“Drug Facts” Boxes Help Patients Make Intelligent Choices

Medical researchers are discovering that patients aren’t quite as dumb and helpless about making intelligent and informed choices about medical treatments as many doctors have assumed over the years. Case in point: prescription drugs. Patients have proven their ability to make smart choices even in the face of complex pro and con information, as long as the data are presented in a straightforward way.

Click on this link to see a “Drug Facts” box on an important drug: Tamoxifen (nolvadex), which can help lower the risk of breast cancer, but with lots of competing risks and benefits. This is a sample, prepared by researchers at Dartmouth medical school, of the way that information ought to be presented on all prescription drugs. Note the clear presentation of the statistical likelihoods of being helped and harmed by Tamoxifen.

You don’t see these Drug Facts boxes anywhere now. Instead, what we have now are ads to consumers that first show happy, healthy, bouncy people, presumably after they’ve taken the drug, along with a few simplistic sentences pushing the drug’s benefits, but next these same ads show acres of fine print with all the downsides of the drug. The subliminal message is that all patients need to do is “ask your doctor” if Drug X is right for you. Meantime, your doctor has been sold a message on Drug X — usually by a well-tailored, attractive sales rep — that is only slightly less simplistic than the one in the “direct to consumer” advertisement.

So really, both patients AND doctors could benefit from a requirement that the drug information be reorganized and presented in an intelligible way. The FDA is now considering such a rule.

The Dartmouth researchers — Lisa M. Schwartz, MD, Steven Woloshin, MD, and H. Gilbert Welch, MD, MPH — have published a study proving that consumers presented the Drug Facts boxes for two competing drugs for prevention of heartburn, one of which was a lot more effective than the other, were a lot more likely to pick the correct drug when the information was presented more clearly. They also found that the consumers presented the standard advertisement tended to over-estimate the drugs’ benefits in preventing disease — no surprise there — and that the Drug Facts box helped set them straight.

I’ve written before in this blog about tamoxifen. There was an interesting study that found that very few women chose to take tamoxifen once the pros and cons were fully laid out in an understandable way. In that study, and in my blog piece, the numbers were presented a little differently than the Drug Facts sample box. I used the “count the people” technique which is detailed in my book, “The Life You Save.” This can make the numbers more graspable than the usual “percentages.”

For example, if we consider a hypothetical 52-year-old woman who had her first baby after age 30 and whose mother had breast cancer, she has about a 1.9% risk of developing breast cancer over the next five years. (The risks of breast cancer vary with age, family history, and age of first childbirth.)

So if 1,000 women just like this 52-year-old took tamoxifen over those five years, the research says that here is what would happen:

* Of the nineteen women (same as 1.9%) who otherwise would have developed breast cancer, nine will not develop breast cancer.

* Thirteen women would avoid broken bones from osteoporosis, another benefit of tamoxifen.

* Twenty-one women would develop endometrial cancer (typically more treatable and less deadly than breast cancer if caught early).

* Twenty-one women would develop blood clots.

* Thirty-one women would develop cataracts.

* Twelve women would experience sexual problems.

* One hundred twenty extra women would get hot flashes and other menopausal symptoms (in addition to those who would get such symptoms anyway).

The researchers who wrote the study bemoaned this as an example of patients being unreasonably scared about shifting off their status quo (not taking the drug), but as I noted in my blog, a lot of patients who read the data in the New York Times and wrote comments on the Times’ “Well” blog concluded that the women in the study who declined tamoxifen were just making reasonable choices for themselves.

The point is: There is no right or wrong answer when it comes to taking a drug over the long haul to prevent a disease. For some patients, it will be worth the downside of the drug. For others, it won’t. But each of us is entitled to make an intelligent and informed choice, and that’s why we need more clearly presented information than we’re currently getting from the drug manufacturers.

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