Safe and Effective, Really? - Pharmaceutical Executive

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Safe and Effective, Really?


Pharmaceutical Executive



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A neighbor of mine recently was told by his GP not to treat his elevated cholesterol with medicines because "all of those drugs have side effects, you know." Instead, he was advised to try more exercise and to eat yogurt. After I had persuaded his wife to construct a sentence for the GP containing the words, "negligence," "disciplinary body," and "compensation," my neighbor got his medicine and his series of appointments with a dietician. His cholesterol is now lower than mine. His GP is still muttering about the benefits of fermented dairy products.

The GP has a point, of course: No completely safe treatment is an option (although statins may be as close as we'll ever get, and more people probably get sick from rancid yogurt than the side effects of statins). The GP's mistake was in thinking that doing nothing was safe.

Those of us who work in pharma policy, advocacy, and marketing conspire in a series of half-truths that cause suffering to patients; confusion among ordinary doctors; and losses to our employers.

Read the central half-truth in every press release about licensing: "the FDA has determined ... to be safe and effective in..." Maybe—back when Time magazine had a raison d'etre and research required libraries—maybe there was a reason for this false certainty. Those times are long gone. If we don't become more truthful, the Internet age will leave us looking not just discredited but silly as well.

Doing Nothing.

It is imperative to be more aggressive about the dangers of not treating and preventing. Doing nothing is often high risk as my neighbor might have found out had he just eaten his yogurt as he was told to.

"Do you want us to tell people that their doctors are putting their health at risk?" a client wailed once.

Absolutely: if doctors are failing to diagnose and treat properly, tell the truth. For example, someone should say, "If you are a man over 50 and you have never had a rectal digital exam, your doctor is putting your life at risk."

The result will be lives saved and an increased number of effective treatment courses for prostate cancer. It will upset primary care physicians (who don't like doing the exams and, anyway, resent the intrusion on golfing time by a diagnostic that they can't charge for), but you shouldn't worry too much.

Our company almost persuaded the European head of a major pharma company to run an ad in the German press with his picture and the legend, "I may know how to cut your risk of a fracture by 85 percent but I'll be prosecuted if I tell you about it. (What's worse, most of you at high risk have never even been tested to see if you can be helped. I'm not allowed to tell you about that either.)"

The ad went on to talk about bisphosphonates and their impact in reducing fractures among women with osteoporosis. It ended with displaying my client's address in case he was wanted for questioning. Of course, special problems with DTC promotion exist in Europe, but the clients were not most worried about their boss spending the night in jail for violating DTC rules, they were worried about upsetting doctors. Doctors (male doctors especially) tend to think that little old ladies should not complain so much about shrinking. We listen to doctors too much.

The truth has to start being told: life is risky and medical intervention can often cut the risks or at least exchange nasty risks for less nasty ones. Patients need to know about it. It's nothing to apologize for.


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