According to a story in today’s Washington Post, “If it seems as though the Food and Drug Administration has been issuing a new drug safety warning almost every week, that's because, for the past three months, it has.â€
“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.â€
"We are trying to act in a responsible way," Seligman says.
According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''
And that’s the rub, because too much information can be as dangerous as too little.
According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.â€
In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.
Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.â€
Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.
Here's a link to the complete article:
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html
“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.â€
"We are trying to act in a responsible way," Seligman says.
According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''
And that’s the rub, because too much information can be as dangerous as too little.
According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.â€
In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.
Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.â€
Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.
Here's a link to the complete article:
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html
