After three years on the tube, skating icon Dorothy Hamill may need to hunt for yet a third career.
In part that's because the Olympic gold medalist returned to the spotlight as a television pitchwoman for Vioxx, the blockbuster painkiller
yanked off the market last fall. But another factor is that Hamill's ads exemplify a type of advertising that some people would like to see banned altogether -- so-called direct-to-consumer prescription drug advertising.
Indeed, Hamill's own commercials -- which helped make Vioxx a household name -- could very well fuel the crusade against DTC spots. Ads for
Celebrex, a drug similar to Vioxx, have already been pulled from the market. Both of the heavily marketed painkillers, known as Cox-2 inhibitors, have been linked to heart attacks.
Some high-profile medical experts were calling for a crackdown on DTC drug advertising even before the Vioxx recall. They insisted that the ads, supposedly designed to "educate" the public, actually did more harm than good.
Now, their warnings are starting to sound more prescient than ever.
"When one considers that the majority of DTC drug ads are now on television -- and that this means a hasty 30- or 60-second spot -- it is hard to imagine that much more than the name and the claimed therapeutic indication could ever be conveyed," Arnold Relman, the retired editor-in-chief of the
New England Journal of Medicine
, testified in July 2003 before the U.S. Senate Special Committee on Aging. "There simply isn't time to provide any useful information about side effects or complications."
In this third of five articles probing Merck's troubles in the wake of the Vioxx scandal,
examines how a tectonic shift in the drug industry's advertising practices -- along with a hands-off stance by regulators -- set the scene for a disaster that has proved hazardous to consumers and Merck investors alike.
During Vioxx's first full year on the market, Merck spent an estimated $160 million marketing the painkiller directly to the public. Millions of consumers, including those swayed by media ads, wound up using the drug.
Many never knew that Vioxx could lead to heart attacks. And some, experts believe, never really needed the risky medicine at all.
Critics blame DTC advertising made possible by a government agency with close ties to the drug industry.
"Most of the most heavily advertised drugs are, in fact, no more effective or safe than other drugs, but billions of dollars 'must' be spent to try to convince doctors and patients otherwise," the consumer watchdog organization Public Citizen declared last April.
"These recent expensive campaigns have probably been much more successful than in years past because the FDA has all but stopped enforcing the laws concerning false and misleading prescription drug advertising -- with an 85% decrease in enforcement actions between 1998 and the end of 2003."
Prior to the Vioxx recall, DTC prescription drug advertising ranked as a growing $3 billion industry. Of the top 25 advertisers in 2002, Public Citizen reported, four were giant drug companies. Pfizer, the maker of Celebrex, stood out as the biggest spender in its group.
Johnson & Johnson
came in second, followed by
. Merck -- despite its heavy Vioxx advertising -- placed fourth.
All spent more than $1 billion on DTC advertising annually, Public Citizen reported. Don Strong, an Oklahoma City attorney representing thousands of Vioxx plaintiffs, understands why.
"When you're spending that kind of money," he says, "you're going to be successful selling whatever you're selling."
The rise of Rogaine, a blockbuster treatment for male pattern baldness, helps illustrate that point.
Figures in millions of dollars. Source: Med Ad News.
Michael Montagne, a professor at the Massachusetts College of Pharmacy, remembers the evolution of DTC prescription drug advertising quite well. Until the 1980s, he says, DTC really didn't exist within the industry because of uncertainties about the liabilities that might erupt. He calls Rogaine, with its "negligible" potential for serious risks, a good first choice to test the waters.
He says the FDA, which oversees drug marketing, eventually suggested a brief moratorium on the new DTC advertising so that it could study its potential effects. But, he says, the agency found no good reason to halt the ads and, over time, their popularity soared.
Vioxx Pain Lingers
Mess Shows FDA Flaws
Wednesday: Ads Added to Vioxx Sizzle
Thursday: Sizing Up Coutroom Foes
Friday: CEO's Ultimate Challenge
Like Rogaine, prescription drugs such as Prozac, Viagra and -- yes -- Vioxx have gone on to become common, everyday names.
Montagne readily admits that DTC drug advertising works quite well. He says an "amazing correlation" exists between money spent advertising a drug and its sales. From a consumer's perspective, however, he sees little value in such advertising and therefore remains fundamentally against it.
Michael Weinstein, president of the AIDS Healthcare Foundation, believes that DTC advertising has actually hurt the drug industry. He says that drug companies now seem far more interested in marketing their current drugs than in developing new ones. As a result, he says, AIDS patients have been forced to rely on government institutions -- and others outside of "Big Pharma" -- for any new breakthrough treatments.
"The big drug companies are spending more on marketing than they are on research," Weinstein said simply. "They have killed the goose that laid the golden egg. ... Now, they're based on sleazy ads on TV."
But outrage is rising. Indeed, DTC critics -- feeling vindicated by the Vioxx recall -- are now crying out from as far away as New Zealand.
"The chorus of opposition to DTC drug advertising that warned it would lead to heavy promotion of unsafe and unnecessary pharmaceuticals has been proven correct," says Sue Kedgley, a spokeswoman for the powerful Green Party in New Zealand. "If DTC advertising had been banned three years ago, then thousands of New Zealanders would not now be facing increased risks of cardiac problems -- because most of them would not have been prescribed Vioxx."
Kedgley went on to blame the New Zealand government for failing to heed clear warnings about Vioxx advertisements.
She noted that the FDA had reprimanded Merck in 2001 for using Vioxx ads that were "false, lacking in fair balance or otherwise misleading." She found it "shocking" that her government had allowed Vioxx ads to keep running anyway.
Back in the U.S., Public Citizen did its part to counter such advertising. It placed Vioxx on its "worst pills" list after learning about the big study that exposed cardiac risks in 2001. It then publicized an eight-page warning letter sent from the FDA to Merck about its Vioxx advertising that same year.
But it also asked the FDA -- and ultimately Congress -- to do more.
"The FDA already has authority to bring criminal charges against companies such as Merck that repeatedly flout existing laws and regulations -- and should start using it," Public Citizen urged in November 2001. But "it would be nice if Congress would also rise to the obvious occasion and give the agency pocketbook authority as well."
Relman has pushed for an even more potent cure.
"We need more -- not less -- regulation of consumer ads. ...
And if the law allows," he declares, "I would favor a total ban on DTC ads."