Friday, August 25, 2017

FDA May Limit ‘Risk Info’ in Direct-to-Consumer TV Drug Ads

The U.S. Food and Drug Administration may shorten the list of caveats for drugs you see advertised on television.
Prescription drug makers must now mention all benefits and risks in direct-to-consumer advertising, presenting viewers with a litany of potential harms, both major and minor. But a new approach being considered could trim those lists to feature only the most serious and potentially fatal side effects, the FDA said Friday.

The “FDA’s own research on broadcast TV drug advertisements suggests that a more targeted method for delivering risk information may lead to better retention of those risks,” FDA Commissioner Dr. Scott Gottlieb said in an agency news release.

To that end, “the agency is exploring the usefulness of limiting the risks in the major statement for most drug advertisements to those that are severe [life-threatening], serious or actionable, couple with a disclosure to alert consumers that there are other product risks not included In the advertisement,” Gottlieb said.

While this might spare TV viewers lengthy lists of relatively insignificant physical complaints, it might also deprive them of critical information. To come to the best solution, the FDA is asking consumers, doctors and others to comment on which risk information is most helpful in TV and other broadcast ads.

Dr. Nachum Katlowitz, director of urology at Staten Island University Hospital in New York City, thinks it’s time to reconsider the advertising requirements. “In a one minute direct-to-consumer advertisement, they spend 55 seconds in a kind, clear, pleasing voice discussing all the wonderful things this product will do to help your life,” said Katlowitz. “Then, in the last five seconds in a rapid, audible but difficult to understand monotone voice, they discuss the risks and end with, ‘Ask your doctor.’”

He said it would be “much more honest, if not safer, if they start with someone clearly sating the following is intended as an infomercial and all questions regarding the proper use of this product are best discussed with and handled with your health care provider.”

My Take:
If this information is “best discussed with and handled with your health care provider,” then what is the value of the commercial? In my opinion, the only value to these drug ads are the scary warnings at the end. Viewers often respond out loud “why on earth would I take that medication? Or, “death, now that’s a side effect!”

The consumer should not be the driving force in asking their doctor “Can you give me this drug I saw on TV?” It should be the other way around – educate the physician about the drug rather than attempting to entice the patient. And no, that education does not include the kickbacks frequently given to physicians for prescribing certain drugs.

I do think there is some value for the patient that is already taking the advertised drug. Quite possibly they are suffering one or more of the side effects associated with that drug and are unaware of the connection.

The Bottom Line:
Rather than limited the risk information to most serious and potentially fatal side effects, how about giving equal time to the benefits and risks. A one minute commercial would have 30 seconds of selling time and another 30 seconds of “buyer beware”, all presented in that “kind, clear, pleasant voice.”

An even better suggestion, recommended by the American Medical Association, is to ban all drug ads from television. The cost of this advertising, millions of dollars each day, is one factor in the skyrocketing costs of prescription drugs.

Source: August 18, 2017 National Institutes of Health

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