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Stuart Lieberman
Stuart Lieberman, Esq.
liebermanblecher.com

*NJ Deputy Attorney General assigned to the State Department of Environmental Protection from 1986 - 1990.
*Partner in the environmental law firm of Lieberman & Blecher, P.C. in Princeton, New Jersey
*Lectures for the N.J. Institute for Continuing Legal Education (ICLE), and is available for other speaking engagements through the year.


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THE ENVIRONMENT
Canada is right on ADD medicine
Stuart Lieberman, Esq.,

Americans have leaned a lot about the drug approval process as of late. I assume they have learned more than they would have liked.

First it was VIOXX. Merck pulled this highly profitable drug off the market when, it says, it learned that it may be killing people. Of course, there have been recently published reports that suggest that Merck could have known there were problems earlier but perhaps was not anxious to know. I certainly don't know what the truth is in this regard.

But there are now many lawsuits in the US that have been filed relating to the potential dangers associated with this drug. One wonders which will be higher: the profits Merck made on Vioxx, which were very high, or the settlement amounts and attorneys fees that will now follow.

No matter what, we will likely learn the truth about what, if anything, Merck knew, and when it first knew it. I question the value of knowing after the harm has been done, but that is another story.

Other drugs are now under similar scrutiny. Included on the list of new targets is a popular cholesterol drug. Now Americans are trying to figure out where the line is between acceptable risk and out right danger. A drug that is effective but ultimately causes worse harm that the underlying disease is probably not worth having.

Why do we have this problem in America? Why does the FDA approve drugs that ultimately are more problematic than originally thought to be?

A common response is that the drug companies informed us of the risk. Maybe that is technically correct. If you read those seemingly impossible to read pamphlets that come with prescription drugs, they often do state an element of risk.

But who reads those papers? And of those who do, who really understands the risk?

Most of us simply assume that if the American government allowed the drug to be sold, it must carry with it an acceptable risk. It appears now that this assumption is not well placed.

Other countries do things differently. They are less likely to approve until studies have been exhaustively completed and it is proven that the products are safe.

I have heard that in the US we approve and then revoke approval when problems arise. Elsewhere, they don't approve at all until a product is proven to be reasonably safe.

Which brings me to the newest nightmare: the dispute over Adderall XR. Canada looked at the data and pulled it. Even though there have just been a few deaths, reportedly involving persons who have pre-dispositions to heart problems, Canada said that is enough.

The US looked at the exact same information. And did nothing at all. It will allow the product to remain on the market for now at least.

Who is right and who is wrong? Every drug has an effect and risk. The question is whether a risk is justified.

I am certain that the fact that some of those who died were pre-disposed to life threatening illness explains some of the difference. In America, our government has likely concluded that the at-risk populations simply should not be given Adderall XR. In Canada the government presumably acknowledged that prescription errors occur and will continue to do so. And, there are some who have undiagnosed pre-dispositions.

Which I suspect means more will die and be hurt in America over time. And in Canada, that risk has been eliminated.

It appears that Canada has it right. Other ADD drugs are available and many work very well. No one should have to die because he or she has ADD.

Of course, the American government does not like being one-upped by our Northern neighbor. Don't be surprised if the FDA follows suit in a few months from now.

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The information provided in this column is written by Stuart Lieberman,a practicing environmental attorney, and is for general information purposes only. It is not legal advice and should not be used in place of legal advice.

Stuart Lieberman, Esq., and IRED.Com, Inc., will not accept any responsibilty for any reliance on the information in this column or any damages whatsoever resulting from reading this column.


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