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August 25, 2014 at 3:07 PMComments: 1 Faves: 0

Health Care Decisions Part 2: Pharmaceuticals

By Jeffrey VanWingen M.D. More Blogs by This Author

(Read "Health Care Decisions Part 1: Understanding Efficacy, Weighing Risks" HERE)

I recently got a call from a patient following a visit for high blood pressure. "I'm not taking that medicineyouput me on. I read all the side effects." Immediately I had replayed the visit in my head.

We discussed the proper diagnosis of high blood pressure based on multiple elevated readings. We discussed the big picture that treating high blood pressure is a means to reduce risk for stroke and heart disease (among other risk factors like obesity, high cholesterol and smoking). And then we discussed the medication, the rationale for starting it and the more common side effects I felt good when she left-- like she understood the risks/benefits and thatwedecided that taking the medicine was a worthy endeavor.

Unfortunately, when she left the office and went to the pharmacy to pick up the medicine, it was just her and that product insert, the pharmaceutical fact sheet that lists some of the more notable research findings and of course, all the possible issues noted in subjects participating in the research trials.

Navigating in apharmaceutical world full of chemistry and government regulations can be scary. Although these medicines are here to help, they operate in a world where we humans are only mostly the same and thus may react differently to substances entering our body.

On this note, let's talk pharmaceutical risks and benefits and the ways in which these attributes are communicated to the public.

Product Insert Pearls

When and if you are reading a product insert, remember that the purpose of this document is to basically outline all the risks and benefits of a medication, putting things in fair balance. This is strictly regulated by the U.S. Food and Drug Administration. The chemical make-up of the drug is outlined followed by all the FDA approved indications for the drug.

These indications are supported by the research trials and results as the drug was being compared to placebo in strictly regulated studies. In addition to effectiveness of the medication, the studies also help to gather information on side effects. Side effects are reported for the medication-taking subjects in the trials and also for the placebo-taking subjects. Sometimes this boils down to misfortune in both groups. For instance, it is hard to fathom that a blood pressure medication could cause the common cold, but it is likely there on the product insert because in all likelihood some subjects had the misfortune of having this common malady while in the study. This is why it is important to compare side effects to placebo and consider the difference for legitimacy. It's also important to consider placebo for effectiveness when analyzing a drug. Just taking a placebo pill has been shown to help as much as 30% of people in research trials.

Deliberations

When I talk to patients about starting a medication, it sometimes seems like they are at their doorstep contemplating whether they'll allow a stranger to come inside their house to do some work. They won't dispute that the work needs to be done, but still they are wary. As a doctor, I feel as though I am required to vouch for this untrusted individual. In the world of fair balance, though, it's right for me to tell my patients that there is a small chance that various issues will arise.

Consider a patient who comes to me for their overactive bladder and I feel that a drug will help with their "plumbing" problem. They know that their house has leaky pipes and I tell them about a plumber I know who will do the best work possible. This plumber, however, has a few issues. About 15% of the time the homeowner experiences dry mouth and constipation - other mechanical issues in the home. For some, living with the ongoing plumbing problem outweighs the potential risk.

Risky Business

But isn't there risk in virtually everything we do? Consider your typical day: eating foods, operating heavy machinery like an automobile, using computer software and other technology. The FDA, however,doesn't regulate crossing the street, driving in a car or getting dressed each morning. Is this risk fundamentally different? According to the government it is and anyone taking a prescription medication is made available the benefits and the risks in a precise fashion with i's dotted and t's crossed.

Exempted

Certain products out there are exempt from this requirement for fair balance. They are natural products and supplements that are marketed under a food category. Skirting around the regulations,claims can be made with lesser scrutiny about effectiveness and scope of treatment without the research to offer as proof. Potential adverse side effects are not required to be reported in advertising or in the product insert. For these products, the balance is certainly tipped. Are they safer? Are they effective? One can't say for sure. But in a world where consumers respond to advertising they are certainly cast in a different light.

Risk and Benefit

Perhaps we are heading in a direction as a society where risks and benefits are more deliberately weighed in our daily actions, not just in the pharmaceutical world. The last time I hired a plumber, I examined the reviews, good and bad, and weighed them with cost. I made a conclusion of value along with risk and benefit. For discerning individuals, the information is there to make educated decisions, analyzing which pharmaceutical products are safer and more effective than others. In this world of Angie's List, Trip Advisor and Google, we seem to be embracing the boost of information to become in effect more informed. While this can be daunting to some, the masses seem to be using it for benefit. And it arguably keeps those providing a service in the necessary role of providing the best service that they can. This is much the same as the pharmaceutical arena has been for years.

So, the next time you hear the tail end of a pharmaceutical commercial talk about all the potentially bad stuff or you listen to your doctor cover risks and benefits take it in with confidence. Know that you are receiving a service aimed at helping you know what may (but likely won't) be around the corner in a world full of various risks. Know also that we live in a world where benefits outweigh those risks. Seek out the benefits that outweigh the risks toward a fuller, happier and healthier life.

Live, and live well!

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1 Comment

  • I am starting to question synthetic meds.

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