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Five Years Later, FDA Guidelines on Elderly Drugs Unenforceable

March 25, 1988

WASHINGTON (AP) _ The government has yet to enact guidelines ensuring that manufacturers of new drugs test their medications on the elderly, a Senate panel was told Friday.

Medical experts appearing before the Senate Special Committee on Aging said the guidelines, along with better labeling, were keys in curbing a ″disturbing frequency″ of harmful drug reactions among people over 60.

On June 28, 1983, Mark Novitch, then Food and Drug Administration deputy commissioner, told the Committee on Aging that the agency was developing standards to make sure elderly patients were included in tests of new drugs for ailments common to senior citizens.

But the guidelines remain unpublished, FDA Commissioner Frank E. Young said in a statement the Senate panel released Friday.

″Five years later, the FDA is still dragging its feet,″ said Sen. John Heinz, R-Pa., the committee’s ranking Republican.

Young said the FDA had not ignored the standards, but rather had been circulating them among drug companies in draft form for comments and fine- tuning.

″The guidelines are already being implemented in that the pharmaceutical industry is using them,″ Young said.

But physician Jerry Avorn of the Harvard Medical School told the panel that without final guidelines, there has been ″great variabiity in the eagerness with which drug companies have sought out the elderly in the investigational stages of a new drug.″

Avorn said there was a ″disturbing frequency″ of adverse drug reactions among senior citizens.

Young did not appear in person for questioning, saying in a letter to committee chairman John Melcher, D-Mont., that he was notified two weeks ago and did not have had adequate time to prepare.

In 1986, people 60 and over accounted for at least 39 percent of 4,481 hospitalizations due to adverse reactions from medication, according to FDA figures.

But researchers have estimated the number of such hospitalizations might actually be much higher. Stereotypes of the elderly as confused, depressed, weak or diarrheic often cause health professionals to miss drug-related ailments, said William Simonson, associate professor of pharmacy at Oregon State University.

″Since the most common manifestations of adverse drug reactions in the elderly are precisely the same symptoms of this unfair stereotype, professionals who believe that aging is synonymous with deterioration of physical and mental function often overlook medications as the cause of their patients’ deterioration,″ Simonson said.

Simonson said the FDA was not being tough enough in ensuring that geriatric-specific information appeared on labels.

FDA spokesman Bill Grigg said in an interview that labeling would improve as better information became available about specific medications.

Two other witnesses, Wilda Henry of Golden Gate, Fla., and Ann Little of Cray, Tenn., said their mothers had suffered needlessly because physicians had prescribed drugs that produced harmful reactions.

Little said doctors had recommended over-the-counter antacids, laxatives and painkillers for her mother, Donnis Ware. More importantly, she said, her mother’s medicine cabinet was a ″mini-drug store″ of 14 prescription drugs, including medication to strengthen the heartbeat and regulate rhythm, control blood pressure and increase urine flow.

She testified that her mother had been hospitalized after a January 1986 overdose left her ″sprawled and lifeless,″ and later confused.

Ms. Henry said her mother, whom she declined to name, had become ″a vegetable″ from legal drug use.

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