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New Drug Ads You Should Be Skeptical Of – or Ignore
June 2007

Ads for prescription drugs are ubiquitous these days. Should you trust them? That’s a complicated question. Drugs ads don’t tell out–and–out lies about the drug being promoted, and in general drug ads are more responsible than many other types of advertising. But drug ads often lack the context and full information you need to make appropriate treatment decisions, in consultation with your doctor.

The reports on this Web site (www.CRBestBuyDrugs.org) aim, in part, to counter drug advertising by providing you with independent and unbiased comparisons of drugs to treat many common conditions and illnesses.

Ads for several drugs in particular have caught our attention lately. Herein a critique of them and our advice:

Celebrex
Celebrex (celecoxib) is used to treat the pain of osteoarthritis and joint inflammation. It’s in the class of drugs known as non–steroidal anti–inflammatories, or NSAIDs. Celebrex received wide attention a few years back when a similar drug, Vioxx, was pulled from the market. Vioxx was linked to an increased risk of heart attack. Amid the controversy and public outcry over Vioxx, Celebrex’s maker (Pfizer) in December 2004 ceased promoting the drug to consumers while its safety, and that of other NSAIDs, was examined.

Now, Pfizer’s is back with a high–profile Celebrex ad campaign. The campaign takes a page from the old football rule, “the best defense is a good offense.“ The ad attempts to take on any comparisons to Vioxx – and links to heart problems – directly. Namely, the new Celebrex ads (TV and print) claim that all NSAIDs increase the risk of heart attack and stroke and that, by implication, Celebrex is no different than any of them. In addition, the ads claim that Celebrex is easier on the stomach than other NSAIDs.

Pfizer’s ad is questionable. While it is true that many NSAIDs appear to have the potential to raise the risk of heart attack, studies clearly indicate this class of drugs – which includes ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac (Voltaren), meloxicam (Mobic) and Salsalate (Disalcid) – has a range of cardiovascular effects (for complicated reasons we won’t belabor here). And while the evidence is mixed, some well–done studies have linked Celebrex, at moderate to high doses, to an increased chance of heart attack compared with naproxen.

Further, the “real life“ use of NSAIDs must be factored into your drug choice. Most people who take an NSAID regularly for long periods to ease osteoarthritis pain are over age 55. But this same population group – men and women – is at higher risk of heart attack and stroke due to both recognized and unrecognized underlying heart disease. That is, if you are over 55 you may be aware that you have heart disease or are at risk for it (for example if you smoke or have high cholesterol or diabetes) but you also may not know that you are at higher risk if your heart disease is not yet advanced enough to cause symptoms and you have no risk factors. Remember, thousands of people every week have a first heart attack who have never been diagnosed with heart disease, don’t smoke, have high blood pressure or high cholesterol.

So, should anyone over age 55 or so take a medicine regularly that could possibly put them at higher risk of heart attack if another medicine can do the same job with apparently less risk (based on the research so far)?

The gathering data led at least one major medical group – the American Heart Association – in February 2007 to declare Celebrex the NSAID of last resort for people with heart disease or who are at risk of heart disease.

Our take: until there’s firmer evidence, if you are 55 or over, talk with your doctor about whether naproxen would not be the best initial treatment if you have osteoarthritis or for other reasons need longer–term pain relief.

As for the Celebrex ad’s claim that it is gentler on the stomach, there’s some data to support that it does indeed carry a somewhat lower risk of causing mild to moderate abdominal pain. But the scientific data is far less certain about whether Celebrex carries less risk of more serious gastrointestinal side effects, such as stomach bleeding and ulcers. As a result, the FDA does not allow Pfizer to make that claim in ads.

There’s also a growing amount of evidence to indicate that only a small percentage of the population (less than 7 percent or so) is vulnerable to the more serious gastrointestinal side effects of the NSAIDs – bleeding and ulcers. If you are vulnerable – for example, you have had ulcers or stomach bleeding in the past – then indeed Celebrex may be an option that you should discuss with your doctor if you have no prior history of heart disease nor any risk factors for heart disease.

One final point on Celebrex – it’s a brand–name drug that is five to 10 times more expensive than generic naproxen and ibuprofen, which relieve arthritis pain just as well at equivalent doses.

Seroquel
Seroquel (quetiapine) is an antipsychotic medicine used primarily to treat people with schizophrenia. But it is also approved to treat people with bipolar depression (often called manic depression). Its maker, Astra–Zeneca, recently launched an ad campaign to tout Seroquel’s benefits in treating bipolar depression.

The 4–page print ad (we are unaware if there is a TV ad) is at pains to be up front about the downsides and potential side effects and dangers of Seroquel. That’s good because all drugs in this class (antipsychotics) are quite potent and can have very nasty and potentially permanent adverse effects.

The problem is that when compared to other drugs in its class, Seroquel does not look particularly good. In particular, a major recent landmark study of antipsychotics found that when used to treat schizophrenia, Seroquel had the highest rate of discontinuation due to side effects compared to the three other main drugs in its class. (It also had the highest rate of hospitalization due to return of symptoms and the highest rate of treatment failure, but both those measures may be irrelevant to treatment of people with bipolar disorder.)

These results are detailed in our report on the antipsychotic drugs on this Web site (www.CRBestBuyDrugs.org).

Ambien CR
Ambien CR is used to treat insomnia. It is the “controlled–release“ (CR) formulation of Ambien (zolpidem). The old Ambien is now “off patent“ and available as a less expensive generic, known by its generic name zolpidem. Ambien CR is still under patent and cost two to four times as much as regular Ambien.

It is a common practice in the pharmaceutical industry to create “extended release,“ “sustained release“ or “controlled release“ versions of drugs about to go off patent. Such follow–on pills are granted several years of “market exclusivity“ and they typically cost about the original version of the medicine cost before it went off patent.

The latest ad for Ambien CR says it is “2–layer sleep aid,“ with one layer “to help you get to sleep fast“ and another to “help you stay asleep.“ The ad plays on the division of sleep into those two segments, with implicit emphasis on the second segment. That’s because people with insomnia often complain of both and want a pill that will keep them asleep as well as help them get to sleep.

The ad is not false in any way, but we have problems with it. Most importantly, for many people Ambien CR may be a waste of money.

Ambien CR is indeed a reformulated version of Ambien which seeks to extend the duration of action of the drug. And, in theory, a more slowly dissolving pill (or part of it) could keep you asleep longer as the drug circulated in your blood stream longer.

But there’s a problem: the ad does not actually say if Ambien CR keeps you asleep longer than regular Ambien or any of the other insomnia drugs. The drug’s maker, Sanofi Aventis, is under no requirement to tell you that. But as a consumer, it’s the critical question given that you have a choice between an inexpensive generic or an expensive “CR“ version of the same drug.

And the answer? In our analysis of dozens of studies for the sleep drugs/insomnia report on this Web site (www.CRBestBuyDrugs.org), we found a couple of studies indicating that Ambien CR did increase so–called sleep duration when compared to regular Ambien. But the increase was marginal.

As our report concludes on the issue: “the evidence is weak that Ambien CR is all that much better than Ambien....and for people whose main problem is getting to sleep Ambien CR probably offers no advantage at all.“

Our report also underscores that sleeping pills should be used more sparingly than they currently are, and have risks when used for long periods. To its credit, the Ambien CR ad notes well the problems, but only in very small print.

That small print includes a line we entirely disagree with. It says: “Ask your health care provider about the latest Ambien, Ambien CR – and don’t forget to mention the CR.“

Our advice: if have are having trouble sleeping, which has lasted more than a few days, talk to your doctor about non–drug treatments and sleeping pills, especially short–term use of nonprescription sleep aids (such as Nytol, Sominex or Unisom, all of which contain antihistamines), generic prescription benzodiazepines (such as ProSom, Dalmane and Restoril), or generic zolpidem.

Lunesta
Speaking of sleeping pills – Lunesta (eszopiclone) is Ambien’s main competitor. Lunesta’s maker, Sepracor, has the burden of trying to retain physician and consumer interest in its drug amid the new availability of generic zolpidem.

Its latest strategy in that effort is to offer seven Lunesta pills free, under the banner of the “Lunesta 7–night Challenge.“ In full page magazine ads the company exhorts: “ask your doctor how to get 7 nights of Lunesta absolutely free.“ (The company has also run TV ads in this campaign.)

The print ad explains how to do this: “Step 1 – Take this page [the magazine ad] to your doctor and ask if Lunesta is right for you. Step 2 – Present both your prescription and this page to your pharmacist for your 7 free tablets of Lunesta.“

Our strong objection to this ad is that it telegraphs loudly to the consumer that taking Lunesta or any sleeping pill every night for 7 consecutive nights is a sound clinical approach to insomnia. For some people who have serious insomnia, seven straight days of treatment may indeed be warranted.

But as our report on sleeping pills on this Web site (www.CRBestBuyDrugs.org) explains in some detail, the majority of people who may benefit from taking a sleeping pill don’t need to take one every night for seven nights, and in fact should not take the medicine for that long. That’s because for most people trouble falling or staying asleep is a transient or temporary condition – relieved by a pill for a night or two or three. In addition, taking Lunesta or any of the sleep aids for more than a few days risks creating psychological dependence and side effects (such as “next–day“ drowsiness or sluggishness if you don’t get 8 hours of sleep).

The ad notes the risk of these problems. But on balance it creates far too much of an impression that seven days of a sleep medicine is a good initial treatment for transient, every–so–often insomnia.

Note: if you have chronic long–term insomnia, over weeks, months or years, experts broadly agree that sleeping pills may be an adjunct in your care but are not the main treatment you need. People with this condition need a full medical evaluation, preferably by a doctor who specializes in sleep disorders.