I am a real fan of medical progress through science. Having met many drug researchers I know how it can take years and many millions of dollars to actually end up with a new, approved medicine. As you know, approval is based on clinical trials – trials where maybe a hundred or a few hundred people participate. If a drug is safe and effective and especially meets an unmet need, it typically gets approved. But it is in the months and years that follow that a more complete story develops.
It is in this time following approval where we can realize that we have at first made two steps forward in the treatment of a condition, but then have to take one step back as we see side effects become apparent as the drug is used by a wider population.
There was one example in the New York Times as some older men are having complications from cataract surgery if they’ve been taking the drug Flomax for urinary flow problems. I hate to poke fun, but that means those virile men in the television commercials where they are river rafting without a care in the world may, some of time at least, need glasses because while their urinary problems were better their vision may have become worse. The drug company says it has always advised patients to talk to their eye surgeon about their use of Flomax and have the surgeon consider a different technique to reduce the risk of a complication. Now experts are saying this may not be enough attention to a real problem.
I heard about another example of a side effect: severe acne in some cancer patients who take one of the new epidermal growth factor inhibitor medicines. It seems epidermal growth factor is important in healthy skin cells and not just cancer cells. The concern is, while the new medicines can really help fight cancer, the skin problems that go with them have to be treated too, and treated early to prevent infection or such severe side effects that cancer fighting treatment has to be suspended and the cancer patient’s prognosis suffers because of it.
So, as I like to say, there is no “free lunch” with powerful medicines, and sometime we don’t know the full picture until they are approved, and out there for thousands of patients and doctors to use. That doesn’t mean it is not medical progress. It is medical progress tempered.
I know from an interview conducted this week with a dermatologist who specializes in helping cancer patients that the skin problems from the new cancer drugs can be managed. And I am betting millions of men who take Flomax can still get the eye care they need when they need it. This comes with more refined treatment plans based on experience. Two steps forward, one step back. It is to be expected.
My advice to patients is to read the fine print as you take a new medicine. There is always a “package insert.” Were eye issues observed with Flomax in the trials? Yes, I believe so. How about skin problems with the EGF inhibitors? Yes, there too. So we patients should prepare and force a discussion with our doctors as we take new medicines to probe how vigilant we should be about side effects and how to limit them. It’s one more time when, like it or not, we have to be a strong advocate.
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