- Jim Edwards

In  recent weeks, Congress has been debating no fewer than four separate bills that would either restrict drug advertising or tax it. A fifth measure—another tax—might have become a provision of the healthcare reform package that President Obama hopes to sign, but drug company lobbyists killed it.

While the surviving bills will probably not become law, they are a measure of the enmity that smolders among both politicians and the the American public for the direct-to-consumer promotion of pharmaceuticals. The widespread ire, presumably, stems from the belief that drug companies (already unpopular for the hefty prices they charge consumers) pass the cost of expensive advertising onto consumers, too.

In truth, drug ads do not substantially increase the cost of healthcare. Then again, they don’t do anything to make it cheaper, either. But if restrictions on drug advertising ever do come to pass, there’s one company that’ll probably end up taking the blame for finally turning Congress against the drug companies: Bayer Healthcare.

If the need to restrict pharmaceutical advertising had a poster child, Bayer would be it. In recent years, and over a range of products, Bayer has been cited for, accused of or required to enter legal settlements over false advertising. (Bayer did not return a call for comment.)
Currently, Bayer is the subject of at least 32 federal lawsuits claiming that its ads for birth- control brands Yaz and Yasmin failed to warn women that the drugs carried increased risks of blood clots that can cause potentially fatal strokes or pulmonary embolisms. Fifty reports of deaths, in women as young as 17, have been filed with the FDA, according to the suits.

Bayer’s advertising will play a central role in the cases. In October 2008, the FDA wrote a warning letter to Bayer, informing it that ads for Yaz were misleading because, in addition to referencing pregnancy prevention, the ads promoted the brand for acne and PMS. Yaz was never approved to treat those conditions. Yaz was approved for the less serious afflictions of moderate acne and “pre-menstrual dysphoric disorder.” The suits claim that Bayer’s advertising thereby attracted patients who never should have used Yaz.

After that, Bayer entered into a unique settlement with a group of state attorneys general. The agreement required the company to spend $20 million on corrective advertising and to submit all future ads for Yaz to the FDA for preapproval.

There’s more. In June, D.C.-based public-health watchdog group the Center for Science in the Public Interest complained to the FTC that Bayer ads for One A Day vitamins claimed the product could prevent prostate cancer. “Did you know that there are more new cases of prostate cancer each year than any other cancer?” said radio spots. “Now, there is something you can do.” According to CSPI, there’s little evidence that One A Day can do anything to prevent prostate cancer.

In 2007, Bayer settled with the FTC for $3.2 million after the company falsely claimed that its One-A-Day WeightSmart vitamins could help with weight loss. That order came after Bayer violated a previous FTC order not to make marketing claims unless those claims could “be supported by competent and reliable scientific evidence.”

And the list goes on. In July 2007, the Council of Better Business Bureaus’ National Advertising Division (NAD) announced that Bayer should discontinue advertising for its All-Day Energy multivitamin. As it turned out, All-Day didn’t last all day. Twice that same year NAD cited Bayer for pushing the envelope over claims made about pain-reliever Aleve and its Ascencia diabetes blood glucose monitor.

In Bayer’s defense, drug companies attract both scrutiny and litigation as a matter of  course. Pick any drug maker and you’ll find similar allegations—proven or not. But the case of Bayer’s Yaz product is singular because it spotlights an issue in which the pharmaceutical industry is uniquely vulnerable: the advertising of products that have more risks than unadvertised products.

Yaz is a so-called “fourth generation” contraceptive pill. As older pills became generic, became unprofitable and therefore went unadvertised, Bayer introduced newer ones with different versions of the two chemicals that all birth-control pills contain: progestin and ethinylestradiol. The Yaz suits allege that the new mixture is less safe than older, “second generation” pills. When the FDA warned Bayer, it noted, “Yaz has additional risks...which may result in potentially serious heart and health problems.”

Regulations require only that the FDA consider each drug on its own. If the drug is safe and effective enough, it’s approved and can be advertised. The FDA doesn’t get into whether drugs are safer or better than their peers.

That’s the issue that will hurt drug advertisers if the Yaz suits ever reach the top of the news agenda: Does it make sense for the FDA to allow drug companies to advertise products that are more dangerous—but no more effective—than existing products on the market?

Meanwhile, Janet Abaray, one of the lead lawyers in the Yaz suits, intends to use Bayer’s ads against it in court. The $20 million in corrective advertising “is another aspect of liability. It goes to the wrongfulness of their conduct,” she says. “When you have that element, it’s even more reason for a jury to award damages.”

Jim Edwards is a contributing writer at Brandweek and CBS Interactive’s BNET Pharma.