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Disregarding Suggestions from Experts, the FDA Has No Plans to Request Drug Makers to Increase the Size of Pre-Approval Clinical Study Groups

Jul 25, 2005 | For several years now there has been a growing concern among independent experts that the pre-approval process used to determine the suitability of a new drug for marketing is getting worse instead of better.

Since the late 1990s, there has been a dramatic increase in the number of drugs which have had to be withdrawn from the market. The institution of an industry-funded a “fast track” drug approval process has lead to inadequately tested drugs being rushed to market and the need for more and more serious (“black box”) warnings.

Many drugs which have caused widespread injuries or deaths have been unceremoniously pulled from the market not long after their release. Some of the more recent “failures” in the longevity department are: • Tysabri – 4 months; Lotronex – 9 months; Duract – 11 months; Posicor – 12 months; Redux – 17 months ; Raplon – 19 months; Raxar – 23 months; Baycol – 27 months; Rezulin – 38 months; and Baycol – 50 months.

One in five new drugs has serious side effects that do not show up until well after FDA approval. This often results from what many experts see as two serious flaws in the current “fast track” or “accelerated” approval process, namely, the lack of longitudinal (long-term) testing and the use of test groups which are far too small to represent an accurate sampling of the true range of patients who are likely to take the drugs being tested.

Significantly, in a high percentage of situations, problems develop either; (1) after patients have taken a drug for greater periods of time than the test groups, or (2) in segments of the population which were never included in the test groups at all or, at least not in a sufficient representative sample size.

Moreover, today’s drugs are being marketed without dosing charts or information with respect to the well-known fact that each person will metabolize a drug differently.

The pharmaceutical industry has also largely ignored the developing science with respect to “pharmacogenetics” which is the branch of genetics that studies the variations in responses to drugs based on individual genes.

These genetically determined differences in reactions to a given drug cannot be properly studied or determined when small test groups are exposed to a drug for a very short test period.   

The Food and Drug Administration (FDA) has also placed itself in a compromising position by accepting huge sums of money from the pharmaceutical industry to fund the agency’s Office of New Drugs which is now expected to “fast-track” drugs to market. That division has about 740 employees.

Unfortunately, no such funding is given to the FDA for post-approval monitoring of adverse reactions and side-effects by the Office of Drug Safety which only has about 112 employees.

Fast-track approvals, which are usually based on short-term testing of small test groups, have had disastrous results when used for drugs which are specifically designed for long-term or lifetime use by large segments of the population.   

Experts fear the pre-approval lack of long-term studies and the use of relatively small test groups can only lead to significant post-approval problems when less common or delayed side-effects become apparent.

At this time, however, it appears that the FDA is unwilling to admit it may have a problem when it comes to approving drugs based on insufficient clinical tests.

According to the director of the FDA’s Office of New Drugs, Dr. John Jenkins, the agency has no plans to act on suggestions from several experts that it request drug manufacturers to conduct larger clinical studies in the pre-approval process in order to detect serious, but less common, side-effects.

Jenkins claimed there might be “unintended consequences to what sounds like an easy, good idea.” One example would be to delay access to new therapies.

Of course, if a new therapy makes it to market on the basis of a fast-track approval and then must be pulled from the market almost immediately due to the emergence of side-effects that were not detected because of inadequacies in the clinical study process, what purpose was served by rushing the approval in the first place?

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