It is high time the FDA considers taking down DTC ads rather than confounding them further

Word is out that the FDA is trying to curtail the number of side-effects stated in Direct-To-Consumer (DTC) pharmaceutical advertisements, in an apparent effort to try and get consumers to understand the key side effects and remember them. This is apparently considered a benefit to the consumer. How? Don't ask me. I think this is a bad idea, and the focus should be to de-emphasize DTC, so that prescribing medicine goes back in the practitioners' courts and pharmaceutical companies can focus on R&D and Translational Research spending. For years now, I have advocated AGAINST DTC ads.

1. Why am I against DTC ads?

The United States is one of the few countries that actually allows DTC ads of this nature. And I have a few critical reasons why many of us, and not just me, are against DTC ads.

1.1 An uninformed public is either given unnecessary hope, with some advertisements. Advertisements have a misleading way of sounding positive, and appear to offer a single point solution, that is quite effective. Needless to say, we don't know how age, sex, gender and other factors differentiate the effectiveness of treatments for many conditions in various patient groups. And where, we do know the effects, the advertisements simply ignore to state such information. Sure, there too, we could be like the FDA and pretend that information overload is the problem. However, when the Doctor finally informs the patient that the drug wont work on them (or tell them so after a few courses of treatment and the associated side effects take their toll), there are the 5 stages of grief, the second opinions, the ensuing loss of trust, the negative effects are too numerous to recount.

1.2 Confusion is the next problem. As the old joke in many television situation comedies (which run the advertisements they mock) that a simple headache medicine could include side-effects ranging from death to, yes, you guessed it, headaches.

Now, let us say that you found a headache medicine or allergy medicine that did indeed have side effects ranging from death to headaches. If you mentioned death only, does that make the patient feel relieved or better prepared? Or, if you leave out the headaches, and the Doctor only mentions them in passing, does the patient take that side-effect seriously? Do they decide to take the medicine? And if they are indeed plagued by headaches from taking the medication, then what?

1.3 Unnecessary Fear is the next problem. Imagine watching a cholesterol ad that warns you of cancer, heart disease or rectal bleeding? This is why the solution is not to MAGNIFY the main side effects. That somehow just makes the problem worse, not better.

1.4 The drug ads are also comically nightmarish. First of all, who in real life walks around telling people they have "moderate to severe Crohn's disease". If they did, it would actually be indicative that they need help of a different kind. And some of the so-called patients appear so deliriously happy after medicating themselves, it almost appears that something else is being advertised. Are you surprised at all that the United States is suffering from an opioid crisis?

Then there are the ads that are downright creepy. While the FDA has agonized over the presence of dogs, I would be more worried about ads that show a patient wandering through some ghoulish cartoon world, right out of the mind of someone who has consumed quite a quantity of hallucinogenic mushrooms.

Now, let me dismantle the reasoning behind this misguided effort at distilling DTC ads to accentuate fear, confusion and misinformation:

2.1. It is based on a study conducted with almost no rigor. The FDA asked 1500 people to watch a few advertisements, asked a few questions and mixed up a cocktail of street-side psychology and came to conclusions. This makes absolutely no sense at all. And this somehow took them years to get to.

2.2. Who decided information retention is the problem? This is what perplexes me. The problem here is patients who probably don't even understand what they ail from fully well, walking into the Doctor's office, demanding to be prescribed WEIRDCONSONANTFILLEDNAMEERASTUMINALIBAB because they watched an ad, that, sure, told them they could have nasal bleeding or brain cancer and something something, but that woman was up the next day smelling flowers and high-five-ing strangers. You see, if we get past all that distraction - the basic problem is - patients should not be making any decisions on their prescription (why have Doctors go through medical school at all then?) and should really leave this to professionals.

2.3. When was the last time a practitioner said, "Phew, I almost forgot about, but I am glad Patient X brought up EASYTOFORGETEXA for his moderate to severe such and such"? (Yes, the "moderate to severe" thing PISSES ME OFF, and to be clear, there is nothing moderate about how much it pisses me off.)

The Solution

This is one of several favorite quotes from one of the shows I love the most, House M.D. :

Dr. Gregory House: You wake up in the morning, your paint's peeling, your curtains are gone, and the water is boiling. Which problem do you deal with first?
Dr. Eric Foreman: House!
Dr. Gregory House: None of them! The building's on fire!

See, the problem is not that there is too much information in DTC ads, or that the amount of side effects retained is the problem. The dog running around in the ad is most certainly NOT the problem.

The problem is the burning house, that is, the fact that we unleash ads about NEARXIGA on people till 11PM, after which the "Non-Attorney Spokesperson" shows up and scares the living lights out of you and does not leave before letting you know that the FDA knows NEARXIGA kills, and equipped with this information, should you notice you've just died, call them.

What the FDA needs to do is to advice pharmaceutical companies to advertise as less of their drugs as possible and focus on spending money over new and more effective therapies. It is that simple. And in fact, that is exactly what a "business friendly" FDA ought to do.

And everyone should watch Dr. House.

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References:

1. The Forbes Article: https://www.forbes.com/sites/arleneweintraub/2017/08/29/fdas-gottlieb-wants-to-rein-in-risk-info-in-drug-ads-but-will-he-succeed/#74f9bf7e2042

2. Dr. House Quotes: http://www.imdb.com/title/tt0774238/quotes

3. Image Courtesy, Pexels: https://www.pexels.com/photo/colors-colours-health-medicine-143654/

The bad workmen, er, bloggers, er, authors that blamed the tool - A tale of sidewikis and pharma.

Hey, when you cannot report actual news, you can simply make something up right? Even if it is not remotely connected? Even if you are attacking the wrong problem or providing the wrong suggestions?

So, I have decided to take the plunge as well. See, we are now on a 24 hour news cycle. Everyone needs to be yelling, yelping, blogging, vlogging, twittering, facebooking, other-anatomical-region-book-ing, and what not.

When there are no new protests to protect "innovation" (read old wine in new stents bottles), or no new articles that Merck never wrote, or no new medical device company "consultants" to write about...

Well, you make something up.

And so is born the great panic of 2012, er, "Sidewiki"!!!

Sidewiki

According to Google, "Google Sidewiki is a browser sidebar that lets you contribute and read information alongside any web page."

In an effort to take on the wikipedias of the world (hey, I can create panic too!), Google has created a tool that can run alongside IE and Firefox 2+ and allows you to add your own mis-truths, truthinesses, truthisms and possibly a few facts to web pages.

This will allow you to go on your favorite (or not) Pharma/Med Device Company's (or any other website for that matter) and leave notes about exactly what you think of them. You can also get creative and leave pieces of your mind as well. And other stick-yer-nose-where-it-don't-belongers sidewiki users can join you in further glorifying these websites with their own colorful interpretations.

Pharma Companies, FDA and the manufacture of news

Now, let's make that into news.

How?

1. Sidewiki is this evil tool that allows the evil patients suffering from mild side-effects of drugs and devices such as permanent disability, blindness, cancer etc., get a chance to go to the websites of the companies that defrauded and/or hid data, or never cared enough to perform studies on the cheap plumbing, I mean stents they make, or companies that made their hips squeak - and spew venom!

2. Sidewiki is also this charming, deceptive tool that will suddenly convert well-meaning, trained marketing folks who have hitherto shown such unparalleled levels of responsibility, to suddenly go on their own companies' sidewiki sites and exaggerate claims of what the devices and drugs can do.

3. The FDA, which is currently well equipped and is doing such an excellent job of regulating itself and the growing list of industries ranging from tobacco to drugs and food, being regulated under it's able command will suddenly loose direction and debilitated and miss out on just this one aspect - the regulation of pharma companies and how they interact on sidewikis!

Should we treat the symptom or the disease?

Wait you say. Isn't it possible for the genius marketing weasels to go and cook things up on the sidewiki and get their companies in trouble? Or for all these patients to go write about what happened to them and prevent these wonderful ineffective drugs and devices from making their investors stinking rich?

Well, yeah. The answer is in the famous words of the pithy cliche, "Your bathtub is overflowing, do you clear the water first or turn off the faucet first?"

Let's look at both possibilities:

You see, inappropriately trained employees who are told to take a laissez-faire attitude on ethics - marketing personnel, telemarketers, bloggers, Presidents, Fox News Reporters and even the unicorns could end up doing the wrong thing.

Merck did it with the fake publications...

Glaxo did it by hiding the news of Avandia..

Then there were Celebrex, Vioxx and Yaz...

The FDA and Congress with the knee implant approvals..

The Obama Administration's "tort reform" with it's misplaced and unfruitful love for "bipartisanship". (Well, then why not simply embrace Fox News? That would be one hell of a bipartisan move. Equally useless, but definitely bipartisan!)

You see, irresponsibility is omnipotent - the medium is not the problem.

The "new headache" that you will read about in the articles I will link below, are after all, not new headaches. If people decided to be ethical and make it policy, at the macro-level, not with individual policies for twitter and Facebook, then the problem is solvable.

A matter of shame

Being regulated and chastised by the FDA for ethical failures should be seen as a matter of shame by the company, not a bright, bubbly, cheerful "You might have recently seen some Yaz commercials that may have been misleading. The FDA, weak, useless and unable to actually do anything by way of real punishment, has asked us to further confuse you idiots.."

Only a bad workman or blogger blames his/her or someone else's tools. Others, try to keep going back to the central theme - the state of the industry, as it is, should have never come to exist.

There is still time to fix it.

Companies can still choose right against wrong.

Now, to the second issue:

Don't fight disgruntled patients and bloggers

Man up! There is bad news about you because YOU covered something up. You released the stent without ever bothering to find out if it worked. You knew your diabetes drug was causing heart attacks. You threw in Doctors' names when they did not even touch the publication. You paid people to "consult" and concoct data for you. You and your Congressman forced the approval of a dysfunctional device. You approved the device...

YOU are the problem. Not dead and dying patients.

Exhort that - don't simply look to score random, nonsensical brownie points dissing sidewiki or facebook.

Links to a couple of articles:

Story 1

Story 2

If you decide that you don't care much for ethics, then maybe Las Vegas is the place for you, not the pharmaceutical industry. It doesn't matter if you are manufacturing or "reporting".