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Does the Federal Drug Administration Really Provide Protection?

In 2005 a new antibiotic for minor respiratory infections Ketek, hit pharmacy shelves and was prescribed to millions of Americans. Ketek has now been linked to 18 deaths and over 130 cases of liver damage. Unfortunately this is a frequent occurrence among newly FDA approved drugs. For over 100 years the American public has put their trust in the Federal Drug Administration to ensure the safety of vaccines, medication, and medical devices however recent headlines have revealed the overburdened and ethically challenged state of agency. The amount of adverse drug reactions has doubled and the amount of deaths has nearly tripled. Despite the recent $145 million government funding increase, the FDA is still learning too late of dangerous drug side-effects and moving too slowly to remedy the problem and protect consumers. A recent article in Reader’s Digest highlighted the five main issues ailing the FDA that we need to be aware of.

1) The FDA is relying too heavily on funding from drug companies who constantly pressure review boards for faster approval of newly developed drugs. Necessary review time has been cut nearly in half and reviewers are asking fewer questions addressing drug safety. Drug companies provide $400 million a year in “user fees” to speed up approval of new drugs which pressures the agency to overlook important safety problems that would prolong the review period.

2) The rush to approve drugs quickly has compromised the quality of the clinical trials designed to discover any dangerous drug side effects. Studies are completed on fewer individuals in shorter periods of time and are also targeted to specific populations and not the general public with different health backgrounds. Therefore many problems are not revealed until drugs have been on the market for years and prescribed to thousands. Currently post-market surveillance to make sure drugs continue to be safe once they are approved is not mandatory. However congress has recently taken action to fine the FDA with $10 million in fines if they don’t follow up on long-term drug effects. Companies also need to make results from all clinical trial available instead of misleading physicians by just publishing favorable findings. Results can be accessed at both www.clinicaltrials.gov & www.fda.gov/medwatch.

3) The FDA also needs to keep better records of reports of adverse drug reactions so bottles can be relabeled or pulled from pharmacy shelves faster. This would require the investment of more time and money into receiving and reporting new findings.

4) The last 2 issues deal with ethical and morale challenges. A recent study has revealed that more than half of the members on 22% of advisory boards have direct financial interest in the drug companies being evaluated, or their rivals. This conflict of interest contributes to the unethical decision-making that speeds up the review process.

5) Lastly staff members are being threatened to down play product dangers or suffer consequences. There have been instances where scientists have been reprimanded for recommending a black box warning (strongest). Many have also been told to provide inaccurate or misleading information to the public. However recently Congress created the Office of Chief Scientist of the FDA, which will provide a forum for staffers to freely express their concerns and make them a part of public awareness.

These findings emphasize the necessity for consumers to be extra cautious of new drugs on the market and take it upon themselves to ensure their safety.


Written by Jodie Sasaki with Eric Sternlicht, Ph.D. Occidental College, Los Angeles, CA.