The Fda's Caution Is Hazardous To Our Health

On the website intelligence squared, doctors and professors hold debates about real world issues. One such issue is “The FDA’s caution is hazardous to our health." Two teams of two people debated the issue. Arguing that the FDA’s caution is hazardous were Dr. Scott Gottlieb and Peter Huber. They believed that the FDA is performing too many tests that take too long in the name of statistics. They said that the FDA should release medication that could save lives as early as possible and let doctors decide if the medication will benefit their patients. Arguing that the FDA’s caution is not hazardous were Dr. Jerry Avorn and Dr. David Challoner. They believed that the FDA should continue with their testing methods if not test more. They said that
the public safety should not be risked if a medication has not been thoroughly tested. Both teams made compelling arguments, but each team had some serious problems in their arguments. Both teams had some significant ambiguity in their arguments. Each team also had opposite value assumption, but neither team explained why their value preference should be believed. Dr. Jerry Avorn gave some statistics in his argument, but he did not give us enough information to know if the statistics could be trusted. Dr. David Challoner gave many examples to support his argument, but he did not address any of the many examples that did not support his argument. Dr. Scott Gottlieb and Peter Huber and Dr. Jerry Avorn and Dr. David Challoner all have a strong appeal to emotion in their argument. They try to manipulate the audience’s emotion to gain their support. Lastly, Dr. Scott Gottlieb and Peter Huber do not address alternate causation in their argument. They state that the FDA’s regulations caused some events, but they do not discuss any other causes for these events. All of these issues affect the audience’s ability to accept each team’s conclusion.

Dr. Scott Gottlieb and Peter Huber’s entire argument is ambiguous because they never state how long the FDA should be testing. They argue that the FDA should be releasing medication earlier and doing less testing, but they never say how much testing should be done. They stated that the FDA should perform some safety testing but not a lot of testing. They never say what tests the FDA should perform and how long it should take. They only say that the FDA should take less time and do less testing. To be able to accept their conclusion, the listener needs to know how much testing they want the FDA to perform. If Dr. Gottlieb and Huber only want one small test that takes two weeks or five tests that take one year, that information will affect the listeners willingness to accept their conclusion.

Dr. Jerry Avorn and Dr. David Challoner’s argument is also ambiguous because they never say how long and how much the FDA should be testing. They both say the FDA should be more cautious about they release to the public. Dr. Avorn and Dr. Challoner cite several medications and devices that were approved by the FDA but ended up causing more problems instead of helping people. However, they never implicitly state how much testing the FDA should be doing. The doctors seem to think the FDA should be performing more tests, but they don’t say how many and how long the tests should take. Their conclusion will be affected depending on whether they want ten more tests that will take ten years to complete or two more tests that will take a year to complete. The audience needs to know what they mean to accept the doctor’s conclusion.

Both teams of debaters have a significant value assumption in their arguments.
Each team has an opposite value assumption fueling their argument. Dr. Scott Gottlieb and Peter Huber are arguing that the FDA needs to release medicine earlier by performing less safety testing. They argue that releasing medicine earlier could save the lives of individuals who need the medicine sooner rather than later. Gottlieb and Huber seem to believe that individual safety is more important than public safety. They argued that a certain medication may not work for everyone, but it should be released to the public if it helps anyone at all. On the other side of the debate, Dr. Jerry Avorn and Dr. David Challoner argue that all medicine should be tested thoroughly before being released to the public. They argue that the safety of all people should come before the health of a few people. They value public safety before individual safety. Dr. Avorn and Dr. Challoner believe that all medication should be tested rigorously to ensure the safety of everyone who may use it. Even if the medication works for some people, if it doesn’t work for most people it is unsafe for the public. Both teams of debaters include doctors and professors. Both teams are composed of intelligent and reasonable individuals, but both teams disagree about their value assumptions. To make their conclusion seem reasonable, both teams need to explain why they believe their value priorities are true. However, neither team
explained their value preferences in the debate.

Dr.
Jerry Avorn gave some statistics about the FDA’s approval of medication in his opening statement. He discusses how “Forbes” magazine said the FDA approves seventy-seven percent of medication the first time it is submitted. Dr. Avorn also says that article in the "New England Journal of Medicine” said that the FDA often approves medication faster than Europe and Canada. While Dr. Avorn gives the audience the source of his information, he does not give them any more information about the research. The audience doesn’t know the actual numbers. Dr. Avorn gives percentages, but percentages can be deceiving. The percentage could be high, but the actual numbers could be small. The audience also doesn’t know if the people reporting the information have any biases. For example, if the researchers’ salaries are paid by the FDA, the researchers might exaggerate the statistics to make their employer look good. The audience is left unaware of any biases and the actual numbers involved in the research. This information could affect whether the audience wants to believe the
statistics.

Dr. David Challoner only gives examples that support his case, and he gives many examples. He talks about how the Shiley heart valve killed people implanted with it. He mentions IUD birth control that could puncture a women's uterus and cause infection. He talks about vaginal and surgical mesh and hip implants that malfunctioned and caused damage to patients’ bodies. He keeps giving the audience examples of the FDA’s mistakes caused by early release of medical devices, but he does not discuss any mistakes the FDA made by not releasing medicine in a timely manner. Dr. Scott Gottlieb discusses how the FDA did tests on a medication designed for Hunter’s syndrome, a disease caused by a lack of an enzyme. The FDA did extensive testing while many children deteriorated waiting for the drug. Dr. Challoner is ignoring the counter-evidence. He only states information that supports his conclusion and does not discuss evidence that does not support his conclusion.