Adverse Events and the Lighter Side of Drug Company Advertisements

Post by
Andrew Paier

Editor?s note: This guest post is the fourth in a series from Larry Taber, BP3?s Digital Strategy Officer for Life Sciences and Pharma.?Larry has over 32 years of deep pharmaceutical and biotech expertise ranging from discovery research to business development. He has over 17 years of leadership of international teams successfully partnering with over 100 companies. Larry is a proven business process problem-solving professional and trainer. He has completed Master Black Belt, Black Belt, and Malcolm Baldrige National Quality Award /Performance Excellence Examiner certifications. He is passionate about the incredible advances in medical science and the enablement that is being made possible for patients through digital technologies. He holds a M.S. in Medical Biochemistry from Indiana University Medical School and a B.S. in Chemistry (Magna Cum Laude) from Purdue University.]

Tell the truth.? Most of us ordinary consumers either turn off drug company commercials, or, you wait for it, and about half way into the ad, after joyously floating through fields of flowers, pairs his and her bathtubs, rejuvenated grandmas, or lazy gazes through merchant windows comes the dreaded list of potential side effects interrupts the fun.

At 90 miles a minute, you struggle to decipher the run-on statement full of precautions, contraindications, side effects, and symptoms you might want to watch out for.

Like, ?may cause death?.?? What?? Death?? That doesn?t sound like a good thing!? Do pharmaceutical companies really think this is a good advertising?

Of course not, but there is a serious reason for those absurdly long statements. For the safety of patients, government legislation pertaining to FDA Oversight of Prescription Drug Advertising requires that companies give equal or more emphasis to a drug or device risks, without ever overstating positive benefits.? It is called the Fair Balance rule.

Oddly the balance tips toward complete confusion and overstatements of risks because many companies default to listing every possible issue regardless of likelihood.? They do this out of an overabundance of caution. This does not explain why their ads seem goofy, but hopefully, you can understand why they sound so scary.

To be sure, the regulatory guidance is a good thing since it prevents false and deceptive claims.

So, in fairness to the FDA and the drug companies, let?s close with the benefits of prescription drug ads:

  • educate the public about certain disease types and treatments,
  • point out that you are unique (not every patient responds the same way)
  • make you more aware of possible contraindications (things to avoid);
  • you understand side effects (yes all drugs have them);
  • reinforce the importance of talking to your doctor whenever you experience anything unexpected (you might, you?re unique)
  • they tell you where you can report anything bad that happens ??Visit www.fda. gov/medwatch, or call 1?800-FDA-1088.? (who knew where to do that?)

At the end of the day, all of us are becoming better educated, better connected, and safer patients.

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