Wednesday, June 6, 2012

FDA--Failed Drug Agency?

On Tuesday, the New York Times published an article discussing debate over the mechanism of the "morning after" pill, Plan B. In recent years, research has indicated that the drug's mechanism of action was not as many had previously thought--that the drug prevented a fertilized egg from implanting in the uterus. This was what the FDA label indicated and what the NIH and Mayo clinic notes on their websites. With this being the understanding of the drug's mechanism, the drug was an abortificant since it prevented implantation. However, recent research has indicated that this may not be how the drug works:
Studies have not established that emergency contraceptive pills prevent fertilized eggs from implanting in the womb, leading scientists say. Rather, the pills delay ovulation, the release of eggs from ovaries that occurs before eggs are fertilized, and some pills also thicken cervical mucus so sperm have trouble swimming.
If this is the case, I'm glad to hear that the drug's mechanism is not as such that it terminates a pregnancy, but that it prevents a pregnancy by preventing fertilization. However, it does raise questions about the FDA's processes. Why did their labeling indicate that the drug prevents implementation of a fertilized egg? Moreover, why was a drug approved in the first place if its pharmacology was not known?

The NYT article notes that the drug was approved in 1999, and that the drug's maker Teva asked to not list the implantation mechanism on their label. However, the article does not indicate why the company chose to not include this. Was the company fearful of the blowback of the pro-life movement? The implantation prevention mechanism was ultimately listed, but apparently without scientific proof.

The article goes on to note the FDA approval process for Plan B:
Back then, scientific research concentrated on whether Plan B’s active ingredient, a synthetic progesterone, safely and effectively prevented pregnancy, not on how it worked, said Dr. Kristina Gemzell-Danielsson, an obstetrics and gynecology professor at the Karolinska Institute in Sweden, who participated in World Health Organization studies leading to F.D.A. approval.
 This statement contradicts what the FDA describes in their multi phase clinical trial process to bring a drug to market.  After being approved as an investigational new drug (which enables researchers to test their drug on humans), the drug will go through three phases of clinical trials before it is approved. After it is approved, the drug will continued to be monitored for long term side effects. What is most shocking about the research claim is that the FDA's multi phase process includes determining drug action early on in the process:
PHASE 1 TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
 "Pharmacologic action" simply means specifically how the drug works. Why wasn't the pharmacologic action of the drug determined during this process? Why did it take further research AFTER the drug was approved to clarify its mechanism? The FDA's role is to confirm efficacy and safety of a drug. How can these be fully understood if the drug's mechanism is not known? A drug may be proven to work if symptoms are relieved, a disease cured, or if a condition prevented. However is the mechanism safe? Safety is equally as important as efficacy. 

The NYT article goes on to note from an FDA official:
Ms. Jefferson of the F.D.A. said it was often difficult when a drug is approved, and even afterward, to pinpoint how it works. Citing confidentiality rules, she would not discuss why the agency declined the company’s request to omit implantation. 
 What contradiction from the FDA! They claim that their regulatory approval includes determining pharmacological action, yet their own personnel claims that it's often difficult to pinpoint how a drug works! While this may be the case, why do they note this as part of the process? They may have specific criteria for how much needs to be known about a drug's pharmocology before it is approved to go to Phase II, but why is not something as different has preventing or ending a pregnancy not determined prior to the drug being approved? This should be the case for any drug, but most assured it should be the case for a drug when it's a matter of preventing pregnancy or terminating it. Government regulation for true safety has its place, but regulation must live up to its own standards.

As a sidenote, the New York Times titled their article " Abortion Qualms on Morning-After-Pill May Be Unfounded", yet another example of the media trying to paint pro life people in a negative light as if the pro life movement was trying to perpetuate an untruth, when in actuality, a government agency did not do its due diligence in its regulatory process.

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