Experimenting with Drugs... The pros and cons of taking brand new medications

Nothing had helped Cathy Adams relieve the chronic pain in her joints, and she was tempted by an ad she saw for Enbrel, a new drug for treating rheumatoid arthritis (and the skin condition psoriasis). With her doctor's blessing, Adams, 54, of Wyckoff, N.J., tried the new drug. The cost: about $1,500 a month.

After four months, she hadn't felt any noticeable relief. Now she says she'll probably switch to another new drug she saw advertised.

Adams is a good example.  It's easy to be seduced by drug ads, especially when they promise relief—and even happiness—and when the "patients" shown are glowing with robust health. That's why direct-to-consumer pharmaceutical advertising in the United States is several billion dollar industry.

But the drug industry is rethinking its consumer advertising, prompted by recalls of popular, extensively advertised new drugs, like the painkillers Bextra and Vioxx, which were found to raise the risk of heart attack and stroke.

Some pharmaceutical companies have announced that they will delay advertising a new drug until it has been on the market for several months or longer to further assess safety.

And at least 23 drugmakers have agreed to new voluntary ad guidelines by the Pharmaceutical Research and Manufacturers of America (PhRMA) that went into effect last month.

"Drug advertisements can be dangerously misleading," says Jerome P. Kassirer, M.D., former editor in chief of the New England Journal of Medicine. "They encourage patients to ask for new drugs that may not be appropriate for them," Kassirer says. "On average, new drugs can be more risky than those that are tried and true."

Drugmakers have strong economic incentives to heavily promote new medicines that are still under patent protection. Not only are the medications typically more expensive than older drugs or generics, but, "ironically, promotion is highest when the available information is lowest in terms of the drug's track record,"  says Jerry Avorn, M.D., of Harvard Medical School and the author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (Knopf, 2004)Even so, he says, "more than ever before, there's a temptation for both patients and doctors to equate "new" with "better." "

For better, for worse

In a survey that the federal Food and Drug Administration conducted in 2002, doctors reported that the exaggeration of medical benefits in advertisements was a significant problem for them and for patients. But the ads have an upside, too.

"Most doctors have a love hate relationship with [drug] commercials," says Robert A. Wolfson, M.D., an internist with the Mount Kisco Medical Group in New York. "On the one hand, they educate people about remedies they had no idea existed and promote dialogue. On the other hand, they can set up unrealistic expectations about what may seem like a sure fire cure."

Indeed, most people agree that a new drug can be a lifesaver under the right circumstances—namely, if you are a patient for whom other drugs are not working well and if the likelihood of benefit is greater than the risks.

Several new drugs have changed the standard of care for various disorders: Inderal, for example, was the first beta-blocker on the market to treat high blood pressure, and Tagamet was the first H2 (histamine) blocker to inhibit the gastric juices associated with severe heartburn.

But consumers need to be circumspect. "We don't have breakthrough drugs that often," Avorn says. "In fact, it seldom happens."

New drugs can pose a risk for a number of reasons:

Most clinical drug trials don't involve enough people or run long enough to identify rare side effects.

Drugs are seldom adequately tested on population subgroups, such as women, minorities, children or older adults, who may respond differently to certain medications.

There may be unknown adverse effects, for example, for people with liver or heart ailments.

With more widespread use, a new drug may be found to have adverse interactions with other prescribed or over-the-counter medications.

Baycol is a notorious example of a new drug that turned bad. The cholesterol-lowering statin was approved by the FDA in 1997 and heavily promoted by its maker, Bayer. About 700,000 Americans were taking Baycol when it was taken off the market in 2001.

It was recalled for raising the risk of rhabdomyolysis, a rare but lethal condition leading to serious muscle damage. With Baycol, patients and doctors had switched to a new drug that was found to be less safe than five other statins already available.

In 2004 the painkiller Vioxx, produced by Merck and used by 20 million Americans since it was introduced in 1999 with high-profile ads, was pulled from the market. Studies showed that patients who had taken the drug for 18 months or longer were at twice the risk for heart attacks or strokes as those who took a placebo.

"Over the years, I have become more hesitant to prescribe new drugs," Wolfson says. "Like most practitioners, I've been in the awkward position of replacing drugs like Baycol and Vioxx when the drugs were taken off the market."

The Vioxx case highlights the difficulty of determining when a drug is no longer considered "new." "There is no real number in terms of months or years," Avorn says. "We saw that Vioxx turned out to have substantial safety problems even though it had been on the market for five years."

Wolfson has developed his own standards for deciding how soon he'll prescribe a new drug: "It depends on whether other 'veteran' drugs are available for the same purpose; whether the potential for helping someone with a bad disease is very high; and whether the medical literature and my colleagues are reporting enough benefit to justify its use."

The health research arm of the advocacy organization Public Citizen recommends the "seven-year rule": Unless a medication is a rare breakthrough drug, don't take it until it has been on the market for seven years. By that time, adverse reactions are often known, and warning labels have been added—or the drug has been recalled.

A moratorium on Advertisements

While advertising to consumers began in the 1980s, industry spending more than tripled in three years after the FDA relaxed ad guidelines in 1997. One study found that every dollar spent on advertising yields more than $4 in sales.

Pressure from the American Medical Association, consumer watchdog groups and Congress has led some drugmakers to institute self imposed moratoriums on advertisements.

In June Bristol-Myers Squibb pledged to refrain from running them until a drug is on the market for at least a year. "Our primary purpose is to ensure that medical professionals have as much information as possible prior to having a dialogue with their patients," says company spokesman Tony Plohoros.

In August Pfizer agreed to delay marketing new drugs to consumers for the first six months after FDA approval. And last month the new PhRMA guidelines went into effect stipulating that ads "achieve a balanced presentation of ... benefits and risks" and that the FDA review TV spots before they're aired.

The FDA is "pleased" that PhRMA has taken steps to address some of the problems associated with advertising, says Tom Abrams, head of the FDA's Division of Drug Marketing, Advertising and Communications.

But Kassirer, author of On the Take: How Medicine's Complicity With Big Business Can Endanger Your Health (Oxford University Press USA, 2004), has doubts about the impact of these changes.
"There is an enormous amount of money tied up not only in advertising but also in lobbying," he says. Avorn adds, "It's a small step in the right direction. But I would prefer a moratorium of 85 years." At an FDA hearing in November, critics collided head-on with industry, calling for reforms ranging from more "consumer-friendly" information about risks, to lengthier (two to three years) moratoriums on new-drug ads, to banning advertising altogether.

Any revision of federal policy, expected this spring, isn't likely to make big waves. "In recent years," Kassirer says, "the FDA has become more closely tied to industry because industry pays for evaluation costs of their own drugs."

Some predict the growth of "unbranded" TV and print campaigns that focus on diseases rather than drugs, and a migration of ads to the Internet.
Pfizer, for example, has launched a "Make the Call" campaign to motivate men to seek information about erectile dysfunction. The ads don't mention Viagra but drive viewers to a website where they can sign up for free samples and a "value card" to save money on every seventh eligible prescription.

Ads or no ads, both doctors and patients have some responsibility for assessing the use, or need, for a new drug. "Patients need to be alert and educated about the nature of their disease and the medications used to treat it," Kassirer says. "When someone receives a new drug, they need to know [about it], too, and understand the risks."
Irene S. Levine of Chappaqua, N.Y., writes frequently about health issues.

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