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Many consumer groups feel that the U.S. Food and Drug Administration (FDA) drug approval process is...

Many consumer groups feel that the U.S. Food and Drug Administration (FDA) drug approval process is too easy and, as a result, too many drugs are approved that are later found to be pushed for a more lenient approval process so that pharmaceutical companies can get new drugs approved more easily and quickly. Consider a null hypothesis that a new, unapproved drug is unsafe and an alternative hypothesis that a new, unapproved drug is safe.

  1. Differentiate Type 1 and Type 2 errors.
  2. Given the case scenario, explain the risks of committing a Type 1 or Type 2 error.
  3. Which type of error are consumer groups trying to avoid?
  4. Which type of error are industry lobbyists trying to avoid?

Solutions

Expert Solution

The hypotheses are

a) Type 1 error is made when we wrongly reject a null hypothesis which is true. In this case we would be making a type 1 error if a new drug is declared safe, when if fact the new, unapproved drug is not safe.

Type 2 error is made when we wrongly accept a null hypothesis which is false. In this case we would be making a type 2 error if a new drug is declared unsafe, when if fact the new, unapproved drug is safe.

b) When FDA commits a type 1, it risks approving a new drug that is not safe and there by having a potential adverse effect on the patient treated using this new drug.

When FDA commits a type 2, it risks not approving a new drug that is safe and there by denying a patient the treatment that could potentially be beneficial and also denying the industry a potential source of revenue.

c) The consumer groups are trying to avoid type 1 error as it has adverse impact on the patient who is treated using such a drug.

d) Industry lobbyists are trying to avoid type 2 error as it can deny the industry a potential source of revenue.

milcah answered 4 weeks ago
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