Consumer Protection

As I was leafing through my March 2008 issue of Pharmaceutical executive, I noticed a focus on consumer protection in the articles I was reading. I’m not sure if it was intentional, but I thought it an interesting topic to mull on for a while, especially given that the state of the economy seems to be the dominant theme in most of my other media sources this week.

Installing More Flashing Red Lights

In “FDA Turns Attention to Detection,” Jill Wechsler concentrates on upcoming changes to the FDA’s Adverse Event Reporting System (AERS). AERS is the FDA’s current surveillance method for drugs currently available to the public, tracking some 4 million case reports and growing by about 300,000 submissions per year. While the information is extensive, its quality varies and has been identified as a major shortcoming in the current iteration of the system. (1)

Regardless of the quality of data, however, the FDA defends AERS’ use because it covers all FDA-regulated products and subsequently reaches a large portion of patients, including any that might be using a drug for an off-label purpose. It is considered especially effective at highlighting rare, unexpected drug safety problems, a sentiment echoed by a majority of healthcare professionals and cited as a reason that the system should be strengthened and augmented by other safety systems, not replaced.

To Imply or Not To Imply

While the FDA works on safety, Congress is staging an investigation into the celebrity endorsements that are accompanying more and more direct-to-consumer (DTC) ads on TV. In “Attack Mounts on DTC Ads,” Jill Wechsler outlines a new effort by Michigan Democrats John Dingell and Bart Stupack to challenge Pfizer’s use of celebrity spokesman Dr. Robert Jarvik, a prominent contributor to the invention of the artificial heart, in commercials for Lipitor (atorvastatin), the blockbuster anti-cholesterol drug. I recall the commercial vividly, its impact perhaps resting in the subconscious part of my brain, and I remember assuming that Jarvik was giving his testimony based on the background of a heart specialist.(2)

Contrary to my belief, Jarvik is not a heart specialist and it’s probably inappropriate to imply as such; it is because of this misleading advertising to consumers that Dingell and Stupack have chosen to investigate. Also on their list for investigation is Vytorin commercials, a joint venture by Merck and Schering-Plough. The Congressmen have been provided documentation by the FDA, and the investigation is currently ongoing.

Rx Email: Redux

In Europe, the United Kingdom is attempting to halt false advertising from another source: illegitimate online pharmacies. According to “UK Tackles Faux Pharmacies Online” by Sarah Houlton, the Royal Pharmaceutical Society of Great Britain (RPSGB) has launched a new logo that will help certify an online pharmacy is a legitimate source of medication for consumers. You may recall I examined the ever-expanding problem of online pharmacies in “Rx Email,” and indicated that the increasing prevalence of this problem necessitates action by agencies around the world; with an estimated 2 million people now use the internet to buy their medications in the UK, it is becoming obvious that the issue likely needs to be dealt with now.

Registered participants in this program will receive a new logo and registration number to be used on their home page. The logo will be a link leading to a list of legitimate sources for online drugs as maintained by the RPSGB. Almost 50 online pharmacies now participate, and the hope is that the system will discourage the dishonest traders. (3)

The magazine, as usual, gave me plenty of material to think about. Does the FDA AERS need to be augmented? Or should the original system be re-examined and re-built to encourage a more efficient and effective process? Should drug companies be allowed to use celebrity endorsements and imply claims that they cannot make? Or is this type of marketing no different than the marketing of a car (buy our car and you will be cool) or some other product? Where do the differences lie? Could the method being developed by the RPSGB really discourage the sales of illegitimate drugs online, or is it simply another roadblock for these bogus sources to overcome?

Regardless of the answers to these and other questions that may arise in my mind as I continue to read, it appears there is increasing effort by governmental organizations to keep their consumers safe from spurious, possibly false and sometimes illegal dissemination of information. No agency is perfect, but it is encouraging to know there are people within them who are doing their best to make me a little safer as a consumer.

What do you think?

(1) See “FDA Turns Attention to Detection,” Jill Wechsler, Pharmaceutical Executive Magazine, March 2008, p. 14.

(2) See “Attack Mounts on DTC Ads,” Jill Wechsler, Pharmaceutical Executive Magazine, March 2008, p. 18.

(3) See “UK Tackles Faux Pharmacies Online,” Sarah Houlton, Pharmaceutical Executive Magazine, March 2008, p. 18.