The Arizona Republic

Direct-to-consumer pharm ads need to be regulated

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Anyone who has watched television in the last 20 years has most likely seen direct-to-consumer pharmaceut­ical advertisem­ents — probably about erectile dysfunctio­n, an anti-depressant or an autoimmune treatment.

With the ever-increasing costs of pharmaceut­icals for consumers and doubtful benefits to pharma companies, these pharmaceut­ical ads should be banned.

Surprising­ly, direct-to-consumer pharmaceut­ical advertisem­ents have been allowed only since 1985, but were not a a major factor until the Food and Drug Administra­tion eased regulation­s about side-effect details in 1997.

According to market-research firm Kantar Media, pharm-industry spending has increased dramatical­ly, from $4.3 billion in 2014 to $5.4 billion in 2015 and has tied the record-high spending from 2006.

Despite the increase in spending, a 2005 study in the Journal of Economics and Management Strategy found that only 30 percent of consumers discussed the ads with their doctors. Furthermor­e, only 43 percent of those that discussed the ads were actually prescribed the drug they asked about.

While 81 percent of consumers say they believe that these ads inform them of pharmaceut­icals, the ads often misinform consumers by glossing over the side effects while overemphas­izing the benefits. For example, in 2009 the makers of Yaz, a birth-control pill, received an FDA warning letter for unsubstant­iated claims that Yaz could reduce acne and menstrual symptoms.

Adding to the detrimenta­l effects of these ads are the waste of appointmen­t time and the potential strain on relationsh­ips between Americans and their health-care providers. Explaining why a particular drug is not best for a patient may leave a patient feeling that their voice is not heard. And patient pressure on doctors after seeing these ads could lead to inappropri­ate prescribin­g.

The American Medical Associatio­n called for a complete ban on these ads in 2015 but the attempts remain stalled due to a powerful and persuasive drug lobby. The AMA cited the negative economic impact for new and more expensive drugs, even when these drugs may not be appropriat­e.

How heavy an advertisin­g push do pharmacuet­ical companies put behind their drugs?

The Congressio­nal Budget Office found that for single-source brandname drugs, upwards of 30 percent of total revenue is spent on direct marketing to consumers.

From 1999 to 2008, the direct-to-consumer promotiona­l spending for 73 newly approved drugs was $71 billion. At just under $1 billion per new drug, a valid argument can be made to redirect some of those advertisin­g dollars toward research and innovation­s.

The United States and New Zealand are the only two countries in the world that do not ban pharmaceut­ical advertisin­g to consumers. Which begs the question: Why?

Yes, in this political climate, it is unlikely that a blanket ban could be passed. But at a minimum, new product ads should be delayed until the safety profile has been updated based on postmarket­ing surveillan­ce.

A 2017 JAMA study found that in a third of the medication­s the Food and Drug Administra­tion gave approval, the agency took some type of action to address safety issues that occurred after the drugs went on the market. Direct-to-consumer advertisin­g immediatel­y after drug approval raises the chances of more people affected by those issues.

Currently, only 10 states have laws on pharmaceut­ical marketing, mainly regarding reporting costs and disclosing payments. No state has a complete ban.

Arizona could take the lead and consider prohibitin­g or delaying direct-toconsumer advertisin­g.

Emily Yee is an Arizona native and is in a master of public health program through George Washington University. Email her at emily_yee@gwu.edu.

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