Health Care & Prescription Drugs News

Thank you for coming. I’m Abigail Caplovitz, Consumer Advocate for NJPIRG Law & Policy Center, and with me is Laurie Yorke, a registered nurse and mother of a Paxil victim. She will speak with you in a minute.

We are here today to release a new report, Turning Medicine into Snake Oil, How Pharmaceutical Marketers Put Patients at Risk,, which documents what has been coming to light in past months with the Vioxx verdicts.

Drug marketers are pushing drugs in deceptive ways that put the public at risk. Vioxx might be the poster child, but our report shows that the problem is pervasive throughout the drug industry. In the past five years, the FDA has sent 170 regulatory letters to 85 different companies calling their marketing of 150 different drugs false or misleading. So, when it comes to putting patients at risk, it seems like everyone is doing it.

The drug marketers are sending deceptive messages to both doctors and the public, and they’re doing it in every way imaginable.

Table 1 here shows that doctors received 38 different types of deceptive marketing—doctors are being targeted in their offices, in their journals, at conferences—everywhere they go.

The public gets inundated too—the letters identified 17 different types of marketing aimed at the public—but especially through broadcast media, as you can see here in table 2. It’s simply impossible to avoid deceptive drug ads.

Table 3 here shows you what kinds of deceptive messages the drug marketers are sending. We’ve grouped them into three categories: Misrepresenting risks, promoting unproven uses, making unsubstantiated claims. You can see here that doctors are targeted for far more deceptive messages than the public is.

In fact, 62% of the deceptive messages were aimed at doctors, the very people who most need accurate information. And 2/3 of the deceptive messages aimed at doctors misrepresented risks or promoted unproven uses. That’s dangerous.

Consider these two examples from the letters:

 Pharmacia promoted Celebrex for use in patients at risk of serious bleeding. Pharmacia promoted Celebrex as safe for patients taking the drug Coumadin, although the prescribing materials state that patients taking both may experience serious bleeding. The FDA explained: “minimization of this risk raises significant public health and safety concerns.” (FDA Warning Letter to Pharmacia 2-1-01)

 Cubist Pharmaceuticals promoted Cubicin for off-label use as a pneumonia treatment despite data showing it is ineffective. Cubist Pharmaceuticals used a website to promote its antibiotic Cubicin for use against the bacteria that causes community-acquired pneumonia even though Cubist knew it doesn’t work for pneumonia. The FDA’s letter noted the promotion for pneumonia “poses a significant public health risk because such practice could lead to therapeutic failure and death.” (FDA Warning Letter 8-17-04)

The deceptive marketing problem goes far beyond what you normally think of as ads. It touches the core science: clinical drug trials and the publication of reports about them.

Several of the case studies in the report—they’re all here in the center spread—illustrate this problem. In the Vioxx case study, Merck, Inc. repeatedly misrepresented the unfavorable heart risk data from the VIGOR study by promoting an unsupported but favorable hypothesis as truth, as well as flatly misstating the numbers.

In the Paxil case study, GlaxoSmithKline went further, choosing not to report four trials showing Paxil’s complete ineffectiveness in adolescents, trials that revealed Paxil use by adolescents puts them at risk of psychosis and suicide. Laurie here can talk about that more. It seems unimaginable that a company could sit on such data, but it did.

A report in the New England Journal of Medicine cited nine examples of trials where data unfavorable to the drug company sponsor were either suppressed or, the investigator believed, misrepresented in the article that was published.

But suppressing and misrepresenting clinical trial data aren’t the only deceptive marketing practice distorting the underlying science. The FDA letters reveal a more subtle and likely more pervasive type of clinical data misrepresentation: citing studies for product claims they do not support.

In the five years we studied, the FDA sent 25 companies a total of 38 Untitled and Warning Letters that involved more than 82 mis-cited studies.

Check out these examples in Table 6. My favorite is this one, from the October 2001 FDA letter to AstraZeneca. AstraZeneca produced a Detail Aid—for use by sales representatives when they talk to doctors—that claimed Zomig was effective for migraines. It cited part two of a two part study to support the migraine claim. The first part was blinded, placebo controlled and randomized—the clinical trial gold standard—and that part showed no benefit from using Zomig for migraines. Part 2 did suggest it was effective, but part 2 was open-label, uncontrolled and non-comparative, a very inferior trial design. It’s hard to see how AstraZeneca could totally disregard the scientifically sound part 1 to make the claim and cite part 2 to support it.

What is the FDA doing in the face of all this deceptive activity? Not much. Its policy is like the line Robin Williams used when talking about British police officers who don’t carry guns: STOP! Or I’ll shout stop again!

Looking here at Tables 4 and 5, you can see that the FDA is completely ineffective, because its enforcement actions don’t deter future false advertising. Table four shows how many companies received multiple letters from the FDA in the five years we studied. Pfizer is in a class by itself, the only one with double digits, here at 15. But by no means is it alone; there’s 28 companies that received multiple letters, and they accounted for two thirds of the letters. And those companies aren’t fringe outfits; they’re blue chip companies. Table 5 shows the problem isn’t just that the companies sell lots of drugs; these 26 companies received more than one letter for marketing the same drug in the same deceptive way.

This high rate of recidivism isn’t the only reason the FDA’s enforcement is ineffective. Under the FDA’s letter approach, deceptive messages reach doctors and the public. The FDA reviews advertising only after the advertising is in use, so it does not prevent deceptive messages from reaching doctors and patients. Indeed, letters can take so long to send out that the deceptive ad has fully run its course.

Also troubling, the FDA doesn’t require marketers to correct their advertising most of the time. Only 23% of the FDA letters call for corrective advertising, allowing whatever misperceptions the false ads created to remain unchallenged in three quarters of the cases.

Bottom line: An enforcement system that responds late, requires corrective advertising a quarter of the time, and experiences significant recidivism is a failure.

Making the situation even worse, the FDA only reviews a tiny fraction of drug marketing.

Clearly the problem is large and dangerous. Thankfully, New Jersey can solve the problem itself, without waiting for Congress or the FDA to act. New Jersey can act on its own, right now, to protect its citizens.

First, New Jersey can solve the problem of clinical trial data suppression and manipulation. New Jersey can create an online database of all the clinically important information from each trial about each drug sold in New Jersey. That kind of database is called a clinical trial registry, and it would be created by requiring the drug companies to submit the information to the department of health and pay a filing fee that’s big enough to pay for the registry.

Second, New Jersey can solve the enforcement problem in the situations it matters most—when the deceptive prescription drug marketing is so dangerous it creates a public health risk. To do that, New Jersey has to give doctors and the public the right to sue drug companies to stop the ads, and require corrective ads. That’s all the suits would be about—an injunction, not damages to the plaintiff. Empowering these suits would enable the people who are targeted with the deceptive messages to do something about it. There’s no way the FDA could ever eavesdrop on every meeting between a sales rep and a doctor, to make sure that what’s said is accurate. These suits would make that a non issue; if a sales force is distributing seriously false literature or making seriously false statements, a doctor could use this suit to make them stop.

Third, New Jersey can do more to publicize the FDA letters and any other evidence of deceptive marketing it receives. For example, NJ could issue an annual report highlighting the key features in every year’s letters, or perhaps create a webpage where it posts all the information it has about deceptive prescription drug marketing.