Cease and Desist

The FDA Says Common Side Effects of Drug Marketing Include Compulsive Lying

SOURCE: iStockphoto To the pharmaceutical companies out there pushing spurious claims about their medications with millions in marketing dollars: Stop. Now. And please submit your data to the FDA for review.

The top 10 pharmaceutical giants spent an average of $1.25 billion each on advertising alone last year—a huge tab that we consumers pick up every time we fill a prescription. But even more worrisome than the inflationary pressure those glossy ads are placing on America’s healthcare system are the misrepresentations and flat-out lies found in so many of them.

That’s a world of deception rarely glimpsed by the public, but one that occasionally comes to light when the Food and Drug Administration releases on its website copies of its latest warning letters sent to drug companies for false advertising. One such batch was released last week, and it offers an enlightening, if depressing, view of the game of cat-and-mouse constantly underway between Big Pharma and our underfunded federal watchdogs.

Consider the FDA letter sent to Forest Laboratories in New York, regarding a medical journal ad for that company’s blood pressure-lowering beta-blocker drug, Bystolic. There are many beta blockers on the market, but the ad calls Bystolic “a novel beta blocker” and a “next generation beta blocker” with a “unique mechanism of action.” In its letter, the FDA notes that anyone who reads such phrases would likely conclude that Bystolic is superior to other beta blockers. There is just one problem: That’s never been shown, or even tested, in a study.

“FDA is not aware of any substantial evidence or substantial clinical experience that demonstrates that Bystolic represents a ‘novel’ or ‘next generation’ beta blocker,” the agency letter states. “Indeed, we are not aware of any well-designed trials comparing Bystolic to other beta blockers. Furthermore, FDA is not aware of any data that would render Bystolic’s mechanism of action ‘unique.’”

In fact, the FDA notes, no one even knows yet how beta blockers really work.

Well, it turns out that one of Straterra’s risks—a risk that has earned it a “black box warning” on its package insert, the most serious warning a drug can be required to have—is that it can get children and adolescents to consider suicide.

The ad also “minimizes risks associated with the use of Bystolic,” the letter goes on. Specifically, the ad boasts a “favorable tolerability profile” (one wonders: Is this the best that Forest Labs can offer? A drug that is “tolerable”?), when in fact, according to the FDA, Bystolic “is associated with a number of serious risks,” including heart failure and liver damage, and there is no evidence that it is any less risky than competing beta blockers.

“If you have data to substantiate these claims, please submit them to the FDA for review,” the agency writes with pointed cordiality.

The last paragraphs, aimed at the company’s lawyers, don’t beat around the Bystolic bush. Your ad, they state plainly, violates 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(i); and e)(6)(ii). Stop running it. Now. And, because the violations are “serious,” submit to FDA an action plan “to disseminate truthful, non-misleading, and complete corrective messages … to the audience(s) that received the violative promotional materials.”

Another FDA letter made public last week, this one to Eli Lilly & Company in Indianapolis, takes that company to task for the “professional sales aid” it produced for its drug Strattera, which is for attention-deficit/hyperactivity disorder (ADHD)—a sales aid that, according to the agency, overstates the drug’s efficacy, minimizes its risks, and wrongly suggests it is useful against a broader range of ailments than the facts can support.

One of those lapses cited by the FDA is especially disturbing: The sales materials give “the overwhelmingly misleading impression … that Straterra has been proven safe and effective for the treatment of anxiety.” What’s the big deal about that? Well, it turns out that one of Straterra’s risks—a risk that has earned it a “black box warning” on its package insert, the most serious warning a drug can be required to have—is that it can get children and adolescents to consider suicide. And guess what? Anxiety, too, has been associated with a higher risk of suicidal thoughts. In other words, the FDA notes, the materials from Lily could lead a doctor to prescribe Strattera, a drug that increases the risk of suicidal thinking, to anxious children, who are already at heightened risk of heading down the path toward suicide.

The Lily sales aid also suggests that Strattera will help kids fall asleep better, without also noting that it can cause insomnia. And it says that the abdominal pain, stomach upset, nausea, and vomiting that affect many patients who take the drug are “commonly transient,” even though, in the words of the FDA, the agency “is not aware of any data supporting the claim that these adverse events are transient in nature.”

“If you have such data, please submit them to the FDA for review,” the letter goes on—a phrase one sees a lot, it turns out, in FDA letters to drug companies.

I could go on. And you know what? I think I will. Let’s look at the latest letter to our friends at Novartis Pharmaceuticals in East Hanover, N.J., about promotional materials developed for its ADHD drug Focalin XR. Here again is a drug with a black box warning, in this case because of the risk of addiction (not to mention a long list of other risks, including “sudden death”). The materials state that “improvements are sustained over 6 months.” But in fact, the FDA notes, the effectiveness of Focalin XR has never been systematically studied for any length of time beyond seven weeks.

So Novartis is pushing for long-term use of a drug whose proven benefits don’t go beyond a few weeks and whose major risk for patients is that it is very addictive.

Who cares if it works longer than seven weeks? Addiction means never having to stop renewing your prescription.

Then there is the letter to Mallinckrodt Inc. of St. Louis, Mo., regarding its patient brochure for Methylin, the company’s drug for attention deficit disorders. The agency notes a number of problems, including unsubstantiated claims of efficacy. But the easiest to appreciate is this one: “The patient brochure presents efficacy claims in consumer-friendly language using colorful, bolded headers and bulleting but presents risk information in medical terminology in paragraph form below the reference list … without any presentation elements that indicate to the reader that it is important risk information.”

Here’s a great idea for some of you artists out there looking to make a statement: Design a full-color drug brochure using all those bold and colorful elements to describe the side effects, and then put all the purported benefits in fine print at the bottom.

And just to be fair (I don’t want you to feel left out, Johnson & Johnson!) a quick shout-out to the good people at J&J in Fort Washington, Pa. They, too, have an ADHD drug on the market, one called Concerta, which also carries a black box warning about addiction. The problem in this case: In a series of informational panels aimed at professionals at medical conventions, Johnson & Johnson suggests that the drug can help kids enjoy after-school activities including “sports, clubs, part-time jobs, socializing with friends, household chores, and, of course, homework.” Oops, the FDA letter notes: “This has not been demonstrated by substantial evidence.” In fact, the agency notes, Concerta has been shown to reduce only a limited array of symptoms, such as fidgeting and talking excessively, and has never been tested for its after-school activity benefits. Moreover, the letter says, the company’s educational panels omit important information about Concerta’s risk of causing long-term growth suppression.

So maybe your kid ends up a little shy of five feet tall. At least he’s not fidgeting anymore.

The good news, of course, is that these letters were written and sent. And that we get a chance to see them—a rare bit of transparency for an agency that is required by law to do much of its work in secrecy, to protect “confidential business information.”

The bad news is that one can only believe that these regulatory efforts are capturing but a tiny percentage of the total deception going on out there. And like a judge telling a jury to ignore evidence that it should not have heard, it all happens too late. How many patients and doctors have already been influenced by the bold twists of truth highlighted in the agency’s most recent batch of letters?

“By the time the FDA issues a warning letter,” complains John Mack on his Pharma Marketing blog, “the cow has long left the barn.”

And they just keep coming. Last Thursday, Ad Age reported that Bayer Healthcare Pharmaceuticals was told by FDA to pull a couple of 60-second ads for its birth-control pill Yaz, which the agency said misleadingly indicated that the drug was useful against premenstrual syndrome and acne. Well, at least one of those ads had already been pulled by then. But the airwaves can’t be recalled. And the checks to Bayer are already in the mail.

Obviously, the system for catching and punishing these crooks needs to be ramped up. The odds of getting caught, and the pain of occasionally getting nabbed, are not providing sufficient deterrence.

Is there a better way? Let me make a modest proposal: For each ad found by the FDA to be false or misleading, pharmaceutical companies must create and promulgate another, equally circulated ad, seriously badmouthing its own drug. As an example, I refer you to this side-splitting Saturday Night Live spoof on Seasonale, a birth control pill made by DuraMed Pharmaceuticals of Pomona, N.Y., which works by reducing the frequency of women’s menstrual periods. (Hat tip to Tara Parker-Pope.)

Maybe with a mix of humor and painful honesty, we can get back to a world in which taking your meds isn’t the same as drinking the Kool Aid.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Tags: FDA

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