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Jerrold S. Parker

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FDA, It's Time to Rein in Misleading Pharmaceutical Ads

Posted: 08/01/11 02:23 PM ET

If you've stayed tuned in for commercial breaks during your favorite primetime show in recent years, then it is safe to assume that you have probably, on more than one occasion, caught a commercial for a popular osteoporosis pill, touted by Sally Field.

What she doesn't say -- and many consumers may not realize -- is that oral bisphosphonates (osteoporosis pills) have been linked to numerous side effects, including femur fractures and osteonecrosis or "dead jaw" syndrome. Just Thursday, the Food & Drug Administration (FDA) announced it would investigate claims that these medications increased the risk of throat cancer as well.

In 2010, the FDA ordered oral bisphosphonates manufacturers to include a warning label to alert patients to the risk of femur fractures, after studies linked the drugs to two rare types of thigh fractures, known as subtrochanteric and diaphyseal femur fracture -- nevertheless, persuasive ads remained on the air.

Osteoporosis medications are not the only pharmaceutical drugs whose ads have warranted FDA mandated-warnings in recent years.

Bayer Healthcare Pharmaceuticals launched the multi-million dollar ad campaign -- at the insistence of the FDA and 27 attorneys general -- after original ads for Yaz oral contraceptives were deemed misleading. The commercials, punctuated by the tagline "beyond birth control" not only downplayed the severe health risks but, according to the FDA, suggested that Yaz was for women with PMS, who in actuality "may not be appropriate candidates for the drug."

While the FDA often requires drug manufacturers to pull deceptive ads, it's quite rare to mandate an on-air correction. As part of a lawsuit settlement, Bayer is also required to submit all Yaz ads for federal screening before they air. Perhaps the popularity of the product (according to The New York Times, Yaz grossed sales of more than $616 million in 2007) and the severity of potential health hazards compelled the FDA to take these measures.

But for the thousands of women who have suffered the side effects, it's too little, too late. Those commercials should never have been approved for air in the first place.

In an age when tiny inserts in prescription packaging have largely replaced one-on-one pharmacist consultations, pharmaceutical ads are becoming a primary source of risk information for many patients. Therefore, it is up to regulators to ensure that dangerous drugs are kept off the airwaves -- as well as off the shelves.

The use of clever marketing to mask the potential risks of popular products is a universal issue. Proctor & Gamble has recently come under fire for similar misinformation around the widely-used denture cream Fixodent.

Approximately 35 million Americans wear dentures and many of them use Fixodent, made famous by the memorable tagline "Fixodent. And Forget It." What the manufacturer failed to disclose is that this adhesive contains zinc, which when absorbed in high amounts can lead to zinc poisoning - a condition that affects the nervous system and sometimes leads to death.

For years Fixodent and other zinc-laden denture adhesives were sold without adequate warning labels. It wasn't until 2009, after studies linking denture cream to zinc poisoning were made public, that the manufacturer added warning labels to Fixodent packages vaguely cautioning that "prolonged zinc intake may be linked to adverse health effects." Failure to properly warn millions of American denture cream users has left many with permanent nerve damage, wheelchair bound and unable to work.

Drug companies have pumped billions of dollars into ad campaigns in recent years for one simple reason: they work. The majority of consumers base their product choices on what they recognize from commercials, and most patients report being prescribed the specific brand-name drugs they request from their doctor.

This is where government oversight becomes crucial.

Regulators must do more than pull spots and mandate corrections when pharmaceutical ads are determined to be inaccurate -- at that point the damage is done. Instead the FDA must tighten regulations on pharmaceutical ads, monitoring accuracy as well as tone, before they're ever approved. It could literally save lives.

 

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