Volume 11  Number 3  September 23, 2014
Second Opinions

Advertising Drugs to the Public: I

Truth is stranger than fiction, but it is because Fiction is obliged to stick to possibilities; Truth isn't.

Mark Twain

It did what all ads are supposed to do: Create an anxiety relievable by purchase.

David Foster Wallace (Infinite Jest)

Prodigious growth has occurred in direct-to-consumer (DCT) pharmaceutical advertising since 1997 when the FDA in its wisdom decided to permit it. According to Pharma Marketing News, total spending in dollars rose from $1.2 billion in 1998 to $4.5 billion in 2009, a 275% increase. While radio and printed advertising declined in the last few years, TV advertising, of course, is where the most of pharma ad spending goes, 60% of the total, over $2 billion last year.

The FDA conducted two consumer surveys of U.S. adults, asking them questions measuring the influence of DTC advertising on their attitudes toward prescription drugs. Two questions in the 2002 survey addressed the issue of accuracy in DTC advertisements, particularly over manufacturers claims. More than half (58%) believed the ads make the products seem better than they really are. 42% felt the advertisements make it seem like the drug will work for everyone! Unfortunately, when a patient sees his doctor and already has a prescription in mind, doctors often feel pressured to oblige.

Is Pharmaceutical Advertising in the U.S. out of Control?

As I also pointed out three years ago, prescription drug marketing directly to the consumer is routinely permitted under U.S. law. Notable, is the profoundly different regulatory environment in the European Union (EU), Australia, and Canada where pharmaceutical manufacturers are forbidden to advertise prescription drugs to the public. The U.S. and New Zealand are the only two developed countries in the world where it is legal for drug companies to advertise to the public.

Such "direct to consumer" or DTC advertising is meant, obviously, to create increased patient demand for specific drugs from their doctors. In this scenario, patients really become consumers, replacing the doctor as prescriber, if the physician is foolish and incompetent enough to surrender his authority. Consumer Reports, in a 2006 survey found that 78 percent of doctors said that patients asked them at one time or another to prescribe drugs they had seen advertised on television.

While Congress a few years ago gave the FDA more authority to regulate ads, it rejected a measure that would have allowed the agency to place a moratorium on ads for new drugs that raise safety concerns. The sad fact remains that Congress seems in no mood to address the main problem, the legality of advertising drugs to the public. Don't expect the ad barrage, TV or otherwise, to subside any time soon. Evening and much of daytime TV is dominated if not contaminated with advertising for various pharmaceutical products, including many with "black box warnings", vide infra: antidepressants, new treatments for arthritis, heart disease, diabetes, sexual malperformance ("erectile dysfunction" anyone?) – and a host of new anticoagulants lacking antidotes for serious bleeding. I could go on.

The Inevitable Disclaimer

What I both like and loathe are the extensive if not similar disclaimers meant primarily to forestall lawsuits. Here's an example from Chantix (Varenicline), Pfizer's anti-smoking drug:

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts ...while using CHANTIX to help them quit smoking. ... If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood... or if you develop suicidal thoughts...anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Some people can have serious (allergic) reactions while taking CHANTIX, some of which can become life-threatening...and include: swelling of the face, mouth, and throat that can cause trouble breathing...

Well, you know the reprise: "Get medical attention right away." Over six years ago, the FAA banned pilots and air traffic controllers from taking the drug. This announcement received wide press attention in the Wall Street Journal and other publications because of the frequency of dangerous side effects. But not to worry, the FAA relented just last month (Aug., 2014) to allow an amended list of drugs, including Chantix, "on a case-by-case-basis." Chantix is now marketed for smokers-and others-with depression! If Big Pharma has convinced the FDA and Congress to sell out, their wingmen are vast numbers of the gullible public, and not a few physicians.

Stay tuned.

Copyright 2014, Mathemedics, Inc.

EasyDiagnosis is an automated online service that analyses existing medical symptoms and predicts likely causes and conditions. Click here to find out more about this unique service.