Monday, November 28, 2005

Patient Safety and the Drug Approval Process in North America

as written by Samna Ghani

The recent withdrawal of Vioxx from the market has brought the Food and Drug Administration (FDA) and its drug approval process in limelight and does raise the question: Does the drug approval process in USA and Canada really guarantee a patient's safety? After this incident, the FDA has been under strict surveillance and its credibility has indeed fallen. It has been accused of having a broken down regulatory system, of approving drugs without completely testing them, failing to follow up and monitor on unexpected side effects of drugs already in the market, of rushing drugs to the market etc. According to statistics obtained from the FDA itself, toxic reactions to marketed drugs are estimated to cost more than $30 billion per year and can be considered to be among the 10 leading causes of death in the United States.

For most of the general public, a drug with FDA approval means that that particular drug is safe and has been properly evaluated. But how much does a general consumer know about the drug approval process in USA and Canada? How much does a general consumer know was identified, studied or examined about a particular drug? The general consumer only learns about a drug when he is either prescribed it, or when he hears that someone else was prescribed, or when he hears it on the news that a particular drug was launched and then withdrawn from the market after causing many injuries and sometimes, even death. The general consumer is, most of the time, unaware that the pharmaceutical companies play a major role in the approval of prescription drugs.

Since 1997, more than a dozen drugs have been taken off the market due to severe side effects or injuries. This may come as a surprise to most US/Canadian consumers who believe that drug approvals by their health authorities guarantee that drug’s safety. They are unaware that when a drug goes on the market, only about 3,000 patients have ever been given that drug and that one never knows whether this drug may result in causing some harm to a patient maybe in 10,000 or 20,000. That would only be revealed once the drug is in the market and is being widely prescribed. And that would also be dependent on the fact that individual doctors and/or clinicians would identify a serious side effect and would actually report it to the FDA. That is a rare occurrence since most doctors report a drug’s side effect to the drug’s manufacturer. Then it’s on the company’s conscience whether it informs the FDA or not. This dependence on pharmaceutical companies to report any adverse events is not very reliable since its not guaranteed that all companies could be trusted to do so. There is no guarantee that these pharmaceutical companies wont hide this information just to avoid their product being pulled off the market or to avoid bad publicity.

Thus the question again is: Does the drug approval process in the USA and Canada guarantee the patient’s safety? No it does not. This can be gauged from the following:

1. Approval of a substantial number of drugs that have recently been approved and then withdrawn from the market as a result of safety problems;

2. Delay in the removal from the market of some recently approved drugs;

3. Drugs banned in other countries for safety reasons, including recently approved drugs, which remain on the market in USA;

4. The conflict of interest created by the existing structure of FDA where the same personnel responsible for approving drugs have a central role in deciding whether a drug should be withdrawn or not due to reports or safety concerns.

This information has been published by the International Biopharmaceutical Association www.ibpassociation.org . Please note this information does not give any medical advice.

The project is sponsored by Kriger Research Center - CRO and Training Services ( www.kriger.com ) , ClinQua CRO (www.clinqua.com ), Biorole Free Resumes Data Base (www.biorole.com ) and Altaspera Designs ( www.altaspera.com )

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