08 September 2017

Drug Safety

Welcome back. Maybe it’s me and my TV viewing habits. Other than Netflix offerings in the evening, I watch nothing but news, though I am eclectic about the network--Bloomberg, CNN, MSNBC, Fox, NBC et al.--even if I often mute the sound and just read the news tapes.

Whatever the reason, I’m seeing an increasing number of ads for drugs, particularly prescription drugs. Presumably, TV viewers are supposed to see the ad, pay attention if the drug treats a malady they or a loved one have, remember the product name and suggest it to their physicians, because the billions of dollars pharmaceutical companies spend marketing directly to physicians isn’t enough.

New drugs are continually coming
to market. (multiple websites)

Given advertising costs and the need to promote new products, it’s likely that what’s being pitched via my TV is in some way new, if not seasonal.

If the new drug is intended to replace an older drug for my malady, my physician and I have to ask, Should I switch? The answer implicit in the results of a study published last May is, Maybe not.

The study was conducted by a team of medical researchers led by an investigator from Brigham and Women’s Hospital in Boston. And once again, I’m indebted to the University of California Berkeley Wellness Letter for bringing the study to my attention.

Monitoring FDA-Approved Drugs
The researchers examined the safety record of all new drugs approved by the U.S. Food and Drug Administration from 2001 through 2010, following up through February 2017.

The post-product release safety issues they tallied included (1) product withdrawals due to safety concerns; (2) FDA-issued “boxed warnings”--warnings added to the label or to a product’s package insert; and (3) FDA-issued safety communications.

About a third of the drugs FDA
approved from 2001 to 2010 had
safety issues after coming to
market. (multiple websites)
They found the FDA had approved 222 new drugs (183 pharmaceuticals and 39 biologics) during the 10 year period. Of these, 32% were affected by post-product release safety issues over a median follow-up period of 11.7 years. There were 123 safety events--3 withdrawals, 61 boxed warnings and 59 safety communications. The average time to the first safety event was about 4 years.

Analyzing the statistics further, the researchers determined the safety events were significantly more frequent among biologics, drugs for treatment of psychiatric disease and drugs that received accelerated and near-regulatory deadline approval.

Wrap Up
For the researchers, the findings highlighted the need for continuous monitoring of new drug safety throughout the drug’s life cycle. The Berkeley Wellness Letter article focused more on the importance of considering all the options before switching to a new drug.

Is the improvement offered by the new drug worth the increased risk? Is it possible to allow more time for the new drug’s benefits and potential problems to be evaluated? When you see those TV commercials, don’t forget the warnings given at the conclusion are only the initially recognized limitations. Of course, unlike me, you have to have the sound on and be listening. Thanks for stopping by.

Drug safety study in Journal of the American Medical Association (JAMA): jamanetwork.com/journals/jama/article-abstract/2625319

University of California, Berkeley Wellness Letter, August 2017, “Sometimes it’s good to be a neophobe.” pg 3.

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