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Tuesday, November 28, 1989 / University Daily Kansan
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Watkins removes a generic drug
By Melanie Matthes Kansan staff writer
The recent uprora about the quality and viability of generic drugs has resulted in the removal of a drug from the Watkins Memorial Health Center pharmacy.
The manufacturer recalled the drug because its effectiveness was under question by the manufacturer and by the Food and Drug Administration.
the generic drug, nitrofurantoin, had been dispersed to 64 patients before it was removed from distribution by the manufacturer, said John Baughman, chief pharmacist.
The drug is a generic version of macrodentin, an antibiotic for urinry tract infections.
Baughman said that Watkins officials had notified each of the patients who had been prescribed the drug and that two patients had returned to Watkins with symptoms of infection.
Manufacturer recalls product
ding generic drugs in the result of a criminal trial against FDA chemists and drug manufacturers, said a representative of the FDA's division of generic drugs. The representative asked that his name be withheld.
Part of the controversy surroun-
Some FDA chemists were approving generic drugs for companies who paid them before they approved drugs for other companies, he said.
"There were reports from the drug industry that FDA chemists were taking bricols for favoritism in approving generic drugs," he said.
Another problem with the generic drug industry is that manufacturers are cheating on tests of a drug's bioequivalency, the FDA representa- said. Bioequivalency means that a generic drug is therapeutically as effective as its brand name counterpart.
"There is a real problem with generic drugs because firms are submitting fraudulent data," he said.
Some companies under FDA scrutiny were putting the brand name drug into their generic version so that the drug would pass the bio-equivalency test, he said.
"We have to be a bit more clever about what we describe," he said.
The representative said that the problems with the generic drug industry had resulted in the recent announcement of FDA commissioner Frank Young's resignation. Young's resignation is effective in December.
Watkins complies with very rigid rules about informing a patient when he is prescribed a generic drug, Yockey said. The patient is always informed of the generic and given the option of taking the brand name drug.
The FDA is looking at the generic drug system and is trying to institute a new protocol, the representative said.
quality.
Patients who get their drugs at Watkins are protected from unsafe generic drugs by a state purchasing system, said Charles Yockey, chief of staff. This system requires that drug companies who have contracts with the University of Kansas show proof that a generic drug is standard
Baughman said that of the 4,000 drugs in the pharmacy's inventory, about 20 percent were generic.
The cost of the generic antibiotic that was recalled from Watkins was half of the cost of the brand name, Baughman said.
As a result of the problems with the generic drug industry the FDA provides the Orange Book to pharmacists and doctors, he said. The book categorizes drugs as to whether they are bioequivalent to their brand name.
"We're going to find that how rapid generic drugs hit the market is going to be slowed because of these problems," he said.
Researchers look into alcohol-based fuel
By Beth Behrens Kansan staff writer
Gasoline companies stopped adding alcohol to gasoline a few years ago because it ruined engine seals if the alcohol was allowed to stagnate.
But a KU professor said members of the Environmental Protection Agency and some KU researchers may be looking to a new alcohol-based fuel as an answer to the pollution problem.
Don Gyorog, chairman of the mechanical engineering department, said Congress was trying to promote the use of methanol, a combination of methane and alcohol, through the introduction of clean air bills. He also said he had been contacted by the EPA to find out what answers KU experiments would reveal.
ments would be.
Gyorog said the department was setting up experiments with the KU chapters of the American Society of Mechanical Engineers and the Society of Automotive Engineers to test power and emissions of engines using methanol.
water after a period of time.
The problems with alcohol in gasoline are not easy open to solve, he said.
in APRIL, ASME will sponsor a student technical writing contest concerning the data collected from these experiments. Gyorog said. The contest will focus on methanol and a reformulation of gasoline to reduce harmful emissions.
Another is that it ruins seals in engines. The alcohol, if allowed to stagnate, will steep into the platic seals and cause them to swell. The seals will then leak. Gyorog said that in some cases, some of
One of the problems is that the alcohol absorbs water from the air, making the gasoline collect
There is a lot of perceived danger, although there is little or no history of propane explosions. It's a very safe fuel, but the psychological aspect is very important.'
— Dennis Lane
professor of civil engineering
the rubber from the seals would dissolve into the gasoline.
He said the task now was to reformulate the gasoline to avoid those problems.
business. Dennis Lane, professor of civil engineering, said a positive aspect about using alcohol was that it was a pure fuel, so it would burn to complete combustion, producing carbon dioxide and water vapor. A negative aspect is the threat of the greenhouse effect.
"The best scientists would indicate that there was probably no substantial evidence supporting that the greenhouse effect was occurring," Lane said. "But if going down the road you see some real
possibilities that this could be happening, you ought to take a really serious look at it to have a grasp on how to solve the problem.
"Any increase in the production of carbon dioxide could produce a problem."
Lane said the fuel of his choice, if he were restricted to changing the fuel only and not the engine of automobiles, would be propane, because it would reduce emissions drastically. It would not produce nitrous oxides, carbon monoxides or hydrochemicals that gasoline combustion produces, he said.
"There is a lot of perceived danger, although there is little or no history of propane explosions," he said. "It's a very safe fuel, but the psychological aspect is very important. 'Propane is liquefied natural gas, so another problem is that we don't have the huge processes it would take to produce. It would take a while to build the industry to satisfy the need in the United States."
He said that propane was used in heavy equipment and farm machines but that it hadn't been seriously considered as an alternative solution to the automobile emissions problem.
He said he thought the trend was aimed at alcohol because it was a product that could be inexpensively produced in the United States.
Lane said automobile emissions made up 60 to 70 percent of the air pollution created by people.
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