Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: FRIDAY, October 14, 1994                   TAG: 9410140091
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-7   EDITION: METRO 
SOURCE: Associated Press
DATELINE: NEW YORK                                 LENGTH: Medium

$50 RX COULD BE HAD FOR $5

The pharmaceutical company said it has complied with medical rules concerning the drug Organidin by informing doctors about the formula change.

But lung disease specialists and others said Carter-Wallace is guilty of at least a breach of medical ethics.

``It's basically a fraud on the public,'' said Dr. Sidney Wolfe, director of the health research unit of Public Citizen, the Ralph Nader consumer organization.

Organidin has been available for generations and is used to clear lungs of mucus in victims of respiratory diseases. Last year, doctors wrote about 956,000 prescriptions for it, according to IMS America Ltd., a research firm.

This year, the Food and Drug Administration ordered Carter-Wallace to change the formula after tests showed its main ingredients, iodinated glycerols, caused cancer in laboratory rats.

Carter-Wallace is shipping the reformulated version, called Organidin NR, to drug stores this month for the same price as the old version.

Its main ingredient is guaifenesin (gwye-FEN-e-sin), the same medication in Robitussin DM, Vicks Formula 44E, Triaminic Expectorant and a variety of other over-the-counter cough and cold medicines.

Dr. Peter Rheinstein, an FDA official who supervises drug information sent to doctors, said Thursday that companies are allowed to package some nonprescription drugs for sale with a prescription. For instance, the painkiller ibuprofin, the main ingredient in Advil, is still sold in prescription form at higher dosages.

But in the Organidin case, the prescription dosages of guaifenesin are similar to the over-the-counter dosages.

Since FDA doesn't regulate drug prices, there's nothing the agency can do about the cost of Organidin NR, Rheinstein said.

``Our responsibility to consumers was to get iodinated glycerols out of the marketplace, and we've done that,'' said FDA spokesman Don McLearn.

Carter-Wallace wouldn't make executives available for an interview, but said through a public relations company that it has met its medical obligations.

``They say they are very careful in the packaging and the instructions to doctors that it's not the same formulation as the old one,'' said Lois Brown of the public relations company Ruder-Finn Inc. ``Doctors should be very much aware of what it is. Doctors must make a new decision as to whether to prescribe the drug.''

But Dr. Stuart Garay, a lung disease specialist at New York University Medical Center, said many doctors may fail to tell patients they can buy the new drug more cheaply.

``Doctors were used to prescribing Organidin before. They may look at this. They may not,'' he said.

Moreover, guaifenesin doesn't work as well, the doctors said.

``They're making people think the new name will convey the same benefits as the old name, but it doesn't. That's deceptive in its intent,'' said Dr. Kevin Cooper, a professor at the Medical College of Virginia in Richmond.

The one benefit to patients is that Organidin NR may be covered by health insurance while over-the counter drugs are not, the doctors said.