immediately seizes on the policy change. TV ad spending goes from 300 million in 1997 to 660 plus million in 1998. The total Direct To Consumer Advertising in 1998 was 1.3 billion, by 2005, 3.3 billion, and shifted from raising awareness of medical conditions, which was their kind of way of skirting around these brief summary requirements, to give all that information about a particular drug. Now that they had this loophole, they're like, all right, let's market all of these drugs directly. The impact or the effect of that is evidenced by this 2002 survey of how DTCA affects consumer's behavior. This large survey showed that 98% of Americans had seen or heard an [00:20:00] ad for a prescription drug. A third of those who saw an ad actually went to their physician to talk about the medicine. A third of that third asked for a prescription. And of the third of that third, 80% of them, or 5% of all Americans who asked for a prescription, got a prescription. So 17.5 million people got a prescription in 2002 because they saw an ad and then went and asked their doctor about it.