New drugs mean self-education for consumers HEAL THYSELF

THE BALTIMORE SUN

In the next year, you will be bombarded with $300 million worth of messages about new, over-the-counter drugs to relieve indigestion.

Your stomach cringes after pizza? Mexican food? Coffee? Suffer no longer, say the ads for Tagamet HB and Pepcid AC. The implication: Give up Tums and Rolaids and Mylanta for stronger stuff. Stuff sold under a name once available only by prescription.

Tagamet HB by SmithKline Beecham PLC, and Pepcid AC by Johnson & Johnson-Merck Co. Inc., are lesser-strength versions of popular drugs prescribed by doctors for ulcers (Tagamet and Pepcid). They are part of a whole new generation of stomach soothers that is expected to displace quickly antacids on the market.

And they are something more. Tagamet HB, which went on sale two weeks ago, and Pepcid AC, introduced two months ago, are the latest and biggest prescription drugs to be made available over the counter. But they won't be the last Rx-to-OTC switch.

The Food and Drug Administration is considering several dozen other drugs -- everything from pain relievers and cholesterol-lowering drugs to anti-viral agents and nicotine patches -- for over-the-counter use. The agency is expected to approve two more over-the-counter heartburn remedies later this year -- Zantac, made by Britain's Glaxo Wellcome PLC and now " the biggest-selling ulcer prescription, and Eli Lilly & Co.'s Axid.

Since 1975, the FDA has approved 55 prescription drugs for over-the-counter sale, including Tylenol, Advil and ALEVE, an analgesic introduced in 1994 that was formerly prescribed by doctors for arthritis and inflammation.

For drug companies, over-the-counter sales can breathe new life into drugs that are in danger of losing their market to generics or new kinds of treatment. For consumers, over-the-counter drugs can save time and, in some cases, money.

Over-the-counter drugs generally are cheaper for the growing millions of people who don't have health insurance coverage. People with insurance, however, could find themselves paying $20 for a remedy that used to cost them just $5 by prescription. Their insurance companies are the major winners here.

"In some cases, it may cost more. But in purely dollars and cents, to get a prescription, you have to go see a doctor, and for millions of people, that is salary out the window," says Frank Rathbun, spokesman for the Washington-based Nonprescription Drug Manufacturers Association.

Increased access

Many consumer health groups and doctors welcome the trend because it increases access to health care and allows patients to self-medicate. But they warn it could prove costly to patients who try to cure themselves of illnesses that are far more serious than heartburn, or patients who over-medicate or mix medications.

"I'm all for trying something other than running to the doctor every few minutes," says Dr. I. A. Razzak, who treats digestive diseases as chief of gastroenterology at the Greater Baltimore Medical Center.

"On the other hand, I am very concerned about people taking the medication when they should be diagnosed first." The new medications are fairly safe and very effective, he says, but "I still think it's not a bad idea to call the family doctor."

The promotion of over-the-counter drugs is likely to result in increased drug use for ailments that can or should be controlled in other ways -- in the case of gastrointestinal diseases, by watching your diet, by surgery and by newer prescription drugs.

One complaint is that manufacturers aren't educating consumers enough when the switch occurs.

"People just assume the OTC is safe. It's safe if you follow directions and if you heed the warnings," says Linda Golodner, ++ president of the National Consumers League, which is lobbying for better labeling and more manufacturer education.

Another concern is reactions from certain foods or other over-the-counter drugs. "People will tend to mix and match their medications until their headaches and heartburn go away," says Ms. Golodner. "We do encourage people to ask a pharmacist, but OTC drugs are not just OTC drugs in a drugstore -- they are OTC in a gas station."

When a drug becomes over-the-counter, it goes from being sold at 50,000 pharmacies to being available at 750,000 to 800,000 groceries, convenience stores, K marts and other retail outlets, says Francis Palumbo, professor and director of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy.

"You have to assume that someone was looking out for the patient when it was prescription, either the doctor or the pharmacist," he says. "But now, with 750,000 outlets where they can get it, there's obviously no one helping to counsel on the use of these products."

Over-the-counter switches are usually lower-dose versions of prescription drugs. They are not meant for long-term use.

Following directions

Druggists worry that patients won't follow directions. "There is a theory that if one works, two is better," says Mitch Rothholz of the American Pharmaceutical Association, which represents 45,000 pharmacists. The group has advocated a third class of drugs since 1964 -- drugs that are available over the counter but only in a drugstore, where use can be monitored. This is the system in Europe.

He advises those taking over-the-counter drugs to let their pharmacist know when filling prescriptions for other drugs so the druggist can screen for reactions.

The growing number of drugs approved for sale over the counter is being fueled by drug companies worried about losing huge markets to generics and newer drugs.

SmithKline faced the loss of a $1 billion market for Tagamet, whose patent expired in May 1994, when it applied for over-the-counter status. It hopes to keep the drug alive for 10, 20, maybe even 50 years, says Paul Madzik, chief of sales.

And switch is a sure-fire way to revive sales of an old drug. Schering-Plough's Gyne-Lotrimin and Johnson & Johnson's Monistat, anti-fungal products to treat vaginal yeast infections, saw sales double after going over the counter in 1991.

But not all candidates sail through the lengthy FDA review

process. Tagamet HB was rejected three times before the federal agency signed off, and it did so only after requiring SmithKline to warn consumers of possible ill effects when mixed with drugs for asthma, blood-thinning or seizures.

In the past two years, the FDA has rejected over-the-counter applications for Rogaine, a hair-loss treatment by the UpJohn Corp., and the herpes drug acyclovir, Burroughs Wellcome Co.'s leading product. In the latter case, health experts feared widespread use without proper treatment would increase viral strains resistant to the drug. Both drugs could be resubmitted for over-the-counter status.

Tagamet is the biggest prescription drug switch in history. It already has been prescribed 237 million times and is widely known as the drug that saved people from surgery for ulcers in the 1970s. In its first week of sales Aug. 14, Tagamet HB was the "No. 1-selling single package in the whole antacid category," Mr. Madzik says.

The market for gastrointestinal drugs , now about $900 million annually, will double as the new drugs are scarfed up by "people who have not had sufficient relief from those now available, or [who are] new to episodic heartburn," says Neil B. Sweig, financial analyst for Ladenburg, Thalmann & Co. in New York City.

The number of people with heartburn in the United States is estimated to be 25 million to 95 million.

"We expect an explosion," says Gary Lachow, spokesman for J&J-Merck.; Some Pepcid AC customers will be converts from Tums, Maalox and similar products, he says, but the company is also pushing the drug to people who want to indulge in certain kinds of food and drink without having to worry about heartburn afterward. Pepcid AC advertises that it can be taken an hour before meals to prevent heartburn.

That pitch troubles Dr. Oleh Haluszka, director of gastrointestinal endoscopy at the University of Maryland Medical Center, even though he welcomes the over-the-counter movement. "We try to get patients to modify lifestyle so they don't have to take drugs, and drug companies are trying to get them to take drugs so they don't have to modify lifestyle," he says.

People with heartburn should avoid coffee, fatty foods and anything with onions and garlic, he says. There are also newer prescription medicines that are more effective for some patients, and surgical solutions -- operations to close the esophagus valve to the stomach and cut off acid production -- for others.

Dr. Haluszka worries that people who don't know they have Barrett's esophagus, a condition often associated with esophageal cancer, will take higher doses of heartburn remedies rather than see a doctor.

In some instances, he warns, the medications appear to work, and patients think they are getting better when their condition actually is worsening. This happens when the lining of the esophagus is so inflamed it loses its sensitivity.

Generally, though, he and others agree that over-the-counter drugs are a low-cost form of health care. They are very appealing to consumers, particularly as people change doctors more and medicine becomes less personal, says Ms. Golodner, of the National Consumers League.

"Consumers," she says, "like to self-medicate."

THE WAITING LIST

Other prescription drugs being considered by the Food and Drug Administration for over-the-counter sales include:

* Claritin (Schering-Plough) for colds

* Clinoril (Johnson & Johnson-Merck) for pain relief

* Flexeril (Johnson & Johnson-Merck), a muscle relaxant

* Mycostatin-topical (Bristol-Myers Squibb) for infections

* Nicoderm (SmithKline Beecham), an anti-smoking nicotine patch

* Nicorette (SmithKline Beecham), an anti-smoking gum

* Questran (Bristol-Meyers Squibb), a cholesterol-lowering drug regimen

Sources: FIND/SVP and the Federal Trade Commission Report's Tan Sheet."

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