I remember well the telephone call Dr. SJ received from her mother, informing her that mom finally knew what her ailments were. Mom, whose maiden name should have been Munchausen, had, she stated with absolute confidence, irritable bowel syndrome and restless legs syndrome. How did she arrive at these diagnoses? Not because any physician said so. Oh no. She knew it because she saw it on a television commercial.
When Dr. SJ suggested that it wasn’t her bowels that were irritable, Mom was miffed. When Dr. SJ urged her to get off her butt and her legs wouldn’t be so restless, Mom was outraged. So what if few, if anyone, knew that these syndromes existed. The TV said there were cures and she was going to the doctors to demand the drugs she saw on the TV commercials. And eventually, her doctor agreed to prescribe the drugs for her just to stop her complaining. That was the affect of television advertising of direct-to-consumer drugs, mostly directed toward older Americans who were more inclined to be susceptible to its influence.
Trump has signed a memorandum directing the FDA to revive its pre-1997 policy that required pharma to include the full panoply of harms drugs could cause that made television advertising untenable. After all, how can you run a 60-second commercial when you’re required to provide seven minutes of risk, including death?
In 1962, the Congress vested the Food and Drug Administration (FDA) with the authority to regulate prescription drug advertising. These advertisements can mislead the public about the risks and benefits, encourage medications over lifestyle changes, inappropriately intervene in the physician-patient relationship, and advantage expensive drugs over cheaper generics.
The FDA has historically stipulated that a manufacturer, packer, or distributor must provide the public with materially complete information that fairly balances both the benefits and the risks of the drug. Over time, however, the FDA’s requirements have permitted drug companies to include less information, particularly in broadcast advertising, and drug manufacturer advertising has skyrocketed in recent decades.
My Administration will ensure that the current regulatory framework for drug advertising results in fair, balanced, and complete information for American consumers.
Of course, this has nothing to do with providing “fair, balanced and complete information,” but putting an end to the ubiquitous TV drugs ads of happy, singing, dancing, smiling people taking prescription drugs for conditions, diseases and syndromes they never knew they had until they saw it on TV. And contrary to what some might believe, this is the right thing to do.*
But what about the free speech of pharmaceutical advertisers and the interest of consumers in learning about new diseases and new cures?
Modern drug ads have been around since the 1980s, mostly in medical journals, newspapers and magazines. But for years, they were largely kept off TV by a requirement that ads naming a specific illness include a litany of information about possible side effects.
But in 1997, the F.D.A. relaxed the rules out of concern that the restriction violated the First Amendment. Going forward, drug advertisers would be allowed to briefly summarize a product’s risks — briefly enough to fit in a 30-second TV ad.
That opened the door to the ubiquitous TV ads that blanket commercial breaks during sporting events, nightly news shows and online streaming services, along with ads on billboards and subway trains. The drug industry spends billions of dollars each year advertising its products.
They aren’t spending billions because these ads are ineffective, but because pharma is making tons of money selling drugs and diseases to the public that can’t purchase without a diagnosis and script. This is commercial speech, a subset of free speech that advertises the availability and quality of goods and services for sale, and subject only to rational basis intermediate scrutiny rather than the strict scrutiny that would otherwise apply to fully protected free speech.
Despite very hard lobbying by pharma, even President Clinton’s FDA commissioner was against drug advertising back then.
Dr. David Kessler, who as commissioner of the Food and Drug Administration in the 1990s opposed loosening restrictions on drug advertising, said, “The approach that they are proposing to follow would in essence remove direct-to-consumer advertising from television.”
“The industry will obviously challenge this on First Amendment grounds,” he added.
The entire concept of marketing prescription drugs direct to consumers was bizarre from the outset. If patients can’t go to the store and buy drugs, what possible purpose is served by convincing them to buy your drug, or any drug for that matter? Consumers can’t diagnose themselves. Consumers can’t prescribe drugs for themselves. It is up to physicians to determine whether a patient had an illness and what to do about it, not consumers. But that would require docs to be willing to fight their patients’ demands for the magical cures for their imagined ailments as seen on TV.
To Big Pharma, however, this is as valuable as speech gets, as their drugs are anything but free.
Bob Ehrlich, a longtime consultant for drug advertisers, said he expects the drug industry to sue over the proposed policy change. The courts would take up the question of whether, in the context of the First Amendment, drug advertising has harmed public health, he said.
“We now have 28 years of advertising,” Mr. Ehrlich said. “And that is what I think the courts would look at and say, ‘Show us the harm by allowing them to do this.’”
If there is no harm from selling drugs with song and dance, and only a passing mention of the risk of death, then why not let pharma fill dead TV air and create a nation of drug-addled old folks with Medicare treatment of syndromes that didn’t exist before there was a drug to cure them?
*Some have suggested that I never agree with any position Trump takes or anything he does. This is untrue. I occasionally agree that something is a problem in need of a solution, but usually find Trump’s solution simplistic, dangerous and wrong. In this case, however, I am in full agreement with ending this blight on television and sound medical care.
Discover more from Simple Justice
Subscribe to get the latest posts sent to your email.
You very much should either refrain from or run your copy through Dr. SJ before posting on medical issues.
You’re “mostly right”‘ about the high visibility extreme cases you care about. But you do actual, real harm to patients based on subleties of course you shouldn’t be expected to understand. (Btw, ask Dr SJ about how many cases of peripheral neuropathy — often treatable, with great results — are caught screening people for nonsense like”restless legs”. Or new onset Crohns for IBS screenings, and how hard it is to get patients to come forward with any kind of colorectal issue). Slamming those things – even if they are nonsense — discouraged patients seeking treatment.
I do not understand, at all, how someone who routinely screams, “F law professors, because trenches! Differences between specialties!”‘ doesn’t get that just because he’s married to a married to a doctor who is kind enough to describe things to her layperson husband means you get to abandon your (admirable) mission to “not make people stupider.”
Seriously, the notion of “primo non nocare” (first, so no harm) is *subtle* . Ask Dr. SJ about it… One of the more vivid examples is treatment for heart failure in the 80s.
“First do no harm” is, again, deceptively subtle. I really do suggest either staying away from medical screeds, or adding Editor to Dr. SJs titles on.medical issues.
I’ve kept to.medical ethics as the reasons your comments on pharmaceuticals are harmful is *far* more scientifically complicated.
I am just here for the comments. Got any popcorn? (Is it still Tuesday?)
You gave me a headache, and completely missed the point of the post. Now I need some Wegovy. Or is it Ozempic? I’ll just watch TV until I figure it out.
I’m afraid I don’t understand much of your reasoning.
The way I read the post, SHG agrees with Trump’s requirement that side effects be enumerated because people often seek flagrantly incorrect medications based on television commercials. (He gives his wife’s mother as an example.)
The way I read your comment, you disagree with this because people who seek incorrect medication based on television commercials often raise a health issue unknown to the provider that can then be correctly treated.
This is followed by the bit that I need you to connect the dots of your thinking. SHG’s position is–even if incorrect–common. You appear to think SHG’s position is not just wrong, but flagrantly wrong. I’m not sure why you think so or what this has to do with the concept of ‘first do no harm’.
Damn. You agree with Trump.
It must be snowing in Hell.
Not only have you been here long enough to know S is as principled as you’ll find on this modern day mess of a web, but I specifically remember him being gracious towards your posts and replies, e.g., what was happening on your Arizona border with cartels.
I’ve disagreed with S on many things over the years, especially his take on many things 2A, Bruen and his post, Guns Of Manhattan (Ooof!), but he has shown an incredible (in the very definition of the word) amount of Grace and Patience to the numerous amount of readers who are Not attorneys who happen to come across this blog.
To wit:
In a message dated 7/10/2016 12:52:17 A.M. Eastern Daylight Time, [email protected] writes:
SHG,
I apologize for my stupid and off-topic comment. Sorry to have wasted
your time. I will read more and talk much less. Donation sent over.
N
“No need to apologize (or the donation, unless you wanted to). Shit happens. New people want to be helpful, and often don’t know what’s come before. It’s no big deal. I just wanted you to know why your otherwise lengthy and thoughtful comment didn’t get posted, and give you a little push toward putting your energies toward more useful comments.
Bear in mind, there are over 8000 posts in almost 10 years at SJ, readers include everyone from cops to federal judges. There is very little that isn’t already up there, and there are ten thousand new readers a day who feel it’s their opportunity to “inform” my readers about something without knowing what came before.
But no worries. And thanks for the donation.”
Not a one off; a few replies via email to a non-lawyer if I’ve show a modicum of non-idiocy. This considering how many emails –slings and arrows and all that– he suffers from actual attorneys.
—
I’ve recently found myself re-reading a previous (how many SHG readers go back and slog through dense posts and PDF links?) from SHG -> Kopf -> to links of SHG on the federal judiciary and originalism (https://blog.simplejustice.us/2019/09/23/kopf-federal-district-judges-should-keep-the-hell-away-from-originalism/), and try desperately to understand why things work the way they do and what small -if imperfect changes- I can consider as a mere citizen to effect some type of change.
N
https://m.youtube.com/shorts/eGhAlNnDDmY
This is a step in the right direction, but it won’t fix the problem. The United States needs to stop being one of 2 countries in the world that allow drug companies to buy the media’s allegiance with advertising dollars.
People watch commercials?
One thing the singing and dancing may spread to common awareness is how big pharma gets a med approved for one condition, then pushes its expansion to other conditions (usually following off-label use on human subjects). The Jardiance jingle, for example, was originally about happy dancers lowering their A1C, but now is also for heart failure and CKD (keeping the choreographers and jingle writers busy).
I show one of those commercials in a biochemistry class to begin a discussion of how blood sugar modifies hemoglobin, which is what the level of A1C indicates.
Commercial speech regulations must survive intermediate scrutiny, not rational basis review. A far cry from strict scrutiny, but still a pretty big hurdle for a ban like this to get over.
{Ed. Note: Crap, you’re right. I’ll correct the post.]
I had many thought but I think the best one is this: from Cracked magazine from sometime in the 60s an ad for “ Sufferin”.. “…why trade a headache for an
Upset stomach when you can have both with “ Sufferin” tablets.