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Careful with New Drugs
By Dr. Herbert S. Denenberg

Item: On May 3, 1979, press reports headlined a New England Journal of Medicine article reporting that men who had been given Tagamet, an anti-ulcer drug, showed some reductions in their sperm count.

Item: On May 11, 1979, a British medical journal raised questions about a possible link between Tagamet and gastric cancer.

Smithkline Corporation, the manufacturer of Tagamet, claims the sperm count study is inconclusive and that the possible cancer link is "without scientific foundation."

But whatever the conclusion on these two studies, there is a larger lesson that emerges from these two reports. There is always some unknown risk when anyone uses a relatively new drug such as Tagamet.

It was introduced on August 17, 1977 by Smithkline Corporation as a "major breakthrough in the treatment of certain gastrointestinal diseases" including ulcer.

As soon as the drug was put on the American market, there were reports of new adverse reactions to Tagamet. For example, on August 3, 1978, the New England Journal of Medicine published a brief letter that claimed Tagamet had caused "moderately severe and persistent diarrhea" that resulted in substantial disability and dehydration.

On September 8, 1978, a highly regarded newsletter for physicians, The Medical Letter, concluded: "Tagamet continues to be useful and generally well tolerated for treatment of duodenal ulcers, but many adverse effects have recently been published. Mental confusion, particularly in elderly patients, may be the most troublesome of these."

All of this is not intended to pass judgment on Tagamet, but only to caution all consumers that there is serious risk, some known and some unknown, when any drug is used, especially a new drug, which has not had time to have the full range of its adverse effect revealed, catalogued, and understood by the medical profession.

Sometimes, the dangers of a drug are well known and well reported. Yet it may continue to be used on a massive scale by physicians. The classic example of this Chloromycetin, the chemical name of which is chloramphenicol.

Dr. Richard Burack of Harvard said that the drug's potential toxicity had been known to the medical profession since the early 1950s. Dr. Burack said that if the drug had been used only for its intended and appropriate purpose only about 10,000 American would have received it each year. Yet, he noted that Congressional hearing in November of 1967 found that as many as four million Americans were getting the drug each year.

The drug killed many people, was considered extremely dangerous, and yet was widely used for trivial purposes; such as the treatment of acne, minor infections, and the common cold.

One of the reasons this drug was widely over-prescribed was because it was highly advertised, and virtually rammed down the throats of doctors and patients by pharmaceutical advertising.

The parallels to Tagamet are not complete, but they are instructive. Tagamet has been subjected to an immense amount of advertising, and it is an important part of the profit picture of Smithkline Corporation, just as Chloromycetin was an important part of the profit picture of its owner, Parke, Davis & Company.

Sometimes, the dangers of a drug are well known and well reported. Yet it may continue to be used on a massive scale by physicians.

Consumers have to protect themselves against possible adverse reactions due to the power of pharmaceutical advertising by asking more questions when they are offered a prescription.

Here are some specific rules that make sense:

Rule One. Ask the doctor why the drug is being prescribed and about its specific dangers and benefits. Make sure the prescription makes sense for you and your medical problem.

Rule Two. Make sure you understand exactly how to take the drug. It's a good idea to take notes. You're not likely to remember the specific instructions hours later when its's time to take the drug. You magnify the dangers of drugs by not taking them correctly.

Rule Three. Don't pressure a doctor to prescribe a drug. There are enough pressures on the doctor coming from the pharmaceutical industry without adding your own silly pressures. Some doctors will do what the patient wants, even against sound medical judgment.

Rule Four. If any unexpected problems develop, get hold of the doctor immediately and ask him how to proceed.

Rule Five. Use a good pharmacist as double-check on a doctor. A skilled pharmacist can advise you on how to take and store drugs, can often answer questions, and can protect you from mistakes of your physician.

*Reprinted with permission from Caveat Emptor.

Caveat Emptor is offering a free introductory copy of its current issue to readers of Cancer Forum. Write to Caveat Emptor, 17 Freeman Street, West Orange, N.J. 07052.

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