Consumers 'virtually defenceless' over drugs
BERMUDA'S pharmacists may be receiving anxious queries after the US Food and Drug Administration's (FDA) top drug researcher said consumers were "virtually defenceless" if another medication such as Vioxx proved to be unsafe after sale.
Speaking to a specially convened meeting of the Senate Finance Committee yesterday, David Graham, Associate Director for Science of the FDA's Office of Drug Safety, warned that there were "at least five other drugs on the market today that should be looked at seriously to see whether they should remain there", according to reports.
He cited the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent. A local pharmacist confirmed that all of these drugs, except Meridia, are currently being prescribed in Bermuda.
"We have, especially recently, had some female patients come in presenting an Accutane prescription," said the pharmacist, "and when they read the warning, or we speak to them about the problems, they decide they don't want it. If used properly, it could be good, but I think too many doctors prescribe it too quickly."
There have been complaints that Accutane has been responsible for a rash of teenage suicides in the US.
"It's a good acne medication, but it has been linked to suicidal tendencies among teenagers, who are the age group most likely to use it," said the source.
She confirmed that appetite suppressants like Meridia were not allowed to be sold in Bermuda.
"Crestor is not the most popular medication," she added, "but Bextra has been picking up a bit. But it is also a 'cox-2 inhibitor' like Vioxx, and like Arcoxia and Celebrex, which are still being prescribed, and this Vioxx thing has opened people's eyes that there may be a problem with all of the cox-2s.
"They are wonderful drugs, and they help people with severe pain, and I don't know what people will do if all of the cox-2 drugs are taken off the market. Serevent is certainly prescribed for asthma."
Another FDA official, Dr. Sandra Kweder, said she did not agree with Dr. Graham's assessment. She said "there is no magic formula" to determine the drugs that pose the most pressing safety concerns, and that there were thousands of drugs on the market, each one carrying risks and benefits. She denied that the FDA intimidates scientists whose opinions differ from their superiors.
Merck CEO Raymond Gilmartin told the committee hearing that the company was surprised by the cardovascular risk posed by Vioxx, and that "my wife was a user of Vioxx until the day we withdrew it from the marketplace".
However, Republican Senator Charles Grassley, the committee chairman, suggested that an independent safety board may be needed to ensure the safety of medications after they're approved for market.
There was no word on whether Mrs. Gilmartin plans to sue Merck.