Dangerous Disconnent on Drug Safety
Sept 30, 2006
This week, scientists completed mapping the mouse brain down to details of individual cells. Because much of the neurochemistry of humans mirrors many of the pathways found in mice and rats, researchers will be able to use this molecular guide to more quickly determine which medicines might work to control or delay the progression of such devastating brain illnesses as Alzheimer's, Parkinson's and Lou Gehrig's disease.
But first some enterprising researcher should use the map to explain the disconnect in the minds of some between the crushing burden such diseases impose on families and society and proposals that that supposedly benefit the public health but in fact delay the development of new medicines. They can also make them more difficult and more expensive to introduce.
One subject of this study should be the Institute of Medicine (IOM), which just released a report on the Food and Drug Administration's ability to monitor the safety of medicines. The study asserts that it is impossible to make a medicine 100 percent safe and harder still to understand (using methods the IOM admits are inaccurate and outdated) why some people react badly and some respond well. Rather than recommending a more computerized and gene-based approach to detecting and predicting safety problems -- which can affect a very small group of patients -- the IOM wants the FDA and companies to spend billions conducting randomized clinical trials that test everybody as if they were the same to discover what current methods rarely find in the first place.
Will this make medicines more expensive to make? IOM is indifferent. Will patients doing great on a drug enroll in a safety study where they have half a chance of not getting the medicine keeping them alive? It never crossed the minds of the IOM solons.
The other subject should be Sen. David Vitter of Louisiana, who sees no connection between barring Customs Agents from inspecting packages of medicines from Canada and the prospect of polluting the entire prescription-drug supply of the United States. Individuals carry much of the illegal narcotics coming into this America under threat of arrest. Thanks to Mr. Vitter's amendment to a Homeland Security bill, counterfeiters and suppliers of controlled narcotics will be able to cross from Canada into America.
A flood of bogus drugs for diseases such as Alzheimer's, heart disease and cancer won't be discovered until they enter the market. By that time it will be too late and too expensive to track the problem. The same can be said for IOM's after-the-fact and outdated approach to drug safety. Both will lead to fewer innovations.
Sept 30, 2006
This week, scientists completed mapping the mouse brain down to details of individual cells. Because much of the neurochemistry of humans mirrors many of the pathways found in mice and rats, researchers will be able to use this molecular guide to more quickly determine which medicines might work to control or delay the progression of such devastating brain illnesses as Alzheimer's, Parkinson's and Lou Gehrig's disease.
But first some enterprising researcher should use the map to explain the disconnect in the minds of some between the crushing burden such diseases impose on families and society and proposals that that supposedly benefit the public health but in fact delay the development of new medicines. They can also make them more difficult and more expensive to introduce.
One subject of this study should be the Institute of Medicine (IOM), which just released a report on the Food and Drug Administration's ability to monitor the safety of medicines. The study asserts that it is impossible to make a medicine 100 percent safe and harder still to understand (using methods the IOM admits are inaccurate and outdated) why some people react badly and some respond well. Rather than recommending a more computerized and gene-based approach to detecting and predicting safety problems -- which can affect a very small group of patients -- the IOM wants the FDA and companies to spend billions conducting randomized clinical trials that test everybody as if they were the same to discover what current methods rarely find in the first place.
Will this make medicines more expensive to make? IOM is indifferent. Will patients doing great on a drug enroll in a safety study where they have half a chance of not getting the medicine keeping them alive? It never crossed the minds of the IOM solons.
The other subject should be Sen. David Vitter of Louisiana, who sees no connection between barring Customs Agents from inspecting packages of medicines from Canada and the prospect of polluting the entire prescription-drug supply of the United States. Individuals carry much of the illegal narcotics coming into this America under threat of arrest. Thanks to Mr. Vitter's amendment to a Homeland Security bill, counterfeiters and suppliers of controlled narcotics will be able to cross from Canada into America.
A flood of bogus drugs for diseases such as Alzheimer's, heart disease and cancer won't be discovered until they enter the market. By that time it will be too late and too expensive to track the problem. The same can be said for IOM's after-the-fact and outdated approach to drug safety. Both will lead to fewer innovations.
