Tom Nesi, author of the new book Poison Pills: The Untold Story of the Vioxx Drug Scandal, wants you to know what you're getting into when you pop a newly approved, heavily marketed prescription drug. A longtime director of public affairs at the pharmaceutical company Bristol-Myers Squibb, Nesi has more than 30 years' experience in medical communications and strategy. Now a writer and consultant, he comes off as no shill for the industry he once served.

His book focuses on the cautionary tale of Vioxx, the prescription painkiller that was pulled from the market after doctors belatedly realized that it caused heart, blood, and kidney problems—including some that were fatal. His broader objective, though, is to help consumers take advantage of good medicines while sidestepping the harm some can cause.

You say the most expensive drug you can take is a free sample. How is that?



They're very seductive—they're free. Merck distributed 17 million samples to 25,000 physicians and 375,000 patients. The problem is that if you've been doing fine on a 20-cent pill, you get the free sample for a month or two, then you have to go to the drugstore to fill the prescription and then it costs you $3 a pill. You argue that in the context of pharmaceuticals, new is not always better. Why?



It's extremely important that people understand that, as extensively as a drug is tested before it's approved [by the Food and Drug Administration], it's still tested on a very small population. It's also tested on a very select population. Drug companies don't go out to try to find the sickest patients to test their drugs on. [With older drugs], not only is there more data but more usage experience. Doctors know how to use it—they become familiar with it. An example in the pain market: When some of these non-steroidal anti-inflammatories were released, like Motrin and Aleve, they were actually given at doses that were too high. As the years go by, [drugs] can actually become safer.

As a veteran drug marketer, you warn consumers to beware huge marketing campaigns for new drugs. In fact, you urge people to ask their doctors for proof that new drugs are superior to older ones before accepting a prescription for the newer medicine.



I would say the larger the marketing campaign, the more you should use caution. I would also say if there are good drugs in a category—in a type of illness that you suffer from—that have been out there for a while, there's no reason not to use those first. How long should a drug be on the market before you try it?



I don't think it hurts to wait a few years. If you are in acute need, if you're just suffering horrible pain, you've tried everything under the sun and you need a new drug, well, that's entirely different than if you're satisfied. I would say, if you're satisfied with your current therapy, stay with it. You caution women, in particular, to find out about a new drug's safety before taking it.



We know that some drugs interfere with reproduction. Any woman who is planning to get pregnant, or who potentially could get pregnant, should definitely discuss that with their doctor. How often do doctors actually recommend their patients stop taking a prescription that works for them and start a newer drug instead? And how often do patients ask to change a medication they're doing well on?



It happens all the time. There are whole huge campaigns based on what they call switching behavior. A classic example that has just earned billions of dollars for no apparent reason: There was a drug I worked on, a very good drug called Prilosec, for treating heartburn, and AstraZeneca, the company that had the patent, wanted to keep making money after Prilosec went off [patent], so they came up with a successor drug called Nexium, which is "the little purple pill." I remember working with a colleague [who, after looking at the preliminary data,] was just astounded and said, "Nexium doesn't work any better." The Vioxx scandal is the main focus of your book. You contend that while the drug's maker, Merck, said it was collecting more data on Vioxx, thousands of people may have died. Is the lesson here to be skeptical when a pharmaceutical company says, "Not all the data are in yet" on a new drug?

Exactly. Some studies simply just get dropped. A lot of data just never gets published. There are ways of presenting data where not even the most sophisticated investigator could really tell what the data was really saying. One of the most disconcerting things, we know that there were more deaths among Alzheimer's patients who took Vioxx. The Alzheimer's trials for Vioxx were sort of published, but not with the complete data sets. This book seems the antithesis, in some ways, of your life's work. Why did you write it?