Wednesday, August 12, 2009

Oh, we're seeing the big picture, all right.

Every now and then one of our adamant free-market types will launch into a lengthy diatribe that reduces to, "What do we need government regulation for, anyway?" In my experience, the folks who take that position tend to be highly educated and informed debaters who are quite successful in their own lives and have compelling case-histories to cite as well as reams of GAO and DoC data at their fingertips. In short, they are very persuasive and can wear you down. And hell, I'm the first to admit that in theory, in the best of all possible worlds, I'd like to live in a society where government intrusiveness is minimal. As noted in my previous post.

Then one night I'm sitting there in the middle of dinner and I see an ad like that shown above for a drug called TriLipix (that's try-LIP-ix), one of the newer entries in the war against cholesterol. The key action comes 24 seconds into the spot:

TriLipix has not been shown to prevent heart attacks or stroke more than a statin alone.
Digest that for a moment. Clearly the whole point of taking this drug is to lower cholesterol and triglycerides in order to reduce the risk of heart attacks and strokes. I quote from earlier in the ad: "Are you taking a statin medication to lower your bad cholesterol, but your good cholesterol and triglycerides are still out of line? Then you may not be seeing the whole picture." A few seconds later, the narrator begins a sentence with, "If you're at high risk of heart disease..." The ad, in other words, is appealing to people who want to reduce their risk of having a heart attack or a stroke. Which means that those 5 seconds in the middle of the spot, in essence (if not in fact), invalidate the other 55 seconds. The disclaimer quoted in red above, which is only there because of FDA regulations, is saying, "This drug is useless to you." (At best, if you want to split hairs, the disclaimer is telling you that the drug has not been shown to be useful.) Remember, too: The absence of a proven benefit does not = the absence of harmful side effects. As the long list of potential health hazards in the balance of the disclaimer shows.

But if the typical model holds, pharmaceutical giant Abbott Labs has spent over $1 billion developing and commercializing TriLipix. Abbott employs 68,000 people in 130 countries, and needs to be able to cut their salary checks while still delivering an adequate return to its investors. And apparently there is clinical evidence that, "along with [a low-fat?] diet," the drug does lower triglycerides (even if, again, all that has not been shown to offer any actual health benefit to people already taking the likes of Zocor or Lipitor). So Abbott is going to sell its glossy new drug. The company wants its share of the $18.4 billion market for cholesterol-lowering meds. Whether TriLipix "works" or not.

More to the point, I ask you to imagine what that ad would look and sound like without the FDA and/or FTC. I'll tell you what it would look like: a giddy symphony of uplifting imagery
a parade of 115-year-old grandparents gleefully running through parks, tossing frisbees with their adoring 75-year-old grandkidsthat made TriLipix out to be the single most important breakthrough in the annals of medical science. (Since the last drug advertised on TV, that is.) The cagey, carefully lawyered wording in the present ad would be replaced by unflinching statements of "fact." There'd be no purposely vague talk about how consumers "may not be seeing the whole picture"; that would give way to bold promises of life everlasting. There would be no disclaimers. In fact, without FDA regulations, I'm betting that TriLipix ads would imply that you don't even need the statins, that TriLipix alone would keep you forever ageless and running marathons through the hilly streets of San Francisco.*

I know what our more libertarian, capitalist types will say: Let it all get sorted out in the marketplace. Really? After how many people waste how many billions foolishly depending on TriLipix to save them from heart attacks and strokes? After how many people die needlessly from, or at least suffer with, the serious side effects? Yeah, well, even so, it's up to the people to be their own advocates. Caveat emptor! Oh please. Twenty percent of all high-school graduates nowadays are functional illiterates. And you're going to ask them to decipher page after page of fine print written in medical jargon? (That's assuming that drug manufacturers even released the information.)
For that matter, SHAMblog has a highly literate audience, and I bet half the people reading this very post probably looked up the term statin just to make sure they understood the issue here.

The free market, left to its own devices, will not usher in untold riches and fulfillment for all. Maybe it might, in an ideal world, if people everywhere were motivated by sincerity and a profound love of all mankind. Alas, that is not the case. We know it's not the case. We've quite recently received plenty of object lessons in just how much it's not the case. Too many of us are motivated by a sincere and profound love of a huge bank account or a vacation home in the Caymans, and we don't give a damn what happens to the people we exploit in order to get there.

Say what you will about the nanny state, the fact is, sometimes we just need to be protected from the worst aspects of human nature.

* Then why didn't the FDA simply refuse to allow the drug to be sold at all? That's a tough one, because, as noted, TriLipix does do something: it lowers triglycerides and seems to raise "good" cholesterol. And in general, I do think we want to err on the side of giving consumers choices. Still, they should be fair choices, where consumers are provided with sufficient info. And based on what we know about TriLipix, you have to ask yourself: What informed consumer would buy this drug?


Dimension Skipper said...

Anymore I pretty much just assume that if something is being advertised, then they're lying (or spinning it like crazy, but it's all the same to me). Not just pharmaceuticals, but anything. (When any ad mentions "best whatever on the planet" I tune out because it can't possibly be true, or provable, just obvious hype. At least try to make your claims semi-reasonable folks!)

The phrase I'm hearing more and more in these prescription drug ads is "XXX is BELIEVED to work by..."

You mean they don't even really know how or why it works? I would think they'd at least want to have a clue before dispensing it to average Joe.

OK, maybe the wording is just a side effect of lawyers and the CYA philosophy such that they can't really say anything too definitive without leaving themselves open to potential lawsuits due to misunderstandings. Who really knows?

Hey, I have another advertising quesiton...

I've vaguely seen these ubiquitous Ford ads with "Mike" who comes on and says what he tells people when they come up to him and ask "Hey Mike, Why Ford, why now?"

My question is this: Who the hell is Mike?

Is he supposed to be somebody well known somehow? Or is he some Ford exec? Personally, I don't have a clue. I haven't noticed any indication of his ID on the screen, but I admit that usually I'm just half listening at commercial time, not looking at the screen.

I kind of assume he's nobody (just an actor), but they want us to think he's somebody. Even if he is somebody, I highly doubt that anybody is coming up to him and asking any questions like that (with the possible exception of specifically mocking the ads).

Hmmm, actually I just thought to Google the phrase "Hey Mike why Ford why now" and I see the guy's name is Mike Rowe apparently of Dirty Jobs fame. I've heard of the show, but never seen it since I only have over-the-air TV reception, no cable or satellite service.

OK, so if he's not a Ford exec, then I don't know why people would be bothering to ask him that question.

Regardless, I just find the ads (and him in them) annoying. Might just be me. But then I usually find all but the very best, most entertaining ads become annoying after I've seen them during every other commercial break on every available channel for weeks on end.

Sorry to be longwinded and perhaps slightly off topic, but advertising shenanigans are one of my major pet peeves and I often react far more negatively than others who just shrug and say "That's advertising, they're supposed to lie"... or words to that effect. I'm always looking for the loopholes in the claims and they're usually easily spotted as they are typically large enough to permit passage of some sort of massive means of transportation.

Steve Salerno said...

DS: Hey, thanks for bringing all this up. I knew the guy looked familiar, but I couldn't place him; I just assumed he was "supposed to look like someone who'd be your buddy," to make Ford buyers (overwhelmingly blue-collar, middle-American men) feel more at-home.

Kind of ironic, isn't it, that Mr. "Dirty Jobs" gets the assignment of pitching Fords to the nation in these critical times?

Sarsabu said...

Statins prevent the formation of plaques in the arteries which leads to less stroke or heart attacks. Your new drug does not do that so therefore the disclaimer. Not familiar with new drug here.
It is illegal to advertise presciption only medicine to the public in Europe. Therefore our golf magazines are much lighter!

Steve Salerno said...

Sars: Thanks for the info. That's pretty funny, about the golf mags!

Jason said...

"In my experience, the folks who take that position tend to be highly educated and informed debaters who are quite successful in their own lives and have compelling case-histories to cite as well as reams of GAO and DoC data at their fingertips. In short, they are very persuasive and can wear you down."

Nothing like the "toot" of one's own horn.:-]

I admit though, if I did not completely agree with this assessment, I would not enjoy reading your blog nearly as much! Keep up the good work!

RevRon's Rants said...

"It is illegal to advertise presciption only medicine to the public in Europe."

This is a very significant point, which should not be glossed over. The pharmaceutical companies who scream that they spend so much on R&D somehow neglect to mention that they spend far more on promotions... many times more, as a matter of fact. I would love to see these commercials banned outright, since they are clearly offered in the hopes that patients will pressure their physicians into prescribing the drugs. Unfortunately, too many doctors will write the prescription just to get the patient off their backs. After all, if the FDA has approved the drug, how much harm can it do, right?

After sitting through the FDA hearings held to determine whether to lift the moratorium on silicone breast implants, I find myself quite cynical even about the efficacy and safety of those drugs and procedures that have been approved. It was obvious that commercial interests trumped safety in those hearings. And there are folks who want to deregulate the industry even further? To classify such an attitude as absurd is, IMO, being overly kind, giving the benefit of the doubt where it is clearly not deserved.

Elizabeth said...

Speaking of the big picture, Steve, see A Day in The Life of Joe Middle-Class Republican.

Anonymous said...

This drug doesn't work better than a statin alone. True. But statins do work in preventing/delaying significantly heart attacks. Thus, this drug does work.

But statins have side effects - about 10% of the population that takes them 9more or less) get severy muscle aches and pains and refulse to take them. what Abbot really has is something as effective as a statin, but without side effects for the minority of people who won't tolerate the side effects. But that's a damn small market.

If you are a cheap person like me, what you want to do is get your generic Zocor ( a typical statin) st Costco for $12 for a 90-day supply. But get it in a stronger dose, and break the pill in half with a pill splitter. Now you are looking at $24 for a whole year's supply of an effective statin - less than 7 cents a day.

Big pharma can't stick it to the little guy if the little guy uses his brain.

a said...

My feeling is the free market response would be that if patented medications were not free, and people had to share in some/all of the cost difference, people would be more motivated to decide if the $100 a month med was really more effective than the $4 generic. I would also like to think that doctors would explain the choices to their patients. As it stands right now everything is free (or the co-pay makes the difference insignificant) so all the pharmaceutical companies have to do is instill the notion that newer = better. An interesting comparison would be the fee only clinicians who don't take insurance vs. the in-network doctors who do. See what drugs each are prescribing to their patients.

Steve Salerno said...

Anon 10:08 and "a" make good points--but I still think we're forgetting the difference between theory and practice. In theory, people can protect themselves against being ripped-off by becoming more educated consumers. But...come on. In America as we know it? Twenty percent of Americans are functionally illiterate, and--incredibly--almost half of all Americans (I think the precise gov't figure is 46%) read well below what you'd expect of people who have been awarded high-school and college degrees. Regardless of where you place the blame for all of that, the fact remains that you have over 100 million American adults who are highly vulnerable to chicanery, and who will buy just about anything that is recommended to them by people they trust and/or feel intellectually subservient to.

I mean, look at all the highly educated people who fall for SHAM-type stuff!

Anonymous said...

Trilipix helps patients get to their HDL and Triglycerides to goal. Statins do an excellent job getting LDL to goal but often fall short getting hdl/trigs to goal. For people who are at higher risk of heart attack and stroke getting hdl & trigs to goal is not often achieved even though the statin they take has their ldl to goal.

Furthermore Trilipix has only been on the market for 6-12 months which is not enough time to establish significant claim on morbidity and mortality. Many statins have morbidity and mortality indications from the FDA however it took them years and many patient studies to earn those indications.

So maybe the real scam here is this blog not big pharma. If you have questions about meds you should take talk to your dr dont seek the advice of bloggers.

Steve Salerno said...

"Dr" Anon 6:25: I'm not buyin' it. We all know what we hope for when we buy such drugs: We want to reduce our risk of heart attack and stroke. Unless and until the drug has been shown to do precisely that, then it doesn't matter what else it appears to do or not do; it isn't doing the job for which it was designed (and is being cleverly promoted).

I don't care if TriLipix lowers trigs as well as blood pressure, reverses diabetes, helps the average user lose 20 pounds of unsightly body-fat, and suddenly and miraculously causes $1 million to appear in each user's savings account. In this context, all that matters is the outcome. If we can't demonstrate a link between TriLipix and a longevity outcome, then what's the point?