Consumers tune out FDA warnings

A high volume of safety alerts from the nation's drug regulator has doctors and patients wondering just what to believe.

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By Aaron Smith, staff writer

Farewell Fosamax
Merck's osteoporosis blockbuster loses patent protection Wednesday and generic drug makers line up cheaper versions.

NEW YORK ( -- A flood of drug safety warnings from the Food and Drug Administration may have physicians and patients suffocating from information saturation. Experts say there are too many red flags for them to pay attention.

"It seems that almost weekly we're getting a safety missive," said Les Funtleyder, an analyst who covers the pharmaceutical industry for trading firm Miller Tabak. "We're almost getting safety fatigue."

Already this year, the FDA has issued a number of high-profile warnings. Patients flood their doctors with anxious phone calls. But doctors and pharmacists don't always know whether the risk outweighs the benefit, and patients can panic.

"I think the biggest problem is when patients just decide that everything is too risky and stop taking their medications without telling anybody," said Funtleyder. "It's more risky to not take the medicines than to take the medicines."

The numbers start to grow

The FDA's credibility took a hit late in 2004, when Merck pulled its blockbuster arthritis painkiller, Vioxx, off the market after a study linked it to increased heart attack and stroke risk, sparking tens of thousands of lawsuits against the company. In November, Merck announced a $4.85 billion settlement that resolved a majority of these cases.

"Vioxx is a good benchmark" in gauging public distrust of the FDA and in spurring government safety warnings, said Doug Christopher, a drug analyst for investment firm Crowell, Weedon.

In 2004, the year of the Vioxx recall, the FDA issued 68 safety alerts or market recalls for drugs and other medical products such as devices. In 2005, that number shot up to 127. It dropped to 86 in 2006, but rose to 94 in 2007.

In the first two months of this year, the FDA has issued 16 safety alerts or market recalls for drugs and other medical products, such as devices. At that rate, it will have issued 96 by the end of this year.

Falling on deaf ears

Many experts believe the increased number of warnings - even of the severe "black box" variety - are loud and attention-getting but ultimately ineffective.

"There's been data over the years suggesting that even putting a black box warning on a product doesn't change the prescribing patterns," said Dr. Steven Nissen, chairman of the Cleveland Clinic's Department of Cardiovascular Medicine, and former president of the American College of Cardiology.

"The net result," he said, "is that the FDA seems to have lost its ability to influence the practice of medicine in how drugs are prescribed."

Raymond Woosley, chief executive of the Critical Path Institute, a non-profit organization that develops drug development tools for the FDA and the pharmaceutical industry, estimates that 80% of safety warnings are ignored or overlooked by pharmacists as they process hundreds of prescriptions per day.

"It's been a chronic problem and I'm sure it's getting worse," he said. "I think it's information overload."

But FDA spokesman Christopher DiFranceso said the warning system has received positive feedback from patient focus groups and physician associations.

"The bottom line is that when we have important information that has the potential to affect prescribing and use decisions by providers and patients as they weigh the benefits and the risks of a product, we communicate that information," he said.

Later this week, the FDA plans to hold a two-day public meeting to talk about a proposed template for product recall announcements.

The list goes on

In its list of red flags so far this year, the FDA has warned of potential fatalities in the off-label use of Allergan's (AGN) Botox as a muscle-calmer in children with cerebral palsy. It also warned of increased suicide risk in anti-epileptic drugs like Lyrica and Neurontin from Pfizer (PFE, Fortune 500) and Topamax from Johnson & Johnson (JNJ, Fortune 500), as well as Pfizer's anti-smoking drug Chantix.

Last year, the FDA strengthened its heart failure warnings for diabetes drugs Avandia from GlaxoSmithKline (GSK) and Takeda's Actos. The government also expanded its long-standing suicide warnings for antidepressants - including Paxil and Wellbutrin from Glaxo, Wyeth's (WYE, Fortune 500) Effexor and Lexapro from Forest Labs (FRX) - to include young adults, in addition to children and adolescents.

But some say a simple warning isn't enough. "Are you more likely to die of a heart attack from Avandia, or suicide from Chantix?" asked Funtleyder. "You can't really tell the difference. The risks usually don't come with a suggestion of what to do. So what you've got is a panicked public and sort of an information gap for physicians."

FDA warnings may not have the desired effect on doctors and patients, but they can scare away investors. Allergan's stock fell 6% on Feb. 8, after the FDA linked Botox to deaths in some children, despite the fact that this has nothing to do with its much more popular and FDA-approved use as a facial cosmetic. Glaxo's stock has plunged by more than 20% since May 2007, when a report linked Avandia to heightened heart attack risks.

Where they work

Warnings appear to be most effective at changing patient behavior when they're aimed at drugs for children, such as the FDA's Jan. 17 red flag to not give over-the-counter cold medicine to children under 2 because of "serious and potentially life-threatening side effects." Christopher of Crowell, Weedon said that pharmacies scaled back their stock of cold medicines after the warning came out.

"I've got four kids, and we wouldn't be using [cold medicine] given the FDA warnings, without further research," he said.

Jon LeCroy, a drug analyst for Natixis Bleichroeder, said the FDA's 2003 warning on the heightened suicide risk associated with antidepressants in children and adolescents was particularly effective in curbing their use.

"Whenever you see a warning involving kids it has a much more significant cutback in prescribing behavior," said LeCroy. "Parents have more concern for their kids than themselves."

A few alternatives

The FDA should use more creative means to attract the attention of physicians, said analysts.

Funtleyder of Miller Tabak believes that doctors and pharmacists would respond better to a color-coded warning system, similar to the Homeland Security Advisory System, where different colors represent different threat levels from terrorism. Red represents a "severe" threat level while green means "low," with five colors in all.

Dr. Nissen, who led a 2007 study that attributed Avandia to heightened heart attack risk, said that health risks often don't emerge until after a drug is approved for use by millions of people. He suggested putting a red triangle on the label of any drug that's been on the market for less than two years, even if no serious side effects turned up in pre-market studies.

As for Avandia, and any other drug associated with potentially life-threatening side effects, Dr. Nissen suggested that patients sign a waiver acknowledging the risks. This would force awareness on patients and physicians.

"That wouldn't be very popular with the pharma industry, but I think patients have a right to be informed," he said.

- The analysts interviewed for this story do not own the stocks mentioned here, but family members of Doug Christopher of Crowell, Weedon own Merck shares. To top of page

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