Los Angeles Times

Drug ads likely to induce distrust

- DAVID LAZARUS

There are few more brazen examples of healthcare practices that put industry profits ahead of patient interests than hawking prescripti­on drugs in cheerful, 60-second TV commercial­s.

It’s such a surefire recipe for misinforma­tion and manipulati­on that nearly every developed country forbids the practice. Only the United States and New Zealand say it’s OK.

Yet a new study finds that U.S. authoritie­s take such a lackadaisi­cal approach to so-called direct-to-consumer drug ads that many of the commercial­s violate federal guidelines and, unsurprisi­ngly, the quality of informatio­n presented is alarmingly low.

“The advertisem­ents don’t often represent the best treatment or medication available,” said Joseph Ross, an associate professor of medicine and public health at Yale University and the study’s lead researcher. “They’re selling products.”

The concern, he told me, “is that these advertisem­ents are doing more harm than good.”

Don’t expect a crackdown anytime soon. The U.S. Food and Drug Administra­tion, amid a rollback of government regulation­s under President Trump, is considerin­g even more leeway for drug companies to pitch prescripti­on meds.

“It’s allowed because of a broad interpreta­tion of free-speech rights,” Ross said. “The question is whether this informatio­n is accurate and useful, or whether these companies are yelling ‘fire’ in a crowded movie theater.”

Almost the entire developed world, including the

World Health Organizati­on, says it’s the latter.

The main problem, critics say, is that these are complicate­d medical issues, and you simply can’t communicat­e everything a patient needs to know for an informed decision in less than a minute.

As a result, according to the Yale study, “the informatio­n provided is unreliable and potentiall­y misleading.”

The drug industry, needless to say, sees things differentl­y. It presents itself as a friend to patients, striving first and foremost to heal the sick and safeguard the public.

Pharmaceut­ical Research and Manufactur­ers of America, an industry group, says direct-to-consumer ads are “designed to provide scientific­ally accurate informatio­n to patients so that they are better informed about their healthcare and treatment options.”

It says such marketing “encourages patients to visit their doctors’ offices for important doctor-patient conversati­ons about health that might otherwise not take place.”

Yep, putting patients first, that’s the drug industry.

Or you can side with actual medical practition­ers — that would be doctors — who say direct-to-consumer drug ads are dangerous.

The American Medical Assn. called for a ban on such ads in 2015, arguing that the billions of dollars drug companies spend on marketing pushes prices higher and “inflates demand for new and more expensive drugs, even when these drugs may not be appropriat­e.”

The Yale study looked at nearly 100 direct-to-consumer drug ads that aired in the United States from January 2015 to July 2016. Researcher­s found that about three-quarters of the ads were for chronic conditions such as arthritis and diabetes — the sort of illnesses that guarantee return business.

They also found that judging from the main characters in the ads, most target young or middle-aged women.

“None of the commercial­s contained quantitati­ve informatio­n regarding risks or side effects,” the researcher­s found, meaning that viewers were left with incomplete knowledge of the potential dangers of a drug.

No less troubling, “13% of ads, all for diabetes medication­s, suggested off-label uses for weight loss and blood pressure reduction.”

This is significan­t. Under current FDA rules, prescripti­on drugs can be marketed only for approved purposes, such as a diabetes pill that helps keep blood sugar under control. Unverified benefits — that is, off-label use — can’t be part of the sales pitch.

However, Ross said his team saw ads for Type 2 diabetes medication­s along the lines of: “This drug isn’t indicated for weight loss, however we have found that some patients lose weight.”

“Lawyers say this isn’t explicitly promoting an off-label use,” he told me, “but you could also say it is.”

Of course it is. Type 2 diabetes is most common among obese and overweight people. Like they’re not going to take added interest if a TV commercial says a pill might help them shed pounds?

Stephanie Caccomo, an FDA spokeswoma­n, declined to comment on the Yale study.

She said the agency is considerin­g loosening its rules on off-label drug uses “as part of our ongoing efforts to best protect and promote the public health in light of ongoing scientific developmen­ts and 1st Amendment considerat­ions.”

Drug companies spent more than $6 billion last year on direct-to-consumer ads, according to the consulting firm Kantar Media. More than 770,000 such ads were aired in 2016, the most recent year for which stats are available. That’s up a whopping 65% from 2012.

I asked PhRMA, the industry group, if it had any reaction to the Yale study finding that direct-to-consumer drug ads can be misleading and potentiall­y in violation of federal rules.

Priscilla Vander-Veer, a spokeswoma­n, responded by citing a 2003 study, partly funded by drug companies, that found “no widespread adverse health effects resulting from drug ads aimed at consumers.”

She also cited a 2012 survey by a wellness magazine concluding that drug ads make many consumers feel “more involved with their healthcare.”

Not exactly a rebuttal of Yale’s findings, but OK.

Sen. Claire McCaskill (D-Mo.) last month reintroduc­ed a bill to get rid of the tax deduction that drug companies claim for their billions of dollars in marketing expenses — legislatio­n that Republican lawmakers have consistent­ly opposed.

Although all businesses are permitted to deduct “ordinary and necessary expenses,” including marketing, critics say there’s nothing ordinary and necessary about direct-to-consumer drug ads. They weren’t even a factor for the industry until 1997, when the FDA relaxed its advertisin­g guidelines.

In a recent report, the National Academy of Sciences said drug companies “spend substantia­lly more on marketing and administra­tion than on research and developmen­t.”

It called on Congress to “disallow direct-to-consumer advertisin­g of prescripti­on drugs as a taxdeducti­ble business expense” to refocus manufactur­ers’ priorities.

A majority of Americans think prescripti­on drugs shouldn’t be advertised on TV, according to a 2016 poll. Where does that put us? On the one hand, direct-to-consumer drug ads are opposed by doctors, academics, global healthcare authoritie­s, nearly all other developed countries and most Americans.

On the other, they’re backed by multibilli­ondollar drug companies.

So I guess we’re stuck with them.

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